Michael Cohen-Wolkowiez | Scholars@Duke

Michael Cohen-Wolkowiez
Kiser-Arena Distinguished Professor

Pediatric and adult clinical pharmacology and clinical trials.

Current Research Interests

Clinical pharmacology, clinical trials, new methods, regulatory science.

Current Appointments & Affiliations

Kiser-Arena Distinguished Professor, Pediatrics, Infectious Diseases, Pediatrics 2020
Professor of Pediatrics, Pediatrics, Infectious Diseases, Pediatrics 2017
Member in the Duke Clinical Research Institute, Duke Clinical Research Institute, Institutes and Centers 2010

Contact Information

300 West Morgan Street, Box 3850, Durham, NC 27701
300 West Morgan Street, Box 3850, Durham, NC 27701
michael.cohenwolkowiez@duke.edu (919) 668-8812
DCRI Pediatrics
Pharmacometrics - DCRI

Background
Education, Training, & Certifications
- Ph.D., University of North Carolina, Chapel Hill, School of Medicine 2012
- Pediatric Infectious Diseases Fellowship, Pediatrics, Duke University 2006 - 2009
- Pediatric Chief Resident, Pediatrics, Nicklaus Children's Hospital 2005 - 2006
- Pediatric Residency, Pediatrics, Nicklaus Children's Hospital 2002 - 2005
- M.D., Universidad Central de Venezuela (Venezuela) 2001
Previous Appointments & Affiliations
- Associate Professor of Pediatrics, Pediatrics, Infectious Diseases, Pediatrics 2015 - 2017
- Associate Professor of Pediatrics, Pediatrics, Infectious Diseases, Pediatrics 2013 - 2015
- Assistant Professor of Pediatrics, Pediatrics, Infectious Diseases, Pediatrics 2009 - 2013
Leadership & Clinical Positions at Duke
- Director, DCRI Innovation Center, 2023 to present
  Therapeutic Area Lead, Pediatrics, Duke Clinical Research Institute, 2020 to 2023
  Co-Director, DCRI Transformation Team, 2019 to present
  Faculty Director, Duke Early Phase Clinical Research Unit, 2015 to 2019
  Director, DCRI Small Trials Program, 2014 to 2020
  Director, DCRI Pharmacometrics, 2011 to 2020
Recognition
In the News
- SEP 16, 2022 School of Medicine Magnify
  
  No More Guessing on the Right Dosage for Children
- FEB 7, 2022 Duke Research Blog
  
  What are Health Care Researchers Doing to Address Health Equity?
- MAY 5, 2021 School of Medicine
  
  Cohen-Wolkowiez, Fecci, and Herman Elected Members of American Society for Clinical Investigation
- OCT 6, 2020 DCRI Pulse
  
  DCRI, UNC, and Partners Receive $80 Million Award from NIH to Help Expand COVID-19 Testing
- APR 14, 2020
  
  Duke Awards 29 University Distinguished Professorships
- OCT 8, 2019 DCRI Pulse Website
  
  DCRI Contributes to FDA Guidance to Improve Medication Safety in Newborns
- JAN 14, 2015 Duke Today
  
  DCRI Awarded Federal Contract to Test New Anti-Infection Drugs
Awards & Honors
- Membership Induction. American Society for Clinical Investigation. April 2021
- Kiser-Arena Distinguished Professor. Duke University. April 2020
- 2019 Michael M. Frank Research Award. Duke Department of Pediatrics. June 2019
- 2016 Young Investigator Award. Pediatric Infectious Diseases Society (PIDS). April 2016
Expertise
Subject Headings
Research
Selected Grants
- Stimulating Access to Research in Residency (StARR) - NHLBI awarded by National Institutes of Health 2018 - 2028
- UNC-Duke Collaborative Clinical Pharmacology Postdoctoral Training Program awarded by University of North Carolina - Chapel Hill 2016 - 2026
- Duke-UNC Collaborative Pediatric Clinical Pharmacology Postdoctoral Training Program awarded by National Institutes of Health 2021 - 2026
- Duke Center for Advancement of Child Health (CAtCH). awarded by National Institutes of Health 2021 - 2026
- RADx-UP CDCC awarded by National Institutes of Health 2020 - 2025
- Optimal Dosing for Biologic Agents in Obese Patients with Rheumatoid and Juvenile Arthritis awarded by National Institutes of Health 2020 - 2025
- Duke Women's Reproductive Health Research Scholars awarded by National Institutes of Health 2020 - 2025
- Real World Data to Support Pediatric Drug Labeling awarded by Burroughs Wellcome Fund 2019 - 2024
- Mentoring in Clinical Pharmacology and Early Phase Trials awarded by National Institutes of Health 2019 - 2024
- Unified Program for Therapeutics in Children awarded by National Institutes of Health 2019 - 2024
- Duke CTSA (TL1) Year 5 awarded by National Institutes of Health 2018 - 2024
- Duke Summer Training in Academic Research (Duke's STAR) awarded by National Institutes of Health 2018 - 2024
- ACTIV-1 awarded by Technical Resources International 2020 - 2023
- Global Pediatric Clinical Trials Network awarded by Food and Drug Administration 2017 - 2023
- 18-0006 Mod 6 (EA) awarded by National Institute of Allergy and Infectious Diseases 2019 - 2023
- Physiologically-Based Pharmacokinetic Modeling to Guide Drug Dosing in Children with Obesity awarded by University of North Carolina - Chapel Hill 2018 - 2023
- Duke Resident Physician-Scientist Program - NIAID awarded by National Institutes of Health 2018 - 2023
- Duration of post-discontinuation antibiotic exposures in premature infants and associated outcomes awarded by Thrasher Research Fund 2021 - 2023
- Immunologic and Virologic Determinants of Congenital Cytomegalovirus Transmission and Disease in Rhesus Monkeys awarded by Weill Cornell Medicine 2020 - 2023
- Application of Physiologically-Based Pharmacokinetic Modeling to Characterize Drug-Drug Interactions in Infants awarded by University of North Carolina - Chapel Hill 2021 - 2023
- TASK ORDER FY.2022.A1.01348 - Task Area A awarded by National Institute of Allergy and Infectious Diseases 2021 - 2022
- VTEU HHSN272201300017I/75N93019F00132-FY2020.A1B1C1D1.0123 Task Order #17 16-0076 Task C Option 3 & Task D Option 6 Extension awarded by National Institutes of Health 2021 - 2022
- Project 2: Impact of immune-based intervention on viral rebound in orally SHIV infected infant monkeys awarded by Weill Cornell Medicine 2020 - 2022
- RTOP 18-0006 Option 1 / Protocol Implementation awarded by National Institute of Allergy and Infectious Diseases 2019 - 2022
- RTOP 18-0006 Option 1 Mod 5 awarded by National Institute of Allergy and Infectious Diseases 2019 - 2022
- TASK ORDER FY.2021.A1.0128 - Task Area A awarded by National Institute of Allergy and Infectious Diseases 2020 - 2021
- Investigating polypharmacy-related adverse events in critically ill children using electronic health records and simulated drug levels awarded by National Institutes of Health 2017 - 2021
- VTEU Task D Option 6 - FY.2017.B2C2D2.0053 awarded by National Institutes of Health 2017 - 2021
- VTEU Task B - FY.2017.B2C2D2.0053 awarded by National Institutes of Health 2016 - 2021
- VTEU Task D Option 5 - FY.2017.B2C2D2.0053 awarded by National Institutes of Health 2016 - 2021
- Project 2: The origin, predictors, and immune correlates of viral rebound in orally SHIV infected infant monkeys awarded by Weill Cornell Medicine 2020 - 2021
- UNC-Duke Collaborative Clinical Pharmacology Postdoctoral Training Program awarded by University of North Carolina - Chapel Hill 2020 - 2021
- PTN 2.0 TO 1 Core Function Activities_Option 2 awarded by Eunice Kennedy Shriver National Institute of Child Health and Human Development 2020 - 2021
- RTOP 18-0006 Option 1 / Protocol Implementation awarded by National Institute of Allergy and Infectious Diseases 2019 - 2021
- TASK AREA A, TASK ORDER FY.2020.A1.0127 - Task Area A awarded by National Institute of Allergy and Infectious Diseases 2019 - 2020
- Zika virus pathophysiology during pregnancy awarded by University of Wisconsin - Madison 2018 - 2020
- Pharmacokinetics, Pharmacodynamics, and Safety of Methylprednisolone in Neonates on Cardiopulmonary Bypass awarded by National Institutes of Health 2017 - 2020
- Relationship between cerebrospinal fluid penetration of antimicrobials in infants and juvenile animals awarded by Food and Drug Administration 2016 - 2020
- PTN2- TO#4 Data Closeout and Dissemination Option Period I awarded by National Institute for Child Health & Human Develo 2019 - 2020
- P1CTU_Task Order 16_Protocol Implementation (Mod 3) awarded by National Institutes of Health 2018 - 2020
- Admin Supplement: Parmacokinetic and pharmacogenomic approach to indomethacin therapy in pregnancy awarded by University of Texas Medical Branch 2018 - 2020
- P1CTU_Task Order 16_Protocol Implementation awarded by National Institute of Allergy and Infectious Diseases 2017 - 2020
- HCQ Pharmacokinetics in Pediatric Lupus awarded by Childhood Arthritis & Rheumatology Research Alliance, Inc. 2019 - 2020
- Physiologically-Based Pharmacokinetic Models for Optimal Drug Dosing in Children awarded by National Institutes of Health 2014 - 2020
- Pediatric Trials Network_ Task Order 1_ Core Function Activities Option Period 1 awarded by National Institute for Child Health & Human Develo 2019 - 2020
- VTEU Task Area D Option 9 Protocol FY.2016.D1.0026 awarded by National Institutes of Health 2017 - 2020
- RTOP 18-0006 Base / Protocol Development awarded by National Institute of Allergy and Infectious Diseases 2019 - 2020
- PTN TO #30 POPS Lab Mod. 2 awarded by National Institute for Child Health & Human Develo 2017 - 2020
- POPS Lab awarded by National Institutes of Health 2014 - 2020
- PHASE 1 CLINICAL TRIAL UNITS FOR THERAPEUTICS AGAINST INFECTIOUS DISEASES ADMINISTRATIVE AND OVERALL CLINICAL OPERATIONS SUPPORT AND CONCEPT DEVELOPMENT TASK AREA A TASK ORDER. awarded by National Institute of Allergy and Infectious Diseases 2018 - 2019
- PTN2- TO# Data Closeout and Dissemination awarded by National Institute for Child Health & Human Develo 2018 - 2019
- PTN Task Order 25 SCAMP Modification awarded by National Institutes of Health 2014 - 2019
- PTN TO #25 SCAMP awarded by National Institutes of Health 2013 - 2019
- P1CTU Protocol Development for 17-0033 (Base) awarded by National Institutes of Health 2017 - 2019
- UNC-Duke Collaborative Clinical Pharmacology Postdoctoral Training Program awarded by University of North Carolina - Chapel Hill 2017 - 2019
- VTEU Task Area D Option 8B Protocol FY.2016.D1.0026 awarded by National Institutes of Health 2016 - 2019
- Pediatric Trials Network_ Task Order 1_ Core Function Activities awarded by National Institute for Child Health & Human Develo 2018 - 2019
- Echocardiogram to Diagnose Pulmonary Hypertension in Premature Infants awarded by University of North Carolina - Chapel Hill 2015 - 2019
- PTN Task Order: CAFFEINE awarded by National Institutes of Health 2014 - 2019
- TASK AREA A, TASK ORDER FY.2018.A1.0095 Task Area A awarded by National Institutes of Health 2017 - 2018
- VTEU Task Area D Option 8 Protocol FY.2016.D1.0026 awarded by National Institutes of Health 2016 - 2018
- SOLI - Solithromycin Pediatric Development Program (Phase 2/3)- Labor & Sub Cost awarded by Cempra Pharmaceuticals, Inc. 2016 - 2018
- Hyperimmune globulin treatment of Zika virus during pregnancy to reduce Congenital Zika Syndrome awarded by University of Wisconsin - Madison 2017 - 2018
- Duke CTSA (UL1) awarded by National Institutes of Health 2013 - 2018
- Pass-Through cost- CLIN04 awarded by Cempra Pharmaceuticals, Inc. 2016 - 2018
- Role of pharmacokinetics and genomics in tocolytic therapy with indomethacin (subcontract) awarded by University of Texas Medical Branch 2015 - 2018
- PTN POPS III awarded by National Institutes of Health 2014 - 2018
- P1CTU_Task Order 16_Protocol Development awarded by National Institute of Allergy and Infectious Diseases 2017
- Phase I CTU Task Area A: Administrative and Overal Clinical Operations Support and Concept Development, Year 3 awarded by National Institutes of Health 2016 - 2017
- PTN Task Order #17: Bioanalytical Analysis: POPS1, Fluconazole, and Meropenem awarded by National Institutes of Health 2012 - 2017
- SOLI - Solithromycin Pediatric Development Program (Phase 2/3 start up)- MOD 2 awarded by Cempra Pharmaceuticals, Inc. 2016 - 2017
- TASK AREA A TASK ORDER FY.2016.A1.0041 awarded by National Institute of Allergy and Infectious Diseases 2015 - 2016
- SOLI - Solithromycin Pediatric Development Program (Phase IB)- MOD 2 awarded by Cempra Pharmaceuticals, Inc. 2014 - 2016
- Clinical Practice Data to Aid Narrow Therapeutic Index Drug Classification awarded by Food and Drug Administration 2013 - 2016
- PTN Task Order #19: Lorazepam awarded by National Institutes of Health 2012 - 2016
- PTN Task Order 29: Clindamycin Bactrim awarded by National Institutes of Health 2014 - 2016
- CISA TO2 Prophylactic Antipyretics Revision 1-A awarded by Centers for Disease Control and Prevention 2014 - 2016
- CISA TO2 Prophylactic Antipyretics Revision 3-A awarded by Centers for Disease Control and Prevention 2014 - 2016
- CISA TO2 Prophylactic Antipyretics awarded by Centers for Disease Control and Prevention 2013 - 2016
- PTN Task Order #20: POPS II awarded by National Institutes of Health 2012 - 2016
- DAP Phase I PK/PD Analysis Budget awarded by Jacobus Pharmaceutical Company, Inc. 2016
- The Pharmacokinetics of Extended Duration High-dose Cefixime Co-administered with Azithromycin for the Decreased Susceptibility of Neisseria gonorrhoeae: A Phase I Pilot Study awarded by National Institutes of Health 2015 - 2016
- The Pharmacokinetics of Extended Duration High-dose Cefixime Co-administered with Azithromycin for the Decreased Susceptibility of Neisseria gonorrhoeae: A Phase I Pilot Study, Option 1 awarded by National Institutes of Health 2015 - 2016
- Phase I CTU Task Area A: Administrative and Overal Clinical Operations Support and Concept Development awarded by National Institutes of Health 2014 - 2015
- Pharmacokinetics and Pharmacodynamics of Antibiotics in Premature Infants awarded by National Institutes of Health 2010 - 2015
- VTEU 13-0053 Task Area B: Phase I, single dose, open-label, parallel group study comparing the pharmacokinetics and safety of PA-824 in subjects with mild, moderate, and severe hepatic impairment to matched, normal, healthy subjects. awarded by National Institutes of Health 2014 - 2015
- PTN Task Order #3 - Safety and Pharmacokinetics of Multiple Dose Metronidazole in Premature Infants awarded by National Institutes of Health 2010 - 2013
- CTSA UL awarded by National Institutes of Health 2006 - 2012
- Best Pharmaceutical for Children Act (BPCA): Use of Meropenem in Infants awarded by National Institutes of Health 2007 - 2010
External Relationships
- Leo Pharmaceuticals
- Lightship
- Merck
- scPharma
Publications & Artistic Works
Selected Publications
- Academic Articles
  - Commander, Sarah Jane, Daniel Gonzalez, Karan R. Kumar, Tracy Spears, Michael Cohen-Wolkowiez, Kanecia O. Zimmerman, Jan Hau Lee, and Christoph P. Hornik. “Association between simulated ketamine exposures and oxygen saturations in children.” International Journal of Pharmacokinetics 6, no. 1 (February 2023): IPK03. https://doi.org/10.4155/ipk-2022-0003.
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  - Carter-Edwards, Lori, Renee Leverty, Alicia Bilheimer, Lindsay Bailey, Bukola Adeshina, Prabisha Shrestha, Zhitong Yu, et al. “Adapting the Evidence Academy model for virtual stakeholder engagement in a national setting during the COVID-19 pandemic.” J Clin Transl Sci 7, no. 1 (2023): e98. https://doi.org/10.1017/cts.2023.37.
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  - Hemmersbach-Miller, Marion, Stephen J. Balevic, Patricia L. Winokur, Cornelia B. Landersdorfer, Kenan Gu, Austin W. Chan, Michael Cohen-Wolkowiez, et al. “Population Pharmacokinetics of Piperacillin/Tazobactam Across the Adult Lifespan.” Clin Pharmacokinet 62, no. 1 (January 2023): 127–39. https://doi.org/10.1007/s40262-022-01198-z.
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  - Singler, Lindsay, Gina Uhlenbrauck, Giselle Corbie-Smith, Al Richmond, Amy Hattem, Kristen Linney, and Michael Cohen-Wolkowiez. “Say Yes! COVID Test: A Health Communication Campaign to Encourage Use of Rapid, At-Home Antigen Testing in Underserved and Historically Marginalized Communities.” Inquiry 60 (2023): 469580221146046. https://doi.org/10.1177/00469580221146046.
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  - Zimmerman, Kanecia O., Tracy G. Spears, Marjan Cobbaert, Felix Boakye-Agyeman, Huali Wu, Michael Cohen-Wolkowiez, Kevin M. Watt, et al. “Use of Electronic Health Records to Identify Exposure-Response Relationships in Critically Ill Children: An Example of Midazolam and Delirium.” J Pediatr Intensive Care 11, no. 4 (December 2022): 300–307. https://doi.org/10.1055/s-0041-1725148.
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  - Balevic, Stephen J., Rachel Randell, Daniel Weiner, Claire Beard, Laura Eve Schanberg, Christoph P. Hornik, Michael Cohen-Wolkowiez, Daniel Gonzalez, and Daniel with the CARRA Registry investigators. “Pharmacokinetics of hydroxychloroquine in paediatric lupus: data from a novel, direct-to-family clinical trial.” Lupus Sci Med 9, no. 1 (November 2022). https://doi.org/10.1136/lupus-2022-000811.
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  - Corbie, Giselle, Emily M. D’Agostino, Susan Knox, Al Richmond, Christopher W. Woods, Gaurav Dave, Krista M. Perreira, et al. “RADx-UP Coordination and Data Collection: An Infrastructure for COVID-19 Testing Disparities Research.” Am J Public Health 112, no. S9 (November 2022): S858–63. https://doi.org/10.2105/AJPH.2022.306953.
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  - D’Agostino, Emily M., Giselle Corbie, Warren A. Kibbe, Christoph P. Hornik, Al Richmond, Angella Dunston, Allyn Damman, Lisa Wruck, Manuel Alvarado, and Michael Cohen-Wolkowiez. “Increasing access and uptake of SARS-CoV-2 at-home tests using a community-engaged approach.” Prev Med Rep 29 (October 2022): 101967. https://doi.org/10.1016/j.pmedr.2022.101967.
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  - Moorthy, Ganga S., Rachel G. Greenberg, Chi D. Hornik, Cara Cassino, Parviz Ghahramani, Karan R. Kumar, Vance G. Fowler, and Michael Cohen-Wolkowiez. “Safety and Pharmacokinetics of Exebacase in an Infant With Disseminated Staphylococcus aureus Infection.” Clin Infect Dis 75, no. 2 (August 25, 2022): 338–41. https://doi.org/10.1093/cid/ciab1015.
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  - Carrillo, Gabriel A., Michael Cohen-Wolkowiez, Emily M. D’Agostino, Keith Marsolo, Lisa M. Wruck, Laura Johnson, James Topping, Al Richmond, Giselle Corbie, and Warren A. Kibbe. “Standardizing, harmonizing, and protecting data collection to broaden the impact of COVID-19 research: the rapid acceleration of diagnostics-underserved populations (RADx-UP) initiative.” J Am Med Inform Assoc 29, no. 9 (August 16, 2022): 1480–88. https://doi.org/10.1093/jamia/ocac097.
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  - Herbert, Carly, Qiming Shi, Vik Kheterpal, Chris Nowak, Thejas Suvarna, Basyl Durnan, Summer Schrader, et al. “Use of a Digital Assistant to Report COVID-19 Rapid Antigen Self-test Results to Health Departments in 6 US Communities.” Jama Netw Open 5, no. 8 (August 1, 2022): e2228885. https://doi.org/10.1001/jamanetworkopen.2022.28885.
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  - Lang, Jason E., Christoph P. Hornik, Carrie Elliott, Adam Silverstein, Chi Hornik, Amira Al-Uzri, Miroslava Bosheva, et al. “Solithromycin in Children and Adolescents With Community-acquired Bacterial Pneumonia.” Pediatr Infect Dis J 41, no. 7 (July 1, 2022): 556–62. https://doi.org/10.1097/INF.0000000000003559.
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  - Le, Jennifer, Rachel G. Greenberg, YoungJun Yoo, Reese H. Clark, Daniel K. Benjamin, Kanecia O. Zimmerman, Michael Cohen-Wolkowiez, Kelly C. Wade, and Kelly C. Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee. “Ampicillin dosing in premature infants for early-onset sepsis: exposure-driven efficacy, safety, and stewardship.” J Perinatol 42, no. 7 (July 2022): 959–64. https://doi.org/10.1038/s41372-022-01344-2.
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  - Commander, Sarah Jane, Daniel Gonzalez, Karan R. Kumar, Tracy Spears, Michael Cohen-Wolkowiez, Kanecia O. Zimmerman, Stephen J. Balevic, and Christoph P. Hornik. “The relationship between simulated milrinone exposure and hypotension in children.” Cardiol Young 32, no. 5 (May 2022): 782–88. https://doi.org/10.1017/S1047951121003103.
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  - Raja, S. M., J. T. Guptill, V. C. Juel, E. B. Walter, M. Cohen-Wolkowiez, H. Hill, E. Sendra, et al. “First-in-Human Clinical Trial to Assess the Safety, Tolerability and Pharmacokinetics of Single Doses of NTM-1633, a Novel Mixture of Monoclonal Antibodies against Botulinum Toxin E.” Antimicrob Agents Chemother 66, no. 4 (April 19, 2022): e0173221. https://doi.org/10.1128/aac.01732-21.
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  - Soni, Apurv, Carly Herbert, Jonggyu Baek, Qiming Shi, Juan Marquez, Emma Harman, Vik Kheterpal, et al. “Association of Mass Distribution of Rapid Antigen Tests and SARS-CoV-2 Prevalence: Results from NIH-CDC funded Say Yes! Covid Test program in Michigan.” Medrxiv, April 2, 2022. https://doi.org/10.1101/2022.03.26.22272727.
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  - Balevic, Stephen J., Shruti M. Raja, Rachel Randell, Gregory A. Deye, Thomas Conrad, Aya Nakamura, David H. Peyton, et al. “Adverse Reactions in a Phase 1 Trial of the Anti-Malarial DM1157: An Example of Pharmacokinetic Modeling and Simulation Guiding Clinical Trial Decisions.” Infect Dis Ther 11, no. 2 (April 2022): 841–52. https://doi.org/10.1007/s40121-022-00605-z.
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  - Herbert, Carly, Qiming Shi, Vik Kheterpal, Chris Nowak, Thejas Suvarna, Basyl Durnam, Summer Schrader, et al. “If you build it, will they use it? Use of a Digital Assistant for Self-Reporting of COVID-19 Rapid Antigen Test Results during Large Nationwide Community Testing Initiative.” Medrxiv, April 1, 2022. https://doi.org/10.1101/2022.03.31.22273242.
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  - Gerhart, Jacqueline G., Fernando O. Carreño, Andrea N. Edginton, Jaydeep Sinha, Eliana M. Perrin, Karan R. Kumar, Aruna Rikhi, et al. “Development and Evaluation of a Virtual Population of Children with Obesity for Physiologically Based Pharmacokinetic Modeling.” Clin Pharmacokinet 61, no. 2 (February 2022): 307–20. https://doi.org/10.1007/s40262-021-01072-4.
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  - Ciccone, Emily J., Donaldson F. Conserve, Gaurav Dave, Christoph P. Hornik, Marlena L. Kuhn, Jessica L. Herling, Michelle Song, et al. “Correction to: At-home testing to mitigate community transmission of SARS-CoV-2: protocol for a public health intervention with a nested prospective cohort study.” Bmc Public Health 22, no. 1 (January 21, 2022): 151. https://doi.org/10.1186/s12889-021-12442-9.
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  - Balevic, Stephen J., Daniel Weiner, Megan E. B. Clowse, Amanda M. Eudy, Anil R. Maharaj, Christoph P. Hornik, Michael Cohen-Wolkowiez, and Daniel Gonzalez. “Hydroxychloroquine PK and exposure-response in pregnancies with lupus: the importance of adherence for neonatal outcomes.” Lupus Sci Med 9, no. 1 (January 2022). https://doi.org/10.1136/lupus-2021-000602.
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  - Jackson, Wesley, Daniel Gonzalez, P Brian Smith, Namasivayam Ambalavanan, Andrew M. Atz, Gregory M. Sokol, Chi D. Hornik, et al. “Safety of sildenafil in extremely premature infants: a phase I trial.” J Perinatol 42, no. 1 (January 2022): 31–36. https://doi.org/10.1038/s41372-021-01261-w.
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  - Ciccone, Emily J., Donaldson F. Conserve, Gaurav Dave, Christoph P. Hornik, Marlena L. Kuhn, Jessica L. Herling, Michelle Song, et al. “At-home testing to mitigate community transmission of SARS-CoV-2: protocol for a public health intervention with a nested prospective cohort study.” Bmc Public Health 21, no. 1 (December 4, 2021): 2209. https://doi.org/10.1186/s12889-021-12007-w.
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  - Salerno, Sara N., Fernando O. Carreño, Andrea N. Edginton, Michael Cohen-Wolkowiez, and Daniel Gonzalez. “Leveraging Physiologically Based Pharmacokinetic Modeling and Experimental Data to Guide Dosing Modification of CYP3A-Mediated Drug-Drug Interactions in the Pediatric Population.” Drug Metab Dispos 49, no. 9 (September 2021): 844–55. https://doi.org/10.1124/dmd.120.000318.
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  - Guptill, J. T., S. M. Raja, V. C. Juel, E. B. Walter, M. Cohen-Wolkowiez, H. Hill, E. Sendra, B. Hauser, P. Jackson, and G. K. Swamy. “Safety, Tolerability, and Pharmacokinetics of NTM-1632, a Novel Mixture of Three Monoclonal Antibodies against Botulinum Toxin B.” Antimicrob Agents Chemother 65, no. 7 (June 17, 2021): e0232920. https://doi.org/10.1128/AAC.02329-20.
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  - Wu, Yi Shuan S., Michael Cohen-Wolkowiez, Christoph P. Hornik, Jacqueline G. Gerhart, Julie Autmizguine, Marjan Cobbaert, Daniel Gonzalez, and Daniel Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee. “External Evaluation of Two Pediatric Population Pharmacokinetics Models of Oral Trimethoprim and Sulfamethoxazole.” Antimicrob Agents Chemother 65, no. 7 (June 17, 2021): e0214920. https://doi.org/10.1128/AAC.02149-20.
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  - Smith, Michael J., Angelique Boutzoukas, Julie Autmizguine, Mark L. Hudak, Erin Zinkhan, Barry T. Bloom, Gloria Heresi, et al. “Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections.” Pediatr Infect Dis J 40, no. 6 (June 1, 2021): 550–55. https://doi.org/10.1097/INF.0000000000003034.
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  - Tan, Wei Wei, Kevin M. Watt, Felix Boakye-Agyeman, Michael Cohen-Wolkowiez, Yee Hui Mok, Chee Fu Yung, and Yoke Hwee Chan. “Optimal Dosing of Meropenem in a Small Cohort of Critically Ill Children Receiving Continuous Renal Replacement Therapy.” J Clin Pharmacol 61, no. 6 (June 2021): 744–54. https://doi.org/10.1002/jcph.1798.
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  - Le, Jennifer, Rachel G. Greenberg, Daniel K. Benjamin, YoungJun Yoo, Kanecia O. Zimmerman, Michael Cohen-Wolkowiez, Kelly C. Wade, and Kelly C. Administrative Core Committee of the Best Pharmaceuticals for Children Act–Pediatric Trials Network. “Prolonged Post-Discontinuation Antibiotic Exposure in Very Low Birth Weight Neonates at Risk for Early-Onset Sepsis.” J Pediatric Infect Dis Soc 10, no. 5 (May 28, 2021): 615–21. https://doi.org/10.1093/jpids/piaa172.
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  - Randell, Rachel L., Lindsay Singler, Anthony Cunningham, Laura E. Schanberg, Michael Cohen-Wolkowiez, Christoph P. Hornik, Stephen J. Balevic, and Stephen J. with the CARRA Registry investigators. “Delivering clinical trials at home: protocol, design and implementation of a direct-to-family paediatric lupus trial.” Lupus Sci Med 8, no. 1 (May 2021). https://doi.org/10.1136/lupus-2021-000494.
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  - Thompson, Elizabeth J., Henry P. Foote, Caitlin E. King, Sabarish Srinivasan, Elizabeth C. Ciociola, Dennis Leung, Alexandre T. Rotta, Kevin D. Hill, Michael Cohen-Wolkowiez, and Christoph P. Hornik. “A systematic review of the evidence supporting post-operative medication use in congenital heart disease.” Cardiol Young 31, no. 5 (May 2021): 707–33. https://doi.org/10.1017/S1047951121001463.
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  - Maharaj, Anil R., Christoph P. Hornik, and Michael Cohen-Wolkowiez. “Rapid Implementation of Model-Based Dosing Recommendations During the Coronavirus Disease 2019 Pandemic-Reply.” Jama Pediatr 175, no. 4 (April 1, 2021): 433. https://doi.org/10.1001/jamapediatrics.2020.5398.
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  - Commander, Sarah Jane, Huali Wu, Felix Boakye-Agyeman, Chiara Melloni, Chi Dang Hornik, Kanecia Zimmerman, Amira Al-Uzri, et al. “Pharmacokinetics of Hydrochlorothiazide in Children: A Potential Surrogate for Renal Secretion Maturation.” J Clin Pharmacol 61, no. 3 (March 2021): 368–77. https://doi.org/10.1002/jcph.1739.
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  - Green, Thomas P., Helen J. Binns, Huali Wu, Adolfo J. Ariza, Eliana M. Perrin, Maheen Quadri, Christoph P. Hornik, and Michael Cohen-Wolkowiez. “Estimation of Body Fat Percentage for Clinical Pharmacokinetic Studies in Children.” Clin Transl Sci 14, no. 2 (March 2021): 509–17. https://doi.org/10.1111/cts.12896.
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  - Maharaj, Anil R., Huali Wu, Kanecia O. Zimmerman, Julie Autmizguine, Rohit Kalra, Amira Al-Uzri, Catherine M. T. Sherwin, et al. “Population pharmacokinetics of olanzapine in children.” Br J Clin Pharmacol 87, no. 2 (February 2021): 542–54. https://doi.org/10.1111/bcp.14414.
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  - Commander, S. J., D. Gonzalez, K. R. Kumar, T. Spears, M. Cohen-Wolkowiez, K. O. Zimmerman, S. J. Balevic, and C. P. Hornik. “The relationship between simulated milrinone exposure and hypotension in children.” Cardiology in the Young, January 1, 2021. https://doi.org/10.1017/S1047951121003103.
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  - Ge, Shufan, Susan R. Mendley, Jacqueline G. Gerhart, Chiara Melloni, Christoph P. Hornik, Janice E. Sullivan, Andrew Atz, et al. “Population Pharmacokinetics of Metoclopramide in Infants, Children, and Adolescents.” Clin Transl Sci 13, no. 6 (November 2020): 1189–98. https://doi.org/10.1111/cts.12803.
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  - Balevic, Stephen J., Christoph P. Hornik, Thomas P. Green, Megan E. B. Clowse, Daniel Gonzalez, Anil R. Maharaj, Laura E. Schanberg, et al. “Dr. Balevic, et al reply.” J Rheumatol 47, no. 10 (October 1, 2020): 1587. https://doi.org/10.3899/jrheum.200681.
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  - Maharaj, Anil R., Huali Wu, Christoph P. Hornik, Stephen J. Balevic, Chi D. Hornik, P Brian Smith, Daniel Gonzalez, et al. “Simulated Assessment of Pharmacokinetically Guided Dosing for Investigational Treatments of Pediatric Patients With Coronavirus Disease 2019.” Jama Pediatr 174, no. 10 (October 1, 2020): e202422. https://doi.org/10.1001/jamapediatrics.2020.2422.
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  - Commander, Sarah Jane, Jamie Gao, Erin K. Zinkhan, Gloria Heresi, Sherry E. Courtney, Adrian P. Lavery, Paula Delmore, et al. “Safety of Metronidazole in Late Pre-term and Term Infants with Complicated Intra-abdominal Infections.” Pediatr Infect Dis J 39, no. 9 (September 2020): e245–48. https://doi.org/10.1097/INF.0000000000002698.
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  - Ericson, Jessica E., Christoph P. Hornik, Rachel G. Greenberg, Reese H. Clark, Adriana H. Tremoulet, Jennifer Le, Michael Cohen-Wolkowiez, P Brian Smith, Daniel K. Benjamin, and Daniel K. Best Pharmaceuticals for Children Act – Pediatric Trials Network. “Paradoxical Antibiotic Effect of Ampicillin: Use of a Population Pharmacokinetic Model to Evaluate a Clinical Correlate of the Eagle Effect in Infants With Bacteremia.” Pediatr Infect Dis J 39, no. 8 (August 2020): 725–29. https://doi.org/10.1097/INF.0000000000002663.
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  - Stark, Ashley, Julie Childers, Morgan England, Reese H. Clark, Matthew Laughon, Michael Cohen-Wolkowiez, Daniel K. Benjamin, P Brian Smith, Kelly Wade, and Rachel G. Greenberg. “Dosing of Antimicrobials in the Neonatal Intensive Care Unit: Does Clinical Practice Reflect Pharmacokinetics-based Recommendations?” Pediatr Infect Dis J 39, no. 8 (August 2020): 713–17. https://doi.org/10.1097/INF.0000000000002657.
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  - Xie, Rujia, Lynn McFadyen, Susan Raber, Robert Swanson, Margaret Tawadrous, Heidi Leister-Tebbe, Michael Cohen-Wolkowiez, Daniel K. Benjamin, and Ping Liu. “Population Analysis of Anidulafungin in Infants to Older Adults With Confirmed or Suspected Invasive Candidiasis.” Clin Pharmacol Ther 108, no. 2 (August 2020): 316–25. https://doi.org/10.1002/cpt.1831.
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  - Maharaj, Anil R., Huali Wu, Christoph P. Hornik, Antonio Arrieta, Laura James, Varsha Bhatt-Mehta, John Bradley, et al. “Use of normalized prediction distribution errors for assessing population physiologically-based pharmacokinetic model adequacy.” J Pharmacokinet Pharmacodyn 47, no. 3 (June 2020): 199–218. https://doi.org/10.1007/s10928-020-09684-2.
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  - Balevic, Stephen J., Christoph P. Hornik, Thomas P. Green, Megan E. B. Clowse, Daniel Gonzalez, Anil R. Maharaj, Laura E. Schanberg, et al. “Hydroxychloroquine in Patients with Rheumatic Disease Complicated by COVID-19: Clarifying Target Exposures and the Need for Clinical Trials.” J Rheumatol, May 11, 2020. https://doi.org/10.3899/jrheum.200493.
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  - Drolet, Beth A., Felix Boakye-Agyeman, Barrie Harper, Kristen Holland, Andrew Lewandowski, Nicole Stefanko, Chiara Melloni, and Chiara Pediatric Trials Network Steering Committee (See Acknowledgments for a listing of committee members.). “Systemic timolol exposure following topical application to infantile hemangiomas.” J Am Acad Dermatol 82, no. 3 (March 2020): 733–36. https://doi.org/10.1016/j.jaad.2019.02.029.
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  - Greenberg, Rachel G., Huali Wu, Anil Maharaj, Michael Cohen-Wolkowiez, Kay M. Tomashek, Blaire L. Osborn, Reese H. Clark, and Emmanuel B. Walter. “A Pharmacoepidemiologic Study of the Safety and Effectiveness of Clindamycin in Infants.” Pediatr Infect Dis J 39, no. 3 (March 2020): 204–10. https://doi.org/10.1097/INF.0000000000002524.
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  - Hornik, Christoph P., Amy A. Gelfand, Christina L. Szperka, Tara Pezzuto, Amanda Utevsky, Shirley Kessel, Susan McCune, John J. Alexander, Daniel K. Benjamin, and Michael Cohen-Wolkowiez. “Development of a Prospective Real-World Data Clinical Registry of Children and Adolescents With Migraine.” Headache 60, no. 2 (February 2020): 405–15. https://doi.org/10.1111/head.13714.
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  - Hornik, Christoph P., Daniel Gonzalez, Julie Dumond, Huali Wu, Eric M. Graham, Kevin D. Hill, and Michael Cohen-Wolkowiez. “Population Pharmacokinetic/Pharmacodynamic Modeling of Methylprednisolone in Neonates Undergoing Cardiopulmonary Bypass.” Cpt Pharmacometrics Syst Pharmacol 8, no. 12 (December 2019): 913–22. https://doi.org/10.1002/psp4.12470.
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  - Beechinor, Ryan J., Michael Cohen-Wolkowiez, Theresa Jasion, Christoph P. Hornik, Jason E. Lang, Robert Hernandez, and Daniel Gonzalez. “A Dried Blood Spot Analysis for Solithromycin in Adolescents, Children, and Infants: A Short Communication.” Ther Drug Monit 41, no. 6 (December 2019): 761–65. https://doi.org/10.1097/FTD.0000000000000670.
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  - Gonzalez, Daniel, Matthew M. Laughon, P Brian Smith, Shufan Ge, Namasivayam Ambalavanan, Andrew Atz, Gregory M. Sokol, et al. “Population pharmacokinetics of sildenafil in extremely premature infants.” Br J Clin Pharmacol 85, no. 12 (December 2019): 2824–37. https://doi.org/10.1111/bcp.14111.
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  - Hornik, Christoph P., Ram Yogev, Peter M. Mourani, Kevin M. Watt, Janice E. Sullivan, Andrew M. Atz, David Speicher, et al. “Population Pharmacokinetics of Milrinone in Infants, Children, and Adolescents.” J Clin Pharmacol 59, no. 12 (December 2019): 1606–19. https://doi.org/10.1002/jcph.1499.
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  - Zimmerman, Kanecia O., Huali Wu, Matthew Laughon, Rachel G. Greenberg, Richard Walczak, Scott R. Schulman, P Brian Smith, Christoph P. Hornik, Michael Cohen-Wolkowiez, and Kevin M. Watt. “Dexmedetomidine Pharmacokinetics and a New Dosing Paradigm in Infants Supported With Cardiopulmonary Bypass.” Anesth Analg 129, no. 6 (December 2019): 1519–28. https://doi.org/10.1213/ANE.0000000000003700.
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  - Fisher, J. W., H. Wu, M. Cohen-Wolkowiez, K. Watt, J. Wang, G. J. Burckart, J. A. Troutman, and X. Yang. “Predicting the pharmacokinetics of piperacillin and tazobactam in preterm and term neonates using physiologically based pharmacokinetic modeling.” Computational Toxicology 12 (November 1, 2019). https://doi.org/10.1016/j.comtox.2019.100104.
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  - Thompson, Elizabeth J., Huali Wu, Chiara Melloni, Stephen Balevic, Janice E. Sullivan, Matthew Laughon, Kira M. Clark, et al. “Population Pharmacokinetics of Doxycycline in Children.” Antimicrob Agents Chemother 63, no. 12 (September 23, 2019). https://doi.org/10.1128/AAC.01508-19.
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  - Balevic, Stephen J., P Brian Smith, Daniela Testoni, Huali Wu, Kim L. R. Brouwer, Kanecia O. Zimmerman, Nazario D. Rivera-Chaparro, Daniel K. Benjamin, and Michael Cohen-Wolkowiez. “Cefazolin pharmacokinetics in premature infants.” J Perinatol 39, no. 9 (September 2019): 1213–18. https://doi.org/10.1038/s41372-019-0368-z.
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  - Thompson, Elizabeth J., Huali Wu, Anil Maharaj, Andrea N. Edginton, Stephen J. Balevic, Marjan Cobbaert, Anthony P. Cunningham, Christoph P. Hornik, and Michael Cohen-Wolkowiez. “Physiologically Based Pharmacokinetic Modeling for Trimethoprim and Sulfamethoxazole in Children.” Clin Pharmacokinet 58, no. 7 (July 2019): 887–98. https://doi.org/10.1007/s40262-018-00733-1.
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  - Maharaj, Anil R., Huali Wu, Christoph P. Hornik, and Michael Cohen-Wolkowiez. “Pitfalls of using numerical predictive checks for population physiologically-based pharmacokinetic model evaluation.” J Pharmacokinet Pharmacodyn 46, no. 3 (June 2019): 263–72. https://doi.org/10.1007/s10928-019-09636-5.
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  - Smith, P Brian, C Michael Cotten, Mark L. Hudak, Janice E. Sullivan, Brenda B. Poindexter, Michael Cohen-Wolkowiez, Felix Boakye-Agyeman, et al. “Rifampin Pharmacokinetics and Safety in Preterm and Term Infants.” Antimicrob Agents Chemother 63, no. 6 (June 2019). https://doi.org/10.1128/AAC.00284-19.
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  - Watt, Kevin M., Christoph P. Hornik, Stephen J. Balevic, Gratias Mundakel, C Michael Cotten, Barrie Harper, Daniel K. Benjamin, et al. “Pharmacokinetics of ticarcillin-clavulanate in premature infants.” Br J Clin Pharmacol 85, no. 5 (May 2019): 1021–27. https://doi.org/10.1111/bcp.13882.
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  - Balevic, Stephen J., Thomas P. Green, Megan E. B. Clowse, Amanda M. Eudy, Laura E. Schanberg, and Michael Cohen-Wolkowiez. “Pharmacokinetics of Hydroxychloroquine in Pregnancies with Rheumatic Diseases.” Clin Pharmacokinet 58, no. 4 (April 2019): 525–33. https://doi.org/10.1007/s40262-018-0712-z.
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  - Rivera-Chaparro, Nazario D., Jessica Ericson, Huali Wu, P Brian Smith, Reese H. Clark, Daniel K. Benjamin, Michael Cohen-Wolkowiez, and Rachel G. Greenberg. “Safety, Effectiveness and Exposure-response of Micafungin in Infants: Application of an Established Pharmacokinetics Model to Electronic Health Records.” Pediatr Infect Dis J 38, no. 2 (February 2019): e26–28. https://doi.org/10.1097/INF.0000000000002045.
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  - Balevic, Stephen J., Michael Cohen-Wolkowiez, Amanda M. Eudy, Thomas P. Green, Laura E. Schanberg, and Megan E. B. Clowse. “Hydroxychloroquine Levels throughout Pregnancies Complicated by Rheumatic Disease: Implications for Maternal and Neonatal Outcomes.” J Rheumatol 46, no. 1 (January 2019): 57–63. https://doi.org/10.3899/jrheum.180158.
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  - Cohen-Wolkowiez, Michael, and Daniel K. Benjamin. “Development of Therapeutics for Children-A Tricky Balancing Act.” Jama Pediatr 173, no. 1 (January 1, 2019): 18–19. https://doi.org/10.1001/jamapediatrics.2018.4026.
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  - Ku, Lawrence C., Christoph P. Hornik, Ryan J. Beechinor, James M. Chamberlain, Jeffrey T. Guptill, Barrie Harper, Edmund V. Capparelli, et al. “Population Pharmacokinetics and Exploratory Exposure-Response Relationships of Diazepam in Children Treated for Status Epilepticus.” Cpt Pharmacometrics Syst Pharmacol 7, no. 11 (November 2018): 718–27. https://doi.org/10.1002/psp4.12349.
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  - Balevic, Stephen J., and Michael Cohen-Wolkowiez. “Innovative Study Designs Optimizing Clinical Pharmacology Research in Infants and Children.” J Clin Pharmacol 58 Suppl 10, no. Suppl 10 (October 2018): S58–72. https://doi.org/10.1002/jcph.1053.
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  - Shakhnovich, Valentina, P. Brian Smith, Jeffrey T. Guptill, Laura P. James, David N. Collier, Huali Wu, Chad E. Livingston, et al. “A Population-Based Pharmacokinetic Model Approach to Pantoprazole Dosing for Obese Children and Adolescents.” Paediatr Drugs 20, no. 5 (October 2018): 483–95. https://doi.org/10.1007/s40272-018-0305-1.
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  - Watt, Kevin M., Michael Cohen-Wolkowiez, Jeffrey S. Barrett, Michael Sevestre, Ping Zhao, Kim L. R. Brouwer, and Andrea N. Edginton. “Physiologically Based Pharmacokinetic Approach to Determine Dosing on Extracorporeal Life Support: Fluconazole in Children on ECMO.” Cpt Pharmacometrics Syst Pharmacol 7, no. 10 (October 2018): 629–37. https://doi.org/10.1002/psp4.12338.
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  - Ge, Shufan, Ryan J. Beechinor, Christoph P. Hornik, Joseph F. Standing, Kanecia Zimmerman, Michael Cohen-Wolkowiez, Matthew M. Laughon, Reese Clark, and Daniel Gonzalez. “External Evaluation of a Gentamicin Infant Population Pharmacokinetic Model Using Data from a National Electronic Health Record Database.” Antimicrob Agents Chemother 62, no. 9 (September 2018). https://doi.org/10.1128/AAC.00669-18.
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  - Autmizguine, Julie, Sylvia Tan, Michael Cohen-Wolkowiez, C Michael Cotten, Nathan Wiederhold, Ronald N. Goldberg, Ira Adams-Chapman, et al. “Antifungal Susceptibility and Clinical Outcome in Neonatal Candidiasis.” Pediatr Infect Dis J 37, no. 9 (September 2018): 923–29. https://doi.org/10.1097/INF.0000000000001913.
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  - Gonzalez, Daniel, Laura P. James, Amira Al-Uzri, Miroslava Bosheva, Felice C. Adler-Shohet, Susan R. Mendley, John S. Bradley, et al. “Population Pharmacokinetics and Safety of Solithromycin following Intravenous and Oral Administration in Infants, Children, and Adolescents.” Antimicrob Agents Chemother 62, no. 8 (August 2018). https://doi.org/10.1128/AAC.00692-18.
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  - Gonzalez, Daniel, Laura P. James, Amira Al-Uzri, Miroslava Bosheva, Felice C. Adler-Shohet, Susan R. Mendley, John S. Bradley, et al. “Population Pharmacokinetics and Safety of Solithromycin following Intravenous and Oral Administration in Infants, Children, and Adolescents.” Antimicrobial Agents and Chemotherapy 62, no. 8 (August 1, 2018). https://doi.org/10.1128/AAC.00692-18;e00692-18.
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  - Hornik, Christoph P., Daniel Gonzalez, John van den Anker, Andrew M. Atz, Ram Yogev, Brenda B. Poindexter, Kee Chong Ng, et al. “Population Pharmacokinetics of Intramuscular and Intravenous Ketamine in Children.” J Clin Pharmacol 58, no. 8 (August 2018): 1092–1104. https://doi.org/10.1002/jcph.1116.
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  - Shakhnovich, Valentina, P Brian Smith, Huali Wu, Michael Cohen-Wolkowiez, and Gregory L. Kearns. “Reply.” J Pediatr 198 (July 2018): 327–28. https://doi.org/10.1016/j.jpeds.2018.03.001.
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  - Dallefeld, Samantha H., Andrew M. Atz, Ram Yogev, Janice E. Sullivan, Amira Al-Uzri, Susan R. Mendley, Matthew Laughon, et al. “A pharmacokinetic model for amiodarone in infants developed from an opportunistic sampling trial and published literature data.” J Pharmacokinet Pharmacodyn 45, no. 3 (June 2018): 419–30. https://doi.org/10.1007/s10928-018-9576-y.
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  - Maharaj, Anil R., Daniel Gonzalez, Michael Cohen-Wolkowiez, Christoph P. Hornik, and Andrea N. Edginton. “Improving Pediatric Protein Binding Estimates: An Evaluation of α1-Acid Glycoprotein Maturation in Healthy and Infected Subjects.” Clin Pharmacokinet 57, no. 5 (May 2018): 577–89. https://doi.org/10.1007/s40262-017-0576-7.
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  - Le, Jennifer, Brenda Poindexter, Janice E. Sullivan, Matthew Laughon, Paula Delmore, Martha Blackford, Ram Yogev, et al. “Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates.” Ther Drug Monit 40, no. 1 (February 2018): 103–8. https://doi.org/10.1097/FTD.0000000000000466.
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  - Autmizguine, Julie, Chiara Melloni, Christoph P. Hornik, Samantha Dallefeld, Barrie Harper, Ram Yogev, Janice E. Sullivan, et al. “Population Pharmacokinetics of Trimethoprim-Sulfamethoxazole in Infants and Children.” Antimicrob Agents Chemother 62, no. 1 (January 2018). https://doi.org/10.1128/AAC.01813-17.
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  - Hornik, Christoph P., Nikolas J. Onufrak, P Brian Smith, Michael Cohen-Wolkowiez, Matthew M. Laughon, Reese H. Clark, and Daniel Gonzalez. “Association between oral sildenafil dosing, predicted exposure, and systemic hypotension in hospitalised infants.” Cardiol Young 28, no. 1 (January 2018): 85–92. https://doi.org/10.1017/S1047951117001639.
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  - Salerno, Sara N., Andrea Edginton, Michael Cohen-Wolkowiez, Christoph P. Hornik, Kevin M. Watt, Brian D. Jamieson, and Daniel Gonzalez. “Development of an Adult Physiologically Based Pharmacokinetic Model of Solithromycin in Plasma and Epithelial Lining Fluid.” Cpt Pharmacometrics Syst Pharmacol 6, no. 12 (December 2017): 814–22. https://doi.org/10.1002/psp4.12252.
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  - Hwang, Michael F., Ryan J. Beechinor, Kelly C. Wade, Daniel K. Benjamin, P Brian Smith, Christoph P. Hornik, Edmund V. Capparelli, et al. “External Evaluation of Two Fluconazole Infant Population Pharmacokinetic Models.” Antimicrob Agents Chemother 61, no. 12 (December 2017). https://doi.org/10.1128/AAC.01352-17.
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  - Hornik, Christoph P., Huali Wu, Andrea N. Edginton, Kevin Watt, Michael Cohen-Wolkowiez, and Daniel Gonzalez. “Development of a Pediatric Physiologically-Based Pharmacokinetic Model of Clindamycin Using Opportunistic Pharmacokinetic Data.” Clin Pharmacokinet 56, no. 11 (November 2017): 1343–53. https://doi.org/10.1007/s40262-017-0525-5.
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  - Balevic, Stephen J., Mara L. Becker, Michael Cohen-Wolkowiez, and Laura E. Schanberg. “Clinical Trial Design in Juvenile Idiopathic Arthritis.” Paediatr Drugs 19, no. 5 (October 2017): 379–89. https://doi.org/10.1007/s40272-017-0244-2.
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  - Greenberg, Rachel G., Huali Wu, Matthew Laughon, Edmund Capparelli, Stevie Rowe, Kanecia O. Zimmerman, P Brian Smith, and Michael Cohen-Wolkowiez. “Population Pharmacokinetics of Dexmedetomidine in Infants.” J Clin Pharmacol 57, no. 9 (September 2017): 1174–82. https://doi.org/10.1002/jcph.904.
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  - Salerno, Sara, Christoph P. Hornik, Michael Cohen-Wolkowiez, P Brian Smith, Lawrence C. Ku, Matthew S. Kelly, Reese Clark, Daniel Gonzalez, and Daniel Best Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committee. “Use of Population Pharmacokinetics and Electronic Health Records to Assess Piperacillin-Tazobactam Safety in Infants.” Pediatr Infect Dis J 36, no. 9 (September 2017): 855–59. https://doi.org/10.1097/INF.0000000000001610.
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  - Rivera-Chaparro, Nazario D., Michael Cohen-Wolkowiez, and Rachel G. Greenberg. “Dosing antibiotics in neonates: review of the pharmacokinetic data.” Future Microbiol 12, no. 11 (September 2017): 1001–16. https://doi.org/10.2217/fmb-2017-0058.
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  - Watt, Kevin M., Michael Cohen-Wolkowiez, Duane C. Williams, Desiree K. Bonadonna, Ira M. Cheifetz, Dhiren Thakker, Daniel K. Benjamin, and Kim L. R. Brouwer. “Antifungal Extraction by the Extracorporeal Membrane Oxygenation Circuit.” J Extra Corpor Technol 49, no. 3 (September 2017): 150–59.
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  - Gonzalez, Daniel, James M. Chamberlain, Jeffrey T. Guptill, Michael Cohen-Wolkowiez, Barrie Harper, Jian Zhao, Edmund V. Capparelli, and Edmund V. Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee. “Population Pharmacokinetics and Exploratory Pharmacodynamics of Lorazepam in Pediatric Status Epilepticus.” Clin Pharmacokinet 56, no. 8 (August 2017): 941–51. https://doi.org/10.1007/s40262-016-0486-0.
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  - Nelson, Cody S., Diana Vera Cruz, Dollnovan Tran, Kristy M. Bialas, Lisa Stamper, Huali Wu, Margaret Gilbert, et al. “Preexisting antibodies can protect against congenital cytomegalovirus infection in monkeys.” Jci Insight 2, no. 13 (July 6, 2017). https://doi.org/10.1172/jci.insight.94002.
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  - Gonzalez, Daniel, John S. Bradley, Jeffrey Blumer, Ram Yogev, Kevin M. Watt, Laura P. James, Debra L. Palazzi, et al. “Dalbavancin Pharmacokinetics and Safety in Children 3 Months to 11 Years of Age.” Pediatr Infect Dis J 36, no. 7 (July 2017): 645–53. https://doi.org/10.1097/INF.0000000000001538.
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  - Smith, Michael J., Daniel Gonzalez, Jennifer L. Goldman, Ram Yogev, Janice E. Sullivan, Michael D. Reed, Ravinder Anand, et al. “Pharmacokinetics of Clindamycin in Obese and Nonobese Children.” Antimicrob Agents Chemother 61, no. 4 (April 2017). https://doi.org/10.1128/AAC.02014-16.
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  - Ericson, Jessica E., Kanecia O. Zimmerman, Daniel Gonzalez, Chiara Melloni, Jeffrey T. Guptill, Kevin D. Hill, Huali Wu, and Michael Cohen-Wolkowiez. “A Systematic Literature Review Approach to Estimate the Therapeutic Index of Selected Immunosuppressant Drugs After Renal Transplantation.” Ther Drug Monit 39, no. 1 (February 2017): 13–20. https://doi.org/10.1097/FTD.0000000000000364.
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  - Wang, Laura A., Daniel Gonzalez, J Steven Leeder, Rachel F. Tyndale, Robin E. Pearce, Daniel K. Benjamin, Gregory L. Kearns, Michael Cohen-Wolkowiez, and Michael Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. “Metronidazole Metabolism in Neonates and the Interplay Between Ontogeny and Genetic Variation.” J Clin Pharmacol 57, no. 2 (February 2017): 230–34. https://doi.org/10.1002/jcph.797.
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  - Fouda, Genevieve G., Joshua Eudailey, Erika L. Kunz, Joshua D. Amos, Brooke E. Liebl, Jonathan Himes, Felix Boakye-Agyeman, et al. “Systemic administration of an HIV-1 broadly neutralizing dimeric IgA yields mucosal secretory IgA and virus neutralization.” Mucosal Immunol 10, no. 1 (January 2017): 228–37. https://doi.org/10.1038/mi.2016.32.
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  - Ku, Lawrence C., Huali Wu, Rachel G. Greenberg, Kevin D. Hill, Daniel Gonzalez, Christoph P. Hornik, Alysha Berezny, et al. “Use of Therapeutic Drug Monitoring, Electronic Health Record Data, and Pharmacokinetic Modeling to Determine the Therapeutic Index of Phenytoin and Lamotrigine.” Ther Drug Monit 38, no. 6 (December 2016): 728–37. https://doi.org/10.1097/FTD.0000000000000354.
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  - Autmizguine, Julie, Christoph P. Hornik, Daniel K. Benjamin, Kim L. R. Brouwer, Susan R. Hupp, Michael Cohen-Wolkowiez, and Kevin M. Watt. “Pharmacokinetics and Safety of Micafungin in Infants Supported With Extracorporeal Membrane Oxygenation.” Pediatr Infect Dis J 35, no. 11 (November 2016): 1204–10. https://doi.org/10.1097/INF.0000000000001268.
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  - Hornik, Christoph P., Daniel K. Benjamin, P Brian Smith, Michael J. Pencina, Adriana H. Tremoulet, Edmund V. Capparelli, Jessica E. Ericson, Reese H. Clark, Michael Cohen-Wolkowiez, and Michael Best Pharmaceuticals for Children Act—Pediatric Trials Network. “Electronic Health Records and Pharmacokinetic Modeling to Assess the Relationship between Ampicillin Exposure and Seizure Risk in Neonates.” J Pediatr 178 (November 2016): 125-129.e1. https://doi.org/10.1016/j.jpeds.2016.07.011.
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  - Zimmerman, Kanecia O., Huali Wu, Rachel Greenberg, Jeffrey T. Guptill, Kevin Hill, Uptal D. Patel, Lawrence Ku, et al. “Therapeutic Drug Monitoring, Electronic Health Records, and Pharmacokinetic Modeling to Evaluate Sirolimus Drug Exposure-Response Relationships in Renal Transplant Patients.” Ther Drug Monit 38, no. 5 (October 2016): 600–606. https://doi.org/10.1097/FTD.0000000000000313.
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  - Thakkar, N., D. Gonzalez, M. Cohen-Wolkowiez, M. M. Massaro, J. Bernhardt, N. R. Zane, and M. M. Laughon. “An opportunistic study evaluating pharmacokinetics of sildenafil for the treatment of pulmonary hypertension in infants.” J Perinatol 36, no. 9 (September 2016): 744–47. https://doi.org/10.1038/jp.2016.79.
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  - Zimmerman, Kanecia, Martin Putera, Christoph P. Hornik, P. Brian Smith, Daniel K. Benjamin, Yeruk Mulugeta, Gilbert J. Burckart, Michael Cohen-Wolkowiez, and Daniel Gonzalez. “Exposure Matching of Pediatric Anti-infective Drugs: Review of Drugs Submitted to the Food and Drug Administration for Pediatric Approval.” Clin Ther 38, no. 9 (September 2016): 1995–2005. https://doi.org/10.1016/j.clinthera.2016.06.003.
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  - Wang, Laura A., Michael Cohen-Wolkowiez, and Daniel Gonzalez. “Advances in Pediatric Pharmacology, Therapeutics, and Toxicology.” Adv Pediatr 63, no. 1 (August 2016): 227–54. https://doi.org/10.1016/j.yapd.2016.04.015.
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  - Gonzalez, Daniel, Paula Delmore, Barry T. Bloom, C Michael Cotten, Brenda B. Poindexter, Elisabeth McGowan, Karen Shattuck, et al. “Clindamycin Pharmacokinetics and Safety in Preterm and Term Infants.” Antimicrob Agents Chemother 60, no. 5 (May 2016): 2888–94. https://doi.org/10.1128/AAC.03086-15.
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  - Gonzalez, Daniel, Debra L. Palazzi, Leena Bhattacharya-Mithal, Amira Al-Uzri, Laura P. James, John Bradley, Natalie Neu, et al. “Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents.” Antimicrob Agents Chemother 60, no. 4 (April 2016): 2572–76. https://doi.org/10.1128/AAC.02561-15.
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  - Hill, Kevin D., Mario R. Sampson, Jennifer S. Li, Robert D. Tunks, Scott R. Schulman, and Michael Cohen-Wolkowiez. “Pharmacokinetics of intravenous sildenafil in children with palliated single ventricle heart defects: effect of elevated hepatic pressures.” Cardiol Young 26, no. 2 (February 2016): 354–62. https://doi.org/10.1017/S1047951115000359.
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  - Greenberg, Rachel G., Chiara Melloni, Huali Wu, Daniel Gonzalez, Lawrence Ku, Kevin D. Hill, Christoph P. Hornik, Michael Cohen-Wolkowiez, and Jeffrey T. Guptill. “Therapeutic Index Estimation of Antiepileptic Drugs: A Systematic Literature Review Approach.” Clin Neuropharmacol 39, no. 5 (2016): 232–40. https://doi.org/10.1097/WNF.0000000000000172.
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  - Zimmerman, Kanecia, Daniel Gonzalez, Geeta K. Swamy, and Michael Cohen-Wolkowiez. “Pharmacologic studies in vulnerable populations: Using the pediatric experience.” Semin Perinatol 39, no. 7 (November 2015): 532–36. https://doi.org/10.1053/j.semperi.2015.08.007.
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  - Arnold, Christopher J., Jessica Ericson, Nathan Cho, James Tian, Shelby Wilson, Vivian H. Chu, Christoph P. Hornik, et al. “Cefepime and Ceftazidime Safety in Hospitalized Infants.” Pediatr Infect Dis J 34, no. 9 (September 2015): 964–68. https://doi.org/10.1097/INF.0000000000000778.
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  - Kanesvaran, Ravindran, Kevin Watt, James D. Turnbull, Andrew J. Armstrong, Michael Cohen Wolkowiez, and Daniel J. George. “A Single-Arm Phase 1b Study of Everolimus and Sunitinib in Patients With Advanced Renal Cell Carcinoma.” Clin Genitourin Cancer 13, no. 4 (August 2015): 319–27. https://doi.org/10.1016/j.clgc.2014.12.011.
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  - Harskamp-van Ginkel, Margreet W., Kevin D. Hill, Kristian C. Becker, Daniela Testoni, Michael Cohen-Wolkowiez, Daniel Gonzalez, Jeffrey S. Barrett, et al. “Drug Dosing and Pharmacokinetics in Children With Obesity: A Systematic Review.” Jama Pediatr 169, no. 7 (July 2015): 678–85. https://doi.org/10.1001/jamapediatrics.2015.132.
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  - Watt, Kevin M., Daniel Gonzalez, Daniel K. Benjamin, Kim L. R. Brouwer, Kelly C. Wade, Edmund Capparelli, Jeffrey Barrett, and Michael Cohen-Wolkowiez. “Fluconazole population pharmacokinetics and dosing for prevention and treatment of invasive Candidiasis in children supported with extracorporeal membrane oxygenation.” Antimicrob Agents Chemother 59, no. 7 (July 2015): 3935–43. https://doi.org/10.1128/AAC.00102-15.
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  - Botero-Calderon, Lorena, Daniel K. Benjamin, and Michael Cohen-Wolkowiez. “Advances in the treatment of invasive neonatal candidiasis.” Expert Opin Pharmacother 16, no. 7 (May 2015): 1035–48. https://doi.org/10.1517/14656566.2015.1031108.
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  - Gonzalez, Daniel, Kim A. Boggess, and Michael Cohen-Wolkowiez. “Lessons learned in pediatric clinical research to evaluate safe and effective use of drugs in pregnancy.” Obstet Gynecol 125, no. 4 (April 2015): 953–58. https://doi.org/10.1097/AOG.0000000000000743.
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  - Ericson, Jessica E., Joshua Thaden, Heather R. Cross, Reese H. Clark, Vance G. Fowler, Daniel K. Benjamin, Michael Cohen-Wolkowiez, Christoph P. Hornik, P Brian Smith, and P Brian Antibacterial Resistance Leadership Group. “No survival benefit with empirical vancomycin therapy for coagulase-negative staphylococcal bloodstream infections in infants.” Pediatr Infect Dis J 34, no. 4 (April 2015): 371–75. https://doi.org/10.1097/INF.0000000000000573.
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  - Ku, Lawrence C., Kim A. Boggess, and Michael Cohen-Wolkowiez. “Bacterial meningitis in infants.” Clin Perinatol 42, no. 1 (March 2015): 29–viii. https://doi.org/10.1016/j.clp.2014.10.004.
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  - Autmizguine, Julie, Christoph P. Hornik, Daniel K. Benjamin, Matthew M. Laughon, Reese H. Clark, C Michael Cotten, Michael Cohen-Wolkowiez, P Brian Smith, and P Brian Best Pharmaceuticals for Children Act—Pediatric Trials Network Administrative Core Committee. “Anaerobic antimicrobial therapy after necrotizing enterocolitis in VLBW infants.” Pediatrics 135, no. 1 (January 2015): e117–25. https://doi.org/10.1542/peds.2014-2141.
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  - Autmizguine, Julie, Michael Cohen-Wolkowiez, Norman Ilowite, and Norman RAPPORT Investigators. “Rilonacept pharmacokinetics in children with systemic juvenile idiopathic arthritis.” J Clin Pharmacol 55, no. 1 (January 2015): 39–44. https://doi.org/10.1002/jcph.372.
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  - Gonzalez, Daniel, Chiara Melloni, Brenda B. Poindexter, Ram Yogev, Andrew M. Atz, Janice E. Sullivan, Susan R. Mendley, et al. “Simultaneous determination of trimethoprim and sulfamethoxazole in dried plasma and urine spots.” Bioanalysis 7, no. 9 (2015): 1137–49. https://doi.org/10.4155/bio.15.38.
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  - Samiee-Zafarghandy, Samira, Sudha R. Raman, John N. van den Anker, Kerstin McHutchison, Christoph P. Hornik, Reese H. Clark, P. Brian Smith, and P. Best Pharmaceuticals for Children Act—Pediatric Trials Network Administrative Core Committee. “Safety of milrinone use in neonatal intensive care units.” Early Hum Dev 91, no. 1 (January 2015): 31–35. https://doi.org/10.1016/j.earlhumdev.2014.10.007.
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  - Cohen-Wolkowiez, Michael, and Daniel K. Benjamin. “Editorial commentary: Fluconazole therapeutic drug monitoring in children with cancer: not today.” Clin Infect Dis 59, no. 11 (December 1, 2014): 1534–36. https://doi.org/10.1093/cid/ciu661.
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  - Sampson, Mario R., Adam Frymoyer, Benjamin Rattray, C Michael Cotten, P Brian Smith, Edmund Capparelli, Sonia L. Bonifacio, and Michael Cohen-Wolkowiez. “Predictive performance of a gentamicin population pharmacokinetic model in neonates receiving full-body hypothermia.” Ther Drug Monit 36, no. 5 (October 2014): 584–89. https://doi.org/10.1097/FTD.0000000000000056.
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  - Autmizguine, Julie, Cassie Moran, Daniel Gonzalez, Edmund V. Capparelli, P Brian Smith, Gerald A. Grant, Daniel K. Benjamin, Michael Cohen-Wolkowiez, and Kevin M. Watt. “Vancomycin cerebrospinal fluid pharmacokinetics in children with cerebral ventricular shunt infections.” Pediatr Infect Dis J 33, no. 10 (October 2014): e270–72. https://doi.org/10.1097/INF.0000000000000385.
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  - Gonzalez, D., C. Melloni, R. Yogev, B. B. Poindexter, S. R. Mendley, P. Delmore, J. E. Sullivan, et al. “Use of opportunistic clinical data and a population pharmacokinetic model to support dosing of clindamycin for premature infants to adolescents.” Clin Pharmacol Ther 96, no. 4 (October 2014): 429–37. https://doi.org/10.1038/clpt.2014.134.
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  - Beam, K. S., S. Aliaga, S. K. Ahlfeld, M. Cohen-Wolkowiez, P. B. Smith, and M. M. Laughon. “A systematic review of randomized controlled trials for the prevention of bronchopulmonary dysplasia in infants.” J Perinatol 34, no. 9 (September 2014): 705–10. https://doi.org/10.1038/jp.2014.126.
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  - Testoni, Daniela, Madoka Hayashi, Michael Cohen-Wolkowiez, Daniel K. Benjamin, Renato D. Lopes, Reese H. Clark, and P Brian Smith. “Late-onset bloodstream infections in hospitalized term infants.” Pediatr Infect Dis J 33, no. 9 (September 2014): 920–23. https://doi.org/10.1097/INF.0000000000000322.
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  - Gonzalez, Daniel, Ian M. Paul, Daniel K. Benjamin, and Michael Cohen-Wolkowiez. “Advances in pediatric pharmacology, therapeutics, and toxicology.” Adv Pediatr 61, no. 1 (August 2014): 7–31. https://doi.org/10.1016/j.yapd.2014.03.005.
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  - Autmizguine, Julie, Jeffrey T. Guptill, Michael Cohen-Wolkowiez, Daniel K. Benjamin, and Edmund V. Capparelli. “Pharmacokinetics and pharmacodynamics of antifungals in children: clinical implications.” Drugs 74, no. 8 (June 2014): 891–909. https://doi.org/10.1007/s40265-014-0227-3.
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  - Tremoulet, Adriana, Jennifer Le, Brenda Poindexter, Janice E. Sullivan, Matthew Laughon, Paula Delmore, Andrea Salgado, et al. “Characterization of the population pharmacokinetics of ampicillin in neonates using an opportunistic study design.” Antimicrob Agents Chemother 58, no. 6 (June 2014): 3013–20. https://doi.org/10.1128/AAC.02374-13.
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  - Gostelow, Martyn, Daniel Gonzalez, P Brian Smith, and Michael Cohen-Wolkowiez. “Pharmacokinetics and safety of recently approved drugs used to treat methicillin-resistant Staphylococcus aureus infections in infants, children and adults.” Expert Rev Clin Pharmacol 7, no. 3 (May 2014): 327–40. https://doi.org/10.1586/17512433.2014.909281.
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  - Cohen-Wolkowiez, Michael, Kevin M. Watt, Chenguang Zhou, Barry T. Bloom, Brenda Poindexter, Lisa Castro, Jamie Gao, Edmund V. Capparelli, Daniel K. Benjamin, and P Brian Smith. “Developmental pharmacokinetics of piperacillin and tazobactam using plasma and dried blood spots from infants.” Antimicrob Agents Chemother 58, no. 5 (May 2014): 2856–65. https://doi.org/10.1128/AAC.02139-13.
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  - Hester, Willie, Caitlyn Fry, Daniel Gonzalez, Michael Cohen-Wolkowiez, Brant A. Inman, and Thomas L. Ortel. “Thromboprophylaxis with fondaparinux in high-risk postoperative patients with renal insufficiency.” Thromb Res 133, no. 4 (April 2014): 629–33. https://doi.org/10.1016/j.thromres.2013.11.019.
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  - Beam, Kristyn S., Matthew M. Laughon, Christoph P. Hornik, Michael Cohen-Wolkowiez, Reese H. Clark, Daniel K. Benjamin, and P Brian Smith. “Predictors of positive cerebrospinal fluid cultures in infants with bacteremia.” Pediatr Infect Dis J 33, no. 4 (April 2014): 360–65. https://doi.org/10.1097/INF.0000000000000115.
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  - Laughon, Matthew M., Debbie Avant, Nidhi Tripathi, Christoph P. Hornik, Michael Cohen-Wolkowiez, Reese H. Clark, P Brian Smith, and William Rodriguez. “Drug labeling and exposure in neonates.” Jama Pediatr 168, no. 2 (February 2014): 130–36. https://doi.org/10.1001/jamapediatrics.2013.4208.
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  - Autmizguine, Julie, Daniel K. Benjamin, P Brian Smith, Mario Sampson, Philippe Ovetchkine, Michael Cohen-Wolkowiez, and Kevin M. Watt. “Pharmacokinetic studies in infants using minimal-risk study designs.” Curr Clin Pharmacol 9, no. 4 (2014): 350–58. https://doi.org/10.2174/1574884709666140520153308.
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  - Sampson, M. R., B. T. Bloom, A. Arrieta, E. Capparelli, D. K. Benjamin, P. B. Smith, G. L. Kearns, J. van den Anker, and M. Cohen-Wolkowiez. “Intestinal fatty-acid binding protein and metronidazole response in premature infants.” J Neonatal Perinatal Med 7, no. 3 (January 1, 2014): 223–28. https://doi.org/10.3233/NPM-1477013.
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  - Sampson, Mario R., Barry T. Bloom, Robert W. Lenfestey, Barrie Harper, Angela D. Kashuba, Ravinder Anand, Daniel K. Benjamin, et al. “Population pharmacokinetics of intravenous acyclovir in preterm and term infants.” Pediatr Infect Dis J 33, no. 1 (January 2014): 42–49. https://doi.org/10.1097/01.inf.0000435509.75114.3d.
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  - Tunks, Robert D., Piers C. A. Barker, Daniel K. Benjamin, Michael Cohen-Wolkowiez, Gregory A. Fleming, Matthew Laughon, Jennifer S. Li, and Kevin D. Hill. “Sildenafil exposure and hemodynamic effect after Fontan surgery.” Pediatr Crit Care Med 15, no. 1 (January 2014): 28–34. https://doi.org/10.1097/PCC.0000000000000007.
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  - Sampson, M. R., B. T. Bloom, R. W. Lenfestey, B. Harper, A. D. Kashuba, R. Anand, D. K. Benjamin, E. Capparelli, M. Cohen-Wolkowiez, and P. B. Smith. “Population Pharmacokinetics of Intravenous Acyclovir in Preterm and Term Infants.” Pediatr Infect Dis J, September 23, 2013. https://doi.org/10.1097/01.inf.0000434359.14847.80.
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  - Pearce, Robin E., Michael Cohen-Wolkowiez, Mario R. Sampson, and Gregory L. Kearns. “The role of human cytochrome P450 enzymes in the formation of 2-hydroxymetronidazole: CYP2A6 is the high affinity (low Km) catalyst.” Drug Metab Dispos 41, no. 9 (September 2013): 1686–94. https://doi.org/10.1124/dmd.113.052548.
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  - Cohen-Wolkowiez, Michael, Mario Sampson, Barry T. Bloom, Antonio Arrieta, James L. Wynn, Karen Martz, Barrie Harper, et al. “Determining population and developmental pharmacokinetics of metronidazole using plasma and dried blood spot samples from premature infants.” Pediatr Infect Dis J 32, no. 9 (September 2013): 956–61. https://doi.org/10.1097/INF.0b013e3182947cf8.
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  - Hill, Kevin D., Robert D. Tunks, Piers C. A. Barker, Daniel K. Benjamin, Michael Cohen-Wolkowiez, Gregory A. Fleming, Matthew Laughon, and Jennifer S. Li. “Sildenafil exposure and hemodynamic effect after stage II single-ventricle surgery.” Pediatr Crit Care Med 14, no. 6 (July 2013): 593–600. https://doi.org/10.1097/PCC.0b013e31828aa5ee.
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  - Hornik, Christoph P., Amy H. Herring, Daniel K. Benjamin, Edmund V. Capparelli, Gregory L. Kearns, John van den Anker, Michael Cohen-Wolkowiez, Reese H. Clark, P Brian Smith, and P Brian Best Pharmaceuticals for Children Act-Pediatric Trials Network. “Adverse events associated with meropenem versus imipenem/cilastatin therapy in a large retrospective cohort of hospitalized infants.” Pediatr Infect Dis J 32, no. 7 (July 2013): 748–53. https://doi.org/10.1097/INF.0b013e31828be70b.
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  - Lestner, Jodi M., P Brian Smith, Michael Cohen-Wolkowiez, Daniel K. Benjamin, and William W. Hope. “Antifungal agents and therapy for infants and children with invasive fungal infections: a pharmacological perspective.” Br J Clin Pharmacol 75, no. 6 (June 2013): 1381–95. https://doi.org/10.1111/bcp.12025.
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  - Downey, L. C., D. K. Benjamin, R. H. Clark, K. M. Watt, C. P. Hornik, M. M. Laughon, M. Cohen-Wolkowiez, and P. B. Smith. “Urinary tract infection concordance with positive blood and cerebrospinal fluid cultures in the neonatal intensive care unit.” J Perinatol 33, no. 4 (April 2013): 302–6. https://doi.org/10.1038/jp.2012.111.
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  - Bauserman, Melissa S., Matthew M. Laughon, Christoph P. Hornik, P Brian Smith, Daniel K. Benjamin, Reese H. Clark, Cyril Engmann, and Michael Cohen-Wolkowiez. “Group B Streptococcus and Escherichia coli infections in the intensive care nursery in the era of intrapartum antibiotic prophylaxis.” Pediatr Infect Dis J 32, no. 3 (March 2013): 208–12. https://doi.org/10.1097/INF.0b013e318275058a.
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  - Lee, Jan Hau, Christoph P. Hornik, Daniel K. Benjamin, Amy H. Herring, Reese H. Clark, Michael Cohen-Wolkowiez, and P Brian Smith. “Risk factors for invasive candidiasis in infants >1500 g birth weight.” Pediatr Infect Dis J 32, no. 3 (March 2013): 222–26. https://doi.org/10.1097/INF.0b013e3182769603.
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  - Cohen-Wolkowiez, M., B. Poindexter, and M. Bidegain. “Erratum: Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections (Clinical Infectious Diseases (2012) 55 (1495-502) DOI: 10.1093/cid/cis758).” Clinical Infectious Diseases 56, no. 3 (February 1, 2013): 470. https://doi.org/10.1093/cid/cis997.
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  - Manzoni, Paolo, Daniel K. Benjamin, Caterina Franco, Stefano Rizzollo, Mauro Stronati, Kevin Watt, Michael Cohen-Wolkowiez, and Evelyne Jacqz-Aigrain. “Echinocandins for the nursery: an update.” Curr Drug Metab 14, no. 2 (February 2013): 203–7.
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  - Watt, Kevin, Paolo Manzoni, Michael Cohen-Wolkowiez, Stefano Rizzollo, Elena Boano, Evelyne Jacqz-Aigrain, and Daniel K. Benjamin. “Triazole use in the nursery: fluconazole, voriconazole, posaconazole, and ravuconazole.” Curr Drug Metab 14, no. 2 (February 2013): 193–202.
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  - Sampson, Mr, M. Cohen-Wolkowiez, Dk Benjamin, Ev Capparelli, and Km Watt. “Pharmacokinetics of Antimicrobials in Obese Children.” Gabi J 2, no. 2 (2013): 76–81. https://doi.org/10.5639/gabij.2013.0202.025.
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  - “Determining population and developmental pharmacokinetics of metronidazole using plasma and dried blood spot samples from premature infants.” Pediatric Infectious Disease Journal 32, no. 9 (January 1, 2013): 956–61. https://doi.org/10.1097/INF0b013e3182947cf8.
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  - Cohen-Wolkowiez, Michael, Brenda Poindexter, Margarita Bidegain, Joern-Hendrik Weitkamp, Robert L. Schelonka, David A. Randolph, Robert M. Ward, et al. “Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections.” Clin Infect Dis 55, no. 11 (December 2012): 1495–1502. https://doi.org/10.1093/cid/cis758.
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  - Hill, Kevin D., Robert Tunks, Gregory A. Fleming, John F. Rhodes, Matthew Laughon, Michael Cohen-Wolkowiez, and Jennifer S. Li. “Sildenafil Pharmacokinetics, Hemodynamic Efficacy and Safety after Stage II Single Ventricle Surgery.” Circulation 126, no. 21 (November 20, 2012).
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  - Watt, Kevin M., Daniel K. Benjamin, Ira M. Cheifetz, Ganesh Moorthy, Kelly C. Wade, P Brian Smith, Kim L. R. Brouwer, Edmund V. Capparelli, and Michael Cohen-Wolkowiez. “Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation.” Pediatr Infect Dis J 31, no. 10 (October 2012): 1042–47. https://doi.org/10.1097/INF.0b013e31825d3091.
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  - Cohen-Wolkowiez, Michael, Kevin M. Watt, Christoph P. Hornik, Daniel K. Benjamin, and P Brian Smith. “Pharmacokinetics and tolerability of single-dose daptomycin in young infants.” Pediatr Infect Dis J 31, no. 9 (September 2012): 935–37. https://doi.org/10.1097/INF.0b013e31825d2fa2.
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  - Sampson, Mario R., Daniel K. Benjamin, and Michael Cohen-Wolkowiez. “Evidence-based guidelines for pediatric clinical trials: focus on StaR Child Health.” Expert Rev Clin Pharmacol 5, no. 5 (September 2012): 525–31. https://doi.org/10.1586/ecp.12.52.
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  - Hornik, Christoph P., Daniel K. Benjamin, Kristian C. Becker, Jennifer Li, Reese H. Clark, Michael Cohen-Wolkowiez, and P Brian Smith. “Use of the complete blood cell count in early-onset neonatal sepsis.” Pediatr Infect Dis J 31, no. 8 (August 2012): 799–802. https://doi.org/10.1097/INF.0b013e318256905c.
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  - Hornik, Christoph P., Daniel K. Benjamin, Kristian C. Becker, Jennifer Li, Reese H. Clark, Michael Cohen-Wolkowiez, and P Brian Smith. “Use of the complete blood cell count in late-onset neonatal sepsis.” Pediatr Infect Dis J 31, no. 8 (August 2012): 803–7. https://doi.org/10.1097/INF.0b013e31825691e4.
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  - Cohen-Wolkowiez, Michael, Daniel K. Benjamin, Ashley Ross, Laura P. James, Janice E. Sullivan, Michele C. Walsh, Arlene Zadell, et al. “Population pharmacokinetics of piperacillin using scavenged samples from preterm infants.” Ther Drug Monit 34, no. 3 (June 2012): 312–19. https://doi.org/10.1097/FTD.0b013e3182587665.
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  - Doby, Elizabeth H., Daniel K. Benjamin, Anne J. Blaschke, Robert M. Ward, Andrew T. Pavia, Paul L. Martin, Timothy A. Driscoll, Michael Cohen-Wolkowiez, and Cassandra Moran. “Therapeutic monitoring of voriconazole in children less than three years of age: a case report and summary of voriconazole concentrations for ten children.” Pediatr Infect Dis J 31, no. 6 (June 2012): 632–35. https://doi.org/10.1097/INF.0b013e31824acc33.
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  - Watt, Kevin M., Michael Cohen-Wolkowiez, Robert M. Ward, and Daniel K. Benjamin. “Commentary: pediatric antifungal drug development: lessons learned and recommendations for the future.” Pediatr Infect Dis J 31, no. 6 (June 2012): 635–37. https://doi.org/10.1097/INF.0b013e31824f8426.
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  - Ascher, S. B., P. B. Smith, R. H. Clark, M. Cohen-Wolkowiez, J. S. Li, K. Watt, E. Jacqz-Aigrain, F. Kaguelidou, P. Manzoni, and D. K. Benjamin. “Sepsis in young infants with congenital heart disease.” Early Hum Dev 88 Suppl 2, no. Suppl 2 (May 2012): S92–97. https://doi.org/10.1016/S0378-3782(12)70025-7.
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  - Ascher, Simon B., P Brian Smith, Kevin Watt, Daniel K. Benjamin, Michael Cohen-Wolkowiez, Reese H. Clark, and Cassandra Moran. “Antifungal therapy and outcomes in infants with invasive Candida infections.” Pediatr Infect Dis J 31, no. 5 (May 2012): 439–43. https://doi.org/10.1097/INF.0b013e3182467a72.
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  - Hornik, C. P., P. Fort, R. H. Clark, K. Watt, D. K. Benjamin, P. B. Smith, P. Manzoni, E. Jacqz-Aigrain, F. Kaguelidou, and M. Cohen-Wolkowiez. “Early and late onset sepsis in very-low-birth-weight infants from a large group of neonatal intensive care units.” Early Hum Dev 88 Suppl 2, no. Suppl 2 (May 2012): S69–74. https://doi.org/10.1016/S0378-3782(12)70019-1.
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  - Hsieh, E., P. B. Smith, E. Jacqz-Aigrain, F. Kaguelidou, M. Cohen-Wolkowiez, P. Manzoni, and D. K. Benjamin. “Neonatal fungal infections: when to treat?” Early Hum Dev 88 Suppl 2, no. Suppl 2 (May 2012): S6–10. https://doi.org/10.1016/S0378-3782(12)70004-X.
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  - Manzoni, P., M. Mostert, M. A. Latino, L. Pugni, I. Stolfi, L. Decembrino, F. Vagnarelli, et al. “Clinical characteristics and response to prophylactic fluconazole of preterm VLBW neonates with baseline and acquired fungal colonisation in NICU: data from a multicentre RCT.” Early Hum Dev 88 Suppl 2 (May 2012): S60–64. https://doi.org/10.1016/S0378-3782(12)70017-8.
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  - Cohen-Wolkowiez, Michael, Daniele Ouellet, P Brian Smith, Laura P. James, Ashley Ross, Janice E. Sullivan, Michele C. Walsh, et al. “Population pharmacokinetics of metronidazole evaluated using scavenged samples from preterm infants.” Antimicrob Agents Chemother 56, no. 4 (April 2012): 1828–37. https://doi.org/10.1128/AAC.06071-11.
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  - Wynn, James L., Daniel K. Benjamin, Michael Cohen-Wolkowiez, Reese H. Clark, and P Brian Smith. “Very late onset infections in the neonatal intensive care unit.” Early Hum Dev 88, no. 4 (April 2012): 217–25. https://doi.org/10.1016/j.earlhumdev.2011.08.009.
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  - Warn, Peter A., Joanne Livermore, Susan Howard, Timothy W. Felton, Andrew Sharp, Lea Gregson, Joanne Goodwin, et al. “Anidulafungin for neonatal hematogenous Candida meningoencephalitis: identification of candidate regimens for humans using a translational pharmacological approach.” Antimicrob Agents Chemother 56, no. 2 (February 2012): 708–14. https://doi.org/10.1128/AAC.05826-11.
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  - Watt, Kevin M., Matthew M. Massaro, Brian Smith, Michael Cohen-Wolkowiez, Daniel K. Benjamin, and Matthew M. Laughon. “Pharmacokinetics of moxifloxacin in an infant with Mycoplasma hominis meningitis.” Pediatr Infect Dis J 31, no. 2 (February 2012): 197–99. https://doi.org/10.1097/INF.0b013e31823980c3.
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  - Turner, K., P. Manzoni, D. K. Benjamin, M. Cohen-Wolkowiez, P. B. Smith, and M. M. Laughon. “Fluconazole pharmacokinetics and safety in premature infants.” Curr Med Chem 19, no. 27 (2012): 4617–20. https://doi.org/10.2174/092986712803306367.
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  - Cohen-Wolkowiez, Michael, Nicole R. White, Arlene Bridges, Daniel K. Benjamin, and Angela D. M. Kashuba. “Development of a liquid chromatography-tandem mass spectrometry assay of six antimicrobials in plasma for pharmacokinetic studies in premature infants.” J Chromatogr B Analyt Technol Biomed Life Sci 879, no. 30 (November 15, 2011): 3497–3506. https://doi.org/10.1016/j.jchromb.2011.09.031.
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  - Smith, P Brian, Michael Cohen-Wolkowiez, Lisa M. Castro, Brenda Poindexter, Margarita Bidegain, Joern-Hendrik Weitkamp, Robert L. Schelonka, et al. “Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid of infants with suspected or complicated intra-abdominal infections.” Pediatr Infect Dis J 30, no. 10 (October 2011): 844–49. https://doi.org/10.1097/INF.0b013e31822e8b0b.
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  - Laughon, Matthew M., Daniel K. Benjamin, Edmund V. Capparelli, Gregory L. Kearns, Katherine Berezny, Ian M. Paul, Kelly Wade, Jeff Barrett, Phillip Brian Smith, and Michael Cohen-Wolkowiez. “Innovative clinical trial design for pediatric therapeutics.” Expert Rev Clin Pharmacol 4, no. 5 (September 2011): 643–52. https://doi.org/10.1586/ecp.11.43.
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  - Watt, Kevin, Jennifer S. Li, Daniel K. Benjamin, and Michael Cohen-Wolkowiez. “Pediatric cardiovascular drug dosing in critically ill children and extracorporeal membrane oxygenation.” J Cardiovasc Pharmacol 58, no. 2 (August 2011): 126–32. https://doi.org/10.1097/FJC.0b013e318213aac2.
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  - Li, Jennifer S., Michael Cohen-Wolkowiez, and Sara K. Pasquali. “Pediatric cardiovascular drug trials, lessons learned.” J Cardiovasc Pharmacol 58, no. 1 (July 2011): 4–8. https://doi.org/10.1097/FJC.0b013e31820d1c54.
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  - Jean-Baptiste, Naomi, Daniel K. Benjamin, Michael Cohen-Wolkowiez, Vance G. Fowler, Matthew Laughon, Reese H. Clark, and P Brian Smith. “Coagulase-negative staphylococcal infections in the neonatal intensive care unit.” Infect Control Hosp Epidemiol 32, no. 7 (July 2011): 679–86. https://doi.org/10.1086/660361.
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  - Greenberg, R. G., D. K. Benjamin, M. Cohen-Wolkowiez, R. H. Clark, C. M. Cotten, M. Laughon, and P. B. Smith. “Repeat lumbar punctures in infants with meningitis in the neonatal intensive care unit.” J Perinatol 31, no. 6 (June 2011): 425–29. https://doi.org/10.1038/jp.2010.142.
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  - Cohen-Wolkowiez, M., D. K. Benjamin, L. Piper, I. M. Cheifetz, C. Moran, P. Liu, J. Aram, et al. “Safety and pharmacokinetics of multiple-dose anidulafungin in infants and neonates.” Clin Pharmacol Ther 89, no. 5 (May 2011): 702–7. https://doi.org/10.1038/clpt.2011.26.
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  - Piper, Lauren, P Brian Smith, Christoph P. Hornik, Ira M. Cheifetz, Jeffrey S. Barrett, Ganesh Moorthy, William W. Hope, Kelly C. Wade, Michael Cohen-Wolkowiez, and Daniel K. Benjamin. “Fluconazole loading dose pharmacokinetics and safety in infants.” Pediatr Infect Dis J 30, no. 5 (May 2011): 375–78. https://doi.org/10.1097/INF.0b013e318202cbb3.
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  - Watt, Kevin, Daniel K. Benjamin, and Michael Cohen-Wolkowiez. “Pharmacokinetics of antifungal agents in children.” Early Hum Dev 87 Suppl 1, no. Suppl 1 (March 2011): S61–65. https://doi.org/10.1016/j.earlhumdev.2011.01.014.
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  - Hope, William W., P Brian Smith, Antonio Arrieta, Donald N. Buell, Michael Roy, Atsunori Kaibara, Thomas J. Walsh, Michael Cohen-Wolkowiez, and Daniel K. Benjamin. “Population pharmacokinetics of micafungin in neonates and young infants.” Antimicrob Agents Chemother 54, no. 6 (June 2010): 2633–37. https://doi.org/10.1128/AAC.01679-09.
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  - Greenberg, Rachel G., Cassandra Moran, Martin Ulshen, P Brian Smith, Daniel K. Benjamin, and Michael Cohen-Wolkowiez. “Outcomes of catheter-associated infections in pediatric patients with short bowel syndrome.” J Pediatr Gastroenterol Nutr 50, no. 4 (April 2010): 460–62. https://doi.org/10.1097/MPG.0b013e3181b99d07.
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  - Downey, L Corbin, P Brian Smith, Daniel K. Benjamin, and Michael Cohen-Wolkowiez. “Recent Advances in the Detection of Neonatal Candidiasis.” Curr Fungal Infect Rep 4, no. 1 (March 1, 2010): 17–22. https://doi.org/10.1007/s12281-010-0002-1.
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  - Cohen-Wolkowiez, M., D. K. Benjamin, and P. B. Smith. “Management of neonatal candidiasis.” Journal of Invasive Fungal Infections 3, no. 1 (December 1, 2009): 9–14.
  - Cohen-Wolkowiez, Michael, Cassandra Moran, Daniel K. Benjamin, C Michael Cotten, Reese H. Clark, and P Brian Smith. “Early and late onset sepsis in late preterm infants.” Pediatr Infect Dis J 28, no. 12 (December 2009): 1052–56. https://doi.org/10.1097/inf.0b013e3181acf6bd.
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  - Cohen-Wolkowiez, Michael, Cassandra Moran, Daniel K. Benjamin, and Phillip B. Smith. “Pediatric antifungal agents.” Curr Opin Infect Dis 22, no. 6 (December 2009): 553–58. https://doi.org/10.1097/QCO.0b013e3283321ccc.
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  - Moran, C., P. B. Smith, M. Cohen-Wolkowiez, and D. K. Benjamin. “Clinical trial design in neonatal pharmacology: effect of center differences, with lessons from the Pediatric Oncology Cooperative Research experience.” Clin Pharmacol Ther 86, no. 6 (December 2009): 589–91. https://doi.org/10.1038/clpt.2009.175.
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  - Cohen-Wolkowiez, Michael, Daniel K. Benjamin, and Edmund Capparelli. “Immunotherapy in neonatal sepsis: advances in treatment and prophylaxis.” Curr Opin Pediatr 21, no. 2 (April 2009): 177–81. https://doi.org/10.1097/MOP.0b013e32832925e5.
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  - Cohen-Wolkowiez, M., P. B. Smith, D. K. Benjamin, V. G. Fowler, and K. C. Wade. “Daptomycin use in infants: report of two cases with peak and trough drug concentrations.” J Perinatol 28, no. 3 (March 2008): 233–34. https://doi.org/10.1038/sj.jp.7211898.
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  - Cohen-Wolkowiez, Michael, Daniel K. Benjamin, Vance G. Fowler, Kelly C. Wade, Barbara D. Alexander, Gordon Worley, Ricki F. Goldstein, and P Brian Smith. “Mortality and neurodevelopmental outcome after Staphylococcus aureus bacteremia in infants.” Pediatr Infect Dis J 26, no. 12 (December 2007): 1159–61. https://doi.org/10.1097/INF.0b013e31814620a6.
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  - Cohen-Wolkowiez, M., P. B. Smith, B. Mangum, W. J. Steinbach, B. D. Alexander, C. M. Cotten, R. H. Clark, T. J. Walsh, and D. K. Benjamin. “Neonatal Candida meningitis: significance of cerebrospinal fluid parameters and blood cultures.” J Perinatol 27, no. 2 (February 2007): 97–100. https://doi.org/10.1038/sj.jp.7211628.
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  - Cohen-Wolkowiez, Michael, Daniel K. Benjamin, William J. Steinbach, and P Brian Smith. “Anidulafungin: a new echinocandin for the treatment of fungal infections.” Drugs Today (Barc) 42, no. 8 (August 2006): 533–44. https://doi.org/10.1358/dot.2006.42.8.996569.
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  - Cohen-Wolkowiez, Michael, and Marcelo Laufer. “Enhanced culture detection of Citrobacter koseri from cerebrospinal fluid in BacTec.” Pediatr Infect Dis J 24, no. 8 (August 2005): 750. https://doi.org/10.1097/01.inf.0000173612.86495.99.
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- Book Sections
  - Dallefeld, S., C. D. Hornik, K. Zimmerman, and M. Cohen-Wolkowiez. “Antibiotic Dosing Considerations for Term and Preterm Infants.” In Infectious Disease and Pharmacology: Neonatology Questions and Controversies, 167–84, 2018. https://doi.org/10.1016/B978-0-323-54391-0.00014-X.
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- Conference Papers
  - Ganguly, Samit, Andrea N. Edginton, Jacqueline G. Gerhart, Michael Cohen-Wolkowiez, Rachel G. Greenberg, Daniel Gonzalez, and Daniel Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. “Physiologically Based Pharmacokinetic Modeling of Meropenem in Preterm and Term Infants.” In Clin Pharmacokinet, 60:1591–1604, 2021. https://doi.org/10.1007/s40262-021-01046-6.
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  - Ganguly, S., A. Edginton, J. Gerhart, M. Cohen-Wolkowiez, R. Greenberg, and D. Gonzalez. “PHYSIOLOGICALLY-BASED PHARMACOKINETIC (PBPK) MODELING OF MEROPENEM IN PRETERM AND TERM INFANTS.” In Clinical Pharmacology & Therapeutics, 107:S11–12. WILEY, 2020.
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  - Gerhart, J., A. Edginton, K. Watt, M. Cohen-Wolkowiez, B. Harper, W. Muller, P. Delmore, et al. “CYP2B6 GENOTYPE AFFECTS METHADONE DISPOSITION IN CHILDREN AS DEMONSTRATED BY PHYSIOLOGICALLY BASED PHARMACOKINETIC (PBPK) MODELING.” In Clinical Pharmacology & Therapeutics, 107:S64–S64. WILEY, 2020.
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  - Gerhart, J., A. Edginton, K. Watt, M. Cohen-Wolkowiez, B. Harper, W. Muller, P. Delmore, et al. “CYP2B6 GENOTYPE AFFECTS METHADONE DISPOSITION IN CHILDREN AS DEMONSTRATED BY PHYSIOLOGICALLY BASED PHARMACOKINETIC (PBPK) MODELING.” In Clinical Pharmacology & Therapeutics, 107:S15–S15. WILEY, 2020.
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  - Salerno, S., A. Edginton, M. Cohen-Wolkowiez, C. Hornik, J. Lang, and D. Gonzalez. “EVALUATION OF A PEDIATRIC PHYSIOLOGICALLY-BASED PHARMACOKINETIC (PBPK) MODEL FOR SOLITHROMYCIN USING PLASMA AND DRIED BLOOD SPOTS (DBS) DRUG CONCENTRATIONS.” In Clinical Pharmacology & Therapeutics, 107:S10–S10. WILEY, 2020.
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  - Salerno, S., A. Edginton, M. Cohen-Wolkowiez, C. Hornik, J. Lang, and D. Gonzalez. “EVALUATION OF A PEDIATRIC PHYSIOLOGICALLY BASED PHARMACOKINETIC (PBPK) MODEL FOR SOLITHROMYCIN USING PLASMA AND DRIED BLOOD SPOTS (DBS) DRUG CONCENTRATIONS.” In Clinical Pharmacology & Therapeutics, 107:S68–S68. WILEY, 2020.
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  - Wu, Y., D. Gonzalez, M. Cohen-Wolkowiez, C. Hornik, J. Gerhart, J. Autmizguine, and M. Cobbaert. “EXTERNAL EVALUATION OF POPULATION PHARMACOKINETIC (PPK) MODELS OF TRIMETHOPRIM (TMP) AND SULFAMETHOXAZOLE (SMX) DEVELOPED USING OPPORTUNISTIC DATA IN INFANTS AND CHILDREN.” In Clinical Pharmacology & Therapeutics, 107:S70–S70. WILEY, 2020.
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  - Gelfand, A. A., C. L. Szperka, T. Pezzuto, A. Hammett, S. Kessel, D. Benjamin, M. Cohen-Wolkowiez, and C. Hornik. “Establishing a National Real-World Data Pediatric Migraine Registry: Proof of Principle.” In Headache, 60:87–87, 2020.
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  - Gelfand, Amy, Christina Szperka, Tara Pezzuto, Alex Hammett, Shirley Kessel, Daniel Benjamin, Michael Cohen-Wolkowiez, and Christoph Hornik. “Creation of a National Real-World Data Pediatric Migraine Registry: Proof of Principle.” In Neurology, Vol. 94, 2020.
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  - Balevic, Stephen, Michael Cohen-wolkowiez, Amanda Eudy, Mara Becker, Laura Schanberg, and Megan Clowse. “Optimal Hydroxychloroquine Drug Levels in Pregnant Women with Systemic Lupus Erythematosus.” In Arthritis & Rheumatology, Vol. 71. WILEY, 2019.
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  - Gerhart, Jacqueline G., Kevin M. Watt, Andrea Edginton, Kelly C. Wade, Sara N. Salerno, Daniel K. Benjamin, P Brian Smith, et al. “Physiologically-Based Pharmacokinetic Modeling of Fluconazole Using Plasma and Cerebrospinal Fluid Samples From Preterm and Term Infants.” In Cpt Pharmacometrics Syst Pharmacol, 8:500–510, 2019. https://doi.org/10.1002/psp4.12414.
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  - Adams, David, Keith Sullivan, Ivan Spasojevic, Ping Fan, Mario Sampson, Michael Cohen-Wolkowiez, L William St Clair, et al. “Pharmacokinetics of Cyclophosphamide in Scleroderma Treated By Cyclophosphamide Versus Transplantation.” In Arthritis & Rheumatology, Vol. 70. WILEY, 2018.
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  - Noveck, R. J., J. T. Guptill, M. Cohen-Wolkowiez, B. M. Hauser, and A. F. Suffredini. “DOSE-RELATED INFLAMMATORY EFFECTS OF INTRAVENOUS ENDOTOXIN IN HUMANS: EVALUATION OF A NEW CLINICAL LOT (CCRE LOT 94332B1) OF ESCHERICHIA COLIO: 113 ENDOTOXIN (LPS).” In Clinical Pharmacology & Therapeutics, 103:S82–83. WILEY, 2018.
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  - Gairhe, S., P. Torabi-Parizi, B. Ingram, E. D. Karoly, J. Guptill, M. Cohen-Wolkowiez, R. J. Noveck, and A. F. Suffredini. “A Dose-Related Hypermetabolic Phenotype Following High and Low Dose Intravenous Endotoxin Challenges in Healthy Volunteers.” In American Journal of Respiratory and Critical Care Medicine, Vol. 197. AMER THORACIC SOC, 2018.
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  - Torabi-Parizi, P., A. Biancotto, G. Fantoni, C. Demirkale, J. T. Guptill, M. Cohen-Wolkowiez, R. J. Noveck, and A. F. Suffredini. “Human Plasma Proteome Analysis Following Endotoxin Challenge Identifies New Proteins that Contribute to Molecular Phenotype of Innate Immunity.” In American Journal of Respiratory and Critical Care Medicine, Vol. 197. AMER THORACIC SOC, 2018.
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  - Hornik, Christoph P., Daniel Gonzalez, Eric M. Graham, Kevin D. Hill, Huali Wu, and Michael Cohen-Wolkowiez. “Exposure - Response Relationship of Methylprednisolone and Inflammatory Biomarkers in Neonates Undergoing Cardiopulmonary Bypass.” In Circulation, Vol. 138, 2018.
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  - Balevic, Stephen, Michael Cohen-Wolkowiez, Amanda M. Eudy, Laura E. Schanberg, and Megan E. B. Clowse. “Hydroxychloroquine Level Decreases throughout Pregnancy: Implications for Maternal and Neonatal Outcomes.” In Arthritis & Rheumatology, Vol. 69. WILEY, 2017.
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  - Thakkar, Nilay, Jeffrey T. Guptill, Kathy Aleš, David Jacobus, Laura Jacobus, Charles Peloquin, Michael Cohen-Wolkowiez, Daniel Gonzalez, and Daniel DAPPER Study Group. “Population Pharmacokinetics/Pharmacodynamics of 3,4-Diaminopyridine Free Base in Patients With Lambert-Eaton Myasthenia.” In Cpt Pharmacometrics Syst Pharmacol, 6:625–34, 2017. https://doi.org/10.1002/psp4.12218.
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  - Guptill, Jeffrey, Nilay Thakkar, Charles Peloquin, Kathy Ales, David Jacobus, Laura Jacobus, Michael Cohen-Wolkowiez, and Daniel Gonzalez. “PK/PD MODELING AND SIMULATION OF 3,4-DIAMINOPYRIDINE BASE IN PATIENTS WITH LAMBERT-EATON MYASTHENIA SYNDROME.” In Muscle & Nerve, 54:528–528. WILEY-BLACKWELL, 2016.
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  - Guptill, Jeff, Rachel Greenberg, Chiara Mellon, Huali Wu, Daniel Gonzalez, Lawrence Ku, Kevin Hill, et al. “Narrow Therapeutic Index Classification of Antiepileptic Drugs Using a Comprehensive Literature Search.” In Neurology, Vol. 86. LIPPINCOTT WILLIAMS & WILKINS, 2016.
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  - Guptill, Jeff, Rachel Greenberg, Chiara Melloni, Huali Wu, Daniel Gonzalez, Lawrence Ku, Kevin Hill, et al. “Narrow Therapeutic Index Classification of Antiepileptic Drugs Using a Comprehensive Literature Search.” In Neurology, Vol. 86. LIPPINCOTT WILLIAMS & WILKINS, 2016.
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  - Burt, Tal, Douglas C. Rouse, Kihak Lee, Huali Wu, Anita T. Layton, Thomas C. Hawk, Douglas H. Weitzel, et al. “Intraarterial Microdosing: A Novel Drug Development Approach, Proof-of-Concept PET Study in Rats.” In J Nucl Med, 56:1793–99, 2015. https://doi.org/10.2967/jnumed.115.160986.
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  - Watt, K., M. Cohen-Wolkowiez, D. Williams, D. Bonadonna, I. Cheifetz, D. K. Benjamin, and K. L. Brouwer. “ANTIFUNGAL EXTRACTION BY THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT EX VIVO.” In Clinical Pharmacology & Therapeutics, 97:S16–S16. WILEY-BLACKWELL, 2015.
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  - Burt, T., D. C. Rouse, K. Lee, H. Wu, A. T. Layton, T. C. Hawk, D. H. Weitzel, et al. “Intra-arterial microdosing (IAM), a novel drug development approach, proof-of-concept in rodents.” In American College of Clinical Pharmacology (Accp) 2015 Annual Meeting., n.d.

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