Shein-Chung Chow
Professor of Biostatistics & Bioinformatics
My research interest includes statistical methodology development and application in the area of biopharmaceutical/clinical statistics such as bioavailability and bioequivalence, clinical trials, bridging studies, medical devices, and translational research/medicine. Most recently, I am interested in statistical methodology development for the use of adaptive design methods in clinical trials and methodology development for assessment of biosimilarity of follow-on biologics. In addition, I am also interested in methodology development for statistical evaluation of traditional Chinese medicine (TCM) clinical trials.
Current Appointments & Affiliations
- Professor of Biostatistics & Bioinformatics, Biostatistics & Bioinformatics, Basic Science Departments 2022
- Member in the Duke Clinical Research Institute, Duke Clinical Research Institute, Institutes and Centers 2005
Contact Information
- 2424 Erwin Road Ste 1102, 11037 Hock Plaza, Durham, NC 27705
- Duke Box 2721, Durham, NC 27710
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sheinchung.chow@duke.edu
(919) 668-0105
- Background
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Education, Training, & Certifications
- Ph.D., University of Wisconsin - Madison 1985
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Previous Appointments & Affiliations
- Professor of Biostatistics & Bioinformatics, Biostatistics & Bioinformatics, Basic Science Departments 2021 - 2022
- Research Professor in the School of Nursing, School of Nursing, Duke University 2019 - 2021
- Professor of Biostatistics and Bioinformatics, Biostatistics & Bioinformatics, Basic Science Departments 2007 - 2020
- Research Professor of Biostatistics and Bioinformatics, Biostatistics & Bioinformatics, Basic Science Departments 2006 - 2007
- Instructor, Temporary in the Department of Biostatistics and Bioinformatics, Biostatistics & Bioinformatics, Basic Science Departments 2005 - 2006
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Academic Positions Outside Duke
- Visiting Distinguished Professor, National Taipei University (Taiwan). 2004 - 2005
- Recognition
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Awards & Honors
- Expertise
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Global Scholarship
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Research
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- Research
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Selected Grants
- Targeting the B Cell Response to Treat Antibody-Mediated Rejection awarded by National Institutes of Health 2021 - 2028
- Red blood cell ATP export and transfusion in sepsis (R01) awarded by National Institutes of Health 2023 - 2026
- The TALK: A Novel Mobile Application marketed in Barbershops and Beauty Salons for Black Fathers and Mothers to promote sexual health among Black male adolescents living in the United States South awarded by University of California - Davis 2020 - 2023
- Data-driven Approaches to Healthcare Provider Resilience & Burnout during COVID-19 awarded by Department of Defense 2021 - 2022
- Optimizing treatment for E. faecalis infective endocarditis: ampicillin plus ceftriaxone versus ampicillin plus gentamicin awarded by National Institutes of Health 2016 - 2019
- RCT of an Integrated Treatment of Persons with Co-Occurring HCV and Alcohol Abuse awarded by National Institutes of Health 2013 - 2019
- Clinical Medication Development for Bipolar Disorder and Alcohol Use Disorders awarded by University of Texas - Southwestern 2015 - 2018
- Study to Evaulate the Kappa Opioid Receptor as a Target for the Treatment of Mood and Anxiety Spectrum Disorders by Evaluating Whether LY2456302 Engages Reward-related Neural Circuitry. awarded by National Institutes of Health 2013 - 2017
- Bacteremia Modification 14 awarded by National Institutes of Health 2009 - 2017
- Mod 11 for Option 3 - Staphylococcal Bacteremia Study awarded by National Institutes of Health 2009 - 2017
- Modification No 13 Staphylococcal Bacteremia Study awarded by National Institutes of Health 2009 - 2017
- Sample Size Requirements for Analytical Similarity Assessments awarded by Boehringer Ingelheim Pharmaceuticals, Inc. 2017
- Modification No. 8 - Staphylococcal Bacteremia Study awarded by National Institutes of Health 2009 - 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
- Phase I CTU Task Area A: Administrative and Overal Clinical Operations Support and Concept Development awarded by National Institutes of Health 2014 - 2015
- Modification No. 5 - Staphylococcal Bacteremia Study awarded by National Institutes of Health 2009 - 2015
- FAST- MAS Administrative Task Year 2 awarded by National Institutes of Health 2013 - 2014
- Optimizing duration of antibiotics after valve surgery for infective endocarditis awarded by National Institutes of Health 2012 - 2014
- Clinical Trial Planning in Pompe Disease awarded by National Institutes of Health 2013 - 2014
- Novel Ondansetron Formulation for Combination Treatment of Psychostimulant Abuse awarded by National Institutes of Health 2009 - 2013
- A Phase III Multi-Center, Randomized, Open-label, Comparative Study to Assess the Efficacy of a Treatment Algorithm to Reduce the Use of Vancomycin in Patients with Intravenous Catheter-Associated Bloodstream Infections (BSI) due to Staphylococci awarded by National Institutes of Health 2009 - 2012
- CTSA UL awarded by National Institutes of Health 2006 - 2012
- Publications & Artistic Works
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Selected Publications
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Books
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Chow, S. C., J. Shao, H. Wang, and Y. Lokhnygina. Sample size calculations in clinical research, third edition, 2017. https://doi.org/10.1201/9781315183084.Full Text
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Pong, A., and S. C. Chow. Handbook of adaptive designs in pharmaceutical and clinical development, 2016.
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Pong, A., and S. C. Chow. Preface, 2016.
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Chow, S. C. Biosimilars: Design and analysis of follow-on biologics, 2013. https://doi.org/10.1201/b15303.Full Text
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Liu, J. P., S. C. Chow, and C. F. Hsiao. Design and analysis of bridging studies, 2012.
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Chow, S. C., and M. Chang. Adaptive design methods in clinical trials, second edition, 2011.
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Chow, S. C., and J. P. Liu. Design and analysis of bioavailability and bioequivalence studies, third edition, 2008.
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Chow, S. C. Statistical design and analysis of stability studies, 2007.
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Chow, S. C. Series introduction, 2005.
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Chow, S. C., and J. P. Liu. Statistical design and analysis in pharmaceutical science: Validation, process controls, and stability, 1995.
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Academic Articles
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Luo, Xingxian, Qixiang Guo, Xin Du, Lin Huang, Shein-Chung Chow, and Yue Yang. “Evaluation of clinical trial designs for novel anticancer drugs in China: A cohort study of drugs approved between 2015 and 2021.” Drug Discov Today 28, no. 6 (March 31, 2023): 103578. https://doi.org/10.1016/j.drudis.2023.103578.Full Text Link to Item
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Liu, Jiajun, and Shein-Chung Chow. “A Proposal for Post Hoc Subgroup Analysis in Support of Regulatory Submission.” Ther Innov Regul Sci 57, no. 2 (March 2023): 196–208. https://doi.org/10.1007/s43441-022-00459-0.Full Text Link to Item
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Luo, Xingxian, Xin Du, Lin Huang, Qixiang Guo, Ruijie Tan, Yue Zhou, Zhuangqi Li, et al. “The price, efficacy, and safety of within-class targeted anticancer medicines between domestic and imported drugs in China: a comparative analysis.” Lancet Reg Health West Pac 32 (March 2023): 100670. https://doi.org/10.1016/j.lanwpc.2022.100670.Full Text Link to Item
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Eucker, Stephanie A., Oliver Glass, Catherine A. Staton, Mitchell R. Knisely, Amy O’Regan, Christi De Larco, Michelle Mill, et al. “Acupuncture for acute musculoskeletal pain management in the emergency department and continuity clinic: a protocol for an adaptive pragmatic randomised controlled trial.” Bmj Open 12, no. 9 (September 2022): e061661. https://doi.org/10.1136/bmjopen-2022-061661.Full Text
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Joshi, Sangeeta P., An-Kwok Ian Wong, Amanda Brucker, Taylor A. Ardito, Shein-Chung Chow, Sandeep Vaishnavi, and Patty J. Lee. “Efficacy of Transcendental Meditation to Reduce Stress Among Health Care Workers: A Randomized Clinical Trial.” Jama Netw Open 5, no. 9 (September 1, 2022): e2231917. https://doi.org/10.1001/jamanetworkopen.2022.31917.Full Text Open Access Copy Link to Item
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O’Kelly, M., A. Zhang, I. Lipkovich, G. Song, R. Reeve, B. Ratitch, S. Li, et al. “A Time-response Measure to Assess Clinical Equivalence in Rheumatoid Arthritis: an Assessment Using Data From Clinical Trials of Biosimilars.” Statistics in Biopharmaceutical Research 14, no. 2 (January 1, 2022): 204–16. https://doi.org/10.1080/19466315.2020.1832567.Full Text
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Song, Fuyu, Xin Zheng, Yujia Wang, Shein-Chung Chow, and Hongqiang Sun. “Innovative Design and Analysis for PK/PD Biosimilar Bridging Studies with Multiple References.” Aaps J 24, no. 1 (November 30, 2021): 3. https://doi.org/10.1208/s12248-021-00658-x.Full Text Link to Item
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Wang, Peijin, and Shein-Chung Chow. “Sample size re-estimation in clinical trials.” Stat Med 40, no. 27 (November 30, 2021): 6133–49. https://doi.org/10.1002/sim.9175.Full Text Link to Item
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Chow, S. C., S. S. Chow, and A. Pong. “Review of current controversial issues in clinical trials.” General Psychiatry 34, no. 5 (October 27, 2021). https://doi.org/10.1136/gpsych-2021-100540.Full Text Open Access Copy
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Song, Fuyu, Chenxuan Zang, Xinyi Ma, Sifan Hu, Qiqing Sun, Shein-Chung Chow, and Hongqiang Sun. “The use of real-world data/evidence in regulatory submissions.” Contemp Clin Trials 109 (October 2021): 106521. https://doi.org/10.1016/j.cct.2021.106521.Full Text Link to Item
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Wegermann, Kara, Melanie E. Garrett, Jiayin Zheng, Andrea Coviello, Cynthia A. Moylan, Manal F. Abdelmalek, Shein-Chung Chow, et al. “Sex and Menopause Modify the Effect of Single Nucleotide Polymorphism Genotypes on Fibrosis in NAFLD.” Hepatol Commun 5, no. 4 (April 2021): 598–607. https://doi.org/10.1002/hep4.1668.Full Text Link to Item
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Chow, S. C., and S. J. Lee. “Current Issues in Analytical Similarity Assessment.” Statistics in Biopharmaceutical Research 13, no. 2 (January 1, 2021): 203–9. https://doi.org/10.1080/19466315.2020.1801497.Full Text
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Chow, Shein-Chung, and Wei Zhang. “Statistical Evaluation of Clinical Trials Under COVID-19 Pandemic.” Ther Innov Regul Sci 54, no. 6 (November 2020): 1551–56. https://doi.org/10.1007/s43441-020-00182-8.Full Text Link to Item
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Cheng, Bin, Bingzhi Zhang, and Shein-Chung Chow. “Unified approaches to assessing treatment effect of traditional Chinese medicine based on health profiles.” J Biopharm Stat 30, no. 3 (May 3, 2020): 564–73. https://doi.org/10.1080/10543406.2020.1726368.Full Text Link to Item
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Son, Sungtaek, Minkyung Oh, Minjoo Choo, Shein-Chung Chow, and Sang Joon Lee. “Some thoughts on the QR method for analytical similarity evaluation.” J Biopharm Stat 30, no. 3 (May 3, 2020): 521–36. https://doi.org/10.1080/10543406.2020.1726372.Full Text Link to Item
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Chow, Shein-Chung, and Zhipeng Huang. “Innovative design and analysis for rare disease drug development.” J Biopharm Stat 30, no. 3 (May 3, 2020): 537–49. https://doi.org/10.1080/10543406.2020.1726371.Full Text Link to Item
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Friedman, Daniel J., Jeffrey G. Gaca, Tongrong Wang, S Chris Malaisrie, David R. Holmes, Jonathan P. Piccini, Rakesh M. Suri, et al. “Use of left atrial appendage occlusion among older cardiac surgery patients with preoperative atrial fibrillation: a national cohort study.” J Interv Card Electrophysiol 57, no. 3 (April 2020): 399–407. https://doi.org/10.1007/s10840-019-00519-w.Full Text Link to Item
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Garman, Katherine S., Teminioluwa A. Ajayi, Harold J. Boutte, Shih-Ting Chiu, Richard J. von Furstenberg, Benjamin R. Lloyd, Cecelia Zhang, Mark W. Onaitis, Shein-Chung Chow, and Shannon J. McCall. “Prior tonsillectomy is associated with an increased risk of esophageal adenocarcinoma.” Plos One 15, no. 7 (2020): e0235906. https://doi.org/10.1371/journal.pone.0235906.Full Text Link to Item
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Li, Min, Tingting Lv, Shanshan Wu, Wei Wei, Xiaohai Wu, Xiaojuan Ou, Hong Ma, et al. “Tenofovir versus entecavir in lowering the risk of hepatocellular carcinoma development in patients with chronic hepatitis B: a critical systematic review and meta-analysis.” Hepatol Int 14, no. 1 (January 2020): 105–14. https://doi.org/10.1007/s12072-019-10005-0.Full Text Link to Item
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Chow, Shein-Chung, and Sang Joon Lee. “Design and Analysis of Biosimilar Switching Studies.” Pharmaceut Med 33, no. 5 (October 2019): 379–88. https://doi.org/10.1007/s40290-019-00296-x.Full Text Link to Item
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Zhu, Jiegao, Shanshan Wu, Yuanyuan Kong, Wei Han, Dong Shang, Dianrong Xiu, Xun Li, et al. “Long-Term Prognosis of Cholecystocholedocholithiasis in Chinese Population,” August 23, 2019.
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Song, Fuyu, Xue Qian, Jianming Li, Shein-Chung Chow, and Minghuang Hong. “Practical Issues in Clinical Inspection Process.” Ther Innov Regul Sci 53, no. 3 (May 2019): 374–80. https://doi.org/10.1177/2168479018769887.Full Text Link to Item
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Spaete, Joshua P., Jiayin Zheng, Shein-Chung Chow, Rebecca A. Burbridge, and Katherine S. Garman. “Inconsistencies in Colonic Tattooing Practice: Differences in Reported and Actual Practices at a Tertiary Medical Center.” South Med J 112, no. 4 (April 2019): 222–27. https://doi.org/10.14423/SMJ.0000000000000964.Full Text Open Access Copy Link to Item
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Schuirmann, Donald J., Stella Grosser, Somesh Chattopadhyay, and Shein-Chung Chow. “On Bayesian Analysis and Hypothesis Testing in the Determination of Bioequivalence.” Clin Pharmacol Ther 105, no. 2 (February 2019): 304–6. https://doi.org/10.1002/cpt.1291.Full Text Link to Item
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Chow, Shein-Chung, and Jiayin Zheng. “The use of 95% CI or 90% CI for drug product development - a controversial issue?” J Biopharm Stat 29, no. 5 (2019): 834–44. https://doi.org/10.1080/10543406.2019.1657141.Full Text Link to Item
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Chow, Shein-Chung, and Yu-Wei Chang. “Statistical considerations for rare diseases drug development.” J Biopharm Stat 29, no. 5 (2019): 874–86. https://doi.org/10.1080/10543406.2019.1657441.Full Text Link to Item
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Chow, Shein-Chung, and Zhipeng Huang. “Innovative Thinking on Endpoint Selection in Clinical Trials.” J Biopharm Stat 29, no. 5 (2019): 941–51. https://doi.org/10.1080/10543406.2019.1657140.Full Text Link to Item
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Chow, Shein-Chung, and Zhipeng Huang. “Demonstrating effectiveness or demonstrating not ineffectiveness - A potential solution for rare disease drug product development?” J Biopharm Stat 29, no. 5 (2019): 897–907. https://doi.org/10.1080/10543406.2019.1657137.Full Text Link to Item
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Huang, Zhipeng, and Shein-Chung Chow. “Probability monitoring procedures for sample size determination.” J Biopharm Stat 29, no. 5 (2019): 887–96. https://doi.org/10.1080/10543406.2019.1657139.Full Text Link to Item
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Zheng, Jiayin, Donglei Yin, Mengdie Yuan, and Shein-Chung Chow. “Simultaneous confidence interval methods for analytical similarity assessment.” J Biopharm Stat 29, no. 5 (2019): 920–40. https://doi.org/10.1080/10543406.2019.1657142.Full Text Link to Item
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Zheng, Jiayin, and Shein-Chung Chow. “Criteria for dose-finding in two-stage seamless adaptive design.” J Biopharm Stat 29, no. 5 (2019): 908–19. https://doi.org/10.1080/10543406.2019.1657130.Full Text Link to Item
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Lu, Qing Shu, Shein-Chung Chow, and Siu-Keung Tse. “Interim analysis of binary outcome data in clinical trials: a comparison of five estimators.” J Biopharm Stat 29, no. 2 (2019): 400–410. https://doi.org/10.1080/10543406.2018.1559852.Full Text Open Access Copy Link to Item
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Feder, Rachel, Shai Posner, Yi Qin, Jiayin Zheng, Shein-Chung Chow, and Katherine S. Garman. “Helicobacter pylori-associated peptic ulcer disease: A retrospective analysis of post-treatment testing practices.” Helicobacter 23, no. 6 (December 2018): e12540. https://doi.org/10.1111/hel.12540.Full Text Link to Item
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Xiao, S., F. Q. Zhao, Q. M. Wang, Y. R. Dong, S. C. Chow, M. Z. Fan, B. Xing, F. Zhai, and R. W. Xiang. “A visual analysis of network pharmacology research trends.” World Journal of Traditional Chinese Medicine 4, no. 4 (October 1, 2018): 163–69. https://doi.org/10.4103/wjtcm.wjtcm_21_18.Full Text
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Patel, Yuval A., Jacqueline B. Henson, Julius M. Wilder, Jiayin Zheng, Schein-Chung Chow, Carl L. Berg, Stuart J. Knechtle, and Andrew J. Muir. “The impact of human leukocyte antigen donor and recipient serotyping and matching on liver transplant graft failure in primary sclerosing cholangitis, autoimmune hepatitis, and primary biliary cholangitis.” Clin Transplant 32, no. 10 (October 2018): e13388. https://doi.org/10.1111/ctr.13388.Full Text Link to Item
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Holland, Thomas L., Issam Raad, Helen W. Boucher, Deverick J. Anderson, Sara E. Cosgrove, P Suzanne Aycock, John W. Baddley, et al. “Effect of Algorithm-Based Therapy vs Usual Care on Clinical Success and Serious Adverse Events in Patients with Staphylococcal Bacteremia: A Randomized Clinical Trial.” Jama 320, no. 12 (September 25, 2018): 1249–58. https://doi.org/10.1001/jama.2018.13155.Full Text Link to Item
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Posner, S., J. Zheng, R. K. Wood, R. A. Shimpi, M. G. Hartwig, S. -. C. Chow, and D. A. Leiman. “Gastroesophageal reflux symptoms are not sufficient to guide esophageal function testing in lung transplant candidates.” Dis Esophagus 31, no. 5 (May 1, 2018). https://doi.org/10.1093/dote/dox157.Full Text Open Access Copy Link to Item
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Friedman, Daniel J., Jonathan P. Piccini, Tongrong Wang, Jiayin Zheng, S Chris Malaisrie, David R. Holmes, Rakesh M. Suri, et al. “Association Between Left Atrial Appendage Occlusion and Readmission for Thromboembolism Among Patients With Atrial Fibrillation Undergoing Concomitant Cardiac Surgery.” Jama 319, no. 4 (January 23, 2018): 365–74. https://doi.org/10.1001/jama.2017.20125.Full Text Link to Item
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Ying, Lisa, Fuyu Song, Shein-Chung Chow, Na Zeng, Jiayin Zheng, Xiaodong Li, David Henry, and Venkat Sethuraman. “On evaluation of consistency in multi-regional clinical trials.” J Biopharm Stat 28, no. 5 (2018): 840–56. https://doi.org/10.1080/10543406.2017.1397008.Full Text Link to Item
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Collins, Lauren F., Austin Chan, Jiayin Zheng, Shein-Chung Chow, Julius M. Wilder, Andrew J. Muir, and Susanna Naggie. “Direct-Acting Antivirals Improve Access to Care and Cure for Patients With HIV and Chronic HCV Infection.” Open Forum Infect Dis 5, no. 1 (January 2018): ofx264. https://doi.org/10.1093/ofid/ofx264.Full Text Open Access Copy Link to Item
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Jung, Sin-Ho, Ho Yun Lee, and Shein-Chung Chow. “Statistical Methods for Conditional Survival Analysis.” J Biopharm Stat 28, no. 5 (2018): 927–38. https://doi.org/10.1080/10543406.2017.1405012.Full Text Link to Item
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Zhao, Yi, Yu-Wei Chang, and Shein-Chung Chow. “On sample size requirement for analytical similarity assessment.” J Biopharm Stat 28, no. 6 (2018): 1143–59. https://doi.org/10.1080/10543406.2018.1437171.Full Text Link to Item
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Chow, S. C., and F. Song. “Analytical similarity assessment.” Wiley Interdisciplinary Reviews: Computational Statistics 9, no. 6 (November 1, 2017). https://doi.org/10.1002/wics.1407.Full Text
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Henson, Jacqueline B., Yuval A. Patel, Julius M. Wilder, Jiayin Zheng, Shein-Chung Chow, Lindsay Y. King, and Andrew J. Muir. “Differences in Phenotypes and Liver Transplantation Outcomes by Age Group in Patients with Primary Sclerosing Cholangitis.” Dig Dis Sci 62, no. 11 (November 2017): 3200–3209. https://doi.org/10.1007/s10620-017-4559-1.Full Text Link to Item
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Filozof, C., S. C. Chow, L. Dimick-Santos, Y. F. Chen, R. N. Williams, B. J. Goldstein, and A. Sanyal. “Clinical endpoints and adaptive clinical trials in precirrhotic nonalcoholic steatohepatitis: Facilitating development approaches for an emerging epidemic.” Hepatology Communications 1, no. 7 (September 1, 2017): 577–85. https://doi.org/10.1002/hep4.1079.Full Text
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Zheng, Jiayin, Shein-Chung Chow, and Mengdie Yuan. “On assessing bioequivalence and interchangeability between generics based on indirect comparisons.” Stat Med 36, no. 19 (August 30, 2017): 2978–93. https://doi.org/10.1002/sim.7326.Full Text Link to Item
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Henson, Jacqueline B., Cristal L. Brown, Shein-Chung Chow, and Andrew J. Muir. “Complementary and Alternative Medicine Use in United States Adults With Liver Disease.” J Clin Gastroenterol 51, no. 6 (July 2017): 564–70. https://doi.org/10.1097/MCG.0000000000000617.Full Text Link to Item
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Henson, Jacqueline B., Yuval A. Patel, Lindsay Y. King, Jiayin Zheng, Shein-Chung Chow, and Andrew J. Muir. “Outcomes of liver retransplantation in patients with primary sclerosing cholangitis.” Liver Transpl 23, no. 6 (June 2017): 769–80. https://doi.org/10.1002/lt.24703.Full Text Link to Item
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Chow, Shein-Chung, Fuyu Song, and Can Cui. “On hybrid parallel-crossover designs for assessing drug interchangeability of biosimilar products.” J Biopharm Stat 27, no. 2 (2017): 265–71. https://doi.org/10.1080/10543406.2017.1275956.Full Text Link to Item
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Chow, Shein-Chung, Fuyu Song, and He Bai. “Sample size requirement in analytical studies for similarity assessment.” J Biopharm Stat 27, no. 2 (2017): 233–38. https://doi.org/10.1080/10543406.2016.1265545.Full Text Link to Item
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Li, Jianghao, and Shein-Chung Chow. “Statistical evaluation of the scaled criterion for drug interchangeability.” J Biopharm Stat 27, no. 2 (2017): 282–92. https://doi.org/10.1080/10543406.2016.1265538.Full Text Link to Item
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Salah, Samir, Shein-Chung Chow, and Fuyu Song. “On the evaluation of reliability, repeatability, and reproducibility of instrumental evaluation methods and measurement systems.” J Biopharm Stat 27, no. 2 (2017): 331–37. https://doi.org/10.1080/10543406.2016.1265547.Full Text Link to Item
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Wang, Tongrong, and Shein-Chung Chow. “On the establishment of equivalence acceptance criterion in analytical similarity assessment.” J Biopharm Stat 27, no. 2 (2017): 206–12. https://doi.org/10.1080/10543406.2016.1265539.Full Text Link to Item
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Zheng, Jiayin, Shein-Chung Chow, and Fuyu Song. “On safety margin for drug interchangeability.” J Biopharm Stat 27, no. 2 (2017): 293–307. https://doi.org/10.1080/10543406.2016.1265540.Full Text Link to Item
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Chen, Meng, and Shein-Chung Chow. “Assessing bioequivalence and drug interchangeability.” J Biopharm Stat 27, no. 2 (2017): 272–81. https://doi.org/10.1080/10543406.2016.1265537.Full Text Link to Item
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Dakik, Hassan K., F Douglas Srygley, Shih-Ting Chiu, Shein-Chung Chow, and Deborah A. Fisher. “Clinical Performance of Prediction Rules and Nasogastric Lavage for the Evaluation of Upper Gastrointestinal Bleeding: A Retrospective Observational Study.” Gastroenterol Res Pract 2017 (2017): 3171697. https://doi.org/10.1155/2017/3171697.Full Text Link to Item
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You, Hong, Yuanyuan Kong, Jinlin Hou, Lai Wei, Yuexin Zhang, Junqi Niu, Tao Han, et al. “Female gender lost protective effect against disease progression in elderly patients with chronic hepatitis B.” Sci Rep 6 (November 28, 2016): 37498. https://doi.org/10.1038/srep37498.Full Text Link to Item
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Himes, Jonathon E., Carrie Ho, Quang N. Nguyen, Joshua D. Amos, Haolin Xu, Cliburn Chan, Shein-Chung Chow, et al. “Characterization of Simian Immunodeficiency Virus Variants Anatomically Compartmentalized in Plasma and Milk in Chronically Infected African Green Monkeys.” J Virol 90, no. 19 (October 1, 2016): 8795–8808. https://doi.org/10.1128/JVI.00701-16.Full Text Link to Item
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Dakik, Hassan K., Alyson A. McGhan, Shih-Ting Chiu, Chetan B. Patel, Carmelo A. Milano, Joseph G. Rogers, Shein-Chung Chow, and Daniel M. Wild. “The Diagnostic Yield of Repeated Endoscopic Evaluation in Patients with Gastrointestinal Bleeding and Left Ventricular Assist Devices.” Dig Dis Sci 61, no. 6 (June 2016): 1603–10. https://doi.org/10.1007/s10620-015-4028-7.Full Text Link to Item
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Chow, Shein-Chung, Fuyu Song, and He Bai. “Analytical Similarity Assessment in Biosimilar Studies.” Aaps J 18, no. 3 (May 2016): 670–77. https://doi.org/10.1208/s12248-016-9882-5.Full Text Link to Item
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Chow, Shein-Chung, Fuyu Song, and Meng Chen. “Some thoughts on drug interchangeability.” J Biopharm Stat 26, no. 1 (2016): 178–86. https://doi.org/10.1080/10543406.2015.1092027.Full Text Link to Item
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Okeke, Nwora Lance, Tammy Chin, Meredith Clement, Shein-Chung Chow, and Charles B. Hicks. “Coronary artery disease risk reduction in HIV-infected persons: a comparative analysis.” Aids Care 28, no. 4 (2016): 475–82. https://doi.org/10.1080/09540121.2015.1099602.Full Text Link to Item
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Wu, Pei-Shien, Min Lin, and Shein-Chung Chow. “On sample size estimation and re-estimation adjusting for variability in confirmatory trials.” J Biopharm Stat 26, no. 1 (2016): 44–54. https://doi.org/10.1080/10543406.2015.1092031.Full Text Link to Item
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Chow, S. C., and F. Song. “On controversial statistical issues in clinical research.” Open Access Journal of Clinical Trials 7 (May 2, 2015): 43–51. https://doi.org/10.2147/OAJCT.S63266.Full Text
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Naggie, Susanna, Keyur Patel, Lan-Yan Yang, Shein-Chung Chow, Victoria Johnson, John R. Guyton, Andrew J. Muir, Mark Sulkowski, and Charles Hicks. “Antiretroviral Effects on Host Lipoproteins Are Associated With Changes in Hepatitis C Virus (HCV) RNA Levels in Human Immunodeficiency Virus/HCV Coinfected Individuals.” Open Forum Infect Dis 2, no. 2 (April 2015): ofv066. https://doi.org/10.1093/ofid/ofv066.Full Text Open Access Copy Link to Item
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Li, J., and S. C. Chow. “Confidence region approach for assessing bioequivalence and biosimilarity accounting for heterogeneity of variability.” Journal of Probability and Statistics 2015 (January 1, 2015). https://doi.org/10.1155/2015/298647.Full Text
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Yuen, Hak-Keung, Shein-Chung Chow, and Siu-Keung Tse. “On statistical tests for homogeneity of two bivariate zero-inflated Poisson populations.” J Biopharm Stat 25, no. 1 (2015): 44–53. https://doi.org/10.1080/10543406.2014.919934.Full Text Link to Item
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Hess, Connie N., Matthew T. Roe, C Michael Gibson, Robert J. Temple, Michael J. Pencina, Deborah A. Zarin, Kevin J. Anstrom, et al. “Independent data monitoring committees: preparing a path for the future.” Am Heart J 168, no. 2 (August 2014): 135-41.e1. https://doi.org/10.1016/j.ahj.2014.05.003.Full Text Link to Item
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Tóthfalusi, Lászlo, László Endrényi, and Shein-Chung Chow. “Statistical and regulatory considerations in assessments of interchangeability of biological drug products.” Eur J Health Econ 15 Suppl 1, no. Suppl 1 (May 2014): S5-11. https://doi.org/10.1007/s10198-014-0589-1.Full Text Link to Item
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Reddy, E. A., B. N. Njau, S. C. Morpeth, K. E. Lancaster, A. C. Tribble, V. P. Maro, L. J. Msuya, et al. “A randomized controlled trial of standard versus intensified tuberculosis diagnostics on treatment decisions by physicians in Northern Tanzania.” Bmc Infectious Diseases 14, no. 1 (February 20, 2014). https://doi.org/10.1186/1471-2334-14-89.Full Text
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Reddy, Elizabeth A., Boniface N. Njau, Susan C. Morpeth, Kathryn E. Lancaster, Alison C. Tribble, Venance P. Maro, Levina J. Msuya, et al. “A randomized controlled trial of standard versus intensified tuberculosis diagnostics on treatment decisions by physicians in Northern Tanzania.” Bmc Infect Dis 14 (February 20, 2014): 89. https://doi.org/10.1186/1471-2334-14-89.Full Text Open Access Copy Link to Item
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Chiu, Shih-Ting, Jen-Pei Liu, and Shein-Chung Chow. “Applications of the bayesian prior information to evaluation of equivalence of similar biological medicinal products.” J Biopharm Stat 24, no. 6 (2014): 1254–63. https://doi.org/10.1080/10543406.2014.941982.Full Text Link to Item
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Chow, S. -. C. “Bioavailability and bioequivalence in drug development.” Wiley Interdisciplinary Reviews: Computational Statistics, 2014.
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Chow, S. C. “Bioavailability and bioequivalence in drug development.” Wiley Interdisciplinary Reviews: Computational Statistics 6, no. 4 (January 1, 2014): 304–12. https://doi.org/10.1002/wics.1310.Full Text
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Chow, Shein-Chung, Laszlo Endrenyi, Peter A. Lachenbruch, and France Mentré. “Scientific factors and current issues in biosimilar studies.” J Biopharm Stat 24, no. 6 (2014): 1138–53. https://doi.org/10.1080/10543406.2014.948961.Full Text Link to Item
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Chow, Shein-Chung. “Adaptive clinical trial design.” Annu Rev Med 65 (2014): 405–15. https://doi.org/10.1146/annurev-med-092012-112310.Full Text Link to Item
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Lu, Y., S. C. Chow, and S. Zhu. “In vivo and in vitro bioequivalence testing.” Journal of Bioequivalence and Bioavailability 6, no. 2 (January 1, 2014): 67–74. https://doi.org/10.4172/jbb.1000182.Full Text
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Lu, Ying, Zhong-Zhan Zhang, and Shein-Chung Chow. “Frequency estimator for assessing of follow-on biologics.” J Biopharm Stat 24, no. 6 (2014): 1280–97. https://doi.org/10.1080/10543406.2014.941985.Full Text Link to Item
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Tóthfalusi, L., L. Endrényi, and S. -. C. Chow. “Statistical and regulatory considerations in assessments of interchangeability of biological drug products.” The European Journal of Health Economics, 2014.
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Wu, Yuh-Jenn, Te-Sheng Tan, Shein-Chung Chow, and Chin-Fu Hsiao. “Sample size estimation of multiregional clinical trials with heterogeneous variability across regions.” J Biopharm Stat 24, no. 2 (2014): 254–71. https://doi.org/10.1080/10543406.2013.859150.Full Text Link to Item
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Zhang, Nan, Jun Yang, Shein-Chung Chow, and Eric Chi. “Nonparametric tests for evaluation of biosimilarity in variability of follow-on biologics.” J Biopharm Stat 24, no. 6 (2014): 1239–53. https://doi.org/10.1080/10543406.2014.941991.Full Text Link to Item
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Wu, Y. J., T. S. Tan, S. C. Chow, and C. F. Hsiao. “Use of Random Effect Models in the Design and Analysis of Multi-regional Clinical Trials.” Springer Proceedings in Mathematics and Statistics 55 (October 28, 2013): 325–44. https://doi.org/10.1007/978-1-4614-7846-1_26.Full Text
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Zhang, Aijing, Jung-Ying Tzeng, and Shein-Chung Chow. “Statistical considerations in biosimilar assessment using biosimilarity index.” J Bioequivalence Bioavailab 5, no. 5 (September 2, 2013): 209–14. https://doi.org/10.4172/jbb.1000160.Full Text Link to Item
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Chow, S. C., and S. T. Chiu. “Sample Size and Data Monitoring for Clinical Trials With Extremely Low Incidence Rates.” Therapeutic Innovation and Regulatory Science 47, no. 4 (July 1, 2013): 438–46. https://doi.org/10.1177/2168479013489298.Full Text
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Lakey, Wanda, Lan-Yan Yang, William Yancy, Shein-Chung Chow, and Charles Hicks. “Short communication: from wasting to obesity: initial antiretroviral therapy and weight gain in HIV-infected persons.” Aids Res Hum Retroviruses 29, no. 3 (March 2013): 435–40. https://doi.org/10.1089/aid.2012.0234.Full Text Link to Item
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Kang, Seung-Ho, and Shein-Chung Chow. “Statistical assessment of biosimilarity based on relative distance between follow-on biologics.” Stat Med 32, no. 3 (February 10, 2013): 382–92. https://doi.org/10.1002/sim.5582.Full Text Link to Item
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Chow, Shein-Chung, Jun Wang, Laszlo Endrenyi, and Peter A. Lachenbruch. “Scientific considerations for assessing biosimilar products.” Stat Med 32, no. 3 (February 10, 2013): 370–81. https://doi.org/10.1002/sim.5571.Full Text Link to Item
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Chow, Shein-Chung, Lan-Yan Yang, Aijing Starr, and Shih-Ting Chiu. “Statistical methods for assessing interchangeability of biosimilars.” Stat Med 32, no. 3 (February 10, 2013): 442–48. https://doi.org/10.1002/sim.5566.Full Text Link to Item
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Chow, Shein-Chung, Laszlo Endrenyi, and Peter A. Lachenbruch. “Comments on the FDA draft guidance on biosimilar products.” Stat Med 32, no. 3 (February 10, 2013): 364–69. https://doi.org/10.1002/sim.5572.Full Text Link to Item
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Chow, Shein-Chung. “Assessing biosimilarity and interchangeability of biosimilar products.” Stat Med 32, no. 3 (February 10, 2013): 361–63. https://doi.org/10.1002/sim.5577.Full Text Link to Item
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Endrenyi, Laszlo, Chiann Chang, Shein-Chung Chow, and Laszlo Tothfalusi. “On the interchangeability of biologic drug products.” Stat Med 32, no. 3 (February 10, 2013): 434–41. https://doi.org/10.1002/sim.5569.Full Text Link to Item
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Hsieh, Tsung-Cheng, Shein-Chung Chow, Lan-Yan Yang, and Eric Chi. “The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics.” Stat Med 32, no. 3 (February 10, 2013): 406–14. https://doi.org/10.1002/sim.5570.Full Text Link to Item
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Lin, Jr-Rung, Shein-Chung Chow, Chih-Hsi Chang, Ya-Ching Lin, and Jen-pei Liu. “Application of the parallel line assay to assessment of biosimilar products based on binary endpoints.” Stat Med 32, no. 3 (February 10, 2013): 449–61. https://doi.org/10.1002/sim.5565.Full Text Link to Item
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Yang, Jun, Nan Zhang, Shein-Chung Chow, and Eric Chi. “An adapted F-test for homogeneity of variability in follow-on biological products.” Stat Med 32, no. 3 (February 10, 2013): 415–23. https://doi.org/10.1002/sim.5568.Full Text Link to Item
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Zhang, Nan, Jun Yang, Shein-Chung Chow, Laszlo Endrenyi, and Eric Chi. “Impact of variability on the choice of biosimilarity limits in assessing follow-on biologics.” Stat Med 32, no. 3 (February 10, 2013): 424–33. https://doi.org/10.1002/sim.5567.Full Text Link to Item
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Grieve, A. P., S. C. Chow, J. Curram, S. Dawe, L. O. Harnisch, N. R. Henig, H. M. J. Hung, et al. “Advancing clinical trial design in pulmonary hypertension.” Pulmonary Circulation 3, no. 1 (January 1, 2013): 217–25. https://doi.org/10.4103/2045-8932.109933.Full Text
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Noveck, Robert J., Pamela S. Douglas, Shein-Chung Chow, Barry Mangum, Shashidhar Kori, and Donald J. Kellerman. “Assessing acute systemic effects of an inhaled drug with serial echocardiography: a placebo-controlled comparison of inhaled and intravenous dihydroergotamine.” Drug Des Devel Ther 7 (2013): 619–25. https://doi.org/10.2147/DDDT.S44093.Full Text Open Access Copy Link to Item
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Chow, Shein-Chung, Chieh Chiang, Jen-pei Liu, and Chin-Fu Hsiao. “Statistical methods for bridging studies.” J Biopharm Stat 22, no. 5 (September 2012): 903–15. https://doi.org/10.1080/10543406.2012.701578.Full Text Link to Item
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Crump, John A., Habib O. Ramadhani, Anne B. Morrissey, Wilbrod Saganda, Mtumwa S. Mwako, Lan-Yan Yang, Shein-Chung Chow, et al. “Bacteremic disseminated tuberculosis in sub-saharan Africa: a prospective cohort study.” Clin Infect Dis 55, no. 2 (July 2012): 242–50. https://doi.org/10.1093/cid/cis409.Full Text Open Access Copy Link to Item
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Liu, J. P., J. R. Lin, and S. C. Chow. “Authors reply to the letter to the editor by L. Chen and Y. X. Liu.” Pharmaceutical Statistics 11, no. 4 (July 1, 2012): 343–45. https://doi.org/10.1002/pst.1518.Full Text
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Wang, Jun, and Shein-Chung Chow. “On the regulatory approval pathway of biosimilar products.” Pharmaceuticals (Basel) 5, no. 4 (March 30, 2012): 353–68. https://doi.org/10.3390/ph5040353.Full Text Link to Item
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Jung, Sin-Ho, and Shein-Chung Chow. “On sample size calculation for comparing survival curves under general hypothesis testing.” J Biopharm Stat 22, no. 3 (2012): 485–95. https://doi.org/10.1080/10543406.2010.550701.Full Text Link to Item
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Chow, Shein-Chung, Ralph Corey, and Min Lin. “On the independence of data monitoring committee in adaptive design clinical trials.” J Biopharm Stat 22, no. 4 (2012): 853–67. https://doi.org/10.1080/10543406.2012.676536.Full Text Link to Item
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Lu, Qingshu, Siu-Keung Tse, Shein-Chung Chow, and Min Lin. “Analysis of time-to-event data with nonuniform patient entry and loss to follow-up under a two-stage seamless adaptive design with weibull distribution.” J Biopharm Stat 22, no. 4 (2012): 773–84. https://doi.org/10.1080/10543406.2012.678528.Full Text Link to Item
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Clowse, Megan E. B., Susannah C. Copland, Tsung-Cheng Hsieh, Shein-Chung Chow, Gary S. Hoffman, Peter A. Merkel, Robert F. Spiera, et al. “Ovarian reserve diminished by oral cyclophosphamide therapy for granulomatosis with polyangiitis (Wegener's).” Arthritis Care Res (Hoboken) 63, no. 12 (December 2011): 1777–81. https://doi.org/10.1002/acr.20605.Full Text Link to Item
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Chow, Shein-Chung, and Ralph Corey. “Benefits, challenges and obstacles of adaptive clinical trial designs.” Orphanet J Rare Dis 6 (November 30, 2011): 79. https://doi.org/10.1186/1750-1172-6-79.Full Text Link to Item
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Chow, S. C. “Sample size calculations for clinical trials.” Wiley Interdisciplinary Reviews: Computational Statistics 3, no. 5 (September 1, 2011): 414–27. https://doi.org/10.1002/wics.155.Full Text
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Crump, John A., Habib O. Ramadhani, Anne B. Morrissey, Levina J. Msuya, Lan-Yan Yang, Shein-Chung Chow, Susan C. Morpeth, et al. “Invasive bacterial and fungal infections among hospitalized HIV-infected and HIV-uninfected children and infants in northern Tanzania.” Trop Med Int Health 16, no. 7 (July 2011): 830–37. https://doi.org/10.1111/j.1365-3156.2011.02774.x.Full Text Link to Item
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Chow, S. C. “Spot the difference.” Ebr European Biopharmaceutical Review, no. SUMMER 2011 (June 1, 2011).
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Yang, Lan-Yan, Yunchan Chi, and Shein-Chung Chow. “Statistical inference for clinical trials with binary responses when there is a shift in patient population.” J Biopharm Stat 21, no. 3 (May 2011): 437–52. https://doi.org/10.1080/10543406.2010.481803.Full Text Link to Item
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Li, Juan, Eric M. Chi, Chunyao Feng, and Shein-Chung Chow. “Imputation method adjusted for covariates for nonrespondents in instruments with applications.” J Biopharm Stat 21, no. 2 (March 2011): 342–54. https://doi.org/10.1080/10543406.2011.550114.Full Text Link to Item
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Crump, John A., Habib O. Ramadhani, Anne B. Morrissey, Wilbrod Saganda, Mtumwa S. Mwako, Lan-Yan Yang, Shein-Chung Chow, et al. “Invasive bacterial and fungal infections among hospitalized HIV-infected and HIV-uninfected adults and adolescents in northern Tanzania.” Clin Infect Dis 52, no. 3 (February 1, 2011): 341–48. https://doi.org/10.1093/cid/ciq103.Full Text Link to Item
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Cheng, Bin, and Shein-Chung Chow. “Assessing departure from dose linearity under a repeated measures incomplete block design.” Pharm Stat 10, no. 4 (2011): 357–62. https://doi.org/10.1002/pst.474.Full Text Link to Item
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Chow, S. C., L. Y. Yang, and Y. Lu. “Some controversial issues in clinical trials.” Drug Information Journal 45, no. 2 (2011): 163–74.
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Cheng, Bin, and Shein-Chung Chow. “On flexibility of adaptive designs and criteria for choosing a good one--a discussion of FDA draft guidance.” J Biopharm Stat 20, no. 6 (November 2010): 1171–77. https://doi.org/10.1080/10543406.2010.514460.Full Text Link to Item
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Chow, Shein-Chung. “A note on special articles on adaptive clinical trial designs.” J Biopharm Stat 20, no. 6 (November 2010): 1088–89. https://doi.org/10.1080/10543406.2010.514444.Full Text Link to Item
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Cheng, B., S. C. Chow, D. Burt, and D. Cosmatos. “Authors' response to "comment on: Cheng, Chow, Burt, and Cosmatos (2008). Statistical assessment of QT/QTc prolongation based on maximum of correlated normal random variables".” Journal of Biopharmaceutical Statistics 20, no. 5 (September 1, 2010): 1074. https://doi.org/10.1080/10543406.2010.494263.Full Text
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Chow, S. C. “Changing with the times.” Ebr European Biopharmaceutical Review, no. AUTUMN (September 1, 2010): 48–52.
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Richmond, Jacqueline A., Donald E. Bailey, Keyur Patel, Janet A. Jezsik, Andrew Muir, Jr-Rung Lin, Shein-Chung Chow, Diane Uzarski, and John G. McHutchison. “The use of complementary and alternative medicine by patients with chronic hepatitis C.” Complement Ther Clin Pract 16, no. 3 (August 2010): 124–31. https://doi.org/10.1016/j.ctcp.2009.10.004.Full Text Link to Item
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Lu, Qingshu, Siu Keung Tse, and Shein-Chung Chow. “Analysis of time-to-event data under a two-stage survival adaptive design in clinical trials.” J Biopharm Stat 20, no. 4 (July 2010): 705–19. https://doi.org/10.1080/10543401003618066.Full Text Link to Item
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Palmer, Scott M., Ajit P. Limaye, Missy Banks, Dianne Gallup, Jeffrey Chapman, E Clinton Lawrence, Jordan Dunitz, et al. “Extended valganciclovir prophylaxis to prevent cytomegalovirus after lung transplantation: a randomized, controlled trial.” Ann Intern Med 152, no. 12 (June 15, 2010): 761–69. https://doi.org/10.7326/0003-4819-152-12-201006150-00003.Full Text Link to Item
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Chow, S. C., and C. F. Hsiao. “Bridging diversity: Extrapolating foreign data to a new region.” Pharmaceutical Medicine 24, no. 6 (January 1, 2010): 349–62. https://doi.org/10.2165/11539610-000000000-00000.Full Text
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Chow, Shein-Chung, Qingshu Lu, Siu-Keung Tse, and Eric Chi. “Statistical methods for assessment of biosimilarity using biomarker data.” J Biopharm Stat 20, no. 1 (January 2010): 90–105. https://doi.org/10.1080/10543400903280373.Full Text Link to Item
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Chow, Shein-Chung, Tsung-Cheng Hsieh, Eric Chi, and Jun Yang. “A comparison of moment-based and probability-based criteria for assessment of follow-on biologics.” J Biopharm Stat 20, no. 1 (January 2010): 31–45. https://doi.org/10.1080/10543400903280308.Full Text Link to Item
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Chow, Shein-Chung, and Jen-Pei Liu. “Statistical assessment of biosimilar products.” J Biopharm Stat 20, no. 1 (January 2010): 10–30. https://doi.org/10.1080/10543400903280266.Full Text Link to Item
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Hsieh, Tsung-Cheng, Shein-Chung Chow, Jen-Pei Liu, Chin-Fu Hsiao, and Eric Chi. “Statistical test for evaluation of biosimilarity in variability of follow-on biologics.” J Biopharm Stat 20, no. 1 (January 2010): 75–89. https://doi.org/10.1080/10543400903367097.Full Text Link to Item
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Tsou, Hsiao-Hui, Shein-Chung Chow, KK Gordon Lan, Jen-Pei Liu, Mey Wang, Herng-Der Chern, Low-Tone Ho, Chao A. Hsiung, and Chin-Fu Hsiao. “Proposals of statistical consideration to evaluation of results for a specific region in multi-regional trials--Asian perspective.” Pharm Stat 9, no. 3 (2010): 201–6. https://doi.org/10.1002/pst.442.Full Text Link to Item
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Lu, Qingshu, Siu-Keung Tse, Shein-Chung Chow, and Jun Yang. “On assessing bioequivalence using genomic data with model misspecification.” J Biopharm Stat 19, no. 4 (July 2009): 571–79. https://doi.org/10.1080/10543400902963177.Full Text Link to Item
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Tse, Siu Keung, Shein Chung Chow, Qingshu Lu, and Dennis Cosmatos. “Testing homogeneity of two zero-inflated Poisson populations.” Biom J 51, no. 1 (February 2009): 159–70. https://doi.org/10.1002/bimj.200710490.Full Text Link to Item
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Lu, Qingshu, Shein Chung Chow, Siu Keung Tse, Yunchan Chi, and Lan Yan Yang. “Sample size estimation based on event data for a two-stage survival adaptive trial with different durations.” J Biopharm Stat 19, no. 2 (2009): 311–23. https://doi.org/10.1080/10543400802622527.Full Text Link to Item
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Hsiao, C. F., H. H. Tsou, A. Pong, J. P. Liu, C. H. Lin, Y. J. Chang, and S. C. Chow. “Statistical validation of traditional Chinese diagnostic procedures.” Drug Information Journal 43, no. 1 (2009): 83–95.
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Liu, J. P., S. C. Chow, and T. C. Hsieh. “Deviations from linearity in statistical evaluation of linearity in assay validation.” Journal of Chemometrics 23, no. 9 (January 1, 2009): 487–94. https://doi.org/10.1002/cem.1242.Full Text
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Liu, Jen-Pei, Jr-Rung Lin, and Shein-Chung Chow. “Inference on treatment effects for targeted clinical trials under enrichment design.” Pharm Stat 8, no. 4 (2009): 356–70. https://doi.org/10.1002/pst.364.Full Text Link to Item
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Chow, Shein-Chung, Siu-Keung Tse, and Min Lin. “Statistical methods in translational medicine.” J Formos Med Assoc 107, no. 12 Suppl (December 2008): 61–73. https://doi.org/10.1016/s0929-6646(09)60010-3.Full Text Link to Item
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Chow, Shein-Chung, and Yi-Hsuan Tu. “On Two-stage Seamless Adaptive Design in Clinical Trials.” J Formos Med Assoc 107, no. 12 Suppl (December 2008): 52–60. https://doi.org/10.1016/s0929-6646(09)60009-7.Full Text Link to Item
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Tse, Siu-Keung, Shein-Chung Chow, and Chunyan Yang. “Statistical tests for one-way/two-way translation in translational medicine.” J Formos Med Assoc 107, no. 12 Suppl (December 2008): 43–51. https://doi.org/10.1016/s0929-6646(09)60008-5.Full Text Link to Item
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Chow, Shein-Chung, and Mark Chang. “Adaptive design methods in clinical trials - a review.” Orphanet J Rare Dis 3 (May 2, 2008): 11. https://doi.org/10.1186/1750-1172-3-11.Full Text Link to Item
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Chang, M., and S. C. Chow. “Strategies for adaptive designs with multiple endpoints (Journal of Biopharmaceutical Statistics 17:6 (1189-1200)).” Journal of Biopharmaceutical Statistics 18, no. 2 (March 1, 2008): 402. https://doi.org/10.1080/10543400802013800.Full Text
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Jung, S. H., C. Kim, and S. C. Chow. “Sample size calculation for the log-rank tests for multi-arm trials with a control.” Journal of the Korean Statistical Society 37, no. 1 (March 1, 2008): 11–22. https://doi.org/10.1016/j.jkss.2007.11.001.Full Text
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Cheng, Bin, Shein-Chung Chow, David Burt, and Dennis Cosmatos. “Statistical assessment of QT/QTc prolongation based on maximum of correlated normal random variables.” J Biopharm Stat 18, no. 3 (2008): 494–501. https://doi.org/10.1080/10543400802020987.Full Text Link to Item
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Chow, Shein-Chung, Bin Cheng, and Dennis Cosmatos. “On power and sample size calculation for QT studies with recording replicates at given time point.” J Biopharm Stat 18, no. 3 (2008): 483–93. https://doi.org/10.1080/10543400801995452.Full Text Link to Item
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Liu, Jen-pei, and Shein-chung Chow. “Statistical issues on the diagnostic multivariate index assay for targeted clinical trials.” J Biopharm Stat 18, no. 1 (2008): 167–82. https://doi.org/10.1080/10543400701668316.Full Text Link to Item
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Chow, S. C., S. K. Tse, C. Yang, D. Cosmatos, and E. Chi. “Statistical test for ordered categorical data in clinical trials.” Drug Information Journal 42, no. 6 (2008): 617–24.
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Tsou, H. H., C. F. Hsiao, S. C. Chow, and J. P. Liu. “A two-stage design for drug screening trials based on continuous endpoints.” Drug Information Journal 42, no. 3 (2008): 253–62.
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Shao, J., and S. C. Chow. “Variable screening in predicting clinical outcome with high-dimensional microarrays.” Journal of Multivariate Analysis 98, no. 8 (September 1, 2007): 1529–38. https://doi.org/10.1016/j.jmva.2004.12.004.Full Text
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Chow, Shein-Chung, and Jun Shao. “Stability analysis for drugs with multiple active ingredients.” Stat Med 26, no. 7 (March 30, 2007): 1512–17. https://doi.org/10.1002/sim.2696.Full Text Link to Item
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Chang, Mark, and Shein-Chung Chow. “Analysis strategies for adaptive designs with multiple endpoints.” J Biopharm Stat 17, no. 6 (2007): 1189–1200. https://doi.org/10.1080/10543400701645348.Full Text Link to Item
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Chow, Shein-Chung, Qingshu Lu, and Siu-Keung Tse. “Statistical analysis for two-stage seamless design with different study endpoints.” J Biopharm Stat 17, no. 6 (2007): 1163–76. https://doi.org/10.1080/10543400701645249.Full Text Link to Item
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Feng, Huaibao, Jun Shao, and Shein-Chung Chow. “Adaptive group sequential test for clinical trials with changing patient population.” J Biopharm Stat 17, no. 6 (2007): 1227–38. https://doi.org/10.1080/10543400701645512.Full Text Link to Item
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Jung, Sin-Ho, Shein-Chung Chow, and Eric M. Chi. “A note on sample size calculation based on propensity analysis in nonrandomized trials.” J Biopharm Stat 17, no. 1 (2007): 35–41. https://doi.org/10.1080/10543400601044790.Full Text Link to Item
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Lu, Qingshu, Shein Chung Chow, and Siu Keung Tse. “Assessing the consistency of traditional Chinese medicine with multiple correlative active components.” J Biopharm Stat 17, no. 5 (2007): 791–808. https://doi.org/10.1080/10543400701513934.Full Text Link to Item
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Tsou, Hsiao-Hui, Chin-Fu Hsiao, Shein-Chung Chow, Lilly Yue, Yunling Xu, and Shiowjen Lee. “Mixed noninferiority margin and statistical tests in active controlled trials.” J Biopharm Stat 17, no. 2 (2007): 339–57. https://doi.org/10.1080/10543400601183861.Full Text Link to Item
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Chang, Mark, Shein-Chung Chow, and Annpey Pong. “Adaptive design in clinical research: issues, opportunities, and recommendations.” J Biopharm Stat 16, no. 3 (May 2006): 299–309. https://doi.org/10.1080/10543400600609718.Full Text Link to Item
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Cheng, Bin, Shein-Chung Chow, and Wei-Lun Su. “On the assessment of dose proportionality: a comparison of two slope approaches.” J Biopharm Stat 16, no. 3 (May 2006): 385–92. https://doi.org/10.1080/10543400600629906.Full Text Link to Item
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Chow, S. C. “Editor's note - JBS is now an SCI journal.” Journal of Biopharmaceutical Statistics 16, no. 3 (May 1, 2006): 273–74. https://doi.org/10.1080/10543400600653385.Full Text
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Shao, J., and S. C. Chow. “Author's reply [4].” Statistics in Medicine 25, no. 8 (April 30, 2006): 1437–38. https://doi.org/10.1002/sim.2348.Full Text
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Chow, Shein-Chung, and Jun Shao. “On non-inferiority margin and statistical tests in active control trials.” Stat Med 25, no. 7 (April 15, 2006): 1101–13. https://doi.org/10.1002/sim.2208.Full Text Link to Item
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Chow, S. C., A. Pong, and Y. W. Chang. “On traditional Chinese medicine clinical trials.” Drug Information Journal 40, no. 4 (January 1, 2006): 395–406. https://doi.org/10.1177/216847900604000404.Full Text
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Tse, Siu-Keung, Jang-Yang Chang, Wei-Lun Su, Shein-Chung Chow, Chao Hsiung, and Qingshu Lu. “Statistical quality control process for traditional Chinese medicine.” J Biopharm Stat 16, no. 6 (2006): 861–74. https://doi.org/10.1080/10543400600808047.Full Text Link to Item
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Shao, Jun, Mark Chang, and Shein-Chung Chow. “Statistical inference for cancer trials with treatment switching.” Stat Med 24, no. 12 (June 30, 2005): 1783–90. https://doi.org/10.1002/sim.2128.Full Text Link to Item
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Ganju, Jitendra. “Analysis of clinical data with breached blindness: by Shein-Chung Chow and Jun Shao Statistics in Medicine 2004; 23:1185-1193.” Stat Med 24, no. 5 (March 15, 2005): 819–21. https://doi.org/10.1002/sim.1944.Full Text Link to Item
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Singer, Julia. “A practical approach for comparing means of two groups without equal variance assumption: H. Wang and S. Chow, Statistics in Medicine 2002; 21:3137-3151.” Stat Med 24, no. 5 (March 15, 2005): 817–18. https://doi.org/10.1002/sim.1531.Full Text Link to Item
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Chow, S. C. “Journal of Biopharmaceutical Statistics: Editor's note.” Journal of Biopharmaceutical Statistics 15, no. 1 (January 31, 2005): 1–2. https://doi.org/10.1081/B1P-200040798.Full Text
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Chang, Mark, and Shein-Chung Chow. “A hybrid Bayesian adaptive design for dose response trials.” J Biopharm Stat 15, no. 4 (2005): 677–91. https://doi.org/10.1081/BIP-200062288.Full Text Link to Item
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Chow, Shein-Chung, Mark Chang, and Annpey Pong. “Statistical consideration of adaptive methods in clinical development.” J Biopharm Stat 15, no. 4 (2005): 575–91. https://doi.org/10.1081/BIP-200062277.Full Text Link to Item
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Chow, Shein-Chung, and Jun Shao. “Inference for clinical trials with some protocol amendments.” J Biopharm Stat 15, no. 4 (2005): 659–66. https://doi.org/10.1081/BIP-200062286.Full Text Link to Item
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Wang, Hansheng, Shein-Chung Chow, and Murphy Chen. “A Bayesian approach on sample size calculation for comparing means.” J Biopharm Stat 15, no. 5 (2005): 799–807. https://doi.org/10.1081/BIP-200067789.Full Text Link to Item
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Chow, Shein-Chung, Jun Shao, and Li Li. “Assessing bioequivalence using genomic data.” J Biopharm Stat 14, no. 4 (November 2004): 869–80. https://doi.org/10.1081/BIP-200035420.Full Text Link to Item
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Li, Li, Shein-Chung Chow, and Woollcott Smith. “Cross-validation for linear model with unequal variances in genomic analysis.” J Biopharm Stat 14, no. 3 (August 2004): 723–39. https://doi.org/10.1081/bip-200025679.Full Text Link to Item
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Lee, Y., J. Shao, and S. C. Chow. “Modified large-sample confidence intervals for linear combinations of variance components: Extension, theory, and application.” Journal of the American Statistical Association 99, no. 466 (June 1, 2004): 467–78. https://doi.org/10.1198/016214504000000322.Full Text
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Chow, Shein-Chung, and Jun Shao. “Analysis of clinical data with breached blindness.” Stat Med 23, no. 8 (April 30, 2004): 1185–93. https://doi.org/10.1002/sim.1694.Full Text Link to Item
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Wang, Hansheng, Bin Chen, and Shein-Chung Chow. “Sample size determination based on rank tests in clinical trials.” J Biopharm Stat 13, no. 4 (November 2003): 735–51. https://doi.org/10.1081/BIP-120024206.Full Text Link to Item
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Chow, Shein-Chung, and Jun Shao. “Stability analysis with discrete responses.” J Biopharm Stat 13, no. 3 (August 2003): 451–62. https://doi.org/10.1081/BIP-120022766.Full Text Link to Item
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Chow, S. C., J. Shao, and H. Wang. “Statistical tests for population bioequivalence.” Statistica Sinica 13, no. 2 (April 1, 2003): 539–54.
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Swenson, Christine E., Lois E. Bolcsak, Gerald Batist, Troy H. Guthrie, Katherine H. Tkaczuk, Harold Boxenbaum, Lauri Welles, Shein-Chung Chow, Rupinder Bhamra, and Philip Chaikin. “Pharmacokinetics of doxorubicin administered i.v. as Myocet (TLC D-99; liposome-encapsulated doxorubicin citrate) compared with conventional doxorubicin when given in combination with cyclophosphamide in patients with metastatic breast cancer.” Anticancer Drugs 14, no. 3 (March 2003): 239–46. https://doi.org/10.1097/00001813-200303000-00008.Full Text Link to Item
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Wang, Wenping, and Shein-Chung Chow. “Examining outlying subjects and outlying records in bioequivalence trials.” J Biopharm Stat 13, no. 1 (February 2003): 43–56. https://doi.org/10.1081/BIP-120017725.Full Text Link to Item
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Chow, Shein-Chung, Jun Shao, and Hansheng Wang. “In vitro bioequivalence testing.” Stat Med 22, no. 1 (January 15, 2003): 55–68. https://doi.org/10.1002/sim.1345.Full Text Link to Item
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Chow, Shein-Chung, Jun Shao, and Hansheng Wang. “A note on sample size calculation for mean comparisons based on noncentral t-statistics.” J Biopharm Stat 12, no. 4 (November 2002): 441–56. https://doi.org/10.1081/BIP-120016229.Full Text Link to Item
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Lee, Yonghee, Jun Shao, Shein-Chung Chow, and Hansheng Wang. “Tests for inter-subject and total variabilities under crossover designs.” J Biopharm Stat 12, no. 4 (November 2002): 503–34. https://doi.org/10.1081/BIP-120016233.Full Text Link to Item
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Wang, Hansheng, Shein-Chung Chow, and Gang Li. “On sample size calculation based on odds ratio in clinical trials.” J Biopharm Stat 12, no. 4 (November 2002): 471–83. https://doi.org/10.1081/BIP-120016231.Full Text Link to Item
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Wang, Hansheng, and Shein-Chung Chow. “A practical approach for comparing means of two groups without equal variance assumption.” Stat Med 21, no. 20 (October 30, 2002): 3137–51. https://doi.org/10.1002/sim.1238.Full Text Link to Item
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Chow, Shein-Chung, and Jun Shao. “A note on statistical methods for assessing therapeutic equivalence.” Control Clin Trials 23, no. 5 (October 2002): 515–20. https://doi.org/10.1016/s0197-2456(02)00222-2.Full Text Link to Item
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Chow, Shein-Chung, Jun Shao, and Oliver Yoa-Pu Hu. “Assessing sensitivity and similarity in bridging studies.” J Biopharm Stat 12, no. 3 (August 2002): 385–400. https://doi.org/10.1081/bip-120014567.Full Text Link to Item
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Chow, Shein-Chung, and Jun Shao. “On the assessment of similarity for dissolution profiles of two drug products.” J Biopharm Stat 12, no. 3 (August 2002): 311–21. https://doi.org/10.1081/bip-120014561.Full Text Link to Item
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Wan, Hansheng, and Shein-Chung Chow. “On statistical power for average bioequivalence testing under replicated crossover designs.” J Biopharm Stat 12, no. 3 (August 2002): 295–309. https://doi.org/10.1081/bip-120014560.Full Text Link to Item
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Liu, Jen-pei, and Shein-Chung Chow. “Bridging studies in clinical development.” J Biopharm Stat 12, no. 3 (August 2002): 359–67. https://doi.org/10.1081/bip-120014564.Full Text Link to Item
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Shao, Jun, and Shein-Chung Chow. “Reproducibility probability in clinical trials.” Stat Med 21, no. 12 (June 30, 2002): 1727–42. https://doi.org/10.1002/sim.1177.Full Text Link to Item
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Chow, Shein-Chung, Jun Shao, and Hansheng Wang. “Individual bioequivalence testing under 2x3 designs.” Stat Med 21, no. 5 (March 15, 2002): 629–48. https://doi.org/10.1002/sim.1056.Full Text Link to Item
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Chow, Shein-Chung, Jun Shao, and Hansheng Wang. “Probability lower bounds for USP/NF tests.” J Biopharm Stat 12, no. 1 (February 2002): 79–92. https://doi.org/10.1081/bip-120005781.Full Text Link to Item
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Blood, Peter. “Sample size calculation in bioequivalence trials.” J Pharmacokinet Pharmacodyn 29, no. 1 (February 2002): 95–97. https://doi.org/10.1023/a:1015724919784.Full Text Link to Item
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Chow, S. C. “Journal of Biopharmaceutical Statistics: Editor's note.” Journal of Biopharmaceutical Statistics 12, no. 3 (January 1, 2002).
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Sénéchal, S., O. Fahy, T. Gentina, H. Vorng, M. Capron, A. F. McEuen, M. G. Buckley, et al. “On sample size calculation in bioequivalence trials (Journal of Pharmacokinetics and Pharmacodynamics (2001) 28 (155-169)).” Journal of Pharmacokinetics and Pharmacodynamics 29, no. 1 (January 1, 2002): 101–2. https://doi.org/10.1023/A:1017454820693.Full Text
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Shao, J., and S. C. Chow. “Drug shelf-life estimation.” Statistica Sinica 11, no. 3 (July 1, 2001): 737–45.
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Shao, J., and S. C. Chow. “Two-phase shelf-life estimation.” Stat Med 20, no. 8 (April 30, 2001): 1239–48. https://doi.org/10.1002/sim.783.Full Text Link to Item
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Chow, S. C., and H. Wang. “On sample size calculation in bioequivalence trials.” J Pharmacokinet Pharmacodyn 28, no. 2 (April 2001): 155–69. https://doi.org/10.1023/a:1011503032353.Full Text Link to Item
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Chow, S. C., and J. P. Liu. “Preface. Bioequilavence measures.” Stat Med 19, no. 20 (October 30, 2000): 2719. https://doi.org/10.1002/1097-0258(20001030)19:20<2719::aid-sim540>3.0.co;2-p.Full Text Link to Item
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Shao, J., S. C. Chow, and B. Wang. “The bootstrap procedure in individual bioequivalence.” Stat Med 19, no. 20 (October 30, 2000): 2741–54. https://doi.org/10.1002/1097-0258(20001030)19:20<2741::aid-sim542>3.0.co;2-3.Full Text Link to Item
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Chow, S. C., J. Shao, and H. T. Ho. “On statistical analysis for placebo-challenging designs in clinical trials.” Stat Med 19, no. 8 (April 30, 2000): 1029–37. https://doi.org/10.1002/(sici)1097-0258(20000430)19:8<1029::aid-sim416>3.0.co;2-s.Full Text Link to Item
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Sun, Y., S. C. Chow, G. Li, and K. W. Chen. “Assessing distributions of estimated drug shelf lives in stability analysis.” Biometrics 55, no. 3 (September 1999): 896–99. https://doi.org/10.1111/j.0006-341x.1999.00896.x.Full Text Link to Item
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Chow, S. C., and J. Shao. “Bioequivalence review for drug interchangeability.” J Biopharm Stat 9, no. 3 (August 1999): 485–97. https://doi.org/10.1081/BIP-100101189.Full Text Link to Item
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Chow, S. C. “Individual bioequivalence - A review of the FDA draft guidance.” Drug Information Journal 33, no. 2 (1999): 435–44.
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Chow, S. C., and A. Pong. “An overview of the regulatory approval process in drug development.” Drug Information Journal 32, no. 4 SUPPL. (January 1, 1998). https://doi.org/10.1177/00928615980320s102.Full Text
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Ho, H. T., and S. C. Chow. “Design and analysis of multinational clinical trials.” Drug Information Journal 32, no. 4 SUPPL. (January 1, 1998). https://doi.org/10.1177/00928615980320s126.Full Text
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Chen, K. W., S. C. Chow, and G. Li. “A note on sample size determination for bioequivalence studies with high-order crossover designs.” J Pharmacokinet Biopharm 25, no. 6 (December 1997): 753–65. https://doi.org/10.1023/a:1025738019069.Full Text Link to Item
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Chow, S. C., and J. Shao. “Statistical methods for two-sequence three-period cross-over designs with incomplete data.” Stat Med 16, no. 9 (May 15, 1997): 1031–39. https://doi.org/10.1002/(sici)1097-0258(19970515)16:9<1031::aid-sim519>3.0.co;2-6.Full Text Link to Item
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Chow, S. C., and F. Y. Ki. “Statistical comparison between dissolution profiles of drug products.” J Biopharm Stat 7, no. 2 (May 1997): 241–58. https://doi.org/10.1080/10543409708835184.Full Text Link to Item
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Chow, S. C., and J. Liu. “Meta-analysis for bioequivalence review.” J Biopharm Stat 7, no. 1 (March 1997): 97–111. https://doi.org/10.1080/10543409708835172.Full Text Link to Item
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Liu, J., and S. C. Chow. “A two one-sided tests procedure for assessment of individual bioequivalence.” J Biopharm Stat 7, no. 1 (March 1997): 49–61. https://doi.org/10.1080/10543409708835169.Full Text Link to Item
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Liu, J., and S. C. Chow. “Some thoughts on individual bioequivalence.” J Biopharm Stat 7, no. 1 (March 1997): 41–48. https://doi.org/10.1080/10543409708835168.Full Text Link to Item
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Wang, W., F. Hsuan, and S. C. Chow. “An adjusted two one-sided t-test for the assessment of bioequivalence with multiple doses.” J Biopharm Stat 7, no. 1 (March 1997): 157–70. https://doi.org/10.1080/10543409708835176.Full Text Link to Item
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Chen, K. W., A. S. Papadopoulos, and S. C. Chow. “On the test of Liu and Chow's procedure for assessing equivalence in variability of bioavailability.” Communications in Statistics Part B: Simulation and Computation 26, no. 3 (January 1, 1997): 1129–38. https://doi.org/10.1080/03610919708813430.Full Text
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Chen, K. W., G. Li, Y. Sun, and S. C. Chow. “Interval estimation for ratios in bioequivalence trials.” Biometrical Journal 39, no. 8 (January 1, 1997): 989–1002. https://doi.org/10.1002/bimj.4710390809.Full Text
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Chow, S. C. “Good statistics practice in the drug development and regulatory approval process.” Therapeutic Innovation &Amp; Regulatory Science 31, no. 4 (January 1, 1997): 1157–66. https://doi.org/10.1177/009286159703100414.Full Text
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Chow, S. C. “Pharmaceutical validation and process controls in drug development.” Therapeutic Innovation &Amp; Regulatory Science 31, no. 4 (January 1, 1997): 1195–1201. https://doi.org/10.1177/009286159703100419.Full Text
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Pong, A., and S. C. Chow. “Statistical/practical issues in clinical trials.” Therapeutic Innovation &Amp; Regulatory Science 31, no. 4 (January 1, 1997): 1167–74. https://doi.org/10.1177/009286159703100415.Full Text
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Ju, H. L., and S. C. Chow. “An overview of stability studies.” Journal of Food and Drug Analysis 4, no. 2 (June 1, 1996): 104–6.
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Wang, W., F. Husan, and S. C. Chow. “The impact of patient compliance on drug concentration profile in multiple doses.” Stat Med 15, no. 6 (March 30, 1996): 659–69. https://doi.org/10.1002/(SICI)1097-0258(19960330)15:6<659::AID-SIM207>3.0.CO;2-E.Full Text Link to Item
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Chow, S. C., and F. Y. Ki. “Statistical issues in quality-of-life assessment.” J Biopharm Stat 6, no. 1 (March 1996): 37–48. https://doi.org/10.1080/10543409608835120.Full Text Link to Item
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Ju, L. H., and S. C. Chow. “A procedure for weight and model selection in assay development.” Journal of Food and Drug Analysis 4, no. 1 (March 1, 1996): 1–12.
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Srinivas, N. R., W. H. Barr, W. C. Shyu, E. Mohandoss, S. Chow, J. Staggers, G. Balan, F. J. Belas, I. A. Blair, and R. H. Barbhaiya. “Bioequivalence of two tablet formulations of nadolol using single and multiple dose data: assessment using stereospecific and nonstereospecific assays.” J Pharm Sci 85, no. 3 (March 1996): 299–303. https://doi.org/10.1021/js950442m.Full Text Link to Item
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Chen, K. W., G. Li, Y. Sun, and S. C. Chow. “A confidence region approach for assessing equivalence in variability of bioavailability.” Biometrical Journal 38, no. 4 (January 1, 1996): 475–87. https://doi.org/10.1002/bimj.4710380413.Full Text
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Liu, J. P., and S. C. Chow. “Statistical issues on the FDA conjugated estrogen tablets bioequivalence guidance.” Drug Information Journal 30, no. 4 (1996): 881–89.
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Liu, J. P., and S. C. Chow. “Comment.” Statistical Science 11, no. 4 (January 1, 1996): 306–12.
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hu, O. Y. P., and S. C. Chow. “Guest editor's note: Practical and regulatory issues on new drug, new dosage form, and generic Drug Development.” Therapeutic Innovation &Amp; Regulatory Science 31, no. 4 (January 1, 1996): 1145–47. https://doi.org/10.1177/009286159703100411.Full Text
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Wang, W., S. C. Chow, and W. W. Wei. “On likelihood distance for outliers detection.” J Biopharm Stat 5, no. 3 (November 1995): 307–22. https://doi.org/10.1080/10543409508835116.Full Text Link to Item
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Ju, H. L., and S. C. Chow. “On stability designs in drug shelf-life estimation.” J Biopharm Stat 5, no. 2 (July 1995): 201–14. https://doi.org/10.1080/10543409508835108.Full Text Link to Item
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Ki, F. Y., J. P. Liu, W. Wang, and S. C. Chow. “The impact of outlying subjects on decision of bioequivalence.” J Biopharm Stat 5, no. 1 (March 1995): 71–94. https://doi.org/10.1080/10543409508835099.Full Text Link to Item
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Chow, S. C. “Guest editor's note: Bioavailability and bioequivalence.” Therapeutic Innovation &Amp; Regulatory Science 29, no. 3 (January 1, 1995): 793–94. https://doi.org/10.1177/009286159502900301.Full Text
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Chow, S. C., and J. P. Liu. “Current issues in bioequivalence trials.” Drug Information Journal 29, no. 3 (1995): 795–804.
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Liu, J. P., and S. C. Chow. “Replicated crossover designs in bioavailability and bioequivalence trials.” Drug Information Journal 29, no. 3 (1995): 871–84.
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Mohandoss, E., S. C. Chow, and F. Y. C. Ki. “Application of Williams' design for bioequivalence trials.” Drug Information Journal 29, no. 3 (1995): 1029–38.
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Tse, S. K., and S. C. Chow. “On model selection for standard curve in assay development.” Journal of Biopharmaceutical Statistics 5, no. 3 (1995): 285–96.
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Wang, S. G., S. C. Chow, and S. K. Tse. “On ordinary least-squares methods for sample surveys.” Statistics and Probability Letters 20, no. 3 (June 22, 1994): 173–82. https://doi.org/10.1016/0167-7152(94)90039-6.Full Text
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Chow, S. C., and F. Y. Ki. “On statistical characteristics of quality of life assessment.” J Biopharm Stat 4, no. 1 (March 1994): 1–17. https://doi.org/10.1080/10543409408835068.Full Text Link to Item
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Chow, S. C., and J. P. Liu. “Statistical considerations in bioequivalence trials.” Communications in Statistics Theory and Methods 23, no. 2 (January 1, 1994): 325–39. https://doi.org/10.1080/03610929408831258.Full Text
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Chow, S. C., and J. P. Liu. “Recent statistical developments in bioequivalence trials - A review of the FDA guidance.” Drug Information Journal 28, no. 3 (January 1, 1994): 851–64. https://doi.org/10.1177/009286159402800321.Full Text
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Chow, S. C., and S. G. Wang. “On the estimation of variance components in stability analysis.” Communications in Statistics Theory and Methods 23, no. 1 (January 1, 1994): 289–303. https://doi.org/10.1080/03610929408831254.Full Text
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Shao, J., and S. C. Chow. “Statistical inference in stability analysis.” Biometrics 50, no. 3 (January 1, 1994): 753–63. https://doi.org/10.2307/2532789.Full Text
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Shao, J., and S. C. Chow. “Two-stage sampling in pharmaceutical applications.” Stat Med 12, no. 21 (November 15, 1993): 1999–2008. https://doi.org/10.1002/sim.4780122104.Full Text Link to Item
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Liu, J. ‐., and S. ‐. Chow. “On Assessment of Bioequivalence for Drugs with Negligible Plasma Levels.” Biometrical Journal 35, no. 1 (January 1, 1993): 109–23. https://doi.org/10.1002/bimj.4710350111.Full Text
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Liu, J. P., and S. C. Chow. “Sample size determination for the two one-sided tests procedure in bioequivalence.” J Pharmacokinet Biopharm 20, no. 1 (February 1992): 101–4. https://doi.org/10.1007/BF01143188.Full Text Link to Item
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Goutis, C., and T. Fearn. “Test for batch-to-batch variation in stability analysis.” Stat Med 11, no. 2 (January 30, 1992): 269–70. https://doi.org/10.1002/sim.4780110213.Full Text Link to Item
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Chow, S. C., and J. P. Liu. “On assessment of bioequivalence under a higher-order crossover design.” J Biopharm Stat 2, no. 2 (1992): 239–56. https://doi.org/10.1080/10543409208835042.Full Text Link to Item
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Chow, S. C., and S. K. Tse. “Correction: Outlier detection in bioavailability/bioequivalence studies (Statistics in Medicine (1990) 9 (549-558)).” Statistics in Medicine 11, no. 3 (January 1, 1992): 425.
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Liu, J. P., and S. C. Chow. “On the assessment of variability in bioavailability/bioequivalence studies.” Communications in Statistics Theory and Methods 21, no. 9 (January 1, 1992): 2591–2607. https://doi.org/10.1080/03610929208830932.Full Text
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Deeter, R. G., D. L. Kalman, M. P. Rogan, and S. C. Chow. “Therapy for pharyngitis and tonsillitis caused by group A beta-hemolytic streptococci: a meta-analysis comparing the efficacy and safety of cefadroxil monohydrate versus oral penicillin V.” Clin Ther 14, no. 5 (1992): 740–54.Link to Item
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Chow, S. C., and S. K. Tse. “On the estimation of total variability in assay validation.” Stat Med 10, no. 10 (October 1991): 1543–53. https://doi.org/10.1002/sim.4780101006.Full Text Link to Item
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Chow, S. C., and J. Shao. “Estimating drug shelf-life with random batches.” Biometrics 47, no. 3 (September 1991): 1071–79.Link to Item
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Chow, S. C. “Erratum: Alternative approaches for assessing bioequivalence regarding normality assumptions (Drug Information Journal (1990;24(4):(753-762)).” Drug Information Journal 25, no. 1 (January 1, 1991): 161.
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Chow, S. C., K. E. Peace, and J. Shao. “Assessment of bioequivalence using a multiplicative model.” J Biopharm Stat 1, no. 2 (1991): 193–203. https://doi.org/10.1080/10543409108835018.Full Text Link to Item
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Chow, S. C., and E. V. Nordheim. “The estimation of parameters from bulked samples.” J Biopharm Stat 1, no. 1 (1991): 1–15. https://doi.org/10.1080/10543409108835002.Full Text Link to Item
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Chow, S. C., and S. K. Tse. “Outlier detection in bioavailability/bioequivalence studies.” Stat Med 9, no. 5 (May 1990): 549–58. https://doi.org/10.1002/sim.4780090508.Full Text Link to Item
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Chow, S. C. “Alternative approaches for assessing bioequivalence regarding normality assumptions.” Drug Information Journal 24, no. 4 (January 1, 1990): 753–62. https://doi.org/10.1177/216847909002400411.Full Text
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Chow, S. ‐., and J. Shao. “An Alternative Approach for the Assessment of Bioequivalence Between Two Formulations of a Drug.” Biometrical Journal 32, no. 8 (January 1, 1990): 969–76. https://doi.org/10.1002/bimj.4710320810.Full Text
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Chow, S. ‐., and S. ‐. Tse. “A Related Problem in Bioavailability/Bioequivalence Studies — Estimation of the Intrasubject Variability With a Common CV.” Biometrical Journal 32, no. 5 (January 1, 1990): 597–607. https://doi.org/10.1002/bimj.4710320511.Full Text
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Wang, S. G., S. K. Tse, and S. C. Chow. “On the measures of multicollinearity in least squares regression.” Statistics and Probability Letters 9, no. 4 (January 1, 1990): 347–55. https://doi.org/10.1016/0167-7152(90)90145-W.Full Text
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Wang, S. G., and S. C. Chow. “A note on adaptive generalized ridge regression estimator.” Statistics and Probability Letters 10, no. 1 (January 1, 1990): 17–21. https://doi.org/10.1016/0167-7152(90)90106-H.Full Text
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Shao, J., and S. ‐. Chow. “TEST FOR TREATMENT EFFECT BASED ON BINARY DATA WITH RANDOM SAMPLE SIZES.” Australian Journal of Statistics 32, no. 1 (January 1, 1990): 53–70. https://doi.org/10.1111/j.1467-842X.1990.tb00999.x.Full Text
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Chow, S. C., and J. Shao. “Test for batch-to-batch variation in stability analysis.” Stat Med 8, no. 7 (July 1989): 883–90. https://doi.org/10.1002/sim.4780080712.Full Text Link to Item
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Chow, S. C., and J. Shao. “A new procedure for the estimation of variance components.” Statistics and Probability Letters 6, no. 5 (January 1, 1988): 349–55. https://doi.org/10.1016/0167-7152(88)90012-0.Full Text
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Book Sections
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Chan, C., M. G. Hudgens, and S. C. Chow. “Preface,” xi–xv, 2017. https://doi.org/10.1201/9781315120805.Full Text
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Endrenyi, L., P. J. Declerck, and S. C. Chow. “Biosimilar drug product development,” 1–477, 2017. https://doi.org/10.1201/9781315119878.Full Text
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Chow, S. C., and A. Pong. “[title field missing].” In Handbook of Adaptive Designs in Pharmaceutical and Clinical Development, 2016.
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Chow, S. C., and A. Pong. “[title field missing].” In Handbook of Adaptive Designs in Pharmaceutical and Clinical Development, 2016.
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Pong, A., and S. C. Chow. “[title field missing].” In Handbook of Adaptive Designs in Pharmaceutical and Clinical Development, 2016.
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Tse, S. K., S. C. Chow, and Q. Lu. “[title field missing].” In Handbook of Adaptive Designs in Pharmaceutical and Clinical Development, 2016.
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Chow, S. C., and A. Pong. “Statistics in biopharmaceutical research and development.” In Advanced Medical Statistics, 507–610, 2015. https://doi.org/10.1142/9789814583312_0014.Full Text
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Pong, A., and S. C. Chow. “Adaptive trial design in clinical research.” In Advanced Medical Statistics, 803–33, 2015. https://doi.org/10.1142/9789814583312_0020.Full Text
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Wang, H., and S. C. Chow. “Sample Size for Comparing Variabilities.” In Methods and Applications of Statistics in Clinical Trials, 2:672–88, 2014. https://doi.org/10.1002/9781118596333.ch42.Full Text
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Wang, H., and S. C. Chow. “Sample Size for Comparing Proportions.” In Methods and Applications of Statistics in Clinical Trials, 2:653–63, 2014. https://doi.org/10.1002/9781118596333.ch40.Full Text
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Wang, H., and S. C. Chow. “Sample Size for Comparing Time-to-Event Data.” In Methods and Applications of Statistics in Clinical Trials, 2:664–71, 2014. https://doi.org/10.1002/9781118596333.ch41.Full Text
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Wang, H., and S. C. Chow. “Sample Size for Comparing Means.” In Methods and Applications of Statistics in Clinical Trials, 2:642–52, 2014. https://doi.org/10.1002/9781118596333.ch39.Full Text
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Chow, S. C., Y. Lu, and L. Y. Yang. “Assessing similarity using the reproducibility and generalizability probabilities and the sensitivity index.” In Design and Analysis of Bridging Studies, 49–78, 2012.
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Chow, S. C., and C. F. Hsiao. “Bridging diversity: Extrapolating foreign data to a new region.” In Design and Analysis of Bridging Studies, 1–16, 2012.
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Conference Papers
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Joshi, S., S. Vaishnavi, A. Brucker, A. Taylor, S. Jessica, T. Harshbarger, S. -. C. Chow, and P. Lee. “Targeting Healthcare Provider Burnout During the COVID-19 Pandemic.” In C14. Burnout, Disparities, and Outcomes of the Covid 19 Pandemic. American Thoracic Society, 2022. https://doi.org/10.1164/ajrccm-conference.2022.205.1_meetingabstracts.a3690.Full Text
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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.Full Text Link to Item
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Barwick, N Rebecca, Corey Fowler, Tong Lee, Steven Szabo, Ashwin Patkar, Melissa Hall, Wayne F. Beyer, et al. “Development and pharmacokinetic characterization of new delayed pulsatile-release ondansetron formulation.” In Pharmacotherapy, 32:E302–E302. WILEY-BLACKWELL, 2012.Link to Item
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Liu, J. P., M. C. Ma, and S. C. Chow. “Statistical evaluation of similarity factor f2 as a criterion for assessment of similarity between dissolution profiles.” In Drug Information Journal, 31:1255–71, 1997.
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Ki, F. Y. C., and S. -. C. Chow. “Statistical justification for the use of composite scores in quality of life assessment.” In Drug Information Journal, 29:715–27, 1995.
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Ki, F. Y. C., and S. C. Chow. “Analysis of quality of life with parallel questionnaires.” In Drug Information Journal, 28:69–80, 1994.
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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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