Shein-Chung Chow | Scholars@Duke

Shein-Chung Chow
Professor of Biostatistics and 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 and Bioinformatics, Biostatistics & Bioinformatics, Basic Science Departments 2007
Research Professor in the School of Nursing, School of Nursing, Duke University 2019
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
sheinchung.chow@duke.edu (919) 668-0105

Background
Education, Training, & Certifications
- Visiting Distinguished Professor, National Health Research Institute, National Taipei University (Taiwan) 2004 - 2005
- Ph.D., University of Wisconsin at Madison 1985
Duke Appointment History
- 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
Recognition
Awards & Honors
- Chapter Service Recognition Award. American Statistical Association. 1998
- ASA Fellows. American Statistical Association. 1995
Expertise
Global Scholarship
- Research
  - China (Country)
  - South Korea (Country)
Research
Selected Grants
- 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 2015 - 2018
- FAST- MAS Phase 2A 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 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
- Staphylococcal Bacteremia Study awarded by National Institutes of Health 2009 - 2012
- CTSA UL awarded by National Institutes of Health 2006 - 2012
Publications & Artistic Works
Selected Publications
- Books
  - Pong, A., and S. C. Chow. Handbook of adaptive designs in pharmaceutical and clinical development, 2016.
  - Pong, A., and S. C. Chow. Preface, 2016.
  - Chow, S. C. Biosimilars: Design and analysis of follow-on biologics, 2013. https://doi.org/10.1201/b15303.
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  - Chow, S. C., and J. P. Liu. Design and analysis of bioavailability and bioequivalence studies, third edition, 2008.
  - Chow, S. C. Statistical design and analysis of stability studies, 2007.
  - Chow, S. C. Series introduction, 2005.
  - Chow, S. C., and J. P. Liu. Statistical design and analysis in pharmaceutical science: Validation, process controls, and stability, 1995.
- Academic Articles
  - Chow, S. C., and S. J. Lee. “Design and Analysis of Biosimilar Switching Studies.” Pharmaceutical Medicine 33, no. 5 (October 1, 2019): 379–88. https://doi.org/10.1007/s40290-019-00296-x.
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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.
  - 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.
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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.
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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, February 2, 2019. https://doi.org/10.1007/s10840-019-00519-w.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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). https://doi.org/10.1111/hel.12540.
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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). https://doi.org/10.1111/ctr.13388.
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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.
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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.
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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.
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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). https://doi.org/10.1093/ofid/ofx264.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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). https://doi.org/10.1155/2017/3171697.
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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.
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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.
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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.
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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.
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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). https://doi.org/10.1038/srep37498.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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). https://doi.org/10.1093/ofid/ofv066.
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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.
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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.
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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.
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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 (May 2014): S5-11. https://doi.org/10.1007/s10198-014-0589-1.
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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.
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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). https://doi.org/10.1186/1471-2334-14-89.
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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.
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  - Chow, S. -. C. “Bioavailability and bioequivalence in drug development.” Wiley Interdisciplinary Reviews: Computational Statistics, 2014.
  - 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.
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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.
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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.
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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.
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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.
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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.
  - 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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  - Zhang, A., J. Y. Tzeng, and S. C. Chow. “Statistical considerations in biosimilar assessment using biosimilarity index.” Journal of Bioequivalence and Bioavailability 5, no. 5 (January 1, 2013). https://doi.org/10.4172/jbb.1000160.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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). https://doi.org/10.1186/1750-1172-6-79.
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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.
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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 (July 2011): 357–62. https://doi.org/10.1002/pst.474.
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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.
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  - Chow, S. C. “Spot the difference.” Ebr European Biopharmaceutical Review, no. SUMMER 2011 (June 1, 2011).
  - 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.
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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.
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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.
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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.
  - 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.
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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.
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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). https://doi.org/10.1080/10543406.2010.494263.
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  - Chow, S. C. “Changing with the times.” Ebr European Biopharmaceutical Review, no. AUTUMN (September 1, 2010): 48–52.
  - 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.
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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.
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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 (July 2010): 201–6. https://doi.org/10.1002/pst.442.
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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.
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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.
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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.
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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.
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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.
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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.
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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 (October 2009): 356–70. https://doi.org/10.1002/pst.364.
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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 (September 1, 2009): 487–94. https://doi.org/10.1002/cem.1242.
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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.
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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.
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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.
  - 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.
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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.
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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.
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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.
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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). https://doi.org/10.1186/1750-1172-3-11.
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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). https://doi.org/10.1080/10543400802013800.
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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.
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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.
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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.
  - 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.
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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.
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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.
  - 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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 (November 15, 2006): 395–406.
  - 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
  - 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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  - Chow, S. C. “Journal of Biopharmaceutical Statistics: Editor's note.” Journal of Biopharmaceutical Statistics 12, no. 3 (January 1, 2002).
  - 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.
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  - Shao, J., and S. C. Chow. “Drug shelf-life estimation.” Statistica Sinica 11, no. 3 (July 1, 2001): 737–45.
  - 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.
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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.
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  - Chow, S. C., and J. P. Liu. “Preface. Bioequilavence measures..” Stat Med 19, no. 20 (October 30, 2000). https://doi.org/10.1002/1097-0258(20001030)19:20<2719::aid-sim540>3.0.co;2-p.
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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.
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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.
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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.
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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.
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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.
  - 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).
  - Ho, H. T., and S. C. Chow. “Design and analysis of multinational clinical trials.” Drug Information Journal 32, no. 4 SUPPL. (January 1, 1998).
  - 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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 (December 1, 1996): 475–86.
  - 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.
  - 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.
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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.
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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.
  - 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.
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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.
  - Liu, J. P., and S. C. Chow. “Comment.” Statistical Science 11, no. 4 (January 1, 1996): 306–12.
  - Wang, W., F. Husan, and S. C. Chow. “The impact of patient compliance on drug concentration profile in multiple doses.” Statistics in Medicine 15, no. 6 (1996): 659–69. https://doi.org/10.1002/(SICI)1097-0258(19960330)15:6<659::AID-SIM207>3.0.CO;2-E.
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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.
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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.
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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.
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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.
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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.
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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.
  - Liu, J. P., and S. C. Chow. “Replicated crossover designs in bioavailability and bioequivalence trials.” Drug Information Journal 29, no. 3 (1995): 871–84.
  - 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.
  - 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.
  - Shao, J., and S. C. Chow. “Statistical inference in stability analysis.” Biometrics 50, no. 3 (October 27, 1994): 753–63. https://doi.org/10.2307/2532789.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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 (September 1992): 740–54.
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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.
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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.
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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.
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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).
  - 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.
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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.
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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.
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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).
  - 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.
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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.
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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.
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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.
  - 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.
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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.
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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.
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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.
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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.
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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.
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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.
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- Book Sections
  - Chan, C., M. G. Hudgens, and S. C. Chow. “Preface,” xi–xv, 2017. https://doi.org/10.1201/9781315120805.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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- Conference Papers
  - 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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  - Burt, T., H. Wu, A. T. Layton, D. C. Rouse, B. B. Chin, T. C. Hawk, D. H. Weitzel, M. Cohen-Wolkowiez, S. Chow, and R. J. Noveck. “Intra-Arterial Microdosing (IAM), a novel Drug development approach, proof of concept in Rats.” In Clinical Therapeutics, 37:e40–41. Elsevier BV, 2015. https://doi.org/10.1016/j.clinthera.2015.05.122.
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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.
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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.
  - 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.
  - 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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