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
Member in the Duke Clinical Research Institute, Duke Clinical Research Institute, Institutes and Centers 2005

Contact Information

2424 Erwin Road Ste 1102, 11068 Hock Plaza, Durham, NC 27705
Duke Box 2721, Durham, NC 27710
sheinchung.chow@duke.edu (919) 668-7523

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
- A Clinic-Based Behavioral Intervention to Reduce Cardiovascular Disease Risk in Persons Living with HIV awarded by National Institutes of Health 2018 - 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
- 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 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
- 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 Chow, SC. Handbook of adaptive designs in pharmaceutical and clinical development. April 19, 2016.
- Book Sections
  - Chan, C, Hudgens, MG, and Chow, SC. "Preface." , xi-xv. January 1, 2017. Full Text
  - Endrenyi, L, Declerck, PJ, and Chow, SC. "Biosimilar drug product development." , 1-477. January 1, 2017. Full Text
  - Wang, H, and Chow, SC. "Sample Size for Comparing Variabilities." In Methods and Applications of Statistics in Clinical Trials, 672-688. June 9, 2014. Full Text
  - Wang, H, and Chow, SC. "Sample Size for Comparing Proportions." In Methods and Applications of Statistics in Clinical Trials, 653-663. June 9, 2014. Full Text
  - Wang, H, and Chow, SC. "Sample Size for Comparing Time-to-Event Data." In Methods and Applications of Statistics in Clinical Trials, 664-671. June 9, 2014. Full Text
  - Wang, H, and Chow, SC. "Sample Size for Comparing Means." In Methods and Applications of Statistics in Clinical Trials, 642-652. June 9, 2014. Full Text
- Conference Papers
  - Burt, T, Rouse, DC, Lee, K, Wu, H, Layton, AT, Hawk, TC, Weitzel, DH, Chin, BB, Cohen-Wolkowiez, M, Chow, S-C, and Noveck, RJ. "Intraarterial Microdosing: A Novel Drug Development Approach, Proof-of-Concept PET Study in Rats." November 2015. Full Text
  - Burt, T, Wu, H, Layton, A, Rouse, D, Chin, B, Hawk, T, Weitzel, D, Cohen-Wolkowiez, M, Chow, S, and Noveck, R. "Intra-Arterial Microdosing (IAM), a novel Drug development approach, proof of concept in Rats." August 2015. Full Text
  - Barwick, NR, Fowler, C, Lee, T, Szabo, S, Patkar, A, Hall, M, Jr, BWF, Yang, L-Y, Chow, S, Burnett, B, Froeliger, B, and Mangum, OB. "Development and pharmacokinetic characterization of new delayed pulsatile-release ondansetron formulation." October 2012. Link to Item
  - Liu, JP, Ma, MC, and Chow, SC. "Statistical evaluation of similarity factor f2as a criterion for assessment of similarity between dissolution profiles." January 1, 1997. Full Text
  - Ki, FYC, and Chow, SC. "Statistical justification for the use of composite scores in quality of life assessment." January 1, 1995.
  - Ki, FYC, and Chow, SC. "Analysis of quality of life with parallel questionnaires." January 1, 1994.
- Journal Articles
  - Zhao, Y, Chang, Y-W, and Chow, S-C. "On sample size requirement for analytical similarity assessment." Journal of Biopharmaceutical Statistics (March 7, 2018): 1-17. Full Text
  - Collins, LF, Chan, A, Zheng, J, Chow, S-C, Wilder, JM, Muir, AJ, and Naggie, S. "Direct-Acting Antivirals Improve Access to Care and Cure for Patients With HIV and Chronic HCV Infection." Open forum infectious diseases 5, no. 1 (January 2018): ofx264-. Full Text Open Access Copy
  - Song, F, Qian, X, Li, J, Chow, S-C, and Hong, M. "Practical Issues in Clinical Inspection Process." Therapeutic Innovation & Regulatory Science (January 2018): 2168479018769887-null. Full Text
  - Ying, L, Song, F, Chow, S-C, Zeng, N, Zheng, J, Li, X, Henry, D, and Sethuraman, V. "On evaluation of consistency in multi-regional clinical trials." Journal of Biopharmaceutical Statistics 28, no. 5 (January 2018): 840-856. Full Text
  - Jung, S-H, Lee, HY, and Chow, S-C. "Statistical Methods for Conditional Survival Analysis." Journal of Biopharmaceutical Statistics (November 29, 2017): 1-12. Full Text
  - Chow, S-C, and Song, F. "Analytical similarity assessment." Wiley Interdisciplinary Reviews: Computational Statistics 9, no. 6 (November 2017): e1407-e1407. Full Text
  - Henson, JB, Patel, YA, Wilder, JM, Zheng, J, Chow, S-C, King, LY, and Muir, AJ. "Differences in Phenotypes and Liver Transplantation Outcomes by Age Group in Patients with Primary Sclerosing Cholangitis." Digestive Diseases and Sciences 62, no. 11 (November 2017): 3200-3209. Full Text
  - Zheng, J, Chow, S-C, and Yuan, M. "On assessing bioequivalence and interchangeability between generics based on indirect comparisons." Statistics in Medicine 36, no. 19 (August 30, 2017): 2978-2993. Full Text
  - Henson, JB, Brown, CL, Chow, S-C, and Muir, AJ. "Complementary and Alternative Medicine Use in United States Adults With Liver Disease." Journal of clinical gastroenterology 51, no. 6 (July 2017): 564-570. Full Text
  - Henson, JB, Patel, YA, King, LY, Zheng, J, Chow, S-C, and Muir, AJ. "Outcomes of liver retransplantation in patients with primary sclerosing cholangitis." Liver Transplantation : Official Publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society 23, no. 6 (June 2017): 769-780. Full Text
  - Dakik, HK, Srygley, FD, Chiu, S-T, Chow, S-C, and Fisher, DA. "Clinical Performance of Prediction Rules and Nasogastric Lavage for the Evaluation of Upper Gastrointestinal Bleeding: A Retrospective Observational Study." Gastroenterology research and practice 2017 (January 26, 2017): 3171697-. Full Text
  - Wang, T, and Chow, S-C. "On the establishment of equivalence acceptance criterion in analytical similarity assessment." Journal of Biopharmaceutical Statistics 27, no. 2 (January 4, 2017): 206-212. Full Text
  - Chen, M, and Chow, S-C. "Assessing bioequivalence and drug interchangeability." Journal of biopharmaceutical statistics 27, no. 2 (January 2017): 272-281. Full Text
  - Chow, S-C, Song, F, and Bai, H. "Sample size requirement in analytical studies for similarity assessment." Journal of Biopharmaceutical Statistics 27, no. 2 (January 2017): 233-238. Full Text
  - Chow, S-C, Song, F, and Cui, C. "On hybrid parallel-crossover designs for assessing drug interchangeability of biosimilar products." Journal of biopharmaceutical statistics 27, no. 2 (January 2017): 265-271. (Review) Full Text
  - Li, J, and Chow, S-C. "Statistical evaluation of the scaled criterion for drug interchangeability." Journal of biopharmaceutical statistics 27, no. 2 (January 2017): 282-292. Full Text
  - Salah, S, Chow, S-C, and Song, F. "On the evaluation of reliability, repeatability, and reproducibility of instrumental evaluation methods and measurement systems." Journal of biopharmaceutical statistics 27, no. 2 (January 2017): 331-337. Full Text
  - Zheng, J, Chow, S-C, and Song, F. "On safety margin for drug interchangeability." Journal of biopharmaceutical statistics 27, no. 2 (January 2017): 293-307. Full Text
  - You, H, Kong, Y, Hou, J, Wei, L, Zhang, Y, Niu, J, Han, T, Ou, X, Dou, X, Shang, J, Tang, H, Xie, Q, Ding, H, Ren, H, Xu, X, Xie, W, Liu, X, Xu, Y, Li, Y, Li, J, Chow, S-C, Zhuang, H, and Jia, J. "Female gender lost protective effect against disease progression in elderly patients with chronic hepatitis B." Scientific Reports 6 (November 28, 2016): 37498-null. Full Text
  - Himes, JE, Ho, C, Nguyen, QN, Amos, JD, Xu, H, Chan, C, Chow, S-C, Ochsenbauer, C, Kaidarova, Z, Keating, SM, Fouda, GG, and Permar, SR. "Characterization of Simian Immunodeficiency Virus Variants Anatomically Compartmentalized in Plasma and Milk in Chronically Infected African Green Monkeys." Journal of Virology 90, no. 19 (October 2016): 8795-8808. Full Text
  - Dakik, HK, McGhan, AA, Chiu, S-T, Patel, CB, Milano, CA, Rogers, JG, Chow, S-C, and Wild, DM. "The Diagnostic Yield of Repeated Endoscopic Evaluation in Patients with Gastrointestinal Bleeding and Left Ventricular Assist Devices." Digestive Diseases and Sciences 61, no. 6 (June 2016): 1603-1610. Full Text
  - Chow, S-C, Song, F, and Bai, H. "Analytical Similarity Assessment in Biosimilar Studies." The AAPS journal 18, no. 3 (May 2016): 670-677. Full Text
  - Chow, S-C, Song, F, and Chen, M. "Some thoughts on drug interchangeability." Journal of biopharmaceutical statistics 26, no. 1 (January 2016): 178-186. (Review) Full Text
  - Okeke, NL, Chin, T, Clement, M, Chow, S-C, and Hicks, CB. "Coronary artery disease risk reduction in HIV-infected persons: a comparative analysis." Aids Care 28, no. 4 (January 2016): 475-482. Full Text
  - Wu, P-S, Lin, M, and Chow, S-C. "On sample size estimation and re-estimation adjusting for variability in confirmatory trials." Journal of biopharmaceutical statistics 26, no. 1 (January 2016): 44-54. (Review) Full Text
  - Naggie, S, Patel, K, Yang, L-Y, Chow, S-C, Johnson, V, Guyton, JR, Muir, AJ, Sulkowski, M, and Hicks, C. "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 infectious diseases 2, no. 2 (April 2015): ofv066-. Full Text
  - Li, J, and Chow, S-C. "Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of Variability." Journal of Probability and Statistics 2015 (2015): 1-13. Full Text
  - Yuen, H-K, Chow, S-C, and Tse, S-K. "On statistical tests for homogeneity of two bivariate zero-inflated Poisson populations." Journal of biopharmaceutical statistics 25, no. 1 (January 2015): 44-53. Full Text
  - Hess, CN, Roe, MT, Gibson, CM, Temple, RJ, Pencina, MJ, Zarin, DA, Anstrom, KJ, Alexander, JH, Sherman, RE, Fiedorek, FT, Mahaffey, KW, Lee, KL, Chow, S-C, Armstrong, PW, and Califf, RM. "Independent data monitoring committees: preparing a path for the future." American Heart Journal 168, no. 2 (August 2014): 135-41.e1. Full Text
  - Chow, S-C. "Bioavailability and bioequivalence in drug development." Wiley Interdisciplinary Reviews: Computational Statistics 6, no. 4 (July 2014): 304-312. Full Text
  - Tóthfalusi, L, Endrényi, L, and Chow, S-C. "Statistical and regulatory considerations in assessments of interchangeability of biological drug products." The European journal of health economics : HEPAC : health economics in prevention and care 15 Suppl 1 (May 16, 2014): S5-11. Full Text
  - Tóthfalusi, L, Endrényi, L, and Chow, S-C. "Statistical and regulatory considerations in assessments of interchangeability of biological drug products." The European Journal of Health Economics 15, no. S1 (May 2014): 5-11. Full Text
  - Reddy, EA, Njau, BN, Morpeth, SC, Lancaster, KE, Tribble, AC, Maro, VP, Msuya, LJ, Morrissey, AB, Kibiki, GS, Thielman, NM, Cunningham, CK, Schimana, W, Shao, JF, Chow, S-C, Stout, JE, Crump, JA, Bartlett, JA, and Hamilton, CD. "A randomized controlled trial of standard versus intensified tuberculosis diagnostics on treatment decisions by physicians in Northern Tanzania." BMC infectious diseases 14 (February 20, 2014): 89-. Full Text Open Access Copy
  - Reddy, EA, Njau, BN, Morpeth, SC, Lancaster, KE, Tribble, AC, Maro, VP, Msuya, LJ, Morrissey, AB, Kibiki, GS, Thielman, NM, Cunningham, CK, Schimana, W, Shao, JF, Chow, SC, Stout, JE, Crump, JA, Bartlett, JA, and Hamilton, CD. "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). Full Text
  - Chiu, S-T, Liu, J-P, and Chow, S-C. "Applications of the bayesian prior information to evaluation of equivalence of similar biological medicinal products." Journal of biopharmaceutical statistics 24, no. 6 (January 2014): 1254-1263. Full Text
  - Chow, S-C, Endrenyi, L, Lachenbruch, PA, and Mentré, F. "Scientific factors and current issues in biosimilar studies." Journal of biopharmaceutical statistics 24, no. 6 (January 2014): 1138-1153. Full Text
  - Chow, S-C. "Bioavailability and bioequivalence in drug development." Wiley Interdisciplinary Reviews: Computational Statistics (2014).
  - Chow, S-C. "Adaptive clinical trial design." Annual review of medicine 65 (January 2014): 405-415. (Review) Full Text
  - Hess, CN, Roe, MT, Gibson, CM, J Temple, R, Pencina, MJ, Zarin, DA, Anstrom, KJ, Alexander, JH, Sherman, RE, Fiedorek, FT, Mahaffey, KW, Lee, KL, Chow, SC, Armstrong, PW, and Califf, RM. "Independent data monitoring committees: Preparing a path for the future." American Heart Journal 168, no. 2 (January 1, 2014). Full Text
  - Lu, Y, Zhang, Z-Z, and Chow, S-C. "Frequency estimator for assessing of follow-on biologics." Journal of biopharmaceutical statistics 24, no. 6 (January 2014): 1280-1297. Full Text
  - Wu, Y-J, Tan, T-S, Chow, S-C, and Hsiao, C-F. "Sample size estimation of multiregional clinical trials with heterogeneous variability across regions." Journal of biopharmaceutical statistics 24, no. 2 (January 2014): 254-271. Full Text
  - Zhang, N, Yang, J, Chow, S-C, and Chi, E. "Nonparametric tests for evaluation of biosimilarity in variability of follow-on biologics." Journal of Biopharmaceutical Statistics 24, no. 6 (January 2014): 1239-1253. Full Text
  - Zhu, S. "In vivo and In vitro Bioequivalence Testing." Journal of Bioequivalence & Bioavailability 06, no. 02 (2014). Full Text
  - Wu, YJ, Tan, TS, Chow, SC, and Hsiao, CF. "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): 325-344. Full Text
  - Lakey, W, Yang, L-Y, Yancy, W, Chow, S-C, and Hicks, C. "Short communication: from wasting to obesity: initial antiretroviral therapy and weight gain in HIV-infected persons." Aids Research and Human Retroviruses 29, no. 3 (March 2013): 435-440. Full Text
  - Chow, S-C. "Assessing biosimilarity and interchangeability of biosimilar products." Statistics in Medicine 32, no. 3 (February 2013): 361-363. Full Text
  - Yang, J, Zhang, N, Chow, S-C, and Chi, E. "An adapted F-test for homogeneity of variability in follow-on biological products." Statistics in Medicine 32, no. 3 (February 2013): 415-423. Full Text
  - Zhang, N, Yang, J, Chow, S-C, Endrenyi, L, and Chi, E. "Impact of variability on the choice of biosimilarity limits in assessing follow-on biologics." Statistics in Medicine 32, no. 3 (February 2013): 424-433. Full Text
  - Chow, S-C, Endrenyi, L, and Lachenbruch, PA. "Comments on the FDA draft guidance on biosimilar products." Statistics in Medicine 32, no. 3 (2013): 364-369. Full Text
  - Chow, S-C, Wang, J, Endrenyi, L, and Lachenbruch, PA. "Scientific considerations for assessing biosimilar products." Statistics in Medicine 32, no. 3 (2013): 370-381. Full Text
  - Chow, S-C, Yang, L-Y, Starr, A, and Chiu, S-T. "Statistical methods for assessing interchangeability of biosimilars." Statistics in Medicine 32, no. 3 (2013): 442-448. Full Text
  - Chow, S-C, and Chiu, S-T. "Sample Size and Data Monitoring for Clinical Trials With Extremely Low Incidence Rates." Therapeutic Innovation and Regulatory Science 47, no. 4 (2013): 438-446. Full Text
  - Endrenyi, L, Chang, C, Chow, S-C, and Tothfalusi, L. "On the interchangeability of biologic drug products." Statistics in Medicine 32, no. 3 (2013): 434-441. Full Text
  - Grieve, AP, Chow, S-C, Curram, J, Dawe, S, Harnisch, LO, Henig, NR, Hung, HMJ, Ivy, DD, Kawut, SM, Rahbar, MH, Xiao, S, and Wilkins, MR. "Advancing Clinical Trial Design in Pulmonary Hypertension." Pulmonary Circulation 3, no. 1 (January 2013): 217-225. Full Text
  - Hsieh, T-C, Chow, S-C, Yang, L-Y, and Chi, E. "The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics." Statistics in Medicine 32, no. 3 (2013): 406-414. Full Text
  - Kang, S-H, and Chow, S-C. "Statistical assessment of biosimilarity based on relative distance between follow-on biologics." Statistics in Medicine 32, no. 3 (2013): 382-392. Full Text
  - Lin, J-R, Chow, S-C, Chang, C-H, Lin, Y-C, and Liu, J-P. "Application of the parallel line assay to assessment of biosimilar products based on binary endpoints." Statistics in Medicine 32, no. 3 (2013): 449-461. Full Text
  - Noveck, RJ, Douglas, PS, Chow, S-C, Mangum, B, Kori, S, and Kellerman, DJ. "Assessing acute systemic effects of an inhaled drug with serial echocardiography: a placebo-controlled comparison of inhaled and intravenous dihydroergotamine." Drug Design, Development and Therapy 7 (January 2013): 619-625. Full Text Open Access Copy
  - Yang, J, Zhang, N, Chow, S-C, and Chi, E. "An adapted F-test for homogeneity of variability in follow-on biological products." Statistics in Medicine 32, no. 3 (2013): 415-423. Full Text
  - Zhang, A, Tzeng, J-Y, and Chow, S-C. "Statistical considerations in biosimilar assessment using biosimilarity index." Journal of Bioequivalence and Bioavailability 5, no. 5 (2013). Full Text
  - Zhang, N, Yang, J, Chow, S-C, Endrenyi, L, and Chi, E. "Impact of variability on the choice of biosimilarity limits in assessing follow-on biologics." Statistics in Medicine 32, no. 3 (2013): 424-433. Full Text
  - Crump, JA, Ramadhani, HO, Morrissey, AB, Saganda, W, Mwako, MS, Yang, L-Y, Chow, S-C, Njau, BN, Mushi, GS, Maro, VP, Reller, LB, and Bartlett, JA. "Bacteremic disseminated tuberculosis in sub-saharan Africa: a prospective cohort study." Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America 55, no. 2 (July 2012): 242-250. Full Text Open Access Copy
  - Chow, S-C, Chiang, C, Liu, J-P, and Hsiao, C-F. "Statistical methods for bridging studies." Journal of Biopharmaceutical Statistics 22, no. 5 (2012): 903-915. Full Text
  - Chow, S-C, Corey, R, and Lin, M. "On the independence of data monitoring committee in adaptive design clinical trials." Journal of Biopharmaceutical Statistics 22, no. 4 (2012): 853-867. Full Text
  - Chow, S-C, Endrenyi, L, and Lachenbruch, PA. "Comments on the FDA draft guidance on biosimilar products." Statistics in Medicine (2012). Full Text
  - Chow, S-C, Wang, J, Endrenyi, L, and Lachenbruch, PA. "Scientific considerations for assessing biosimilar products." Statistics in Medicine (2012).
  - Chow, S-C, Yang, L-Y, Starr, A, and Chiu, S-T. "Statistical methods for assessing interchangeability of biosimilars." Statistics in Medicine (2012). Full Text
  - Endrenyi, L, Chang, C, Chow, S-C, and Tothfalusi, L. "On the interchangeability of biologic drug products." Statistics in Medicine (2012). Full Text
  - Hsieh, T-C, Chow, S-C, Yang, L-Y, and Chi, E. "The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics." Statistics in Medicine (2012). Full Text
  - Jung, S-H, and Chow, S-C. "On sample size calculation for comparing survival curves under general hypothesis testing." Journal of Biopharmaceutical Statistics 22, no. 3 (2012): 485-495. Full Text
  - Kang, S-H, and Chow, S-C. "Statistical assessment of biosimilarity based on relative distance between follow-on biologics." Statistics in Medicine (2012).
  - Lin, J-R, Chow, S-C, Chang, C-H, Lin, Y-C, and Liu, J-P. "Application of the parallel line assay to assessment of biosimilar products based on binary endpoints." Statistics in Medicine (2012). Full Text
  - Liu, J-P, Lin, J-R, and Chow, S-C. "Authors reply to the letter to the editor by L. Chen and Y. X. Liu." Pharmaceutical Statistics 11, no. 4 (2012): 343-345. Full Text
  - Lu, Q, Tse, S-K, Chow, S-C, and Lin, M. "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." Journal of Biopharmaceutical Statistics 22, no. 4 (2012): 773-784. Full Text
  - Wang, J, and Chow, S-C. "On the regulatory approval pathway of biosimilar products." Pharmaceuticals 5, no. 4 (2012): 353-368. Full Text
  - Clowse, MEB, Copland, SC, Hsieh, T-C, Chow, S-C, Hoffman, GS, Merkel, PA, Spiera, RF, Davis, JC, McCune, WJ, Ytterberg, SR, St Clair, EW, Allen, NB, Specks, U, Stone, JH, and WGET Research Group, . "Ovarian reserve diminished by oral cyclophosphamide therapy for granulomatosis with polyangiitis (Wegener's)." Arthritis Care & Research 63, no. 12 (December 2011): 1777-1781. Full Text
  - Crump, JA, Ramadhani, HO, Morrissey, AB, Msuya, LJ, Yang, L-Y, Chow, S-C, Morpeth, SC, Reyburn, H, Njau, BN, Shaw, AV, Diefenthal, HC, Bartlett, JA, Shao, JF, Schimana, W, Cunningham, CK, and Kinabo, GD. "Invasive bacterial and fungal infections among hospitalized HIV-infected and HIV-uninfected children and infants in northern Tanzania." Tropical Medicine & International Health : Tm & Ih 16, no. 7 (July 2011): 830-837. Full Text
  - Chow, S-C, Yang, L-Y, and Lu, Y. "Some Controversial Issues in Clinical Trials." Drug Information Journal 45, no. 2 (March 2011): 163-174. Full Text
  - Crump, JA, Ramadhani, HO, Morrissey, AB, Saganda, W, Mwako, MS, Yang, L-Y, Chow, S-C, Morpeth, SC, Reyburn, H, Njau, BN, Shaw, AV, Diefenthal, HC, Shao, JF, Bartlett, JA, and Maro, VP. "Invasive bacterial and fungal infections among hospitalized HIV-infected and HIV-uninfected adults and adolescents in northern Tanzania." Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America 52, no. 3 (February 2011): 341-348. Full Text
  - Cheng, B, and Chow, S-C. "Assessing departure from dose linearity under a repeated measures incomplete block design." Pharmaceutical Statistics 10, no. 4 (2011): 357-362. Full Text
  - Chow, S-C, Yang, L-Y, and Lu, Y. "Some controversial issues in clinical trials." Drug Information Journal 45, no. 2 (2011): 163-174.
  - Chow, S-C, and Corey, R. "Benefits, challenges and obstacles of adaptive clinical trial designs." Orphanet Journal of Rare Diseases 6, no. 1 (2011). Full Text
  - Chow, S-C. "Sample size calculations for clinical trials." Wiley Interdisciplinary Reviews: Computational Statistics 3, no. 5 (2011): 414-427. Full Text
  - Chow, S-C. "Spot the difference." EBR - European Biopharmaceutical Review , no. SUMMER 2011 (2011).
  - Li, J, Chi, EM, Feng, C, and Chow, S-C. "Imputation method adjusted for covariates for nonrespondents in instruments with applications." Journal of Biopharmaceutical Statistics 21, no. 2 (2011): 342-354. Full Text
  - Yang, L-Y, Chi, Y, and Chow, S-C. "Statistical inference for clinical trials with binary responses when there is a shift in patient population." Journal of Biopharmaceutical Statistics 21, no. 3 (2011): 437-452. Full Text
  - Richmond, JA, Bailey, DE, Patel, K, Jezsik, JA, Muir, A, Lin, J-R, Chow, S-C, Uzarski, D, and McHutchison, JG. "The use of complementary and alternative medicine by patients with chronic hepatitis C." Complement Ther Clin Pract 16, no. 3 (August 2010): 124-131. Full Text Link to Item
  - Palmer, SM, Limaye, AP, Banks, M, Gallup, D, Chapman, J, Lawrence, EC, Dunitz, J, Milstone, A, Reynolds, J, Yung, GL, Chan, KM, Aris, R, Garrity, E, Valentine, V, McCall, J, Chow, S-C, Davis, RD, and Avery, R. "Extended valganciclovir prophylaxis to prevent cytomegalovirus after lung transplantation: a randomized, controlled trial." Ann Intern Med 152, no. 12 (June 15, 2010): 761-769. Full Text Link to Item
  - Palmer, SM, Limaye, AP, Banks, M, Gallup, D, Chapman, J, Lawrence, EC, Dunitz, J, Milstone, A, Reynolds, J, Yung, GL, Chan, KM, Aris, R, Garrity, E, Valentine, V, McCall, J, Chow, S-C, Davis, RD, and Avery, R. "Extended valganciclovir prophylaxis to prevent cytomegalovirus after lung transplantation: a randomized, controlled trial." Annals of internal medicine 152, no. 12 (June 2010): 761-769. Full Text
  - Cheng, B, Chow, S-C, Burt, D, and Cosmatos, D. "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 (2010): 1074--. Full Text
  - Cheng, B, and Chow, S-C. "On flexibility of adaptive designs and criteria for choosing a good one - A discussion of FDA draft guidance." Journal of Biopharmaceutical Statistics 20, no. 6 (2010): 1171-1177. Full Text
  - Chow, S-C, Hsieh, T-C, Chi, E, and Yang, J. "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. (Review) Full Text Link to Item
  - Chow, S-C, Lu, Q, Tse, S-K, and Chi, E. "Statistical methods for assessment of biosimilarity using biomarker data." Journal of Biopharmaceutical Statistics 20, no. 1 (2010): 90-105. Full Text
  - Chow, S-C, and Hsiao, C-F. "Bridging diversity: Extrapolating foreign data to a new region." Pharmaceutical Medicine 24, no. 6 (2010): 349-362. Full Text
  - Chow, S-C, and Liu, J-P. "Statistical assessment of biosimilar products." Journal of Biopharmaceutical Statistics 20, no. 1 (2010): 10-30. Full Text
  - Chow, S-C. "A note on special articles on adaptive clinical trial designs." Journal of Biopharmaceutical Statistics 20, no. 6 (2010): 1088-1089. Full Text
  - Chow, S-C. "Changing with the times." EBR - European Biopharmaceutical Review , no. AUTUMN (2010): 48-52.
  - Hsieh, T-C, Chow, S-C, Liu, J-P, Hsiao, C-F, and Chi, E. "Statistical test for evaluation of biosimilarity in variability of follow-On biologics." Journal of Biopharmaceutical Statistics 20, no. 1 (2010): 75-89. Full Text
  - Lu, Q, Tse, SK, and Chow, S-C. "Analysis of time-to-event data under a two-stage survival adaptive design in clinical trials." Journal of Biopharmaceutical Statistics 20, no. 4 (2010): 705-719. Full Text
  - Tsou, H-H, Chow, S-C, Lan, KKG, Liu, J-P, Wang, M, Chern, H-D, Ho, L-T, Hsiung, CA, and Hsiao, C-F. "Proposals of statistical consideration to evaluation of results for a specific region in multi-regional trials - Asian perspective." Pharmaceutical Statistics 9, no. 3 (2010): 201-206. Full Text
  - Hsiao, C-F, Tsou, H-H, Pong, A, Liu, J-P, Lin, C-H, Chang, Y-J, and Chow, S-C. "Statistical Validation of Traditional Chinese Diagnostic Procedures." Drug Information Journal 43, no. 1 (January 2009): 83-95. Full Text
  - Hsiao, C-F, Tsou, H-H, Pong, A, Liu, J-P, Lin, C-H, Chang, Y-J, and Chow, S-C. "Statistical validation of traditional Chinese diagnostic procedures." Drug Information Journal 43, no. 1 (2009): 83-95.
  - Liu, J-P, Chow, S-C, and Hsieh, T-C. "Deviations from linearity in statistical evaluation of linearity in assay validation." Journal of Chemometrics 23, no. 9 (2009): 487-494. Full Text
  - Liu, J-P, Jr, RL, and Chow, S-C. "Inference on treatment effects for targeted clinical trials under enrichment design." Pharmaceutical Statistics 8, no. 4 (2009): 356-370. Full Text
  - Lu, Q, Chow, SC, Tse, SK, Chi, Y, and Yang, LY. "Sample size estimation based on event data for a two-stage survival adaptive trial with different durations." Journal of Biopharmaceutical Statistics 19, no. 2 (2009): 311-323. Full Text
  - Lu, Q, Tse, S-K, Chow, S-C, and Yang, J. "On assessing bioequivalence using genomic data with model misspecification." Journal of Biopharmaceutical Statistics 19, no. 4 (2009): 571-579. Full Text
  - Tse, SK, Chow, SC, Qingshu, L, and Cosmatos, D. "Testing homogeneity of two zero-inflated poisson populations." Biometrical Journal 51, no. 1 (2009): 159-170. Full Text
  - Chow, S-C, Tse, S-K, Yang, C, Cosmatos, D, and Chi, E. "Statistical Test for Ordered Categorical Data in Clinical Trials." Drug Information Journal 42, no. 6 (November 2008): 617-624. Full Text
  - Tsou, H-H, Hsiao, C-F, Chow, S-C, and Liu, J-P. "A Two-Stage Design for Drug Screening Trials Based on Continuous Endpoints." Drug Information Journal 42, no. 3 (May 2008): 253-262. Full Text
  - Chang, M, and Chow, S-C. "Strategies for adaptive designs with multiple endpoints (Journal of Biopharmaceutical Statistics 17:6 (1189-1200))." Journal of Biopharmaceutical Statistics 18, no. 2 (2008): 402--. Full Text
  - Cheng, B, Chow, S-C, Burt, D, and Cosmatos, D. "Statistical assessment of QT/QTc prolongation based on maximum of correlated normal random variables." Journal of Biopharmaceutical Statistics 18, no. 3 (2008): 494-501. Full Text
  - Chow, S-C, Cheng, B, and Cosmatos, D. "On power and sample size calculation for QT studies with recording replicates at given time point." Journal of Biopharmaceutical Statistics 18, no. 3 (2008): 483-493. Full Text
  - Chow, S-C, Tse, S-K, Yang, C, Cosmatos, D, and Chi, E. "Statistical test for ordered categorical data in clinical trials." Drug Information Journal 42, no. 6 (2008): 617-624.
  - Chow, S-C, Tse, S-K, and Lin, M. "Statistical methods in translational medicine." Journal of the Formosan Medical Association = Taiwan yi zhi 107, no. 12 Suppl (2008): 61-73.
  - Chow, S-C, and Chang, M. "Adaptive design methods in clinical trials - a review." Orphanet Journal of Rare Diseases 3 (January 2008): 11-null. (Review) Full Text
  - Chow, S-C, and Tu, Y-H. "On Two-stage Seamless Adaptive Design in Clinical Trials." Journal of the Formosan Medical Association = Taiwan yi zhi 107, no. 12 Suppl (2008): 52-60.
  - Jung, S-H, Kim, C, and Chow, S-C. "Sample size calculation for the log-rank tests for multi-arm trials with a control." Journal of the Korean Statistical Society 37, no. 1 (2008): 11-22. Full Text
  - Liu, J-P, and Chow, S-C. "Statistical issues on the diagnostic multivariate index assay for targeted clinical trials." Journal of Biopharmaceutical Statistics 18, no. 1 (2008): 167-182. Full Text
  - Tse, S-K, Chow, S-C, and Yang, C. "Statistical tests for one-way/two-way translation in translational medicine." Journal of the Formosan Medical Association = Taiwan yi zhi 107, no. 12 Suppl (2008): 43-51.
  - Tsou, H-H, Hsiao, C-F, Chow, S-C, and Liu, J-P. "A two-stage design for drug screening trials based on continuous endpoints." Drug Information Journal 42, no. 3 (2008): 253-262.
  - Chang, M, and Chow, S-C. "Analysis strategies for adaptive designs with multiple endpoints." Journal of Biopharmaceutical Statistics 17, no. 6 (2007): 1189-1200. Full Text
  - Chow, S-C, Lu, Q, and Tse, S-K. "Statistical analysis for two-stage seamless design with different study endpoints." Journal of Biopharmaceutical Statistics 17, no. 6 (2007): 1163-1176. Full Text
  - Chow, S-C, and Shao, J. "Stability analysis for drugs with multiple active ingredients." Statistics in Medicine 26, no. 7 (2007): 1512-1517. Full Text
  - Feng, H, Shao, J, and Chow, S-C. "Adaptive group sequential test for clinical trials with changing patient population." Journal of Biopharmaceutical Statistics 17, no. 6 (2007): 1227-1238. Full Text
  - Jung, S-H, Chow, S-C, and Chi, EM. "A note on sample size calculation based on propensity analysis in nonrandomized trials." Journal of Biopharmaceutical Statistics 17, no. 1 (2007): 35-41. Full Text
  - Lu, Q, Chow, SC, and Tse, SK. "Assessing the consistency of traditional Chinese medicine with multiple correlative active components." Journal of Biopharmaceutical Statistics 17, no. 5 (2007): 791-808. Full Text
  - Shao, J, and Chow, S-C. "Variable screening in predicting clinical outcome with high-dimensional microarrays." Journal of Multivariate Analysis 98, no. 8 (2007): 1529-1538. Full Text
  - Tsou, H-H, Hsiao, C-F, Chow, S-C, Yue, L, Xu, Y, and Lee, S. "Mixed noninferiority margin and statistical tests in active controlled trials." Journal of Biopharmaceutical Statistics 17, no. 2 (2007): 339-357. Full Text
  - Chow, S-C, Pong, A, and Chang, Y-W. "On Traditional Chinese Medicine Clinical Trials." Drug Information Journal 40, no. 4 (December 2006): 395-406. Full Text
  - Chow, S-C, and Shao, J. "On non-inferiority margin and statistical tests in active control trials." Stat Med 25, no. 7 (April 15, 2006): 1101-1113. Full Text Link to Item
  - Chang, M, Chow, S-C, and Pong, A. "Adaptive design in clinical research: Issues, opportunities, and recommendations." Journal of Biopharmaceutical Statistics 16, no. 3 (2006): 299-309. Full Text
  - Cheng, B, Chow, S-C, and Su, W-L. "On the assessment of dose proportionality: A comparison of two slope approaches." Journal of Biopharmaceutical Statistics 16, no. 3 (2006): 385-392. Full Text
  - Chow, S-C. "Editor's note - JBS is now an SCI journal." Journal of Biopharmaceutical Statistics 16, no. 3 (2006): 273-274. Full Text
  - Shao, J, and Chow, S-C. "Author's reply [4]." Statistics in Medicine 25, no. 8 (2006): 1437-1438. Full Text
  - Tse, S-K, Chang, J-Y, Su, W-L, Chow, S-C, Hsiung, C, and Lu, Q. "Statistical quality control process for traditional Chinese medicine." Journal of Biopharmaceutical Statistics 16, no. 6 (2006): 861-874. Full Text
  - Shao, J, Chang, M, and Chow, S-C. "Statistical inference for cancer trials with treatment switching." Stat Med 24, no. 12 (June 30, 2005): 1783-1790. Full Text Link to Item
  - Chang, M, and Chow, S-C. "A hybrid Bayesian adaptive design for dose response trials." J Biopharm Stat 15, no. 4 (2005): 677-691. Full Text Link to Item
  - Chow, S-C, Chang, M, and Pong, A. "Statistical consideration of adaptive methods in clinical development." J Biopharm Stat 15, no. 4 (2005): 575-591. Full Text Link to Item
  - Chow, S-C, and Shao, J. "Inference for clinical trials with some protocol amendments." J Biopharm Stat 15, no. 4 (2005): 659-666. Full Text Link to Item
  - Chow, S-C, and Shao, J. "Analysis of clinical data with breached blindness (multiple letters) [2]." Statistics in Medicine 24, no. 5 (2005): 819-822. Full Text
  - Chow, S-C. "Journal of Biopharmaceutical Statistics: Editor's note." Journal of Biopharmaceutical Statistics 15, no. 1 (2005): 1-2. Full Text
  - Wang, H, Chow, S-C, and Chen, M. "A Bayesian approach on sample size calculation for comparing means." J Biopharm Stat 15, no. 5 (2005): 799-807. Full Text Link to Item
  - Wang, H, and Chow, S. "A practical approach for comparing means of two groups without equal variance assumption [1]." Statistics in Medicine 24, no. 5 (2005): 817-818. Full Text
  - Chow, S-C, Shao, J, and Li, L. "Assessing bioequivalence using genomic data." J Biopharm Stat 14, no. 4 (November 2004): 869-880. Full Text Link to Item
  - Li, L, Chow, S-C, and Smith, W. "Cross-validation for linear model with unequal variances in genomic analysis." J Biopharm Stat 14, no. 3 (August 2004): 723-739. Link to Item
  - Chow, S-C, and Shao, J. "Analysis of clinical data with breached blindness." Stat Med 23, no. 8 (April 30, 2004): 1185-1193. Full Text Link to Item
  - Lee, Y, Shao, J, and Chow, S-C. "Modified large-sample confidence intervals for linear combinations of variance components: Extension, theory, and application." Journal of the American Statistical Association 99, no. 466 (2004): 467-478. Full Text
  - Wang, H, Chen, B, and Chow, S-C. "Sample size determination based on rank tests in clinical trials." J Biopharm Stat 13, no. 4 (November 2003): 735-751. Full Text Link to Item
  - Chow, S-C, and Shao, J. "Stability analysis with discrete responses." J Biopharm Stat 13, no. 3 (August 2003): 451-462. Full Text Link to Item
  - Swenson, CE, Bolcsak, LE, Batist, G, Guthrie, TH, Tkaczuk, KH, Boxenbaum, H, Welles, L, Chow, S-C, Bhamra, R, and Chaikin, P. "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." Anti Cancer Drugs 14, no. 3 (March 2003): 239-246. Full Text
  - Wang, W, and Chow, S-C. "Examining outlying subjects and outlying records in bioequivalence trials." J Biopharm Stat 13, no. 1 (February 2003): 43-56. Full Text Link to Item
  - Chow, S-C, Shao, J, and Wang, H. "In vitro bioequivalence testing." Stat Med 22, no. 1 (January 15, 2003): 55-68. Full Text Link to Item
  - Chow, S-C, Shao, J, and Wang, H. "Statistical tests for population bioequivalence." Statistica Sinica 13, no. 2 (2003): 539-554.
  - Chow, S-C, Shao, J, and Wang, H. "A note on sample size calculation for mean comparisons based on noncentral t-statistics." J Biopharm Stat 12, no. 4 (November 2002): 441-456. Full Text Link to Item
  - Lee, Y, Shao, J, Chow, S-C, and Wang, H. "Tests for inter-subject and total variabilities under crossover designs." J Biopharm Stat 12, no. 4 (November 2002): 503-534. Full Text Link to Item
  - Wang, H, Chow, S-C, and Li, G. "On sample size calculation based on odds ratio in clinical trials." J Biopharm Stat 12, no. 4 (November 2002): 471-483. Full Text Link to Item
  - Wang, H, and Chow, S-C. "A practical approach for comparing means of two groups without equal variance assumption." Stat Med 21, no. 20 (October 30, 2002): 3137-3151. Full Text Link to Item
  - Chow, S-C, and Shao, J. "A note on statistical methods for assessing therapeutic equivalence." Control Clin Trials 23, no. 5 (October 2002): 515-520. Link to Item
  - Chow, S-C, Shao, J, and Hu, OY-P. "Assessing sensitivity and similarity in bridging studies." J Biopharm Stat 12, no. 3 (August 2002): 385-400. Link to Item
  - Chow, S-C, and Shao, J. "On the assessment of similarity for dissolution profiles of two drug products." J Biopharm Stat 12, no. 3 (August 2002): 311-321. Link to Item
  - Liu, J-P, and Chow, S-C. "Bridging studies in clinical development." J Biopharm Stat 12, no. 3 (August 2002): 359-367. Link to Item
  - Wan, H, and Chow, S-C. "On statistical power for average bioequivalence testing under replicated crossover designs." J Biopharm Stat 12, no. 3 (August 2002): 295-309. Link to Item
  - Shao, J, and Chow, S-C. "Reproducibility probability in clinical trials." Stat Med 21, no. 12 (June 30, 2002): 1727-1742. Full Text Link to Item
  - Chow, S-C, Shao, J, and Wang, H. "Individual bioequivalence testing under 2x3 designs." Statistics in Medicine 21, no. 5 (March 2002): 629-648. Full Text
  - Chow, S-C, Shao, J, and Wang, H. "Probability lower bounds for USP/NF tests." J Biopharm Stat 12, no. 1 (February 2002): 79-92. Link to Item
  - Blood, P, Wang, H, and Chow, S-C. "Sample size calculation in bioequivalence trials [multiple letter]." Journal of Pharmacokinetics and Pharmacodynamics 29, no. 1 (2002): 95-99. Full Text
  - Chow, S-C, and Wang, H. "Erratum: On sample size calculation in bioequivalence trials (Journal of Pharmacokinetics and Pharmacodynamics (2001) 28 (155-169))." Journal of Pharmacokinetics and Pharmacodynamics 29, no. 1 (2002): 101-102. Full Text
  - Chow, S-C. "Journal of Biopharmaceutical Statistics: Editor's note." Journal of Biopharmaceutical Statistics 12, no. 3 (2002): v-vi.
  - Shao, J, and Chow, SC. "Two-phase shelf-life estimation." Stat Med 20, no. 8 (April 30, 2001): 1239-1248. Full Text Link to Item
  - Chow, SC, and Wang, H. "On sample size calculation in bioequivalence trials." J Pharmacokinet Pharmacodyn 28, no. 2 (April 2001): 155-169. Link to Item
  - Shao, J, and Chow, S-C. "Drug shelf-life estimation." Statistica Sinica 11, no. 3 (2001): 737-745.
  - Chow, SC, and Liu, JP. "Individual bioequivalence: Preface." Statistics in Medicine 19, no. 20 (October 30, 2000): 2719-null. Full Text
  - Shao, J, Chow, SC, and Wang, B. "The bootstrap procedure in individual bioequivalence." Statistics in Medicine 19, no. 20 (October 30, 2000): 2741-2754. Full Text
  - Shao, J, Chow, SC, and Wang, B. "The bootstrap procedure in individual bioequivalence." Stat Med 19, no. 20 (October 30, 2000): 2741-2754. Link to Item
  - Chow, SC, Shao, J, and Ho, HT. "On statistical analysis for placebo-challenging designs in clinical trials." Statistics in Medicine 19, no. 8 (April 30, 2000): 1029-1037. Full Text
  - Chow, SC, Shao, J, and Ho, HT. "On statistical analysis for placebo-challenging designs in clinical trials." Stat Med 19, no. 8 (April 30, 2000): 1029-1037. Link to Item
  - Chow, S-C, and Liu, J-P. "Individual bioequivalence: Preface." Statistics in Medicine 19, no. 20 (2000): 2719--. Full Text
  - Chow, SC, and Liu, JP. "Preface. Bioequilavence measures." Statistics in Medicine 19, no. 20 (2000): 2719--.
  - Chow, SC. "Individual bioequivalence - A review of the FDA draft guidance." Drug Information Journal 33, no. 2 (June 8, 1999): 435-444. (Review)
  - Chow, S-C. "Individual Bioequivalence—A Review of the FDA Draft Guidance." Drug Information Journal 33, no. 2 (April 1999): 435-444. Full Text
  - Chow, S-C, and Shao, J. "Bioequivalence review for drug interchangeability." Journal of Biopharmaceutical Statistics 9, no. 3 (1999): 485-497. Full Text
  - Sun, Y, Chow, S-C, Li, G, and Chen, K-W. "Assessing distributions of estimated drug shelf lives in stability analysis." Biometrics 55, no. 3 (1999): 896-899.
  - Chow, S-C, and Pong, A. "An overview of the regulatory approval process in drug development." Drug Information Journal 32, no. 4 SUPPL. (1998): 1175S-1185S.
  - Ho, H-T, and Chow, S-C. "Design and analysis of multinational clinical trials." Drug Information Journal 32, no. 4 SUPPL. (1998): 1309S-1316S.
  - Chow, S-C. "Good Statistics Practice in the Drug Development and Regulatory Approval Process." Drug Information Journal 31, no. 4 (October 1997): 1157-1166. Full Text
  - Chow, S-C. "Pharmaceutical Validation and Process Controls in Drug Development." Drug Information Journal 31, no. 4 (October 1997): 1195-1201. Full Text
  - Hu, OY-P, and Chow, S-C. "Guest Editor's Note: Practical and Regulatory Issues on New Drug, New Dosage form, and Generic Drug Development." Drug Information Journal 31, no. 4 (October 1997): 1145-1147. Full Text
  - Liu, J-P, Ma, M-C, and Chow, S-C. "Statistical Evaluation of Similarity Factor f 2 as a Criterion for Assessment of Similarity between Dissolution Profiles." Drug Information Journal 31, no. 4 (October 1997): 1255-1271. Full Text
  - Pong, A, and Chow, S-C. "Statistical/Practical Issues in Clinical Trials." Drug Information Journal 31, no. 4 (October 1997): 1167-1174. Full Text
  - Chow, SC, and Shao, J. "Statistical methods for two-sequence three-period cross-over designs with incomplete data." Statistics in medicine 16, no. 9 (May 1997): 1031-1039. (Review) Full Text
  - Chen, K-W, Chow, S-C, and Li, G. "A note on sample size Determination for Bioequivalence studies with higher-order crossover designs." Journal of Pharmacokinetics and Biopharmaceutics 25, no. 6 (1997): 753-765. Full Text
  - Chen, K-W, Li, G, Sun, Y, and Chow, S-C. "Interval estimation for ratios in bioequivalence trials." Biometrical Journal 39, no. 8 (1997): 989-1002.
  - Chen, K-W, Papadopoulos, AS, and Chow, S-C. "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 (1997): 1129-1138.
  - Chow, S-C, and Ki, FYC. "Statistical comparison between dissolution profiles of drug products." Journal of Biopharmaceutical Statistics 7, no. 2 (1997): 241-258.
  - Chow, S-C, and Liu, J. "Meta-analysis for bioequivalence review." Journal of Biopharmaceutical Statistics 7, no. 1 (1997): 97-111.
  - Chow, S-C, and Shao, J. "Statistical methods for two-sequence three-period cross-over designs with incomplete data." Statistics in Medicine 16, no. 9 (1997): 1031-1039. Full Text
  - Liu, J, and Chow, S-C. "A two one-sided tests procedure for assessment of individual bioequivalence." Journal of Biopharmaceutical Statistics 7, no. 1 (1997): 49-61.
  - Liu, J, and Chow, S-C. "Some thoughts on individual bioequivalence." Journal of Biopharmaceutical Statistics 7, no. 1 (1997): 41-48.
  - Wang, W, Hsuan, F, and Chow, S-C. "An adjusted two one-sided t-test for the assessment of bioequivalence with multiple doses." Journal of Biopharmaceutical Statistics 7, no. 1 (1997): 157-170.
  - Liu, J-P, and Chow, S-C. "Statistical Issues on the FDA Conjugated Estrogen Tablets Bioequivalence Guidance." Drug Information Journal 30, no. 4 (October 1996): 881-889. Full Text
  - Wang, W, Husan, F, and Chow, SC. "The impact of patient compliance on drug concentration profile in multiple doses." Statistics in Medicine 15, no. 6 (March 1996): 659-669. Full Text
  - Chen, K-W, Li, G, Sun, Y, and Chow, S-C. "A confidence region approach for assessing equivalence in variability of bioavailability." Biometrical Journal 38, no. 4 (1996): 475-486.
  - Chow, S-C, and Ki, FYC. "Statistical issues in quality-of-life assessment." Journal of Biopharmaceutical Statistics 6, no. 1 (1996): 37-48.
  - Ju, HL, and Chow, S-C. "An overview of stability studies." Journal of Food and Drug Analysis 4, no. 2 (1996): 104-106.
  - Ju, LH, and Chow, S-C. "A procedure for weight and model selection in assay development." Journal of Food and Drug Analysis 4, no. 1 (1996): 1-12.
  - Liu, JP, and Chow, SC. "Statistical issues on the FDA conjugated estrogen tablets bioequivalence guidance." Drug Information Journal 30, no. 4 (January 1, 1996): 881-889. (Review)
  - Liu, JP, and Chow, SC. "Comment." Statistical Science 11, no. 4 (January 1, 1996): 306-312.
  - Srinivas, NR, Barr, WH, Shyu, WC, Mohandoss, E, Chow, S, Staggers, J, Balan, G, Belas, FJ, Blair, IA, and Barbhaiya, RH. "Bioequivalence of two tablet formulations of nadolol using single and multiple dose data: Assessment using stereospecific and nonstereospecific assays." Journal of Pharmaceutical Sciences 85, no. 3 (1996): 299-303. Full Text
  - Wang, W, Husan, F, and Chow, S-C. "The impact of patient compliance on drug concentration profile in multiple doses." Statistics in Medicine 15, no. 6 (1996): 659-669. Full Text
  - Chow, S-C, and Liu, J-P. "Current Issues in Bioequivalence Trials." Drug Information Journal 29, no. 3 (July 1995): 795-804. Full Text
  - Chow, S-C. "Guest Editor's Note: Bioavailability and Bioequivalence." Drug Information Journal 29, no. 3 (July 1995): 793-794. Full Text
  - Liu, J-P, and Chow, S-C. "Replicated Crossover Designs in Bioavailability and Bioequivalence Trials." Drug Information Journal 29, no. 3 (July 1995): 871-884. Full Text
  - Mohandoss, E, Chow, S-C, and Ki, FYC. "Application of Williams' Design for Bioequivalence Trials." Drug Information Journal 29, no. 3 (July 1995): 1029-1038. Full Text
  - Ki, FYC, and Chow, S-C. "Statistical Justification for the Use of Composite Scores in Quality of Life Assessment." Drug Information Journal 29, no. 2 (April 1995): 715-727. Full Text
  - Chow, SC, and Liu, JP. "Current issues in bioequivalence trials." Drug Information Journal 29, no. 3 (January 1, 1995): 795-804. (Review)
  - Ju, HL, and Chow, S-C. "On stability designs in drug shelf-life estimation." Journal of Biopharmaceutical Statistics 5, no. 2 (1995): 201-214.
  - Ki, FYC, Liu, J-P, Wang, W, and Chow, S-C. "The impact of outlying subjects on decision of bioequivalence." Journal of Biopharmaceutical Statistics 5, no. 1 (1995): 71-94.
  - Liu, JP, and Chow, SC. "Replicated crossover designs in bioavailability and bioequivalence trials." Drug Information Journal 29, no. 3 (January 1, 1995): 871-884.
  - Mohandoss, E, Chow, SC, and Ki, FYC. "Application of Williams' design for bioequivalence trials." Drug Information Journal 29, no. 3 (January 1, 1995): 1029-1038.
  - Tse, S-K, and Chow, S-C. "On model selection for standard curve in assay development." Journal of Biopharmaceutical Statistics 5, no. 3 (1995): 285-296.
  - Wang, W, Chow, S-C, and Wei, WWS. "On likelihood distance for outliers detection." Journal of Biopharmaceutical Statistics 5, no. 3 (1995): 307-322.
  - Chow, S-C, and Ki, FYC. "On statistical characteristics of quality of life assessment." Journal of Biopharmaceutical Statistics 4, no. 1 (1994): 1-17.
  - Chow, S-C, and Liu, J-P. "Statistical considerations in bioequivalence trials." Communications in Statistics - Theory and Methods 23, no. 2 (January 1994): 325-339. Full Text
  - Chow, S-C, and Liu, J-P. "Recent statistical developments in bioequivalence trials - A review of the FDA guidance." Drug Information Journal 28, no. 3 (1994): 851-864.
  - Ki, FYC, and Chow, S-C. "Analysis of Quality of Life with Parallel Questionnaires." Drug Information Journal 28, no. 1 (January 1994): 69-80. Full Text
  - Shao, J, and Chow, S-C. "Statistical inference in stability analysis." Biometrics 50, no. 3 (1994): 753-763. Full Text
  - Shein-Chung, C, and Song-Gui, W. "On the estimation of variance components in stability analysis." Communications in Statistics - Theory and Methods 23, no. 1 (January 1994): 289-303. Full Text
  - Wang, S-G, Chow, S-C, and Tse, S-K. "On ordinary least-squares methods for sample surveys." Statistics and Probability Letters 20, no. 3 (1994): 173-182.
  - Liu, J-P, and Chow, S-C. "On Assessment of Bioequivalence for Drugs with Negligible Plasma Levels." Biometrical Journal 35, no. 1 (1993): 109-123. Full Text
  - Shao, J, and Chow, S-C. "Two-stage sampling in pharmaceutical applications." Statistics in Medicine 12, no. 21 (1993): 1999-2008.
  - Chow, SC, and Liu, JP. "On assessment of bioequivalence under a higher-order crossover design." Journal of biopharmaceutical statistics 2, no. 2 (1992): 239-256.
  - Chow, SC, and Tse, SK. "Correction: Outlier detection in bioavailability/bioequivalence studies (Statistics in Medicine (1990) 9 (549-558))." Statistics in Medicine 11, no. 3 (1992): 425--.
  - Deeter, RG, Kalman, DL, Rogan, MP, and Chow, S-C. "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." Clinical Therapeutics 14, no. 5 (1992): 740-754.
  - Goutis, C, and Fearn, T. "Test for batch-to-batch variation in stability analysis." Statistics in medicine 11, no. 2 (January 1992): 269-270. (Letter) Full Text
  - Liu, J-P, and Chow, S-C. "On the assessment of variability in bioavailability/bioequivalence studies." Communications in Statistics - Theory and Methods 21, no. 9 (January 1992): 2591-2607. Full Text
  - Liu, J-P, and Chow, S-C. "Sample size determination for the two one-sided tests procedure in bioequivalence." Journal of Pharmacokinetics and Biopharmaceutics 20, no. 1 (1992): 101-104. Full Text
  - Chow, S-C, and Shao, J. "Estimating drug shelf-life with random batches." Biometrics 47, no. 3 (1991): 1071-1079.
  - Chow, S-C, and Tse, S-K. "On the estimation of total variability in assay validation." Statistics in Medicine 10, no. 10 (1991): 1543-1553.
  - 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 (1991): 161--.
  - Chow, SC, Peace, KE, and Shao, J. "Assessment of bioequivalence using a multiplicative model." Journal of biopharmaceutical statistics 1, no. 2 (1991): 193-203.
  - Chow, SC, and Nordheim, EV. "The estimation of parameters from bulked samples." Journal of biopharmaceutical statistics 1, no. 1 (1991): 1-15.
  - Shao, J, and Chow, S-C. "TEST FOR TREATMENT EFFECT BASED ON BINARY DATA WITH RANDOM SAMPLE SIZES." Australian Journal of Statistics 32, no. 1 (March 1990): 53-70. Full Text
  - Chow, S-C, and Shao, J. "An Alternative Approach for the Assessment of Bioequivalence Between Two Formulations of a Drug." Biometrical Journal 32, no. 8 (1990): 969-976. Full Text
  - Chow, S-C, and Tse, S-K. "A Related Problem in Bioavailability/Bioequivalence Studies - Estimation of the Intrasubject Variability With a Common CV." Biometrical Journal 32, no. 5 (1990): 597-607. Full Text
  - Chow, S-C, and Tse, S-K. "Outlier detection in bioavailability/bioequivalence studies." Statistics in Medicine 9, no. 5 (1990): 549-558.
  - Chow, S-C. "Alternative approaches for assessing bioequivalence regarding normality assumptions." Drug Information Journal 24, no. 4 (1990): 753-762.
  - Wang, S-G, Tse, S-K, and Chow, S-C. "On the measures of multicollinearity in least squares regression." Statistics and Probability Letters 9, no. 4 (1990): 347-355.
  - Wang, S-G, and Chow, S-C. "A note on adaptive generalized ridge regression estimator." Statistics and Probability Letters 10, no. 1 (1990): 17-21.
  - Chow, S-C, and Shao, J. "Test for batch-to-batch variation in stability analysis." Statistics in Medicine 8, no. 7 (1989): 883-890.
  - Chow, S-C, and Shao, J. "A new procedure for the estimation of variance components." Statistics and Probability Letters 6, no. 5 (1988): 349-355.
  - Chow, S-C, and Song, F. "On controversial statistical issues in clinical research (Published online)." Open Access Journal of Clinical Trials : 43-43. Full Text
  - Henson, JB, Patel, Y, Wilder, J, Zheng, J, Chow, SC, King, LY, and Muir, AJ. "Differences in Phenotypes and Liver Transplantation Outcomes by Age Group in Patients with Primary Sclerosing Cholangitis." Digestive Diseases and Sciences . Full Text
Teaching & Mentoring
Recent Courses
- BIOSTAT 708: Clinical Trial Design and Analysis 2017

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