Shein‐Chung Chow

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All published works
Action Title Year Authors
+ PDF Chat A Proposed Confidence Ellipse Approach for Benefit-Risk Assessment in Clinical Trials 2024 Y. Zhang
Xiaofang Zhang
Peijing Wang
Yangfeng Wu
Shein‐Chung Chow
+ Statistical Analysis for Rating Scale in Clinical Trials 2024 Mengyao Shi
Shein‐Chung Chow
+ Utility of real-world evidence in biosimilar development 2024 Ramin B. Arani
Jessie Wang
Dong Pang
Samriddhi Buxy Sinha
Martina Uttenreuther‐Fischer
Shein‐Chung Chow
+ The use of real-world data for clinical investigation of effectiveness in drug development 2024 Peijin Wang
Shein‐Chung Chow
+ Analysis of innovative two-stage seamless adaptive design with different endpoints and population shift 2024 Weijia Mai
Shein‐Chung Chow
+ On the use of RWD in support of regulatory submission in drug development 2024 Shein‐Chung Chow
Peijin Wang
+ PDF Chat Statistical Analysis for Rating Scale in Clinical Trials 2024 Mengyao Shi
Shein‐Chung Chow
+ PDF Chat Evidence of pre-approval clinical trial supporting the granted conditional approval for novel cancer drugs in China between 2015 and 2022 2023 Xingxian Luo
Xin Du
Lin Huang
Qixiang Guo
Xufeng Lv
Cen Wang
Haopeng Liu
Yue Zhou
Xuecai Xue
Zhuangqi Li
+ Statistical tests for detecting reference product change in biosimilar studies 2023 Jiayin Zheng
Peijin Wang
Yixin Wang
Shein‐Chung Chow
+ Statistical Evaluation of Responder Analysis in Stem Cell Clinical Trials 2023 Jiajun Liu
Emily Poehlein
Shein‐Chung Chow
+ Evaluation of clinical trial designs for novel anticancer drugs in China: A cohort study of drugs approved between 2015 and 2021 2023 Xingxian Luo
Qixiang Guo
Xin Du
Lin Huang
Shein‐Chung Chow
Yang Yue
+ A Proposal for Post Hoc Subgroup Analysis in Support of Regulatory Submission 2022 Jiajun Liu
Shein‐Chung Chow
+ Introduction 2022 Wei Zhang
Fangrong Yan
Feng Chen
Shein‐Chung Chow
+ Advanced Statistics in Regulatory Critical Clinical Initiatives 2022 Wei Zhang
Fangrong Yan
Feng Chen
Shein‐Chung Chow
+ Statistical Methods for Assessment of Biosimilars 2022 Yafei Zhang
Vivian Gu
Xiuyu Julie Cong
Shein‐Chung Chow
+ Rare Diseases Drug Development 2022 Shein‐Chung Chow
Shutian Zhang
Wei Zhang
+ PDF Chat The impact of block size on treatment imbalance and blinding integrity in randomized clinical trials 2022 Peijin Wang
Shein‐Chung Chow
+ PDF Chat Statistical evaluation of absolute change versus responder analysis in clinical trials 2022 Peijin Wang
Sarah B. Peskoe
Rebecca Byrd
Patrick J. Smith
Rachel Breslin
Shein‐Chung Chow
+ Innovative Design and Analysis for PK/PD Biosimilar Bridging Studies with Multiple References 2021 Fuyu Song
Xin Xiao Zheng
Yujia Wang
Shein‐Chung Chow
Hongqiang Sun
+ PDF Chat Review of current controversial issues in clinical trials 2021 Shein‐Chung Chow
Susan S. Chow
Annpey Pong
+ Innovative Two-Stage Seamless Adaptive Clinical Trial Designs 2021 Shein‐Chung Chow
Xinyu Zhang
Weijia Mai
+ Sample size re‐estimation in clinical trials 2021 Peijin Wang
Shein‐Chung Chow
+ PK/PD Bridging Studies 2021 Fuyu Song
Xin Zheng
Shein‐Chung Chow
+ Detecting Reference Product Change in Biosimilar Studies 2021 Jiayin Zheng
Peijin Wang
Yixin Wang
Shein‐Chung Chow
+ Two One-Sided Tests Versus Confidence Interval Approach 2021 Jingyu Julia Luan
Weijia Mai
Shein‐Chung Chow
+ Biosimilar Product Development 2021 Sang Joon Lee
Shein‐Chung Chow
+ Modified Quality Range Method for Analytical Similarity Evaluation 2021 Sung Taek Son
Min Kyung Oh
Min Joo Choo
Shein‐Chung Chow
Sang Joon Lee
+ Sensitivity Analysis for Assessment of Extrapolation 2021 Junheng Gao
Chenxuan Zang
Ying Lyu
Shein‐Chung Chow
+ Stability Studies 2021 Mo Liu
Yuqing Liu
Shein‐Chung Chow
+ Non-inferiority/Similarity Margin 2021 Jingyu Julia Luan
Wenyue Zhuo
Shein‐Chung Chow
+ Quality by Design 2021 Min Joo Choo
Ji Youn Kim
Shein‐Chung Chow
Sang Joon Lee
+ Equivalence Test with Flexible Margin 2021 Sang Joon Lee
Minkyung Oh
Shein‐Chung Chow
+ Design and Analysis of Biosimilar Switching Studies 2021 Shein‐Chung Chow
Sang Joon Lee
+ The use of real-world data/evidence in regulatory submissions 2021 Fuyu Song
Chenxuan Zang
Xinyi Ma
Sifan Hu
Qiqing Sun
Shein‐Chung Chow
Hongqiang Sun
+ Statistical Considerations for Gene Therapy Rare Disease Clinical Trials 2021 Chenxuan Zang
Wei Zhang
Shein‐Chung Chow
+ A Time-response Measure to Assess Clinical Equivalence in Rheumatoid Arthritis: an Assessment Using Data From Clinical Trials of Biosimilars 2020 Michael O’Kelly
Aijing Zhang
Ilya Lipkovich
Guochen Song
Russell Reeve
Bohdana Ratitch
Siying Li
Martha Behnke
Jonathan Kay
Shein‐Chung Chow
+ Innovative Methods for Rare Disease Drug Development 2020 Shein‐Chung Chow
+ Endpoint Selection in Clinical Trials 2020 Shein‐Chung Chow
+ Probability of Inconclusiveness 2020 Shein‐Chung Chow
+ The n-of-1 Trial Design and Its Application 2020 Shein‐Chung Chow
+ Two-Stage Adaptive Seamless Trial Design 2020 Shein‐Chung Chow
+ Master Protocol – Platform Trial Design 2020 Shein‐Chung Chow
+ PDF Chat Time to Revisit Endpoint Selection in Clinical Trials 2020 Shein‐Chung Chow
+ PDF Chat Statistical Evaluation of Clinical Trials Under COVID-19 Pandemic 2020 Shein‐Chung Chow
Wei Zhang
+ Some thoughts on the QR method for analytical similarity evaluation 2020 Sungtaek Son
Minkyung Oh
Minjoo Choo
Shein‐Chung Chow
Sang Joon Lee
+ Innovative design and analysis for rare disease drug development 2020 Shein‐Chung Chow
Zhipeng Huang
+ Innovative Statistics in Regulatory Science 2019 Shein‐Chung Chow
+ Adaptive Trial Design 2019 Shein‐Chung Chow
+ Hypotheses Testing versus Confidence Interval 2019 Shein‐Chung Chow
+ Multiplicity 2019 Shein‐Chung Chow
+ Criteria for dose-finding in two-stage seamless adaptive design 2019 Jiayin Zheng
Shein‐Chung Chow
+ Innovative Thinking on Endpoint Selection in Clinical Trials 2019 Shein‐Chung Chow
Zhipeng Huang
+ Simultaneous confidence interval methods for analytical similarity assessment 2019 Jiayin Zheng
Donglei Yin
Mengdie Yuan
Shein‐Chung Chow
+ Statistical considerations for rare diseases drug development 2019 Shein‐Chung Chow
Yu‐Wei Chang
+ Demonstrating effectiveness or demonstrating not ineffectiveness – A potential solution for rare disease drug product development? 2019 Shein‐Chung Chow
Zhipeng Huang
+ Probability monitoring procedures for sample size determination 2019 Zhipeng Huang
Shein‐Chung Chow
+ The use of 95% CI or 90% CI for drug product development — a controversial issue? 2019 Shein‐Chung Chow
Jiayin Zheng
+ Design and Analysis of Biosimilar Switching Studies 2019 Shein‐Chung Chow
Sang Joon Lee
+ Statistics In the Pharmaceutical Industry 2019 Ronald J. Bosch
C. Ralph Buncher
Shein‐Chung Chow
Satya D. Dubey
J. Y. Tsay
Charles W. Dunnett
P.H. van Ewijk
Roger E. Flora
Paul S. Horn
Irving K. Hwang
+ On Bayesian Analysis and Hypothesis Testing in the Determination of Bioequivalence 2019 Donald J. Schuirmann
Stella Grosser
Somesh Chattopadhyay
Shein‐Chung Chow
+ Interim analysis of binary outcome data in clinical trials: a comparison of five estimators 2019 Qing Lu
Shein‐Chung Chow
Siu‐Keung Tse
+ Practical Statistical Issues in Evaluation of Average Bioequivalence 2019 Shein‐Chung Chow
Mo Liu
+ Sample Size Requirement 2018 Shein‐Chung Chow
+ Imputation with Item Nonrespondents 2018 Hansheng Wang
Shein‐Chung Chow
+ Translational medicine: Concepts, Statistical Methods, and Related Issues 2018 Siu‐Keung Tse
Shein‐Chung Chow
+ Clinical Trial: N -of-1 Design Analysis 2018 Can Cui
Shein‐Chung Chow
+ Generalizability Probability in Clinical Research 2018 Shein‐Chung Chow
+ Multi-Regional Clinical Trials: Consistency Test 2018 Jiayin Zheng
Lisa Ying
Zeng Na
Shein‐Chung Chow
+ Biosimilarity of Follow-On Biologics 2018 Shein‐Chung Chow
Jen‐pei Liu
+ Drug Interchangeability: Meta-Analysis for Safety Monitoring 2018 Liu Wenwei
Shein‐Chung Chow
+ Sample Size Calculation: Nonparametrics 2018 Hansheng Wang
Shein‐Chung Chow
+ In Vitro Testing: Bioequivalence 2018 Hansheng Wang
Ying Zhang
Jun Shao
Shein‐Chung Chow
+ Good Statistics Practice (GSP) 2018 Shein‐Chung Chow
+ Seamless Adaptive Trial Design: Dose Selection Criteria 2018 Jiayin Zheng
Shein‐Chung Chow
+ Multivariate Normal and Related Distributions 2018 Song-Gui Wang
Shein‐Chung Chow
+ Statistical Design and Analysis in Pharmaceutical Science 2018 Shein‐Chung Chow
Jen‐pei Liu
+ On sample size requirement for analytical similarity assessment 2018 Yi Zhao
Yu‐Wei Chang
Shein‐Chung Chow
+ Adaptive Trial Design in Clinical Research 2018 Annpey Pong
Shein‐Chung Chow
+ Analysis of Two-Stage Adaptive Trial Designs 2018 Shein‐Chung Chow
Min Lin
+ Design and Analysis of Biosimilar Studies 2018 Shein‐Chung Chow
Fuyu Song
+ PDF Chat Statistical Methods for Conditional Survival Analysis 2017 Sin‐Ho Jung
Ho Yun Lee
Shein‐Chung Chow
+ On evaluation of consistency in multi-regional clinical trials 2017 Lisa Ying
Fuyu Song
Shein‐Chung Chow
Na Zeng
Jiayin Zheng
Xiaodong Li
David Henry
Venkat Sethuraman
+ Tests for Goodness-of-Fit and Contingency Tables 2017 Shein‐Chung Chow
Jun Shao
Hansheng Wang
Yuliya Lokhnygina
+ Sample Size Calculation in Other Areas 2017 Shein‐Chung Chow
Jun Shao
Hansheng Wang
Yuliya Lokhnygina
+ Large Sample Tests for Proportions 2017 Shein‐Chung Chow
Jun Shao
Hansheng Wang
Yuliya Lokhnygina
+ Considerations Prior to Sample Size Calculation 2017 Shein‐Chung Chow
Jun Shao
Hansheng Wang
Yuliya Lokhnygina
+ Sample Size for Clinical Trials with Extremely Low Incidence Rate 2017 Shein‐Chung Chow
Jun Shao
Hansheng Wang
Yuliya Lokhnygina
+ Sample Size Calculation for Two-Stage Adaptive Trial Design 2017 Shein‐Chung Chow
Jun Shao
Hansheng Wang
Yuliya Lokhnygina
+ Sample Size Calculations for Cluster Randomized Trials 2017 Shein‐Chung Chow
Jun Shao
Hansheng Wang
Yuliya Lokhnygina
+ Sample Size Calculations in Clinical Research: Third Edition 2017 Shein‐Chung Chow
Jun Shao
Hansheng Wang
Yuliya Lokhnygina
+ Bioequivalence Testing 2017 Shein‐Chung Chow
Jun Shao
Hansheng Wang
Yuliya Lokhnygina
+ Bayesian Sample Size Calculation 2017 Shein‐Chung Chow
Jun Shao
Hansheng Wang
Yuliya Lokhnygina
+ Test for Homogeneity of Two Zero-Inflated Poisson Population 2017 Shein‐Chung Chow
Jun Shao
Hansheng Wang
Yuliya Lokhnygina
+ Analytical similarity assessment 2017 Shein‐Chung Chow
Fuyu Song
+ Quantitative Methods for Clinical Trials and Epidemiology 2017 Cliburn Chan
Michael G. Hudgens
Shein‐Chung Chow
+ Adaptive Clinical Trial Design 2017 Shein‐Chung Chow
Fuyu Song
+ On assessing bioequivalence and interchangeability between generics based on indirect comparisons 2017 Jiayin Zheng
Shein‐Chung Chow
Mengdie Yuan
+ Design and Analysis of Studies for Assessing Interchangeability 2017 Shein‐Chung Chow
László Endrényi
+ Statistical Methods for Assessing Biosimilarity 2017 Shein‐Chung Chow
Fuyu Song
+ On the establishment of equivalence acceptance criterion in analytical similarity assessment 2017 Tongrong Wang
Shein‐Chung Chow
+ On hybrid parallel–crossover designs for assessing drug interchangeability of biosimilar products 2016 Shein‐Chung Chow
Fuyu Song
Can Cui
+ Statistical evaluation of the scaled criterion for drug interchangeability 2016 Jianghao Li
Shein‐Chung Chow
+ Assessing bioequivalence and drug interchangeability 2016 Meng Chen
Shein‐Chung Chow
+ Sample size requirement in analytical studies for similarity assessment 2016 Shein‐Chung Chow
Fuyu Song
He Bai
+ On safety margin for drug interchangeability 2016 Jiayin Zheng
Shein‐Chung Chow
Fuyu Song
+ On the evaluation of reliability, repeatability, and reproducibility of instrumental evaluation methods and measurement systems 2016 Samir Salah
Shein‐Chung Chow
Fuyu Song
+ Seamless Adaptive Trial Designs 2016 Shein‐Chung Chow
+ PDF Chat Analytical Similarity Assessment in Biosimilar Studies 2016 Shein‐Chung Chow
Fuyu Song
He Bai
+ On sample size estimation and re-estimation adjusting for variability in confirmatory trials 2015 Pei-Shien Wu
Min Lin
Shein‐Chung Chow
+ PDF Chat Bioavailability and Bioequivalence 2015 Shein‐Chung Chow
+ Some thoughts on drug interchangeability 2015 Shein‐Chung Chow
Fuyu Song
Meng Chen
+ PDF Chat Intraarterial Microdosing: A Novel Drug Development Approach, Proof-of-Concept PET Study in Rats 2015 Tal Burt
Douglas Rouse
Kihak Lee
Huali Wu
Anita T. Layton
Thomas C. Hawk
Douglas H. Weitzel
Bennett B. Chin
Michael Cohen‐Wolkowiez
Shein‐Chung Chow
+ STATISTICS IN BIOPHARMACEUTICAL RESEARCH AND DEVELOPMENT 2015 Shein‐Chung Chow
Annpey Pong
+ PDF Chat Challenging issues in assessing analytical similarity in biosimilar studies 2015 Shein‐Chung Chow
+ PDF Chat On controversial statistical issues in clinical research 2015 Shein‐Chung Chow
Fuyu Song
+ PDF Chat Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of Variability 2015 Jianghao Li
Shein‐Chung Chow
+ Minimum Therapeutically Effective Dose 2014 Jen‐pei Liu
Shein‐Chung Chow
+ Median Effective Dose 2014 Jen‐pei Liu
Shein‐Chung Chow
+ Sample Size Calculation for Comparing Variabilities 2014 Hansheng Wang
Shein‐Chung Chow
+ Sample Size Calculation for Comparing Proportions 2014 Hansheng Wang
Shein‐Chung Chow
+ Sample Size Calculation for Comparing Time‐to‐Event Data 2014 Hansheng Wang
Shein‐Chung Chow
+ PDF Chat Bioavailability and Bioequivalence 2014 Shein‐Chung Chow
+ Scientific Factors and Current Issues in Biosimilar Studies 2014 Shein‐Chung Chow
László Endrényi
Peter A. Lachenbruch
France Mentré
+ Frequency Estimator for Assessing of Follow-On Biologics 2014 Ying Lü
Zhongzhan Zhang
Shein‐Chung Chow
+ Nonparametric Tests for Evaluation of Biosimilarity in Variability of Follow-on Biologics 2014 Nan Zhang
Jun Yang
Shein‐Chung Chow
Eric Chi
+ Applications of the Bayesian Prior Information to Evaluation of Equivalence of Similar Biological Medicinal Products 2014 Shih‐Ting Chiu
Jen‐pei Liu
Shein‐Chung Chow
+ PDF Chat Bioavailability and bioequivalence in drug development 2014 Shein‐Chung Chow
+ On Statistical Tests for Homogeneity of Two Bivariate Zero-Inflated Poisson Populations 2014 Hak-Keung Yuen
Shein‐Chung Chow
Siu‐Keung Tse
+ PDF Chat Independent data monitoring committees: Preparing a path for the future 2014 Connie N. Hess
Matthew T. Roe
C. Michael Gibson
Robert J. Temple
Michael Pencina
Deborah A. Zarin
Kevin J. Anstrom
John H. Alexander
Rachel E. Sherman
Fred T. Fiedorek
+ Sample Size for Comparing Time‐to‐Event Data 2014 Hansheng Wang
Shein‐Chung Chow
+ Sample Size Estimation of Multiregional Clinical Trials with Heterogeneous Variability Across Regions 2014 Yuh‐Jenn Wu
Te-Sheng Tan
Shein‐Chung Chow
Chin‐Fu Hsiao
+ PDF Chat Adaptive Clinical Trial Design 2014 Shein‐Chung Chow
+ Statistical Designs for Pharmaceutical/Clinical Development 2014 Shein‐Chung Chow
+ PDF Chat Establishment of reference standards in biosimilar studies 2013 Aijing Zhang
Jung-Ying Tzeng
Shein‐Chung Chow
+ Design and Analysis of Clinical Trials: Concepts and Methodologies 2013 Shein‐Chung Chow
Jen‐pei Liu
+ Censored Data and Interim Analysis 2013 Shein‐Chung Chow
Jen‐pei Liu
+ Basic Design Considerations 2013 Shein‐Chung Chow
Jen‐pei Liu
+ Basic Statistical Concepts 2013 Shein‐Chung Chow
Jen‐pei Liu
+ Classification of Clinical Trials 2013 Shein‐Chung Chow
Jen‐pei Liu
+ Data Management of a Clinical Trial 2013 Shein‐Chung Chow
Jen‐pei Liu
+ Designs for Cancer Clinical Trials 2013 Shein‐Chung Chow
Jen‐pei Liu
+ Trials for Evaluating Accuracy of Diagnostic Devices 2013 Shein‐Chung Chow
Jen‐pei Liu
+ Biomarkers and Targeted Clinical Trials 2013 Shein‐Chung Chow
Jen‐pei Liu
+ Preparation and Implementation of a Clinical Protocol 2013 Shein‐Chung Chow
Jen‐pei Liu
+ Design and Analysis of Clinical Trials 2013 Shein‐Chung Chow
Jen‐Pei Liu
+ PDF Chat Wiley Series in Probability and Statistics 2013 Shein‐Chung Chow
Jen‐pei Liu
+ PDF Chat References 2013 Shein‐Chung Chow
Jen‐pei Liu
+ Index 2013 Shein‐Chung Chow
Jen‐pei Liu
+ Appendix A 2013 Shein‐Chung Chow
Jen‐pei Liu
+ Safety Assessment 2013 Shein‐Chung Chow
Jen‐pei Liu
+ Data Monitoring Committees in adaptive clinical trials 2013 Min Lin
Shein‐Chung Chow
+ Sample Size and Data Monitoring for Clinical Trials With Extremely Low Incidence Rates 2013 Shein‐Chung Chow
Shih‐Ting Chiu
+ Assessing biosimilarity and interchangeability of biosimilar products 2013 Shein‐Chung Chow
+ PDF Chat Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act 2013 Shein‐Chung Chow
+ Use of Random Effect Models in the Design and Analysis of Multi-regional Clinical Trials 2013 Yuh‐Jenn Wu
Te-Sheng Tan
Shein‐Chung Chow
Chin‐Fu Hsiao
+ Sample-Size Determination 2013 Shein‐Chung Chow
Jen‐pei Liu
+ Statistical Considerations in Biosimilar Assessment Using Biosimilarity Index 2013 Aijing Zhang
Jung-Ying Tzeng
Shein‐Chung Chow
+ Statistical assessment of biosimilarity based on relative distance between follow‐on biologics 2012 Seung‐Ho Kang
Shein‐Chung Chow
+ Statistical Methods for Bridging Studies 2012 Shein‐Chung Chow
Chieh Chiang
Jen‐pei Liu
Chin‐Fu Hsiao
+ An adapted <i>F</i>‐test for homogeneity of variability in follow‐on biological products 2012 Jun Yang
Nan Zhang
Shein‐Chung Chow
Eric Chi
+ Impact of variability on the choice of biosimilarity limits in assessing follow‐on biologics 2012 Nan Zhang
Jun Yang
Shein‐Chung Chow
László Endrényi
Eric Chi
+ Scientific considerations for assessing biosimilar products 2012 Shein‐Chung Chow
Jun Wang
László Endrényi
Peter A. Lachenbruch
+ On the interchangeability of biologic drug products 2012 László Endrényi
Chang Chiann
Shein‐Chung Chow
László Tóthfalusi
+ Application of the parallel line assay to assessment of biosimilar products based on binary endpoints 2012 Jr‐Rung Lin
Shein‐Chung Chow
Chih‐Hsi Chang
Ya‐Ching Lin
Jen‐pei Liu
+ Comments on the FDA draft guidance on biosimilar products 2012 Shein‐Chung Chow
László Endrényi
Peter A. Lachenbruch
+ The evaluation of biosimilarity index based on reproducibility probability for assessing follow‐on biologics 2012 Tsung‐Cheng Hsieh
Shein‐Chung Chow
Lan‐Yan Yang
Eric Chi
+ Statistical methods for assessing interchangeability of biosimilars 2012 Shein‐Chung Chow
Lan‐Yan Yang
Aijing Starr
Shih‐Ting Chiu
+ 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 2012 Qingshu Lu
Siu‐Keung Tse
Shein‐Chung Chow
Min Lin
+ On the Independence of Data Monitoring Committee in Adaptive Design Clinical Trials 2012 Shein‐Chung Chow
Ralph Corey
Min Lin
+ PDF Chat On Sample Size Calculation for Comparing Survival Curves Under General Hypothesis Testing 2012 Sin‐Ho Jung
Shein‐Chung Chow
+ Flexible, Adaptive or Attractive Clinical Trial Design 2012 Shein‐Chung Chow
+ Adaptive Design Methods in Clinical Trials 2011 Shein‐Chung Chow
Mark Chang
+ Controversial Statistical Issues in Clinical Trials 2011 Shein‐Chung Chow
+ PDF Chat Scientific factors for assessing biosimilarity and drug interchangeability of follow-on biologics 2011 Lan‐Yan Yang
Shein‐Chung Chow
László Endrényi
Lachenbruch
Чи
+ Sample size calculations for clinical trials 2011 Shein‐Chung Chow
+ Some Controversial Issues in Clinical Trials 2011 Shein‐Chung Chow
Lan‐Yan Yang
Ying Lu
+ Imputation Method Adjusted for Covariates for Nonrespondents in Instruments with Applications 2011 Juan Li
M. Eric
Chunyao. Feng
Shein‐Chung Chow
+ PDF Chat Benefits, challenges and obstacles of adaptive clinical trial designs 2011 Shein‐Chung Chow
Ralph Corey
+ Quantitative evaluation of Bioequivalence/ Biosimilarity 2011 Shein‐Chung Chow
+ Handbook of Adaptive Designs in Pharmaceutical and Clinical Development 2010 Annpey Pong
Shein‐Chung Chow
+ Bridging Diversity 2010 Shein‐Chung Chow
Chin‐Fu Hsiao
+ Assessing departure from dose linearity under a repeated measures incomplete block design 2010 Bin Cheng
Shein‐Chung Chow
+ On Flexibility of Adaptive Designs and Criteria for Choosing A Good One—A Discussion of FDA Draft Guidance 2010 Bin Cheng
Shein‐Chung Chow
+ A Note on Special Articles on Adaptive Clinical Trial Designs 2010 Shein‐Chung Chow
+ Clinical Strategy for Study Endpoint Selection 2010 Siu‐Keung Tse
Shein‐Chung Chow
Qingshu Lu
+ Sample Size Estimation/Allocation for Two-Stage Seamless Adaptive Trial Designs 2010 Shein‐Chung Chow
Annpey Pong
+ The Impact of Protocol Amendments in Adaptive Trial Designs 2010 Shein‐Chung Chow
Annpey Pong
+ Overview of Adaptive Design Methods in Clinical Trials 2010 Annpey Pong
Shein‐Chung Chow
+ Proposals of statistical consideration to evaluation of results for a specific region in multi‐regional trials – Asian perspective 2010 Hsiao‐Hui Tsou
Shein‐Chung Chow
K. K. Gordon Lan
Jen‐pei Liu
Mey Wang
Herng‐Der Chern
­Low‐Tone Ho
Chao A. Hsiung
Chin‐Fu Hsiao
+ Reproducibility Probability in Clinical Research 2010 Shein‐Chung Chow
+ Analysis of Time-to-Event Data Under a Two-Stage Survival Adaptive Design in Clinical Trials 2010 Qingshu Lu
Siu‐Keung Tse
Shein‐Chung Chow
+ Adaptive Design Methods in Clinical Trials 2010 Shein‐Chung Chow
Mark Chang
+ Imputation in Clinical Research 2010 Hansheng Wang
Shein‐Chung Chow
+ Test for Ordered Categorical Data 2010 Shein‐Chung Chow
Siu‐Keung Tse
Chunyan Yang
+ Biosimilarity of Follow-On Biologics 2010 Shein‐Chung Chow
Jen‐pei Liu
+ Randomization 2010 Shein‐Chung Chow
Jun Shao
+ Validity of LOCF 2010 Bin Cheng
Shein‐Chung Chow
+ Calibration 2010 Shein‐Chung Chow
+ Translational Medicine: Concepts, Statistical Methods, and Related Issues 2010 Siu‐Keung Tse
Shein‐Chung Chow
+ Comparing Variabilities in Clinical Research 2010 Yonghee Lee
Hansheng Wang
Shein‐Chung Chow
+ Good Statistics Practice 2010 Shein‐Chung Chow
+ <i>In Vitro</i>Bioequivalence Testing 2010 Hansheng Wang
Ying Zhang
Jun Shao
Shein‐Chung Chow
+ Slope Approach for Assessment of Dose Proportionality/Linearity Under a Crossover Design 2010 Bin Cheng
Shein‐Chung Chow
+ Individual Bioequivalence 2010 Shein‐Chung Chow
Jen‐pei Liu
+ Generalizability Probability in Clinical Research 2010 Shein‐Chung Chow
+ Reproducibility Probability in Clinical Research 2010 Shein‐Chung Chow
+ Bayesian Approach for Analysis of Binary Responses in Clinical Trials with Protocol Amendments 2010 L.‐C. Yang
Shein‐Chung Chow
Yunchan Chi
+ Statistical Methods for Assessment of Biosimilarity Using Biomarker Data 2009 Shein‐Chung Chow
Qingshu Lu
Siu‐Keung Tse
Eric Chi
+ Statistical Test for Evaluation of Biosimilarity in Variability of Follow-On Biologics 2009 Tsung‐Cheng Hsieh
Shein‐Chung Chow
Jen‐pei Liu
Chin‐Fu Hsiao
Eric Chi
+ A Comparison of Moment-Based and Probability-Based Criteria for Assessment of Follow-On Biologics 2009 Shein‐Chung Chow
Tsung‐Cheng Hsieh
Eric Chi
Jun Yang
+ On Assessing Bioequivalence Using Genomic Data with Model Misspecification 2009 Qingshu Lu
Siu‐Keung Tse
Shein‐Chung Chow
Jun Yang
+ Deviations from linearity in statistical evaluation of linearity in assay validation 2009 Jen‐pei Liu
Shein‐Chung Chow
Tsung‐Cheng Hsieh
+ Statistical Methods in Translational Medicine 2008 Shein‐Chung Chow
Siu‐Keung Tse
Dennis Cosmatos
+ Statistical Methods in Translational Medicine 2008 Shein‐Chung Chow
Siu‐Keung Tse
Min Lin
+ Statistical Test for Ordered Categorical Data in Clinical Trials 2008 Shein‐Chung Chow
Siu‐Keung Tse
Chunyan Yang
Dennis Cosmatos
Eric Chi
+ Assessment of Bioequivalence for More Than Two Formulations 2008 Shein‐Chung Chow
Jen‐pei Liu
+ Assumptions of Outlier Detection for Average Bioequivalence 2008 Shein‐Chung Chow
Jen‐pei Liu
+ Statistical Methods for Average Bioequivalence 2008 Shein‐Chung Chow
Jen‐pei Liu
+ Optimal Crossover Designs for Two Formulations for Average Bioequivalence 2008 Shein‐Chung Chow
Jen‐pei Liu
+ Statistical Procedures for Assessment of Population and Individual Bioequivalence 2008 Shein‐Chung Chow
Jen‐pei Liu
+ Population and Individual Bioequivalence 2008 Shein‐Chung Chow
Jen‐pei Liu
+ Design of Bioavailability Studies 2008 Shein‐Chung Chow
Jen‐pei Liu
+ Design and Analysis of Bioavailability and Bioequivalence Studies 2008 Shein‐Chung Chow
Jen‐pei Liu
+ Design and Analysis of Bioavailability and Bioequivalence Studies, The Third Edition 2008 Shein‐Chung Chow
Jen‐pei Liu
+ On Power and Sample Size Calculation for QT Studies with Recording Replicates at Given Time Point 2008 Shein‐Chung Chow
Bin Cheng
Dennis Cosmatos
+ Statistical Assessment of QT/QTc Prolongation Based on Maximum of Correlated Normal Random Variables 2008 Bin Cheng
Shein‐Chung Chow
David Burt
Dennis Cosmatos
+ PDF Chat Adaptive design methods in clinical trials – a review 2008 Shein‐Chung Chow
Mark Chang
+ A Two-Stage Design for Drug Screening Trials Based on Continuous Endpoints 2008 Hsiao‐Hui Tsou
Chin‐Fu Hsiao
Shein‐Chung Chow
Jen‐pei Liu
+ Sample size calculation for the log-rank tests for multi-arm trials with a control 2008 Sin‐Ho Jung
Shein‐Chung Chow
Choongrak Kim
+ Statistical Issues on the Diagnostic Multivariate Index Assay for Targeted Clinical Trials 2007 Jen‐pei Liu
Shein‐Chung Chow
+ Statistical Analysis for Two-Stage Seamless Design with Different Study Endpoints 2007 Shein‐Chung Chow
Qingshu Lu
Siu‐Keung Tse
+ Adaptive Group Sequential Test for Clinical Trials with Changing Patient Population 2007 Huaibao Feng
Jun Shao
Shein‐Chung Chow
+ Analysis Strategies for Adaptive Designs with Multiple Endpoints 2007 Mark Chang
Shein‐Chung Chow
+ Bioequivalence Studies in Drug Development, Methods and Applications by D. HAUSCHKE, V. STEINIJANS, and I. PIGEOT 2007 Shein‐Chung Chow
+ Bayesian Sample Size Calculation 2007 Shein‐Chung Chow
Jun Shao
Hansheng Wang
Yuliya Lokhnygina
+ Sample Size Calculations in Clinical Research, Second Edition 2007 Jun Shao
Shein‐Chung Chow
Hansheng Wang
+ Sample Size Calculations in Clinical Research 2007 Shein‐Chung Chow
Hansheng Wang
Jun Shao
+ Mixed Noninferiority Margin and Statistical Tests in Active Controlled Trials 2007 Hsiao‐Hui Tsou
Chin‐Fu Hsiao
Shein‐Chung Chow
Lilly Q. Yue
Yunling Xu
Shiowjen Lee
+ Power and Sample Size for Dose Response Studies 2006 Mark Chang
Shein‐Chung Chow
+ A Note on Sample Size Calculation Based on Propensity Analysis in Nonrandomized Trials 2006 Sin‐Ho Jung
Shein‐Chung Chow
M. Eric
+ Adaptive Design Methods in Clinical Trials 2006 Shein‐Chung Chow
Mark Chang
+ Sample Size Calculation for Comparing Time‐to‐Event Data 2006 Hansheng Wang
Shein‐Chung Chow
+ Sample Size Calculation for Comparing Proportions 2006 Hansheng Wang
Shein‐Chung Chow
+ Sample Size Calculation for Comparing Variabilities 2006 Hansheng Wang
Shein‐Chung Chow
+ Adaptive Design in Clinical Research: Issues, Opportunities, and Recommendations 2006 Mark Chang
Shein‐Chung Chow
Annpey Pong
+ On the Assessment of Dose Proportionality: A Comparison of Two Slope Approaches 2006 Bin Cheng
Shein‐Chung Chow
Wei‐Lun Su
+ On non-inferiority margin and statistical tests in active control trials 2005 Shein‐Chung Chow
Jun Shao
+ Bioavailability and Bioequivalence 2005 Shein‐Chung Chow
+ Sample Size Calculation for Comparing Proportions 2005 Hansheng Wang
Shein‐Chung Chow
+ Sample Size Calculation for Comparing Time‐to‐Event Data 2005 Hansheng Wang
Shein‐Chung Chow
+ Sample Size Calculation for Comparing Means 2005 Hansheng Wang
Shein‐Chung Chow
+ Sample Size Calculation for Comparing Variabilities 2005 Hansheng Wang
Shein‐Chung Chow
+ A Bayesian Approach on Sample Size Calculation for Comparing Means 2005 Hansheng Wang
Shein‐Chung Chow
Murphy Chen
+ A Hybrid Bayesian Adaptive Design for Dose Response Trials 2005 Mark Chang
Shein‐Chung Chow
+ Statistical Consideration of Adaptive Methods in Clinical Development 2005 Shein‐Chung Chow
Mark Chang
Annpey Pong
+ Inference for Clinical Trials with Some Protocol Amendments 2005 Shein‐Chung Chow
Jun Shao
+ Minimum Therapeutically Effective Dose 2005 Jen‐pei Liu
Shein‐Chung Chow
+ Median Effective Dose 2005 Jen‐pei Liu
Shein‐Chung Chow
+ Authors' Reply 2005 Jun Shao
Shein‐Chung Chow
+ Statistical inference for cancer trials with treatment switching 2005 Jun Shao
Mark Chang
Shein‐Chung Chow
+ Assessing Bioequivalence Using Genomic Data 2004 Shein‐Chung Chow
Jun Shao
Li Li
+ Bioavailability and Bioequivalence 2004 Shein‐Chung Chow
+ Modified Large-Sample Confidence Intervals for Linear Combinations of Variance Components 2004 Yonghee Lee
Jun Shao
Shein‐Chung Chow
+ Inference in Case-Control Studies 2004 Gary King
Langche Zeng
Shein‐Chung Chow
+ Designs for Clinical Trials 2003 Shein‐Chung Chow
Jen‐pei Liu
+ Analysis of Categorical Data 2003 Shein‐Chung Chow
Jen‐pei Liu
+ Design and Analysis of Clinical Trials 2003 Shein‐Chung Chow
Jen‐pei Liu
+ Analysis of Continuous Data 2003 Shein‐Chung Chow
Jen‐pei Liu
+ Issues in Efficacy Evaluation 2003 Shein‐Chung Chow
Jen‐pei Liu
+ Censored Data and Interim Analysis 2003 Shein‐Chung Chow
Jen‐pei Liu
+ Preparation and Implementation of a Clinical Protocol 2003 Shein‐Chung Chow
Jen‐pei Liu
+ Wiley Series in Probability and Statistics 2003 Shein‐Chung Chow
Jen‐pei Liu
+ Bibliography 2003 Shein‐Chung Chow
Jen‐pei Liu
+ Designs for Cancer Clinical Trials 2003 Shein‐Chung Chow
Jen‐pei Liu
+ Classification of Clinical Trials 2003 Shein‐Chung Chow
Jen‐pei Liu
+ Basic Design Considerations 2003 Shein‐Chung Chow
Jen‐pei Liu
+ Basic Statistical Concepts 2003 Shein‐Chung Chow
Jen‐pei Liu
+ STATISTICS IN BIOPHARMACEUTICAL RESEARCH 2003 Shein‐Chung Chow
Annpey Pong
+ Sample Size Calculations in Clinical Research 2003 Shein‐Chung Chow
Hansheng Wang
Jun Shao
+ Sample Size Determination Based on Rank Tests in Clinical Trials 2003 Hansheng Wang
Bin Chen
Shein‐Chung Chow
+ Stability Analysis with Discrete Responses 2003 Shein‐Chung Chow
Jun Shao
+ Examining Outlying Subjects and Outlying Records in Bioequivalence Trials 2003 Wenping Wang
Shein‐Chung Chow
+ STATISTICAL TESTS FOR POPULATION BIOEQUIVALENCE 2003 Shein‐Chung Chow
Jun Shao
Hansheng Wang
+ Imputation in Clinical Research 2003 Hansheng Wang
Shein‐Chung Chow
+ <i>In vitro</i> bioequivalence testing 2002 Shein‐Chung Chow
Jun Shao
Hansheng Wang
+ A practical approach for comparing means of two groups without equal variance assumption 2002 Hansheng Wang
Shein‐Chung Chow
+ A note on statistical methods for assessing therapeutic equivalence 2002 Shein‐Chung Chow
Jun Shao
+ Reproducibility probability in clinical trials 2002 Jun Shao
Shein‐Chung Chow
+ Bioavailability and Bioequivalence 2002 Shein‐Chung Chow
+ Statistics in Drug Research 2002 Shein‐Chung Chow
Jun Shao
+ Individual bioequivalence testing under 2×3 designs 2002 Shein‐Chung Chow
Jun Shao
Hansheng Wang
+ ON SAMPLE SIZE CALCULATION BASED ON ODDS RATIO IN CLINICAL TRIALS 2002 Hansheng Wang
Shein‐Chung Chow
Gang Li
+ TESTS FOR INTER-SUBJECT AND TOTAL VARIABILITIES UNDER CROSSOVER DESIGNS 2002 Yonghee Lee
Jun Shao
Shein‐Chung Chow
Hansheng Wang
+ A NOTE ON SAMPLE SIZE CALCULATION FOR MEAN COMPARISONS BASED ON NONCENTRAL <i>t</i>-STATISTICS 2002 Shein‐Chung Chow
Jun Shao
Hansheng Wang
+ Statistics in Drug Research: Methodologies and Recent Developments 2002 Shein‐Chung Chow
Jun Shao
+ BRIDGING STUDIES IN CLINICAL DEVELOPMENT 2002 Jen‐pei Liu
Shein‐Chung Chow
+ Probability lower bounds for USP/NF tests 2002 Shein‐Chung Chow
Jun Shao
Hansheng Wang
+ ON STATISTICAL POWER FOR AVERAGE BIOEQUIVALENCE TESTING UNDER REPLICATED CROSSOVER DESIGNS 2002 Hansheng Wang
Shein‐Chung Chow
+ On sample size calculation in bioequivalence trials. 2001 Shein‐Chung Chow
Hansheng Wang
+ DRUG SHELF-LIFE ESTIMATION 2001 Jun Shao
Shein‐Chung Chow
+ On statistical analysis for placebo-challenging designs in clinical trials 2000 Shein‐Chung Chow
Jun Shao
Hsin‐Tsung Ho
+ On statistical analysis for placebo‐challenging designs in clinical trials 2000 Shein‐Chung Chow
Jun Shao
Hsin‐Tsung Ho
+ BIOEQUIVALENCE REVIEW FOR DRUG INTERCHANGEABILITY 1999 Shein‐Chung Chow
Jun Shao
+ Individual Bioequivalence—A Review of the FDA Draft Guidance 1999 Shein‐Chung Chow
+ An Overview of the Regulatory Approval Process in Drug Development 1998 Shein‐Chung Chow
Annpey Pong
+ Design and Analysis of Multinational Clinical Trials 1998 Hsin‐Tsung Ho
Shein‐Chung Chow
+ Design and analysis of clinical trials : concept and methodologies 1998 Shein‐Chung Chow
Jen‐pei Liu
+ Good Statistics Practice in the Drug Development and Regulatory Approval Process 1997 Shein‐Chung Chow
+ Statistical/Practical Issues in Clinical Trials 1997 Annpey Pong
Shein‐Chung Chow
+ STATISTICAL METHODS FOR TWO-SEQUENCE THREE-PERIOD CROSS-OVER DESIGNS WITH INCOMPLETE DATA 1997 Shein‐Chung Chow
Jun Shao
+ A note on sample size determination for bioequivalence studies with high-order crossover designs. 1997 Keh-Wei Chen
Shein‐Chung Chow
Gang Li
+ A two one-sided tests procedure for assessment of individual bioequivalence 1997 Jen‐pei Liu
Shein‐Chung Chow
+ Guest editor's note: recent issues in bioequivalence trials 1997 Shein‐Chung Chow
+ Meta-analysis for bioequivalence review 1997 Shein‐Chung Chow
Jen‐pei Liu
+ An adjusted two one-sided <i>t</i>-test for the assessment of bioequivalence with multiple doses 1997 Wenping Wang
Francis Hsuan
Shein‐Chung Chow
+ Some thoughts on individual bioequivalence 1997 Jen‐pei Liu
Shein‐Chung Chow
+ A Note on sample Size Determination for 1997 Keh-Wei Chen
Shein‐Chung Chow
Gang Li
+ PDF Chat Statistical Issues on the FDA Conjugated Estrogen Tablets Bioequivalence Guidance 1996 Jen‐pei Liu
Shein‐Chung Chow
+ Statistical Design and Analysis in Pharmaceutical Science. 1996 Michael Hale
Russell L. Reeve
Carol Francisco
Shein‐Chung Chow
Jen‐pei Liu
+ PDF Chat THE IMPACT OF PATIENT COMPLIANCE ON DRUG CONCENTRATION PROFILE IN MULTIPLE DOSES 1996 Wen‐Ping Wang
FRANCIS HUSAN
Shein‐Chung Chow
+ Statistical Design and Analysis in Pharmaceutical Science 1996 Eric R. Ziegel
Shein‐Chung Chow
Jiewen Liu
+ Guest Editor's Note: Bioavailability and Bioequivalence 1995 Shein‐Chung Chow
+ Replicated Crossover Designs in Bioavailability and Bioequivalence Trials 1995 Jen‐pei Liu
Shein‐Chung Chow
+ Application of Williams' Design for Bioequivalence Trials 1995 Emmanuel Mohandoss
Shein‐Chung Chow
Fanny Y. C. Ki
+ Current Issues in Bioequivalence Trials 1995 Shein‐Chung Chow
Jen‐pei Liu
+ Current Issues in Regulatory Requirements of Drug Stability 1995 Shein‐Chung Chow
Annpey Pong
+ Statistical Justification for the Use of Composite Scores in Quality of Life Assessment 1995 Fanny Y. C. Ki
Shein‐Chung Chow
+ The impact of outlying subjects on decising of bioequivalence 1995 Fanny Y. C. Ki
Jen‐pei Liu
Wenping Wang
Shein‐Chung Chow
+ On likelihood distance for outliers detection 1995 Wenping Wang
Shein‐Chung Chow
William W. S. Wei
+ On model selection for standard curve in assay development 1995 Siu‐Keung Tse
Shein‐Chung Chow
+ On stability designs in drug shelf-life estimation 1995 Huey L. Ju
Shein‐Chung Chow
+ Statistical Inference in Stability Analysis 1994 Jun Shao
Shein‐Chung Chow
+ Recent Statistical Developments in Bioequivalence Trials — A Review of the FDA Guidance* 1994 Shein‐Chung Chow
Jen‐pei Liu
+ On ordinary least-squares methods for sample surveys 1994 Song-Gui Wang
Shein‐Chung Chow
Siu‐Keung Tse
+ Statistical considerations in bioequivalence trials 1994 Shein‐Chung Chow
Jen‐pei Liu
+ On statistical characteristics of quality of life assessment 1994 Shein‐Chung Chow
Fanny Y. C. Ki
+ Constructing Release Targets for Drug Products: a Bayesian Decision Theory Approach 1993 Tom Fearn
Costas Goutis
Jun Shao
Shein‐Chung Chow
+ On Assessment of Bioequivalence for Drugs with Negligible Plasma Levels 1993 Jen‐pei Liu
Shein‐Chung Chow
+ Sample size determination for the two one-sided tests procedure in bioequivalence 1992 Jen‐pei Liu
Shein‐Chung Chow
+ On assessment of bioequivalence under a higher-order crossover design 1992 Shein‐Chung Chow
Jen‐pei Liu
+ On the assessment of variability in bioavailability/bioequivalence studies 1992 Jen‐pei Liu
Shein‐Chung Chow
+ Test for batch‐to‐batch variation in stability analysis 1992 Costas Goutis
Tom Fearn
Shein‐Chung Chow
Jun Shao
+ The estimation of parameters from bulked samples 1991 Shein‐Chung Chow
Erik V. Nordheim
+ Assessment of bioequivalence using a multiplicative model 1991 Shein‐Chung Chow
Karl E. Peace
Jun Shao
+ Alternative Approaches for Assessing Bioequivalence regarding Normality Assumptions 1990 Shein‐Chung Chow
+ A note on adaptive generalized ridge regression estimator 1990 Song-Gui Wang
Shein‐Chung Chow
+ On the measures of multicollinearity in least squares regression 1990 Song-Gui Wang
Siu‐Keung Tse
Shein‐Chung Chow
+ TEST FOR TREATMENT EFFECT BASED ON BINARY DATA WITH RANDOM SAMPLE SIZES 1990 Jun Shao
Shein‐Chung Chow
+ An Alternative Approach for the Assessment of Bioequivalence Between Two Formulations of a Drug 1990 Shein‐Chung Chow
Jun Shao
+ A Related Problem in Bioavailability/Bioequivalence Studies — Estimation of the Intrasubject Variability With a Common CV 1990 Shein‐Chung Chow
Siu‐Keung Tse
+ On the Difference Between the Classical and Inverse Methods of Calibration 1990 Shein‐Chung Chow
Jun Shao
+ A new procedure for the estimation of variance components 1988 Shein‐Chung Chow
Jun Shao
+ some results on cononical correlations and measures of multivariate association 1987 Song-Gui Wang
Shein‐Chung Chow
Common Coauthors
Commonly Cited References
Action Title Year Authors # of times referenced
+ PDF Chat A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability 1987 Donald J. Schuirmann
38
+ Design and Analysis of Bioavailability and Bioequivalence Studies 1994 Eric R. Ziegel
Shein Chung Chow
Jiewen Liu
36
+ Reproducibility probability in clinical trials 2002 Jun Shao
Shein‐Chung Chow
30
+ Design and Analysis of Bioavailability and Bioequivalence Studies 2008 Shein‐Chung Chow
Jen‐pei Liu
25
+ Statistical Consideration of Adaptive Methods in Clinical Development 2005 Shein‐Chung Chow
Mark Chang
Annpey Pong
23
+ Sample Size Calculations in Clinical Research 2003 Shein‐Chung Chow
Hansheng Wang
Jun Shao
21
+ ASSESSING SENSITIVITY AND SIMILARITY IN BRIDGING STUDIES 2002 Shein‐Chung Chow
Jun Shao
Oliver Yoa‐Pu Hu
19
+ On population and individual bioequivalence 1993 Robert Schall
H. G. Luus
19
+ A small sample confidence interval approach to assess individual bioequivalence 2000 Terry Hyslop
Francis Hsuan
Daniel Holder
19
+ Consideration of individual bioequivalence 1990 Sharon Anderson
Walter W. Hauck
18
+ Statistics in Drug Research 2002 Shein‐Chung Chow
Jun Shao
18
+ Symmetrical Confidence Intervals for Bioequivalence Trials 1976 Wilfred J. Westlake
17
+ Adaptive Design Methods in Clinical Trials 2010 Shein‐Chung Chow
Mark Chang
17
+ Adaptive Design Methods in Clinical Trials 2006 Shein‐Chung Chow
Mark Chang
16
+ Inference for Clinical Trials with Some Protocol Amendments 2005 Shein‐Chung Chow
Jun Shao
16
+ Design and Analysis of Clinical Trials 2003 Shein‐Chung Chow
Jen‐pei Liu
15
+ Design and Analysis of Cross-Over Trials 1989 Byron Jones
Michael G. Kenward
15
+ Adaptive design method based on sum of <i>p</i>‐values 2006 Mark Chang
14
+ Adaptive Designs in Clinical Drug Development—An Executive Summary of the PhRMA Working Group 2006 Paul Gallo
Christy Chuang‐Stein
Vladimir Dragalin
Brenda Gaydos
Michael Krams
José Cirı́aco Pinheiro
13
+ A Comparison of Moment-Based and Probability-Based Criteria for Assessment of Follow-On Biologics 2009 Shein‐Chung Chow
Tsung‐Cheng Hsieh
Eric Chi
Jun Yang
13
+ Adaptive Seamless Phase II/III Designs—Background, Operational Aspects, and Examples 2006 Jeff Maca
Sumon Bhattacharya
Vladimir Dragalin
Paul Gallo
Michael Krams
12
+ Current Issues in Bioequivalence Trials 1995 Shein‐Chung Chow
Jen‐pei Liu
12
+ On non-inferiority margin and statistical tests in active control trials 2005 Shein‐Chung Chow
Jun Shao
12
+ On assessment of bioequivalence under a higher-order crossover design 1992 Shein‐Chung Chow
Jen‐pei Liu
11
+ Bioequivalence Approaches for Highly Variable Drugs and Drug Products 2007 Sam Haidar
Barbara M. Davit
Mei‐Ling Chen
Dale P. Conner
LaiMing Lee
Qian H. Li
Robert Lionberger
Fairouz Makhlouf
Devvrat T. Patel
Donald J. Schuirmann
11
+ Statistical Analysis for Two-Stage Seamless Design with Different Study Endpoints 2007 Shein‐Chung Chow
Qingshu Lu
Siu‐Keung Tse
11
+ PDF Chat Scientific factors for assessing biosimilarity and drug interchangeability of follow-on biologics 2011 Lan‐Yan Yang
Shein‐Chung Chow
László Endrényi
Lachenbruch
Чи
10
+ Adaptive Design Methods in Clinical Trials 2011 Shein‐Chung Chow
Mark Chang
10
+ An Alternative Approach for the Assessment of Bioequivalence Between Two Formulations of a Drug 1990 Shein‐Chung Chow
Jun Shao
10
+ Modification of Sample Size in Group Sequential Clinical Trials 1999 Lu Cui
H. M. James Hung
Sue‐Jane Wang
10
+ Sample size determination for the two one-sided tests procedure in bioequivalence 1992 Jen‐pei Liu
Shein‐Chung Chow
10
+ On sample size calculation in bioequivalence trials. 2001 Shein‐Chung Chow
Hansheng Wang
10
+ Statistical Design and Analysis in Pharmaceutical Science 1996 Eric R. Ziegel
Shein‐Chung Chow
Jiewen Liu
10
+ Power of the two one-sided tests procedure in bioequivalence 1990 Kem F. Phillips
9
+ Evaluation of Experiments with Adaptive Interim Analyses 1994 Péter Bauer
Karl Kohne
9
+ 15 Design and Analysis of Cross-Over Trials 2007 Michael G. Kenward
Byron Jones
9
+ Continual Reassessment Method: A Practical Design for Phase 1 Clinical Trials in Cancer 1990 John O’Quigley
Margaret S. Pepe
Lloyd D. Fisher
9
+ Individual bioequivalence—a regulatory update 1997 Mei‐Ling Chen
9
+ Clinical Trials for Drug Registrations in Asian-Pacific Countries 2001 Weichung Joe Shih
9
+ A Unified Theory of Two-Stage Adaptive Designs 2002 Qing Liu
Michael A. Proschan
Gordon Pledger
9
+ Statistical Design and Analysis in Pharmaceutical Science 2018 Shein‐Chung Chow
Jen‐pei Liu
9
+ DESIGN AND ANALYSIS OF INTRA-SUBJECT VARIABILITY IN CROSS-OVER EXPERIMENTS 1996 Vernon M. Chinchilli
James D. Esinhart
9
+ Outlier detection in bioavailability/bioequivalence studies 1990 Shein‐Chung Chow
Siu‐Keung Tse
9
+ Sample Size Calculations in Clinical Research: Third Edition 2017 Shein‐Chung Chow
Jun Shao
Hansheng Wang
Yuliya Lokhnygina
9
+ Individual Bioequivalence—A Review of the FDA Draft Guidance 1999 Shein‐Chung Chow
9
+ A new procedure for testing equivalence in comparative bioavailability and other clinical trials 1983 Sharon Anderson
Walter W. Hauck
9
+ Bioequivalence revisited 1992 Lewis B. Sheiner
9
+ Some Problems in Interval Estimation 1954 E. C. Fieller
8
+ Extension to the use of tolerance intervals for the assessment of individual bioequivalence 1994 James D. Esinhart
Vernon M. Chinchilli
8
+ An adaptive method for establishing a dose‐response relationship 1995 Péter Bauer
Joachim Röhmel
8