Table Of ContentBioequivalence and
Statistics in Clinical
Pharmacology
Second Edition
Editor-in-Chief
Shein-Chung Chow, Ph.D., Professor, Department of Biostatistics and Bioinformatics,
Duke University School of Medicine, Durham, North Carolina
Series Editors
Byron Jones, Biometrical Fellow, Statistical Methodology, Integrated Information Sciences,
Novartis Pharma AG, Basel, Switzerland
Jen-pei Liu, Professor, Division of Biometry, Department of Agronomy,
National Taiwan University, Taipei, Taiwan
Karl E. Peace, Georgia Cancer Coalition, Distinguished Cancer Scholar, Senior Research Scientist
and Professor of Biostatistics, Jiann-Ping Hsu College of Public Health,
Georgia Southern University, Statesboro, Georgia
Bruce W. Turnbull, Professor, School of Operations Research and Industrial Engineering,
Cornell University, Ithaca, New York
Published Titles
Adaptive Design Methods in Clinical Bayesian Analysis Made Simple:
Trials, Second Edition An Excel GUI for WinBUGS
Shein-Chung Chow and Mark Chang Phil Woodward
Adaptive Designs for Sequential Bayesian Designs for Phase I–II
Treatment Allocation Clinical Trials
Alessandro Baldi Antognini Ying Yuan, Hoang Q. Nguyen,
and Alessandra Giovagnoli and Peter F. Thall
Adaptive Design Theory and Bayesian Methods for Measures
Implementation Using SAS and R, of Agreement
Second Edition Lyle D. Broemeling
Mark Chang
Bayesian Methods for Repeated Measures
Advanced Bayesian Methods for Lyle D. Broemeling
Medical Test Accuracy
Bayesian Methods in Epidemiology
Lyle D. Broemeling
Lyle D. Broemeling
Applied Biclustering Methods for Big
Bayesian Methods in Health Economics
and High-Dimensional Data Using R
Gianluca Baio
Adetayo Kasim, Ziv Shkedy,
Bayesian Missing Data Problems: EM,
Sebastian Kaiser, Sepp Hochreiter,
Data Augmentation and Noniterative
and Willem Talloen
Computation
Applied Meta-Analysis with R
Ming T. Tan, Guo-Liang Tian,
Ding-Geng (Din) Chen and Karl E. Peace
and Kai Wang Ng
Basic Statistics and Pharmaceutical
Bayesian Modeling in Bioinformatics
Statistical Applications, Second Edition
Dipak K. Dey, Samiran Ghosh,
James E. De Muth
and Bani K. Mallick
Bayesian Adaptive Methods for
Benefit-Risk Assessment in
Clinical Trials
Pharmaceutical Research and
Scott M. Berry, Bradley P. Carlin,
Development
J. Jack Lee, and Peter Muller
Andreas Sashegyi, James Felli,
and Rebecca Noel
Published Titles
Benefit-Risk Assessment Methods in Design and Analysis of Animal Studies
Medical Product Development: Bridging in Pharmaceutical Development
Qualitative and Quantitative Assessments Shein-Chung Chow and Jen-pei Liu
Qi Jiang and Weili He
Design and Analysis of Bioavailability
Bioequivalence and Statistics in Clinical and Bioequivalence Studies, Third Edition
Pharmacology, Second Edition Shein-Chung Chow and Jen-pei Liu
Scott Patterson and Byron Jones
Design and Analysis of Bridging Studies
Biosimilars: Design and Analysis of Jen-pei Liu, Shein-Chung Chow,
Follow-on Biologics and Chin-Fu Hsiao
Shein-Chung Chow
Design & Analysis of Clinical Trials for
Biostatistics: A Computing Approach Economic Evaluation & Reimbursement:
Stewart J. Anderson An Applied Approach Using SAS & STATA
Iftekhar Khan
Cancer Clinical Trials: Current and
Controversial Issues in Design and Design and Analysis of Clinical Trials
Analysis for Predictive Medicine
Stephen L. George, Xiaofei Wang, Shigeyuki Matsui, Marc Buyse,
and Herbert Pang and Richard Simon
Causal Analysis in Biomedicine and Design and Analysis of Clinical Trials with
Epidemiology: Based on Minimal Time-to-Event Endpoints
Sufficient Causation Karl E. Peace
Mikel Aickin
Design and Analysis of Non-Inferiority Trials
Clinical and Statistical Considerations in Mark D. Rothmann, Brian L. Wiens,
Personalized Medicine and Ivan S. F. Chan
Claudio Carini, Sandeep Menon, and Mark Chang
Difference Equations with Public Health
Clinical Trial Data Analysis using R Applications
Ding-Geng (Din) Chen and Karl E. Peace Lemuel A. Moyé and Asha Seth Kapadia
Clinical Trial Methodology DNA Methylation Microarrays:
Karl E. Peace and Ding-Geng (Din) Chen Experimental Design and Statistical
Analysis
Computational Methods in Biomedical
Sun-Chong Wang and Arturas Petronis
Research
Ravindra Khattree and Dayanand N. Naik DNA Microarrays and Related Genomics
Techniques: Design, Analysis, and
Computational Pharmacokinetics
Interpretation of Experiments
Anders Källén
David B. Allison, Grier P. Page,
Confidence Intervals for Proportions
T. Mark Beasley, and Jode W. Edwards
and Related Measures of Effect Size
Dose Finding by the Continual
Robert G. Newcombe
Reassessment Method
Controversial Statistical Issues in
Ying Kuen Cheung
Clinical Trials
Dynamical Biostatistical Models
Shein-Chung Chow
Daniel Commenges and
Data Analysis with Competing Risks
Hélène Jacqmin-Gadda
and Intermediate States
Elementary Bayesian Biostatistics
Ronald B. Geskus
Lemuel A. Moyé
Data and Safety Monitoring Committees
Empirical Likelihood Method in
in Clinical Trials
Survival Analysis
Jay Herson
Mai Zhou
Published Titles
Essentials of a Successful Biostatistical Modern Adaptive Randomized Clinical
Collaboration Trials: Statistical and Practical Aspects
Arul Earnest Oleksandr Sverdlov
Exposure–Response Modeling: Methods Monte Carlo Simulation for the
and Practical Implementation Pharmaceutical Industry: Concepts,
Jixian Wang Algorithms, and Case Studies
Mark Chang
Frailty Models in Survival Analysis
Andreas Wienke Multiregional Clinical Trials for
Fundamental Concepts for New Clinical Simultaneous Global New Drug
Trialists Development
Scott Evans and Naitee Ting Joshua Chen and Hui Quan
Generalized Linear Models: A Bayesian Multiple Testing Problems in
Perspective Pharmaceutical Statistics
Dipak K. Dey, Sujit K. Ghosh, and Alex Dmitrienko, Ajit C. Tamhane,
Bani K. Mallick and Frank Bretz
Handbook of Regression and Modeling: Noninferiority Testing in Clinical Trials:
Applications for the Clinical and Issues and Challenges
Pharmaceutical Industries Tie-Hua Ng
Daryl S. Paulson Optimal Design for Nonlinear Response
Inference Principles for Biostatisticians Models
Ian C. Marschner Valerii V. Fedorov and Sergei L. Leonov
Interval-Censored Time-to-Event Data: Patient-Reported Outcomes:
Methods and Applications Measurement, Implementation and
Ding-Geng (Din) Chen, Jianguo Sun, Interpretation
and Karl E. Peace Joseph C. Cappelleri, Kelly H. Zou,
Andrew G. Bushmakin, Jose Ma. J. Alvir,
Introductory Adaptive Trial Designs:
Demissie Alemayehu, and Tara Symonds
A Practical Guide with R
Mark Chang Quantitative Evaluation of Safety in Drug
Development: Design, Analysis and
Joint Models for Longitudinal and Time-
Reporting
to-Event Data: With Applications in R
Qi Jiang and H. Amy Xia
Dimitris Rizopoulos
Quantitative Methods for Traditional
Measures of Interobserver Agreement
Chinese Medicine Development
and Reliability, Second Edition
Shein-Chung Chow
Mohamed M. Shoukri
Randomized Clinical Trials of
Medical Biostatistics, Third Edition
Nonpharmacological Treatments
A. Indrayan
Isabelle Boutron, Philippe Ravaud,
Meta-Analysis in Medicine and
and David Moher
Health Policy
Randomized Phase II Cancer
Dalene Stangl and Donald A. Berry
Clinical Trials
Mixed Effects Models for the Population
Sin-Ho Jung
Approach: Models, Tasks, Methods
Sample Size Calculations for Clustered
and Tools
and Longitudinal Outcomes in Clinical
Marc Lavielle
Research
Modeling to Inform Infectious Disease
Chul Ahn, Moonseong Heo,
Control
and Song Zhang
Niels G. Becker
Published Titles
Sample Size Calculations in Clinical Statistical Methods in Drug Combination
Research, Second Edition Studies
Shein-Chung Chow, Jun Shao, Wei Zhao and Harry Yang
and Hansheng Wang
Statistical Testing Strategies in the
Statistical Analysis of Human Growth Health Sciences
and Development Albert Vexler, Alan D. Hutson,
Yin Bun Cheung and Xiwei Chen
Statistical Design and Analysis of Clinical Statistics in Drug Research:
Trials: Principles and Methods Methodologies and Recent
Weichung Joe Shih and Joseph Aisner Developments
Shein-Chung Chow and Jun Shao
Statistical Design and Analysis of
Stability Studies Statistics in the Pharmaceutical Industry,
Shein-Chung Chow Third Edition
Ralph Buncher and Jia-Yeong Tsay
Statistical Evaluation of Diagnostic
Performance: Topics in ROC Analysis Survival Analysis in Medicine and
Kelly H. Zou, Aiyi Liu, Andriy Bandos, Genetics
Lucila Ohno-Machado, and Howard Rockette Jialiang Li and Shuangge Ma
Statistical Methods for Clinical Trials Theory of Drug Development
Mark X. Norleans Eric B. Holmgren
Statistical Methods for Drug Safety Translational Medicine: Strategies and
Robert D. Gibbons and Anup K. Amatya Statistical Methods
Dennis Cosmatos and Shein-Chung Chow
Statistical Methods for Healthcare
Performance Monitoring
Alex Bottle and Paul Aylin
Statistical Methods for Immunogenicity
Assessment
Harry Yang, Jianchun Zhang, Binbing Yu,
and Wei Zhao
Bioequivalence and
Statistics in Clinical
Pharmacology
Second Edition
Scott Patterson
Pfizer Vaccines Clinical Research & Development
Collegeville, Pennsylvania
Byron Jones
Novartis Pharma AG
Basel, Switzerland
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This book is for
– my dearest Karen, who has given me the most precious gift in life, and our children
Daniel, Mary Grace, Michael, Joseph, Robert, Thomas, and Little Bit, who have given us
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