Bioequivalence and Statistics in Clinical Pharmacology, Second Edition PDF
Preview Bioequivalence and Statistics in Clinical Pharmacology, Second Edition
Bioequivalence 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 CRC Press Taylor & Francis Group 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742 © 2017 by Taylor & Francis Group, LLC CRC Press is an imprint of Taylor & Francis Group, an Informa business No claim to original U.S. Government works Printed on acid-free paper Version Date: 20161123 International Standard Book Number-13: 978-1-4665-8520-1 (Hardback) This book contains information obtained from authentic and highly regarded sources. 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