Shein-Chung Chow

Book · January 1, 2022 Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of th ... Full text Cite

Encyclopedia of Biopharmaceutical Statistics, 4th Edition - Four Volume Set

Book · January 1, 2018 Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and anal ... Full text Cite

Sample size calculations in clinical research, third edition

Book · August 15, 2017 Praise for the Second Edition:"This is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics. "This impressive book co ... Full text Cite

Handbook of adaptive designs in pharmaceutical and clinical development

Book · April 19, 2016 In response to the US FDA's Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development. Handbook of Adaptive Designs in Pharmaceut ... Cite

Preface

Book · April 19, 2016 Cite

Biosimilars: Design and analysis of follow-on biologics

Book · January 1, 2013 As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator ... Full text Cite

Design and Analysis of Clinical Trials: Concepts and Methodologies

Book · January 1, 2013 Praise for the Second Edition: “...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite.” —Journal of Clinical Research Best Practices The Third Edition of Desig ... Full text Cite

Design and analysis of bridging studies

Book · July 26, 2012 As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development process and shorten approval time, researchers are begin ... Cite

Adaptive design methods in clinical trials, second edition

Book · December 1, 2011 With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition ... Cite

Design and analysis of bioavailability and bioequivalence studies, third edition

Book · January 1, 2008 Preeminent Experts Update a Well-Respected Book Taking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides a complete ... Cite

Statistical design and analysis of stability studies

Book · January 1, 2007 The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to chara ... Cite

Series introduction

Book · January 1, 2005 Cite

Statistical design and analysis in pharmaceutical science: Validation, process controls, and stability

Book · January 1, 1995 “Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples”. ... Cite