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 analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences.
Features of the Fourth Edition:
1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters.
2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies.
3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development.
4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics.
About the Editor:
Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.
Table of Contents
Partial list of topics: Acceptance Sampling Active Control Trials Adaptive Design Methods in Clinical Trials Adaptive Survival Trials Adjustment for Covariates Adverse Event Reporting Alpha Spending Function Ames Test Analysis of 2 K Tables Analysis of Clustered Binary Data Analysis of Clustered Categorical Data Analysis of Heritability Analysis of Repeated Measures Data with Missing Values: An Overview of Methods Analysis of Variance ANCOVA Approach for Premarketing Shelf Life Determination with Multiple Factors Assay Development Assay Validation Bayesian Approach to Stability Analysis Bayesian Methods in Meta-Analysis Bayesian Statistics Bayesian Designs for Phase II Oncology Clinical Trials Binary 2 × 2 Crossover Trials Bioassay Bioavailability and Bioequivalence Bioinformatics Biologics Biomarker in Clinical Trials
Shein-Chung Chow, Ph.D. is currently a Professor at the Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina. Prior to joining Duke University, he was the Director of TCOG (Taiwan Cooperative Oncology Group) Statistical Center and the Executive Director of National Clinical Trial Network Coordination Center. Prior to that, Dr. Chow also held various positions in the pharmaceutical industry such as Vice President, Biostatistics, Data Management, and Medical Writing at Millennium Pharmaceuticals, Inc., Cambridge, MA; Executive Director, Statistics and Clinical Programming at Covance, Inc., Director and Department Head at Bristol-Myers Squibb Company, Plansboro, NJ; Senior Statistician and Research Statistician at Parke-Davis Pharmaceutical Division, Warner-Lambert Company, Ann Arbor, MI and Wyeth-Ayerst Laboratories, Rouses Point, NY. Through these positions, Dr. Chow provided technical supervision and guidance to project teams on statistical issues and presentations before partners, regulatory agencies or scientific bodies, defending the appropriateness of statistical methods used in clinical trial design or data analyses or the validity of reported statistical inferences. Dr. Chow identified the best statistical and data management practices, organizes and leads working parties for development of statistical design, analyses and presentation applications, and participated on Data Safety Monitoring Boards in clinical research and development.
“For nearly every topic one might come across when working as a statistician in drug development, one will find an article describing what it is all about, along with a reference list for when deeper knowledge is desired. Depending on the complexity of each topic, the articles vary in length but in most instances one can expect less than 15 pages, which means one quickly gets a good idea about a specific topic.”
~International Society for Clinical Biostatistics