Biopharmaceutical statistics plays an extremely important role in ensuring not only the efficacy and safety of the medicine under investigation, but also that the pharmaceutical product possesses good drug characteristics. This 4 volume set is an essential resource on the evolving state of this important field.

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.

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