and New Drug Development Process -- Dose Finding Based on Preclinical Studies -- Dose-Finding Studies in Phase I and Estimation of Maximally Tolerated Dose -- Dose-Finding in Oncology—Nonparametric Methods -- Dose Finding in Oncology—Parametric Methods -- Dose Response: Pharmacokinetic–Pharmacodynamic Approach -- General Considerations in Dose–Response Study Designs -- Clinical Trial Simulation—A Case Study Incorporating Efficacy and Tolerability Dose Response -- Analysis of Dose–Response Studies—Emax Model -- Analysis of Dose–Response Studies—Modeling Approaches -- Multiple Comparison Procedures in Dose Response Studies -- Partitioning Tests in Dose–Response Studies with Binary Outcomes -- Analysis of Dose–Response Relationship Based on Categorical Outcomes -- Power and Sample Size for Dose Response Studies.

When you go to the pharmacy and fill a prescription, have you ever wondered if the dose of the medication is right for you? Can the dose be too low so that the drug will not work? Can the dose be too high that it may cause some potential problem? How do people learn about dosing information? This book answers some of these questions. Dosing information on the drug label is based on discussion and agreement between the pharmaceutical manufacturer and the drug regulatory agency. A drug label is a high level summary of results obtained from many scientific experiments. Scientists with biological, chemical, medical, or statistical background working in the pharmaceutical industry designed and executed these experiments to obtain information to help understand the dosing information. This book introduces the drug development process, the design and analysis of clinical trials. Many of the discussions are based on applications of statistical methods in the design and analysis of dose response studies. Although the book is prepared mainly for statisticians/biostatisticians, it also serves as a useful reference to a variety of professionals working for the pharmaceutical industry. The potential readers include pharmacokienticists, clinical scientists, clinical pharmacologists, pharmacists, project managers, pharmaceutical scientists, clinicians, programmers, data managers, regulatory specialists, and study report writers. This book is also a good reference for professionals working in a drug regulatory environment, for example, the FDA. Scientists and/or reviewers from both U.S. and foreign drug regulatory agencies can benefit greatly from this book. In addition, statistical and medical professionals in academia may find this book helpful in understanding the drug development process and practical concerns in selecting doses for a new drug. Naitee Ting received his Ph. D. in statistics from Colorado State University in 1987 and joined Pfizer Research right after obtaining his Ph. D. Dr. Ting is currently an Associate Director of Biostatistics in Pfizer Global Research and Development, supporting clinical development of new drugs. He has over 18 years of experiences in designing and analyzing late phase clinical trials. During his tenure at Pfizer, Dr. Ting has published more than 20 statistical papers in peer-reviewed journals and book chapters. He has also taught clinical trials courses at the University of Connecticut and University of Rhode Island.