This book will answer questions for anyone who has ever visited the pharmacy and wondered how the dosage of their prescription is determined. Dosing information on drug labels is based on discussion between the pharmaceutical manufacturer and the drug regulatory agency, and the label is a summary of results obtained by scientists. This book introduces the drug development process, the design and analysis of clinical trials. Important procedural steps from a pharmaceutical industry perspective are also examined. Although the book is written mainly for statisticians/biostatisticians, it also serves as a useful reference to a variety of professionals working for the pharmaceutical industry and those in a drug regulatory environment. Additionally, 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.

Introduces the drug development process, the design and analysis of clinical trials Presents statistical applications in the design and analysis of dose response studies Examines important procedural steps from a pharmaceutical industry perspective Audience includes pharmacokineticists, clinical pharmacologists, pharmacists, pharmaceutical scientists, clinicians, programmers, data managers, regulatory specialists, and study report writers Includes supplementary material: sn.pub/extras

Klappentext

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.

Inhalt
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 OncologyNonparametric Methods.- Dose Finding in OncologyParametric Methods.- Dose Response: PharmacokineticPharmacodynamic Approach.- General Considerations in DoseResponse Study Designs.- Clinical Trial SimulationA Case Study Incorporating Efficacy and Tolerability Dose Response.- Analysis of DoseResponse StudiesEmax Model.- Analysis of DoseResponse StudiesModeling Approaches.- Multiple Comparison Procedures in Dose Response Studies.- Partitioning Tests in DoseResponse Studies with Binary Outcomes.- Analysis of DoseResponse Relationship Based on Categorical Outcomes.- Power and Sample Size for Dose Response Studies.