Dose Finding in Drug Development

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.