Introduction and New Drug Development Process (Naitee Ting).- Dose Finding Based on Pre-clinical Studies (David Salsburg.- Dose-finding Studies in Phase I and Estimation of Maximally Tolerated Dose (Marlene Modi) .-Dose-finding in Oncology - Non-parametric Methods (Anastasia Ivanova) .- Dose Response in Oncology - Parametric Methods (Mourad Tighiouart and André Rogatko) .- Dose Response - pharmacokinetic-pharmacodynamic approach (Nick Holford) .-General Considerations in Dose Response Study Designs (Naitee Ting) .- Clinical Trial Simulation - a Case Study incorporating efficacy and tolerability dose response (Wayne Ewy, Peter Lockwood, and Candace Bramson) .- Analysis of Dose Response Studies - Emax Model (Jim MacDougall) .- Analysis of Dose Response Studies - Modeling Approaches (José Pinheiro, Frank Bretz, Michael Branson) .- Multiple Comparison Procedures in Dose Response Studies (Ajit Tamhane, Brent Logan) .-Partitioning tests in dose response studies with binary outcome (Xiang Ling, Jason Hsu and Naitee Ting) .- Analysis of Dose Response Relationship Based on Categorical Outcomes (Christy Chuang-Stein, Zhengqing Li) .- Power and Sample Size for Dose Response Studies (Mark Chang, Shein-Chung Chow).
If you have ever wondered when visiting the pharmacy how the dosage of your prescription is determined this book will answer your questions. 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 from many scientific experiments. The book introduces the drug development process, the design and the analysis of clinical trials. Many of the discussions are based on applications of statistical methods in the design and analysis of dose response studies. Important procedural steps from a pharmaceutical industry perspective are also examined.
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.