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Dose Finding in Drug Development

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Table of Contents

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 Andre 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 (Jose 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).


From the reviews: "The book will be of particular interest to statisticians with some pharmaceutical industry experience who find themselves working on phase II dose finding problems. It will also be valuable for clinicians and pharmacokineticists with some statistical background. All chapters in the book are extensively referenced as they each do not pretend to exhaust their subject." Journal of Biopharmaceutical Statistics, Issue #2, 2007 "The book is a collection of chapters contributed by different authors, each addressing a different aspect of the important problem of how to identify appropriate doses of medication during the drug development process ... . Consequently the most appropriate audience is statisticians and biostatisticians who desire an overview of the medical and regulatory contexts of the design and analysis of dose response studies ... . On the whole the individual chapters are well written, and the book overall is a nice reference ... ." (C. A. Fung, Short Book Reviews, Vol. 26 (2), 2006) "Dose Finding in Drug Development is a contemporary roadmap to the statistical design and analysis of dose-response studies, particularly those in phases II and III of drug development. ...In general, the book is easy to read. ...At roughly $5.71 per chapters, with each chapter authored by between one and three established experts, the book is a high-yield investment of any reader's time and money." (Thomas E. Bradstreet, Journal of the American Statistical Association, Vol. 102, No. 477, 2007)

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