Dose Finding in Drug Development (eBook, PDF)

Redaktion: Ting, Naitee

• Format: PDF

Produktbeschreibung

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.

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Produktdetails

• Verlag: Springer US
• Seitenzahl: 248
• Erscheinungstermin: 29. Dezember 2006
• Englisch
• ISBN-13: 9780387337067
• Artikelnr.: 37286854

Autorenporträt

Naitee Ting, Pfizer, New London, CT, USA

Inhaltsangabe

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.

Rezensionen

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)