Statistics for Biology and Health: Dose Finding in Drug Development (eBook / PDF)
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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.
Inhaltsverzeichnis zu „Statistics for Biology and Health: Dose Finding in Drug Development (eBook / PDF)“
Introduction And New Drug Development Process.- Dose Finding Based on Pre-Clinical Studies (David Salsburg).- Dose-Finding Studies in Phase I and Estimation of Maximally Tolerated Dose.- Dose-Finding In Oncology - Non-Parametric Methods.- Dose Response 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 Outcome.- Analysis of Dose Response Relationship Based on Categorical Outcomes.- Power and Sample Size for Dose Response Studies.Pressezitat
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)
Produktdetails
2006, Englisch, Verlag: Springer, New York, ISBN-10: 0387337067, ISBN-13: 9780387337067, Erscheinungsdatum: 29.12.2006
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eBook Informationen
- Dateiformat: PDF
- Größe: 3.58 MB
- Mit Kopierschutz
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