Dose Finding in Drug Development
(Sprache: Englisch)
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...
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Klappentext zu „Dose Finding in Drug Development “
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 „Dose Finding in Drug Development “
From the contents:- 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.
Bibliographische Angaben
- 2006, 248 Seiten, mit Abbildungen, Maße: 16,3 x 24,1 cm, Gebunden, Englisch
- Herausgegeben: Naitee Ting
- Verlag: Springer, New York
- ISBN-10: 0387290745
- ISBN-13: 9780387290744
Sprache:
Englisch
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