Biochemistry

Interface between Regulation and Statistics in Drug Development

Name: Interface between Regulation and Statistics in Drug Development
Brand: Chapman and Hall/CRC
SKU: 9780367490485
Price: 20507.00 INR
Availability: InStock
ISBN: 9780367490485

Contributor(s): Alemayehu, Demissie Author , Emir, Birol Author , Gaffney, Michael Author Format: Hardback

Hardback · ISBN 9780367490485

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Key Specifications

ISBN	9780367490485
Publisher	Chapman and Hall/CRC
Publication date	November 2020
Language	English
MRP	£145.99 GBP
Page count	174
Item weight	94 g

With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the available literature on this important topic is sporadic, and often not readily accessible to drug developers or regulatory personnel. This book provides a systematic exposition of the interplay between the two disciplines, including emerging themes pertaining to the acceleration of the development of pharmaceutical medicines to serve patients with unmet needs.

Features:

Regulatory and statistical interactions throughout the drug development continuum

The critical role of the statistician in relation to the changing regulatory and healthcare landscapes

Statistical issues that commonly arise in the course of drug development and regulatory interactions

Trending topics in drug development, with emphasis on current regulatory thinking and the associated challenges and opportunities

The book is designed to be accessible to readers with an intermediate knowledge of statistics, and can be a useful resource to statisticians, medical researchers, and regulatory personnel in drug development, as well as graduate students in the health sciences. The authors' decades of experience in the pharmaceutical industry and academia, and extensive regulatory experience, comes through in the many examples throughout the book.

Interface between Regulation and Statistics in Drug Development

Key Specifications

Alemayehu, Demissie Author

Emir, Birol Author

Gaffney, Michael Author

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