Interface between Regulation and Statistics in Drug Development

by Mike Gaffney, Demissie Alemayehu, Birol Emir, et al.

Book Overview

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...

• Format: Paperback
• Language: English
• ISBN: 0367608286
• ISBN13: 9780367608286
• Release Date: August 2022
• Publisher: CRC Press
• Length: 146 Pages
• Weight: 0.56 lbs.
• Dimensions: 0.4" x 6.1" x 9.2"