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byDemissie Alemayehu(Author), Birol Emir(Author), Michael Gaffney(Author)&0moreWith 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 continuumThe critical role of the statistician in relation to the changing regulatory and healthcare landscapesStatistical issues that commonly arise in the course of drug development and regulatory interactionsTrending topics in drug development, with emphasis on current regulatory thinking and the associated challenges and opportunitiesThe 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.Product DetailsItem Weight:14.1 ouncesHardcover:172 pagesISBN-13:978-0367490485ISBN-13:9780367490485eText ISBN: 9781000215908Dimensions:9.53 x 0.43 x 6.26 inchesPublisher:Chapman and Hall/CRC; 1st edition (November 12, 2020)Language::English
