{"product_id":"interface-between-regulation-and-statistics-demissie-alemayehu-9780367490485","title":"Interface Between Regulation and Statistics in Drug Development","description":"\u003cp\u003eWith 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. \u003c\/p\u003e\u003cp\u003eFeatures: \u003c\/p\u003e\u003cul\u003e \u003cp\u003e \u003c\/p\u003e \u003cli\u003eRegulatory and statistical interactions throughout the drug development continuum\u003c\/li\u003e \u003cp\u003e \u003c\/p\u003e \u003cli\u003eThe critical role of the statistician in relation to the changing regulatory and healthcare landscapes \u003c\/li\u003e \u003cp\u003e \u003c\/p\u003e \u003cli\u003eStatistical issues that commonly arise in the course of drug development and regulatory interactions\u003c\/li\u003e \u003cp\u003e \u003c\/p\u003e \u003cli\u003eTrending topics in drug development, with emphasis on current regulatory thinking and the associated challenges and opportunities \u003c\/li\u003e \u003c\/ul\u003e\u003cp\u003eThe 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.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Demissie Alemayehu,Birol Emir,Michael Gaffney\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 036749048X\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9780367490485\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e CRC Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 11\/12\/2020\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 146\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 0.93lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.21h x 6.14w x 0.44d","brand":"Demissie Alemayehu","offers":[{"title":"Hardcover","offer_id":48136012431615,"sku":"9780367490485","price":180.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_6fdc9bec-8e14-43d2-91ec-4cb5bc311830.jpg?v=1770159926","url":"https:\/\/www.whiterainbookhouse.com\/products\/interface-between-regulation-and-statistics-demissie-alemayehu-9780367490485","provider":"WR Book House","version":"1.0","type":"link"}