Interface between regulation and statistics in drug development

by Alemayehu, Demissie Emir, Birol Gaffney, Michael

Type Book

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"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"--

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Title Statements

Full title :Interface between regulation and statistics in drug development / [edited by] Demissie Alemayehu, Birol Emir, Michael Gaffney.

Summary

Edition Statements

Publication Date:©2021
Edition:First edition

Publication Statements

Publisher(s):CRC Press, Taylor & Francis Group
Place of Publication:Boca Raton
Language:eng
Publication Date:©2021

The Physical Object

Description:1 online resource (xxvi, 146 pages) : : illustrations.

Edition Identifiers

ISBN:9781003044208, 1003044204
oclc:on1183399584
LC Classification:RM301.27
Dewey Decimal:615.1072/4

Fundamental principles of clinical trials -- Selected statistical topics of regulatory importance -- Statistical engagement in regulatory interactions -- Emerging topics.

Subjects

Clinical trials -- Law and legislation Clinical trials -- Law and legislation … Clinical trials -- Reporting Clinical trials -- Reporting -- United … Clinical trials -- Statistical methods Clinical trials -- Statistical methods.… Drug development Drug development -- United States Drugs -- Testing Drugs -- Testing. -- United States Études cliniques -- Méthodes statistiqu… Médicaments -- Développement -- États-U… Médicaments -- Essais cliniques. -- Éta… Médicaments -- Politique gouvernemental… Parliamentary practice Pharmaceutical policy Pharmaceutical policy -- United States United States United States., Food and Drug Administr…