Interface between regulation and statistics in drug development / edited by Demissie Alemayehu, Birol Emir, Michael Gaffney.

Contents Fundamental principles of clinical trials -- Selected statistical topics of regulatory importance -- Statistical engagement in regulatory interactions -- Emerging topics.
Abstract "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"-- Provided by publisher.
Bibliography noteIncludes bibliographical references and index.
Access restrictionAvailable only to authorized users.
Technical detailsMode of access: World Wide Web
Genre/formElectronic books.
LCCN 2020025306
ISBN9780367490485 (hardback)
ISBN9780367608286 (paperback)
ISBN(ebook)

Availability

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Electronic Resources Access Content Online ✔ Available