Regulatory Statistics

Authored by: Estelle Russek-Cohen , Tsai-Lien Lin , Shiowjen Lee

Encyclopedia of Biopharmaceutical Statistics

Print publication date:  August  2018
Online publication date:  August  2018

Print ISBN: 9781498733953
eBook ISBN: 9781351110273
Adobe ISBN:

10.1201/9781351110273-140000086

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Abstract

Regulatory statistics is the scientific discipline consisting of the development and application of statistical methods, tools, approaches and other relevant processes derived from statistical science (and its sister disciplines) used to assess the safety, efficacy, quality and performance of regulated pharmaceutical products. In this article we highlight why such research is essential and touch on a number of topics in this arena. Finally we discuss topics in this area likely to gain prominence over the next few years.

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