Protocol Development

Authored by: Robert D. Chew

Encyclopedia of Biopharmaceutical Statistics

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

Print ISBN: 9781498733953
eBook ISBN: 9781351110273
Adobe ISBN:

10.1201/9781351110273-130001176

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Abstract

The goal of this entry is to abstract the guidance published by the European Medicines Agency and the U.S. Food and Drug Administration as a convenience for the statistical practitioner faced with the task of describing in the protocol the planned analysis of a clinical trial and also to offer some suggestions based on practical experience in the field.

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