Pharmaceutical Development: Statistical Designs

Authored by: Annpey Pong , Shein-Chung Chow

Encyclopedia of Biopharmaceutical Statistics

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

Print ISBN: 9781498733953
eBook ISBN: 9781351110273
Adobe ISBN:

10.1201/9781351110273-140000099

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Abstract

A pharmaceutical development process consists of non-clinical (e.g., assay and process validation and stability testing), pre-clinical (e.g., animal and bioavailability bioequivalence studies), and clinical (e.g., phases 1–3 clinical trials) development. In this entry, various statistical designs that are commonly considered for achieving desired good drug characteristics as described in the United States Pharmacopeia and National Formulary (USP/NF) at various stages are reviewed.

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