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ISSN: 2169-0138

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Review Article

Statistical Designs for Pharmaceutical/Clinical Development

Shein-Chung Chow1 and Annpey Pong2*
1Duke University School of Medicine, Durham, North Carolina, USA
2Merck Research Laboratories, Rahway, New Jersey, USA
Corresponding Author : Annpey Pong, PhD
Principal Scientist of Biostatistics and Research Decision Science
Merck Research Laboratories, 126 E. Lincoln Avenue
RY34 A240, Rahway, NJ 07065, USA
Tel: (732) 594-5265
E-mail: [email protected]
Received May 09, 2014; Accepted June 16, 2014; Published June 20, 2014
Citation: Chow SC, Pong A (2014) Statistical Designs for Pharmaceutical/Clinical Development. Drug Des 3:112. doi:10.4172/2169-0138.1000112
Copyright: © 2014 Chow SC, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

In recent years, the concept of quality by design in (global) pharmaceutical development has received much attention. The purpose is to ensure that the compound under investigation will possess good drug characteristics such as identity, strength, purity, quality, safety, efficacy and stability before and post approval. A pharmaceutical development process consists of non-clinical (e.g., assay/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 article, 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 of non-clinical, pre-clinical, and clinical development are reviewed. In addition, the possible use of innovative adaptive clinical trial designs that may lead to (i) the identification of any signals, trends/patterns, and optimal clinical benefits of a test treatment under investigation, and (ii) increase the probability of success of the development process with limited resources available are discussed.

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