Drug Designing: Open Access

Drug Designing: Open Access
Open Access

ISSN: 2169-0138


Annpey Pong

Annpey Pong
Principal Scientist of Biostatistics and Research Decision Science, Merck Research Laboratories,
126 E. Lincoln Avenue, RY34 A240, Rahway, NJ 07065

  • Review Article
    Statistical Designs for Pharmaceutical/Clinical Development
    Author(s): Shein-Chung Chow and Annpey PongShein-Chung Chow and Annpey Pong

    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 in.. Read More»
    DOI: 10.4172/2169-0138.1000112

    Abstract PDF

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