Test for batch‐to‐batch variation in stability analysis

descriptionPublicationkeyboard_double_arrow_right Article 01 Jul 1989 English Publisher:WileyJournal:Statistics in Medicine, volume 8, pages 883-890 (issn: 0277-6715, eissn: 1097-0258,

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Authors: S C, Chow; J, Shao;

doi: 10.1002/sim.4780080712

pmid: 2772446

Test for batch‐to‐batch variation in stability analysis

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Abstract

AbstractWe propose several statistical tests for batch‐to‐batch variation in the stability analysis of a drug product and present applications with data from new drug application stability and marketing stability analyses.

Related Organizations

Purdue University System
United States
Purdue University West Lafayette
United States
Parke-Davis
United States

Keywords

Drug Industry, Drug Stability, Statistics as Topic

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