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FIP Guidelines for Dissolution Testing of Solid Oral Products
Horst Dieter Friedel1, Cynthia K Brown2, Amy R Barker2
1Bayer Aktiengesellschaft, Corporate Quality, Berlin, Germany.
Abstract:
Dissolution testing is an important physiochemical test for the development of solid oral dosage forms, tablets, and capsules. As a quality control test, the dissolution test is used for assessment of drug product quality and is specified for batch release and regulatory stability studies. In vitro dissolution test results can often be correlated with the biopharmaceutical behavior of a product.This article provides a summary of views from major global agencies (Europe, Japan, United States), pharmacopoeias, academia, and industry. Based on available guidance and literature, this article summarizes highlights for development and validation of a suitable dissolution method, setting appropriate specifications, in vitro-in vivo comparison, and how to obtain a biowaiver.
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