Revision of the dissolution procedure: Development and validation <1092>

Abstract

In this Stimuli article a Subcommittee of the Pharmaceutical Dosage Forms Expert Committee discusses a proposed revision to general information chapter The Dissolution Procedure: Development and Validation <1092>. Published elsewhere in this issue of PF, the proposed revision provides a new structure that divides the process of development and validation of the dissolution test into its component parts. The revision adds sections about preliminary assessments needed before initiating method development and about automation. A new section, Interpretation, within Acceptance Criteria clarifies the interpretation of results from the dissolution test. The relationship between bioavailability, bioequivalence, and the dissolution test is considered in general chapter Assessment of Drug Product Performance-Bioavailability, Bioequivalence, and Dissolution <1090>. © 2013 The United States Pharmacopeial Convention. All rights reserved.