In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When —Workshop Summary Report

This article summarizes key points from the podium presentations and breakout (BO) sessions focusing on (1) contrasting the advantages and disadvantages of several statistical methods; (2) the importance of experimental design for successful similarity evaluation; (3) the value of similarity evaluation in light of clinically relevant specifications; and (4) the need for creating a robust and scientifically appropriate path (e.g., non-prescriptive decision tree) for dissolution profile similarity assessment as a stepping stone for global harmonization.
Source: The AAPS Journal - Category: Drugs & Pharmacology Source Type: research