Dissolution Testing for Generic Drugs: An FDA Perspective

Abstract

In vitro dissolution testing is an important tool used for development and approval of generic dosage forms. The objective of this article is to summarize how dissolution testing is used for the approval of safe and effective generic drug products in the United States (US). Dissolution testing is routinely used for stability and quality control purposes for… (More)
DOI: 10.1208/s12248-011-9272-y

Topics

2 Figures and Tables