The General Chapters—Dosage Forms Expert Committee is proposing this new informational chapter to support Injections and Implanted Drug Products (Parenterals)—Product Quality Tests 〈1〉. This information initially appeared as a Stimuli article, In Vitro Release Test Methods for Drug Formulations for Parenteral Applications, in PF 44(6) [Nov.–Dec. 2018]. The Stimuli article discusses in vitro drug release methods for those parenteral drug formulations that are not solutions and outlines the challenges involved in using these methods for each formulation type.
(GCPD: D. Hunt.)
Correspondence Number—C247837