ICH Q1E vs. FDA Expectations for Stability Justification
While ICH Q1E offers a harmonized international approach to evaluating stability data, the USFDA has additional expectations when it comes to drug product shelf life justification. Understanding both can help ensure your submission is globally compliant and avoids unnecessary regulatory queries. ➀ Overview of ICH Q1E Guidance The ICH Q1E guideline, “Evaluation of Stability Data,”…
Read More “ICH Q1E vs. FDA Expectations for Stability Justification” »