Preparing a Shelf Life Justification Memo Using ICH Q1E Principles
Pharmaceutical shelf life justification is a regulatory requirement for all new drug applications, variations, and periodic reviews. ICH Q1E outlines the statistical principles for evaluating stability data, and one key deliverable during this process is the “Shelf Life Justification Memo.” This article explains how to prepare this critical document, integrating statistical reasoning, regulatory compliance, and…
Read More “Preparing a Shelf Life Justification Memo Using ICH Q1E Principles” »