By Kim Huynh-Ba*, Pharmalytik LLC, and Christopher Latoz, Hollister Incorporated
Published in: KENX Insight: Pharma Pulse
Published on: January 10, 2025
Pharmaceutical products require expiration dates and storage conditions on their labels, determined through stability studies conducted from clinical trials through post-approval. These studies ensure that any chemical, physical, or microbiological changes over time do not affect the product’s quality, safety, or efficacy. ICH Q1A(R2) provides guidance for stability programs but focuses on new drugs and lacks a comprehensive approach where prior stability knowledge can be applied...
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