Reassessing and Updating Regulatory Standards on the Declaration of Storage Conditions in the Product Information of Medicinal Products: An Evidence-Based Proposal under EMA Guidance
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Purpose: The European Medicines Agency (EMA) guideline Declaration of Storage Conditions in the Product Information of Medicinal Products (CPMP/QWP/609/96/Rev.2) was last revised in 2007. Since then, advances in stability science... ...
