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Q » Which regulations govern drug stability be optimized during drug trials?
31 Oct, 2025
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A » Drug stability during trials is governed by regulations such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, specifically ICH Q1A(R2), which outlines stability testing protocols. These guidelines ensure that pharmaceutical products meet safety, efficacy, and quality standards throughout their shelf life. Adherence to these regulations is crucial for successful drug approval and market release.
31 Oct, 2025
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