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Pharma Stability: Insights, Guidelines, and Expertise

Tag: temperature excursion reporting

Regulatory Challenges in Stability Testing for Emerging Markets

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Regulatory Challenges in Stability Testing for Emerging Markets Navigating Regulatory Challenges in Stability Testing for Emerging Markets Introduction Stability testing is a critical pillar in the development and approval of pharmaceutical products, ensuring that drug quality is maintained under defined environmental conditions over its intended shelf life. However, in emerging markets—spanning Asia, Africa, Latin America,…

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Regulatory Challenges in Stability Testing for Emerging Markets, Stability Studies in Emerging Markets

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