Tag: FDA Stability Testing Requirements

How to Conduct Stability Studies for Dermatological Products in Compliance with Regulatory Guidelines Stability Testing for Dermatological Products: A Regulatory Guide Introduction Dermatological products, including creams, ointments, gels, and lotions, require specific stability testing to ensure their safety, efficacy, and quality. These products are often sensitive to environmental factors such as light, temperature, and humidity,…

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How to Implement Stability Studies for Drug Products in Multi-Layered Packaging under Regulatory Guidelines Stability Testing for Drug Products in Multi-Layered Packaging: Regulatory Compliance Guide Introduction Drug products in multi-layered packaging, such as blister packs or pouches, require specific stability testing to ensure their safety, efficacy, and quality throughout their shelf life. Multi-layered packaging can…

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How to Address Stability Testing for Combination Antiretroviral Therapy (cART) under Regulatory Guidelines Stability Testing for Combination Antiretroviral Therapy: A Regulatory Guide Introduction Combination Antiretroviral Therapy (cART) is a critical treatment regimen for managing HIV/AIDS, involving the use of multiple antiretroviral drugs in a single formulation. Stability testing for cART is essential to ensure the…

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How to Conduct Stability Testing for Biosimilars in Compliance with WHO Guidelines Stability Testing for Biosimilars: A WHO Compliance Guide Introduction Biosimilars, which are biological products highly similar to their reference biologics, require comprehensive stability testing to ensure their safety, efficacy, and quality. The World Health Organization (WHO) provides guidelines for stability testing of biosimilars,…

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How to Implement Stability Testing for Pediatric Formulations under US FDA and EMA Guidelines Stability Testing for Pediatric Formulations: A Regulatory Compliance Guide Introduction Pediatric formulations, which are specifically designed for children, require tailored stability testing to ensure their safety, efficacy, and quality. The US FDA and EMA have established guidelines that address the unique…

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How to Conduct Stability Studies for Drug Products Stored at Subzero Temperatures under Regulatory Guidelines Stability Studies for Drug Products at Subzero Temperatures: A Regulatory Guide Introduction Drug products stored at subzero temperatures, such as biologics, vaccines, and certain advanced therapies, require specific stability studies to ensure their safety, efficacy, and quality throughout their shelf…

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How to Implement Stability Testing for Polymorphic Drug Substances under Regulatory Guidelines Stability Testing for Polymorphic Drug Substances: Ensuring Regulatory Compliance Introduction Polymorphism in drug substances can significantly impact their stability, solubility, and bioavailability. Polymorphic forms of a drug may exhibit different physical and chemical properties, making stability testing essential to ensure the safety, efficacy,…

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How to Address Stability Testing Requirements for Global Harmonization under ICH Guidelines Global Harmonization of Stability Testing: Navigating ICH Guidelines Introduction Global harmonization of stability testing is crucial for ensuring consistent quality, safety, and efficacy of pharmaceutical products across different markets. The International Council for Harmonisation (ICH) provides guidelines that unify stability testing requirements for…

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