Tag: Stability analysis

How to Address Stability Testing for Drugs under Expedited Approval Pathways Stability Testing for Drugs Under Expedited Approval: Navigating Regulatory Requirements Introduction Drugs developed under expedited approval pathways, such as the FDA’s Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review, require specialized stability testing to ensure their safety, efficacy, and quality while meeting accelerated…

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How to Conduct Stability Studies for Complex Parenteral Products in Compliance with Regulatory Guidelines Stability Testing for Complex Parenteral Products: A Regulatory Guide Introduction Complex parenteral products, such as injectable emulsions, suspensions, and liposomes, require rigorous stability testing to ensure their safety, efficacy, and quality throughout their shelf life. These products present unique challenges due…

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How to Implement Stability Testing for Solid Dispersions in Compliance with Regulatory Guidelines Stability Testing for Solid Dispersions: A Regulatory Compliance Guide Introduction Solid dispersions, which improve the solubility and bioavailability of poorly water-soluble drugs, require specific stability testing to ensure their safety, efficacy, and quality. These formulations present unique challenges due to the potential…

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How to Conduct Stability Studies for Combination Vaccines under WHO and FDA Guidelines Stability Testing for Combination Vaccines: A Guide to WHO and FDA Compliance Introduction Combination vaccines, which protect against multiple diseases with a single injection, require rigorous stability testing to ensure their safety, efficacy, and quality. Regulatory authorities, including the WHO and FDA,…

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How to Implement Stability Testing for Nanomedicines under Regulatory Guidelines Stability Testing for Nanomedicines: Navigating Regulatory Requirements Introduction Nanomedicines, which utilize nanoscale materials to deliver therapeutic agents, pose unique challenges in stability testing due to their complex structures, surface properties, and interactions with biological systems. Regulatory authorities, including the US FDA, EMA, and WHO, have…

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How to Conduct Stability Studies for Drug Products in Extreme Conditions per Regulatory Guidelines Stability Testing for Drug Products in Extreme Conditions: Ensuring Regulatory Compliance Introduction Drug products intended for use in extreme conditions, such as high altitude, extreme temperatures, or high humidity, require specialized stability testing to ensure their safety, efficacy, and quality. Regulatory…

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How to Apply ICH Q6A for Specification Setting in Stability Testing Applying ICH Q6A for Specification Setting in Stability Studies Introduction ICH Q6A, “Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products,” provides guidelines for setting specifications that define the quality of a drug substance or product. Applying ICH Q6A…

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