Tag: Stability System

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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How to Conduct Stability Testing for Liposomal Drug Products under Regulatory Guidelines Stability Testing for Liposomal Drug Products: A Regulatory Compliance Guide Introduction Liposomal drug products, which utilize lipid-based carriers to deliver active ingredients, require specific stability testing to ensure their safety, efficacy, and quality throughout their shelf life. These formulations present unique challenges due…

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How to Implement Stability Testing for Drug Products in Compliance with Regional Regulatory Requirements Stability Testing for Drug Products: Navigating Regional Regulatory Requirements Introduction Drug products must meet specific stability requirements to ensure safety, efficacy, and quality across different regions. Various regulatory authorities, such as the US FDA, EMA, and other regional agencies, have distinct…

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How to Conduct Stability Studies for Novel Excipient-Drug Combinations in Compliance with Regulatory Guidelines Stability Testing for Novel Excipient-Drug Combinations: A Regulatory Guide Introduction Novel excipients are substances not previously used in approved drug products, often introduced to enhance formulation properties or delivery of the active drug. Stability testing for drug products containing novel excipient-drug…

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How to Address Stability Testing for Drug Products with Multiple Active Ingredients under Regulatory Guidelines Stability Testing for Drug Products with Multiple Active Ingredients: A Regulatory Guide Introduction Drug products with multiple active ingredients, such as combination therapies, require thorough stability testing to ensure that each ingredient remains stable and maintains its intended efficacy and…

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How to Implement ICH Q1A(R2) for Stability Testing in Tropical and Subtropical Regions Stability Testing in Tropical and Subtropical Regions: Applying ICH Q1A(R2) Guidelines Introduction Drug products intended for distribution in tropical and subtropical regions face unique challenges due to high temperatures and humidity levels that can affect their stability. The ICH Q1A(R2) guideline provides…

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How to Conduct Stability Studies for Drugs with Complex API in Compliance with Regulatory Guidelines Stability Testing for Drugs with Complex APIs: A Regulatory Compliance Guide Introduction Drugs with complex Active Pharmaceutical Ingredients (APIs), such as peptides, proteins, and other large molecules, pose unique challenges in stability testing due to their susceptibility to degradation and…

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