Tag: Stability Testing in Extreme Conditions

How to Document Stability Studies for New Drug Applications (NDAs) to the US FDA Documenting Stability Studies for NDAs: A Guide to FDA Compliance Introduction Stability studies are a critical component of a New Drug Application (NDA) submitted to the US FDA, providing evidence that a drug product will maintain its quality, safety, and efficacy…

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How to Conduct Stability Studies for Modified Release Products per FDA and ICH Guidelines Stability Testing for Modified Release Products: FDA and ICH Requirements Introduction Modified release products, such as extended-release or delayed-release formulations, require specific stability studies to ensure that they maintain their release profile, potency, and safety throughout their shelf life. Both the…

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How to Design Stability Studies for Combination Products as per Regulatory Guidelines Creating Stability Studies for Combination Products: A Regulatory Perspective Introduction Combination products, which include a combination of drug, device, or biological products, pose unique challenges for stability testing. Regulatory authorities such as the US FDA and EMA have specific guidelines for conducting stability…

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How to Implement ICH Q1E for Stability Data Evaluation Applying ICH Q1E Guidelines for Effective Stability Data Evaluation Introduction The ICH Q1E guideline provides recommendations on the evaluation and extrapolation of stability data to support the shelf life of drug substances and products. Proper implementation of these guidelines ensures that stability data is interpreted correctly…

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How to Conduct Stability Studies for Drug Substances Under US FDA Guidelines Stability Testing of Drug Substances as per US FDA Requirements Introduction Stability studies for drug substances are essential to demonstrate that the active pharmaceutical ingredient (API) remains stable and maintains its intended quality, safety, and efficacy over its shelf life. The US FDA…

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How to Develop a Stability-Indicating Method in Compliance with ICH Q2(R1) Creating Stability-Indicating Methods According to ICH Q2(R1) Guidelines Introduction A stability-indicating method is a validated analytical procedure that accurately and precisely measures active ingredients, excipients, and degradation products to assess the stability of a drug substance or product. The ICH Q2(R1) guideline outlines the…

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How to Address Stability Issues in ANDA Submissions to the US FDA Handling Stability Challenges in ANDA Submissions to the FDA Introduction Abbreviated New Drug Application (ANDA) submissions to the US FDA require comprehensive stability data to demonstrate that a generic drug product meets the same quality, safety, and efficacy standards as its reference listed…

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How to Conduct Stability Studies for Biologics Following FDA Guidelines Guidelines for Stability Testing of Biologics as per FDA Requirements Introduction Biologics, or biological products, require rigorous stability studies to ensure their safety, efficacy, and quality over their shelf life due to their complex nature and sensitivity to environmental factors. The US FDA provides specific…

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