Author: digi

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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How to Implement Stability Studies for Drug Products in Compliance with US FDA CFR Title 21 Conducting Stability Studies for Drug Products as per US FDA CFR Title 21 Requirements Introduction Stability studies are essential for ensuring that drug products meet their quality, safety, and efficacy standards throughout their shelf life. The US Food and…

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