Tag: Stability testing

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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How to Prepare a Stability Protocol in Accordance with ICH Q1A(R2) Developing a Stability Protocol Following ICH Q1A(R2) Guidelines Introduction A well-defined stability protocol is critical for conducting stability studies that are compliant with regulatory requirements. The ICH Q1A(R2) guidelines provide a comprehensive framework for the stability testing of drug substances and products, including the…

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How to Conduct Stability Testing for Drug Products Under ASEAN Guidelines Guidelines for Stability Testing of Drug Products in ASEAN Countries Introduction Stability testing is essential to ensure that drug products maintain their quality, safety, and efficacy throughout their shelf life. The Association of Southeast Asian Nations (ASEAN) has established specific guidelines for stability testing…

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How to Perform Stability Studies Following EMA (European Medicines Agency) Guidelines Conducting Stability Studies in Compliance with EMA Requirements Introduction Stability studies are a fundamental aspect of the pharmaceutical development process, ensuring that a product maintains its intended quality, safety, and efficacy throughout its shelf life. The European Medicines Agency (EMA) has established specific guidelines…

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