Tag: FDA Stability Testing Requirements

How to Evaluate the Stability of Drug-Excipient Mixtures Assessing Stability in Drug-Excipient Combinations Introduction The stability of drug-excipient mixtures is a critical factor in the development of pharmaceutical formulations. Excipients, while inactive on their own, can interact with the active pharmaceutical ingredient (API) and influence its stability, potentially leading to reduced efficacy or increased toxicity….

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How to Perform Stability Testing for Amorphous Drug Forms Effective Stability Testing Methods for Amorphous Drug Forms Introduction Amorphous drug forms are known for their enhanced solubility and bioavailability compared to their crystalline counterparts. However, their lack of a defined molecular structure can make them more susceptible to stability issues, including recrystallization, which can affect…

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How to Conduct Stability Studies for Vaccine Products Effective Methods for Conducting Stability Studies on Vaccine Products Introduction Stability studies for vaccine products are critical for ensuring their safety, efficacy, and shelf life. Vaccines, being biological products, are highly sensitive to environmental conditions such as temperature, light, and humidity. Conducting rigorous stability studies allows manufacturers…

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How to Prepare Stability Testing Reports for US FDA Inspections Preparing Stability Testing Reports for US FDA Inspections Introduction Stability testing reports are crucial documents that must be prepared accurately to demonstrate compliance with regulatory standards during US FDA inspections. These reports provide comprehensive data on the stability of drug products, ensuring that they maintain…

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How to Design Stability Studies for Drug Products with Extended Shelf Life under Regulatory Guidelines Stability Testing for Drug Products with Extended Shelf Life: Compliance with Regulatory Guidelines Introduction Drug products with an extended shelf life require robust stability testing to demonstrate that they maintain their quality, safety, and efficacy over longer periods. Regulatory authorities,…

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How to Conduct Stability Testing for Advanced Therapy Medicinal Products (ATMPs) per EMA Guidelines Stability Testing for Advanced Therapy Medicinal Products: Compliance with EMA Guidelines Introduction Advanced Therapy Medicinal Products (ATMPs), including gene therapies, cell therapies, and tissue-engineered products, require rigorous stability testing to ensure they maintain their quality, safety, and efficacy throughout their shelf…

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How to Implement Stability Testing for Drugs with Novel Delivery Systems under US FDA Guidelines Stability Testing for Drugs with Novel Delivery Systems: Compliance with FDA Guidelines Introduction Drugs with novel delivery systems, such as transdermal patches, nanoparticles, or implantable devices, require specialized stability testing to ensure their quality, safety, and efficacy throughout their shelf…

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