‘How to’ – Stability Studies

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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How to Conduct Stability Studies for Drug Products in Compliance with Indian Regulatory Requirements (CDSCO) Stability Testing for Drug Products: Meeting CDSCO Guidelines in India Introduction Drug products marketed in India require stability testing to demonstrate that they maintain their quality, safety, and efficacy throughout their shelf life. The Central Drugs Standard Control Organization (CDSCO),…

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How to Apply ICH Guidelines to Stability Testing for Radiopharmaceuticals Stability Testing for Radiopharmaceuticals: Compliance with ICH Guidelines Introduction Radiopharmaceuticals, which are radioactive compounds used for diagnosis or therapy, require specific stability testing to ensure they maintain their safety, efficacy, and quality throughout their shelf life. The International Council for Harmonisation (ICH) provides guidelines that…

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How to Implement Stability Testing for Cell Therapy Products under ICH Q5A Stability Testing for Cell Therapy Products: Compliance with ICH Q5A Guidelines Introduction Cell therapy products, which involve the use of living cells for therapeutic purposes, require specific stability testing to ensure they maintain their quality, safety, and efficacy throughout their shelf life. The…

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How to Conduct Stability Testing for Gene Therapy Products as per FDA Guidelines Stability Testing for Gene Therapy Products: Compliance with FDA Guidelines Introduction Gene therapy products, which involve the transfer of genetic material into cells to treat or prevent diseases, require rigorous stability testing to ensure they maintain their quality, safety, and efficacy throughout…

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How to Perform Stability Studies for Vaccines in Compliance with WHO Guidelines Stability Testing for Vaccines: Compliance with WHO Guidelines Introduction Vaccines, which are crucial for preventing infectious diseases, require stringent stability testing to ensure they remain safe and effective throughout their shelf life. The World Health Organization (WHO) provides specific guidelines for conducting stability…

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  Stability Testing for Injectable Products: Applying ICH Guidelines Introduction Injectable products, such as solutions, emulsions, and suspensions for injection, require rigorous stability testing to ensure their safety, efficacy, and quality throughout their shelf life. The International Council for Harmonisation (ICH) provides specific guidelines, including ICH Q1A(R2) and ICH Q1E, for conducting stability studies for…

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