‘How to’ – Stability Studies

Emergency Use Authorization (EUA) allows for the use of medical products during public health emergencies, even when they have not completed the standard approval process. Stability testing for products under EUA is crucial to ensure their safety, efficacy, and quality in urgent situations. This guide provides a detailed approach to addressing stability testing requirements for products under EUA, in compliance with regulatory authorities like the US FDA.
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Controlled drugs, including narcotics and psychotropics, require stringent stability testing to ensure their safety, efficacy, and quality throughout their shelf life. Regulatory authorities, such as the US DEA, FDA, and international bodies, provide specific guidelines for conducting stability studies on these drugs to prevent misuse, abuse, and degradation. This guide outlines the steps to conduct stability studies for controlled drugs in compliance with these regulations.
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Orally Inhaled and Nasal Drug Products (OINDPs), including inhalers, nasal sprays, and nebulizers, are complex formulations that require rigorous stability testing to ensure their safety, efficacy, and quality throughout their shelf life. The US FDA provides specific guidelines for stability testing of OINDPs due to their unique delivery systems and susceptibility to environmental factors. This guide outlines the steps to implement stability testing for OINDPs in compliance with FDA guidelines.
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Global harmonization of stability testing is crucial for ensuring consistent quality, safety, and efficacy of pharmaceutical products across different markets. The International Council for Harmonisation (ICH) provides guidelines that unify stability testing requirements for the US, EU, Japan, and other regions. This guide outlines the steps to address stability testing requirements for global harmonization under ICH guidelines, ensuring compliance and facilitating international market access.
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Polymorphism in drug substances can significantly impact their stability, solubility, and bioavailability. Polymorphic forms of a drug may exhibit different physical and chemical properties, making stability testing essential to ensure the safety, efficacy, and quality of the pharmaceutical product. This guide outlines how to implement stability testing for polymorphic drug substances in compliance with regulatory guidelines such as those provided by the US FDA, EMA, and ICH.
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Drug products stored at subzero temperatures, such as biologics, vaccines, and certain advanced therapies, require specific stability studies to ensure their safety, efficacy, and quality throughout their shelf life. These products are highly sensitive to temperature fluctuations, necessitating rigorous stability testing under regulatory guidelines provided by authorities like the FDA, EMA, and WHO. This guide outlines the steps to conduct stability studies for drug products stored at subzero temperatures.
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Pediatric formulations, which are specifically designed for children, require tailored stability testing to ensure their safety, efficacy, and quality. The US FDA and EMA have established guidelines that address the unique needs of pediatric populations, including considerations for taste, dosing, and excipients. This guide outlines the steps to implement stability testing for pediatric formulations in compliance with FDA and EMA guidelines.
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Biosimilars, which are biological products highly similar to their reference biologics, require comprehensive stability testing to ensure their safety, efficacy, and quality. The World Health Organization (WHO) provides guidelines for stability testing of biosimilars, focusing on demonstrating similarity to the reference product under various environmental conditions. This guide outlines the steps to conduct stability testing for biosimilars in compliance with WHO guidelines.
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Combination Antiretroviral Therapy (cART) is a critical treatment regimen for managing HIV/AIDS, involving the use of multiple antiretroviral drugs in a single formulation. Stability testing for cART is essential to ensure the safety, efficacy, and quality of these combination products throughout their shelf life. This guide outlines the steps to address stability testing requirements for cART under regulatory guidelines from agencies such as the US FDA, EMA, and WHO.
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Drug products in multi-layered packaging, such as blister packs or pouches, require specific stability testing to ensure their safety, efficacy, and quality throughout their shelf life. Multi-layered packaging can protect against environmental factors like moisture, oxygen, and light, but it also poses unique challenges for stability testing. This guide outlines the steps to implement stability studies for drug products in multi-layered packaging in compliance with regulatory guidelines from authorities like the US FDA, EMA, and WHO.
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