‘How to’ – Stability Studies

How to Conduct Stability Testing for Biosimilars in Compliance with WHO Guidelines

How to Conduct Stability Testing for Biosimilars in Compliance with WHO Guidelines Stability Testing for Biosimilars: A WHO Compliance Guide Introduction 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,…

'How to' - Stability Studies

How to Implement Stability Testing for Pediatric Formulations under US FDA and EMA Guidelines

How to Implement Stability Testing for Pediatric Formulations under US FDA and EMA Guidelines Stability Testing for Pediatric Formulations: A Regulatory Compliance Guide Introduction 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…

'How to' - Stability Studies

How to Conduct Stability Studies for Drug Products Stored at Subzero Temperatures under Regulatory Guidelines

How to Conduct Stability Studies for Drug Products Stored at Subzero Temperatures under Regulatory Guidelines Stability Studies for Drug Products at Subzero Temperatures: A Regulatory Guide Introduction 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…

'How to' - Stability Studies

How to Implement Stability Testing for Polymorphic Drug Substances under Regulatory Guidelines

How to Implement Stability Testing for Polymorphic Drug Substances under Regulatory Guidelines Stability Testing for Polymorphic Drug Substances: Ensuring Regulatory Compliance Introduction 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,…

'How to' - Stability Studies

How to Address Stability Testing Requirements for Global Harmonization under ICH Guidelines

How to Address Stability Testing Requirements for Global Harmonization under ICH Guidelines Global Harmonization of Stability Testing: Navigating ICH Guidelines Introduction 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…

'How to' - Stability Studies

How to Implement Stability Testing for Orally Inhaled and Nasal Drug Products (OINDP) under FDA Guidelines

How to Implement Stability Testing for Orally Inhaled and Nasal Drug Products (OINDP) under FDA Guidelines Ensuring Stability of Orally Inhaled and Nasal Drug Products: A Guide to FDA Compliance Introduction Orally Inhaled and Nasal Drug Products (OINDPs), including inhalers, nasal sprays, and nebulizers, are complex formulations that require rigorous stability testing to ensure their…

'How to' - Stability Studies

How to Conduct Stability Studies for Controlled Drugs under Regulatory Guidelines

How to Conduct Stability Studies for Controlled Drugs under Regulatory Guidelines Ensuring Compliance in Stability Studies for Controlled Drugs Introduction 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…

'How to' - Stability Studies

How to Address Stability Testing for Products under Emergency Use Authorization (EUA)

How to Address Stability Testing for Products under Emergency Use Authorization (EUA) Stability Testing for Products under EUA: Navigating Regulatory Requirements Introduction 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…

'How to' - Stability Studies

How to Implement Stability Testing for High-Risk Drug Products under Regulatory Guidelines

How to Implement Stability Testing for High-Risk Drug Products under Regulatory Guidelines Stability Testing for High-Risk Drug Products: Regulatory Compliance Guide Introduction High-risk drug products, such as controlled substances, cytotoxic agents, and biologics, require stringent stability testing to ensure their safety, efficacy, and quality. Regulatory authorities, including the US FDA, EMA, and WHO, have established…

'How to' - Stability Studies

How to Conduct Stability Studies for Drugs with Narrow Therapeutic Index under US FDA Guidelines

How to Conduct Stability Studies for Drugs with Narrow Therapeutic Index under US FDA Guidelines Stability Studies for Drugs with Narrow Therapeutic Index: A Guide to US FDA Compliance Introduction Drugs with a narrow therapeutic index (NTI) have a small margin between therapeutic and toxic doses, making precise and rigorous stability testing essential to ensure…

'How to' - Stability Studies