Tag: Stability testing

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…

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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…

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How to Implement Stability Testing for Non-Oral Dosage Forms in Compliance with Regulatory Guidelines Ensuring Compliance in Stability Testing for Non-Oral Dosage Forms Introduction Non-oral dosage forms, such as injectables, inhalers, transdermal patches, and ophthalmic solutions, present unique challenges in stability testing due to their distinct formulations, delivery mechanisms, and storage conditions. Ensuring compliance with…

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How to Conduct Stability Testing for Biologics Under Biosimilar Regulatory Guidelines Stability Testing for Biologics: Adhering to Biosimilar Guidelines Introduction Biologics, including biosimilars, are complex molecules that require stringent stability testing to ensure their safety, efficacy, and quality. Stability studies for biosimilars must demonstrate that the product remains comparable to its reference biologic under specified…

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How to Address Stability Testing for Breakthrough Therapy Drugs under FDA Guidelines Stability Testing for Breakthrough Therapy Drugs: Navigating FDA Requirements Introduction Breakthrough therapy drugs are designated by the FDA for expedited development and review due to their potential to provide substantial improvement over existing therapies for serious conditions. These drugs require specific stability testing…

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How to Implement ICH Q1A(R2) for Stability Testing of APIs and Drug Products Applying ICH Q1A(R2) Guidelines for Stability Testing of APIs and Drug Products Introduction Stability testing is a critical component of the drug development process, ensuring that Active Pharmaceutical Ingredients (APIs) and finished drug products maintain their intended quality, safety, and efficacy over…

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How to Conduct Stability Studies for Complex Generic Drug Products as per US FDA Guidelines Conducting Stability Studies for Complex Generic Drugs: A US FDA Compliance Guide Introduction Complex generic drugs, which include formulations such as liposomal drugs, injectables, and transdermal systems, require rigorous stability studies to ensure their safety, efficacy, and quality throughout their…

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How to Prepare a Stability Testing Plan in Compliance with Global Regulatory Requirements Creating a Comprehensive Stability Testing Plan: A Global Regulatory Perspective Introduction A well-prepared stability testing plan is essential for ensuring that pharmaceutical products maintain their safety, efficacy, and quality throughout their shelf life. Compliance with global regulatory requirements, such as those set…

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