Tag: ICH Stability Studies

How to Implement Stability Testing for Orphan Drugs Under US FDA Guidelines Guidelines for Stability Testing of Orphan Drugs in Compliance with US FDA Introduction Orphan drugs, which are intended to treat rare diseases, have unique regulatory requirements, including stability testing to ensure they meet quality, safety, and efficacy standards. The US FDA provides specific…

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How to Apply FDA Guidance for Industry on Drug Product Stability Testing Implementing FDA Guidance for Drug Product Stability Testing Introduction Drug product stability testing is essential for ensuring that a drug maintains its intended quality, safety, and efficacy throughout its shelf life. The US FDA provides detailed guidance for industry on conducting stability testing,…

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How to Conduct Stability Studies in Compliance with Japanese Regulatory Requirements (PMDA) Guidelines for Stability Testing in Accordance with PMDA Requirements Introduction Stability studies are essential for demonstrating that drug products meet quality, safety, and efficacy standards over their intended shelf life. The Pharmaceutical and Medical Devices Agency (PMDA) in Japan has specific guidelines for…

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How to Manage Stability Testing of Post-Approval Changes According to US FDA Guidelines Conducting Stability Testing for Post-Approval Changes per FDA Guidelines Introduction After a drug product receives marketing approval, manufacturers may need to implement changes to the product or its manufacturing process, such as changes in formulation, packaging, or manufacturing site. The US FDA…

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How to Apply ICH Q1C Guidelines for Stability Testing of New Dosage Forms Implementing ICH Q1C Guidelines for Stability Testing of New Dosage Forms Introduction Stability testing is a vital process for establishing the shelf life and storage conditions of new dosage forms of existing drug substances. The ICH Q1C guideline provides specific instructions on…

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How to Develop Stability Study Reports for ANDA Submissions Creating Stability Study Reports for ANDA Submissions: A Comprehensive Guide Introduction Stability study reports are a critical component of Abbreviated New Drug Application (ANDA) submissions to the US FDA, providing evidence that a generic drug product maintains the same quality, safety, and efficacy as its reference…

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How to Document Stability Studies for New Drug Applications (NDAs) to the US FDA Documenting Stability Studies for NDAs: A Guide to FDA Compliance Introduction Stability studies are a critical component of a New Drug Application (NDA) submitted to the US FDA, providing evidence that a drug product will maintain its quality, safety, and efficacy…

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How to Conduct Stability Studies for Modified Release Products per FDA and ICH Guidelines Stability Testing for Modified Release Products: FDA and ICH Requirements Introduction Modified release products, such as extended-release or delayed-release formulations, require specific stability studies to ensure that they maintain their release profile, potency, and safety throughout their shelf life. Both the…

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