Tag: Photostability,

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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How to Conduct Stability Testing for Ophthalmic Products under Regulatory Guidelines Ensuring Stability of Ophthalmic Products: A Regulatory Guide Introduction Ophthalmic products, including eye drops and ointments, require specific stability testing to ensure their safety, efficacy, and quality throughout their shelf life. These products are particularly sensitive to microbial contamination and environmental factors, making rigorous…

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How to Implement Stability Studies for Oncology Drugs under US FDA and EMA Guidelines Stability Studies for Oncology Drugs: Ensuring Compliance with US FDA and EMA Standards Introduction Oncology drugs, which are often life-saving medications, require rigorous stability studies to ensure their safety, efficacy, and quality throughout their shelf life. The US FDA and EMA…

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How to Address Stability Testing for Drugs in Special Populations as per Regulatory Guidelines Stability Testing for Drugs in Special Populations: A Regulatory Overview Introduction Drugs intended for special populations, such as pediatric, geriatric, or pregnant patients, require tailored stability testing to ensure their safety and efficacy. Regulatory authorities, including the US FDA, EMA, and…

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How to Conduct Stability Testing for Temperature-Sensitive Biologics in Compliance with Regulatory Guidelines Ensuring Compliance in Stability Testing for Temperature-Sensitive Biologics Introduction Temperature-sensitive biologics, such as vaccines and gene therapies, require rigorous stability testing to ensure they maintain their safety, efficacy, and quality throughout their shelf life. Regulatory authorities, including the US FDA, EMA, and…

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