Tag: Regulatory Stability Guidelines

How to Evaluate Stability of Combination Products Evaluating the Stability of Combination Products: A Step-by-Step Guide Introduction Combination products, which include two or more regulated components (e.g., drug-device, biologic-device), present unique challenges in stability testing due to the interaction between the different components. Evaluating the stability of combination products is essential to ensure that the…

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How to Perform Stability Studies for Generic Drugs Conducting Stability Studies for Generic Drugs: A Step-by-Step Guide Introduction Stability studies are a key requirement in the development and approval of generic drugs, ensuring that these products maintain their quality, safety, and efficacy throughout their shelf life. Conducting stability studies for generic drugs is essential for…

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How to Monitor Microbial Stability in Drug Products Monitoring Microbial Stability in Drug Products: A Comprehensive Guide Introduction Microbial stability is a critical aspect of ensuring the safety and efficacy of drug products, particularly those that are susceptible to microbial contamination. Monitoring microbial stability involves assessing the ability of a drug product to resist microbial…

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How to Conduct Stability Studies for Liquid Dosage Forms Conducting Stability Studies for Liquid Dosage Forms: A Step-by-Step Guide Introduction Liquid dosage forms, such as solutions, suspensions, and emulsions, present unique challenges in stability studies due to their susceptibility to physical and chemical changes over time. Conducting stability studies for liquid dosage forms is essential…

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How to Assess the Impact of Packaging on Drug Stability Evaluating the Impact of Packaging on Drug Stability: A Comprehensive Guide Introduction Packaging plays a crucial role in maintaining the stability, safety, and efficacy of drug products throughout their shelf life. The right packaging can protect drug products from environmental factors such as light, moisture,…

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How to Establish a Stability-Indicating Method A Comprehensive Guide to Establishing Stability-Indicating Methods Introduction Establishing a stability-indicating method is a critical step in the pharmaceutical development process, ensuring that drug products maintain their quality, safety, and efficacy throughout their shelf life. A stability-indicating method is an analytical procedure that accurately detects changes in a drug…

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How to Perform Stability Studies for Lyophilized Products A Step-by-Step Guide to Conducting Stability Studies for Lyophilized Products Introduction Stability studies for lyophilized (freeze-dried) products are crucial for ensuring that these delicate formulations maintain their intended quality, safety, and efficacy throughout their shelf life. Lyophilization is a common method used to stabilize biopharmaceuticals, vaccines, and…

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