Tag: FDA Stability Testing Requirements

How to Conduct Stability Studies for Fixed-Dose Combination Products under Regulatory Guidelines Conducting Stability Studies for Fixed-Dose Combination Drugs: A Regulatory Approach Introduction Fixed-dose combination (FDC) products combine two or more active pharmaceutical ingredients (APIs) in a single dosage form. Conducting stability studies for these products is crucial to ensure their safety, efficacy, and quality…

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How to Ensure Compliance with Global Stability Testing Requirements (US FDA, EMA, WHO) Ensuring Compliance with International Stability Testing Standards: A Comprehensive Guide Introduction Stability testing is a critical aspect of pharmaceutical development and quality assurance. Ensuring compliance with global stability testing requirements is essential for the approval, distribution, and maintenance of drug products in…

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