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Q » Which regulations govern controlled drug release be optimized during drug trials?
31 Oct, 2025
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A » Controlled drug release during trials is governed by regulations such as the FDA's Code of Federal Regulations (CFR) Title 21 in the United States, and the European Medicines Agency (EMA) regulations in the EU. These frameworks ensure safety, efficacy, and quality, requiring comprehensive data on pharmacokinetics, bioavailability, and release mechanisms. Compliance with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) is also essential throughout the trial process.
31 Oct, 2025
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