Regulatory, Quality Control, and Translational Aspects

Bringing new drug delivery systems from the laboratory to clinical practice requires navigating complex regulatory landscapes and ensuring that products meet strict quality control standards. This process involves rigorous testing for drug stability, safety, and bioequivalence to ensure that formulations are both effective and safe for patients. Translational research plays a key role in this process, as it bridges the gap between laboratory findings and real-world application. Pharmaceutical companies and researchers must work within regulatory frameworks set by agencies like the FDA and EMA, which oversee the approval of new drug delivery technologies. The track will also cover the importance of good manufacturing practices (GMP) and the steps involved in scaling up formulations for large-scale production. Key challenges in clinical translation, including clinical trial design and patient recruitment, will also be discussed.
Keywords: regulatory compliance, quality control, GMP, stability testing, bioequivalence, clinical translation, drug approval, manufacturing practices.

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