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Journal Highlights

Innovative Drug Discovery Strategies
Medicinal Chemistry and Drug Design
Preclinical and Translational Research
Natural Products and Drug Development
Pharmacology and Mechanism of Action
Biologics and Biopharmaceuticals
Drug Delivery Systems and Nanomedicine
Regulatory Science and Drug Approval Pathways

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    Regulatory Science and Drug Approval Pathways

    Regulatory science plays a critical role in translating scientific discoveries into safe, effective, and high-quality medical products. It involves the application of biological, chemical, clinical, and statistical knowledge to evaluate the safety, efficacy, and quality of drugs, vaccines, and biologics. At its core, regulatory science supports public health by shaping the drug approval pathways that guide how new therapies reach patients.

    Regulatory science encompasses the tools, standards, and frameworks used by regulatory authorities such as the U.S. FDA, EMA (Europe), PMDA (Japan), and CDSCO (India) to assess and oversee pharmaceutical development. It includes preclinical evaluation, clinical trial design, benefit-risk assessment, pharmacovigilance, and lifecycle management.