Unique Skill ID: KS1236170NK4PC0BYFSG

Drug Development

Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug. The entire process – from concept through preclinical testing in the laboratory to clinical trial development, including Phase I–III trials – to approved vaccine or drug typically takes more than a decade.

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Biologics License Applications (BLA)
Clinical Pharmacology
Clinical Study Reports
Clinical Trials
ICH Guidelines
Medical Writing
Non-Disclosure Agreement (Intellectual Property Law)
Pharmacovigilance
Pre-Clinical Development
Regulatory Documents

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