Skip to main content

Drug Development

Meaning

Drug development is the comprehensive, multi-stage process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through discovery. This complex journey involves preclinical research, which includes laboratory and animal testing, followed by a rigorous series of clinical trials (Phases I, II, and III) to establish safety, dosage, and efficacy in human subjects. The process culminates in regulatory approval by agencies like the FDA, ensuring the medication meets established standards for patient use. Success in drug development requires extensive capital investment, adherence to strict protocols, and a deep understanding of disease pathophysiology.