Phase 1 Clinical Pharmacology Studies in the United States: Design, Regulation, and Execution
Phase 1 Clinical Pharmacology Studies in the United States: Design, Regulation, and Execution Conducting Phase 1 Clinical Pharmacology Studies in the U.S.: Regulatory Expectations and Best Practices Introduction Phase 1 clinical pharmacology studies mark the transition from preclinical research to first-in-human (FIH) investigation, providing the foundation for later-phase clinical development. Conducted primarily in healthy volunteers,…