Photograph by Darlyne A. Murawski, National Geographic. The peanut worm has a proboscis that resembles an elephantâs trunk, as well as a mouth that boasts an impressive array of tentacles. This bottom burrower feeds on organic materials found in mud and sand, and when done feasting it can turn the proboscis inside out to retract it inside its body.
Early clinical development is primarily composed of human proof of principle/pilot clinical studies â to confirm feasibility in human, explore patient populations and performance claims. Concomitantly, subsequent clinical trials are outlined and prepared for.
1 Objectives. â¢. 2  Outline the Phase 1 studies conducted to characterize. the Clinical Pharmacology of a drug; describe important. design elements of and the information gained from. these studies. â¢. List the Clinical Pharmacology characteristics of an Ideal. Drug. â¢. Describe how the Clinical Pharmacology information from. Phase 1 can help design Phase 2/3 trials. â¢. Discuss the timing of Clinical Pharmacology studies. during drug development, and provide examples of how. the information generated could impact the overall clinical. development plan and product labeling. Phase 1 of Drug Development.