Studies in volunteers and its regulation

Abstract

Studies in volunteers are most important in the research and development of a medicinal product or, as defined by the FDA (see below), of a drug. Clinical trials in humans can be performed only if preceding toxicological studies and practical considerations rule out a risk for the subjects/patients. The tests provide evidence of safety, efficacy (drugs), and thresholds. Many regulations, such as insurance, privacy, and ethics committee, must be observed.