Definition: Studies performed to evaluate the safety of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques in healthy subjects and to determine the safe dosage range (if appropriate). These tests also are used to determine pharmacologic and pharmacokinetic properties (toxicity, metabolism, absorption, elimination, and preferred route of administration). They involve a small number of persons and usually last about 1 year. This concept includes phase I studies conducted both in the U.S. and in other countries.
for general design, methodology, economics, etc. of phase I clinical trials; a different heading CLINICAL TRIAL, PHASE I is used for reports of a specific phase I clinical trial
See AlsoNontherapeutic Human Experimentation
Other names Phase I Clinical Trials; Evaluation Studies, FDA Phase I; Drug Evaluation, FDA Phase I; Clinical Trials, Phase I; Trials, Human Microdosing; Trial, Human Microdosing; Microdosing Trial, Human; Human Microdosing Trial; Phase 1 Clinical Trials; Microdosing Trials, Human; Human Microdosing Trials; Evaluation Studies, FDA Phase 1; Drug Evaluation, FDA Phase I as Topic; Drug Evaluation, FDA Phase 1; Clinical Trials, Phase 1
