Clinical Trials, Phase I as Topic
Synonyms
Clinical Trials, Phase 1
Clinical Trials, Phase I
Drug Evaluation, FDA Phase 1
Drug Evaluation, FDA Phase I
Drug Evaluation, FDA Phase I as Topic
Evaluation Studies, FDA Phase 1
Evaluation Studies, FDA Phase I
Human Microdosing Trial
Human Microdosing Trials
Microdosing Trial, Human
Microdosing Trials, Human
Phase 1 Clinical Trials
Phase I Clinical Trials
Trial, Human Microdosing
Trials, Human Microdosing
Works about 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.