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.

Annotation

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

DUI

D017321 MeSH Browser

CUI

M0026303

Previous indexing

Clinical Trials (1980-1992); Drug Evaluation (1980-1992)

History note

2008(1993)

Public note

2008; see CLINICAL TRIALS, PHASE I 1993-2007; for DRUG EVALUATION, FDA PHASE I see DRUG EVALUATION 1980-1992; for EVALUATION STUDIES, FDA PHASE I see DRUG EVALUATION 1982-1992