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Clinical Trials, Phase I as Topic MeSH Descriptor Data 2026
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
Scope Note
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.
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
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.
Use of doses at only 1% of the pharmacological dose in humans in order to evaluate the pharmacokinetics. Such trials are sometimes referred to as phase zero trials.