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Mesh term Clinical Trials, Phase I as Topic

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Clinical Trials as Topic

Description

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.



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jenkins-FCD Prod-480 9a4deaf152b0b06dd18151814fff2e18f6c05280