Subject h. | skúšanie klinické, fáza I, ako téma
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Subject h. | Clinical Trials, Phase I as Topic
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Entry terms | štúdie klinické, fáza I štúdie klinické, fáza I, ako téma pokusy klinické, prvá fáza, ako téma testy klinické, prvá fáza, ako téma štúdie vyhodnocovacie, FDA fáza I, ako téma štúdie vyhodnocovacie, FDA fáza I štúdie hodnotiace, FDA fáza 1, ako téma hodnotenie liekov, FDA fáza I, ako téma štúdia mikrodávková humánna skúška klinická, fáza 1
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English X references | Clinical Trials, Phase I Drug Evaluation, FDA Phase I Evaluation Studies, FDA Phase I Human Microdosing Trial Phase 1 Clinical Trial Phase I Clinical Trial Phase I Clinical Trials
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Scope note in English | 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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See also reference (FX) in Slovak | experimentovanie na ľuďoch, neterapeutické
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See also reference (FX) in English | Nontherapeutic Human Experimentation
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Links | (12) - ARTICLES
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| (1) - MeSH descriptor
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| (1) - CiBaMed
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| (4) - BOOKS
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