Concept information
...
Epidemiologic Methods
Epidemiologic Study Characteristics
Clinical Studies as Topic
Clinical Trials as Topic
...
Epidemiologic Methods
Epidemiologic Study Characteristics
Clinical Studies as Topic
Clinical Trials as Topic
...
Epidemiologic Methods
Epidemiologic Study Characteristics
Clinical Studies as Topic
Clinical Trials as Topic
...
Epidemiologic Methods
Epidemiologic Study Characteristics
Clinical Studies as Topic
Clinical Trials as Topic
Terme préférentiel
Clinical Trials, Phase I as Topic
Type
-
mesh:Descriptor
Définition
- 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.
Concept générique
Synonyme(s)
- Clinical Trials, Phase 1
- Clinical Trials, Phase I
- Phase 1 Clinical Trial
- Phase 1 Clinical Trials
- Phase I Clinical Trial
- Phase I Clinical Trials
Qualificatif(s) autorisé(s)
Traductions
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français
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Essais cliniques de phase 1
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Essais cliniques de phase 1 comme sujet
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Essais cliniques de phase I
URI
http://data.loterre.fr/ark:/67375/JVR-VD3LL101-T
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