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Concept information

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

Traductions

URI

http://data.loterre.fr/ark:/67375/JVR-VD3LL101-T

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RDF/XML TURTLE JSON-LD Date de création 13/05/1992, dernière modification le 27/05/2020