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... > Investigative Techniques > Epidemiologic Methods > Epidemiologic Study Characteristics > Clinical Studies as Topic > Clinical Trials as Topic > Clinical Trials, Phase I as Topic
... > Health Occupations > Medicine > Public Health > Epidemiologic Methods > Epidemiologic Study Characteristics > Clinical Studies as Topic > Clinical Trials as Topic > Clinical Trials, Phase I as Topic
... > Population Characteristics > Health > Public Health > Epidemiologic Methods > Epidemiologic Study Characteristics > Clinical Studies as Topic > Clinical Trials as Topic > Clinical Trials, Phase I as Topic
... > Environment and Public Health > Public Health > Epidemiologic Methods > Epidemiologic Study Characteristics > Clinical Studies as Topic > Clinical Trials as Topic > Clinical Trials, Phase I as Topic
... > Health Care Quality, Access, and Evaluation > Quality of Health Care > Health Care Evaluation Mechanisms > Epidemiologic Study Characteristics > Clinical Studies as Topic > Clinical Trials as Topic > Clinical Trials, Phase I as Topic
... > Health Occupations > Health Services Administration > Quality of Health Care > Health Care Evaluation Mechanisms > Epidemiologic Study Characteristics > Clinical Studies as Topic > Clinical Trials as Topic > Clinical Trials, Phase I as Topic

Preferred term

Clinical Trials, Phase I as Topic  

Type

  • mesh:Descriptor

Definition

  • 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.

Broader concept

Related concepts

Entry terms

  • Clinical Trials, Phase 1
  • Clinical Trials, Phase I
  • Phase 1 Clinical Trial
  • Phase 1 Clinical Trials
  • Phase I Clinical Trial
  • Phase I Clinical Trials

Allowable Qualifier(s)

In other languages

URI

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

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RDF/XML TURTLE JSON-LD Created 5/13/92, last modified 5/27/20