Analytical, Diagnostic and Therapeutic Techniques, and Equipment

Phase I as Topic Clinical Trials

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.

National Library of MedicineMedical Subject Headings2026

Structured Summary

Abstract

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.

MeSH Record

Classification

Broader headings

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See Also

MeSH Record

Synonyms

18 entry terms
  • Clinical Trials, Phase 1
  • Clinical Trials, Phase I
  • Clinical Trials, Phase I as Topic
  • Phase 1 Clinical Trial
  • Phase 1 Clinical Trials
  • Phase I Clinical Trial
  • Phase I Clinical Trials
  • Drug Evaluation, FDA Phase 1
  • Drug Evaluation, FDA Phase I
  • Drug Evaluation, FDA Phase I as Topic
  • Evaluation Studies, FDA Phase 1
  • Evaluation Studies, FDA Phase I
  • Human Microdosing Trial
  • Human Microdosing Trials
  • Microdosing Trials, Human
  • Microdosing Trial, Human
  • Trial, Human Microdosing
  • Trials, Human Microdosing

MeSH Record

Aspects Covered

11 allowable subheadings

Indexed with the subheadings classification, economics, ethics, history, instrumentation, legislation & jurisprudence, methods, psychology, standards, statistics & numerical data, veterinary.

MeSH Record

Indexing Annotation

for general design, methodology, economics, etc. of phase I clinical trials; a different heading CLINICAL TRIAL, PHASE I is used for reports of a specific phase I clinical trial

MeSH Record

History Note

2008(1993)

MeSH Record

Previous Indexing

  • Clinical Trials (1980-1992)
  • Drug Evaluation (1980-1992)

MeSH Hierarchy

Tree Numbers

AMA Style

References

  1. National Library of Medicine. Phase I as Topic Clinical Trials. Medical Subject Headings (MeSH). 2026. Unique ID D017321. http://id.nlm.nih.gov/mesh/2026/D017321
  2. Phase I as Topic Clinical Trials. In: Wikipedia. https://en.wikipedia.org/wiki/First-in-man_study
  3. Phase I as Topic Clinical Trials. In: Wikidata. https://www.wikidata.org/wiki/Q5452194