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Descriptor English: Clinical Trials, Phase I as Topic
Descriptor Spanish: Ensayos Clínicos Fase I como Asunto
Descriptor ensayos clínicos en fase I como asunto
Entry term(s) ensayo clínico de fase 1
ensayo clínico de fase I
ensayo de microdosificación en seres humanos
ensayos clínicos en fase I
ensayos clínicos en fase I como tema
estudios clínicos en fase I
estudios de evaluación FDA en fase I
estudios de evaluación FDA fase I
evaluación de fármacos FDA en fase I
evaluación de fármacos, FDA en fase I
Scope note: Trabajos sobre estudios realizados para evaluar la seguridad de medicamentos, dispositivos o técnicas diagnósticas, terapéuticas o preventivas en sujetos sanos y para determinar el intervalo de dosificación segura (si procede). Estos estudios también se usan para determinar propiedades farmacológicas y farmacocinéticas (toxicidad, metabolismo, absorción, eliminación y ruta de administración preferente). Involucran a un pequeño número de personas y generalmente duran cerca de 1 año. Este concepto incluye los ensayos en fase 1 efectuados en los Estados Unidos y en otros países.
Descriptor Portuguese: Ensaios Clínicos Fase I como Assunto
Descriptor French: Essais cliniques de phase I comme sujet
Entry term(s): Clinical Trials, Phase 1
Clinical Trials, Phase I
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 Trial, Human
Microdosing Trials, Human
Phase 1 Clinical Trial
Phase 1 Clinical Trials
Phase I Clinical Trial
Phase I Clinical Trials
Trial, Human Microdosing
Trials, Human Microdosing
Tree number(s): E05.318.372.250.250.200
N05.715.360.330.250.250.200
N06.850.520.450.250.250.200
VS2.002.003.001.003.001
RDF Unique Identifier: https://id.nlm.nih.gov/mesh/D017321
Scope note: 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.
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
Allowable Qualifiers: CL classification
EC economics
ES ethics
HI history
IS instrumentation
LJ legislation & jurisprudence
MT methods
PX psychology
SN statistics & numerical data
ST standards
VE veterinary
Previous Indexing: Clinical Trials (1980-1992)
Drug Evaluation (1980-1992)
Public MeSH Note: 2008; see CLINICAL TRIALS, PHASE I 1993-2007; for DRUG EVALUATION, FDA PHASE I see DRUG EVALUATION 1980-1992; for EVALUATION STUDIES, FDA PHASE I see DRUG EVALUATION 1982-1992
History Note: 2008(1993)
Related: Nontherapeutic Human Experimentation MeSH
DeCS ID: 30784
Unique ID: D017321
Documents indexed in the Virtual Health Library (VHL): Click here to access the VHL documents
Date Established: 1993/01/01
Date of Entry: 1992/05/13
Revision Date: 2020/05/27
Clinical Trials, Phase I as Topic - Preferred
Concept UI M0026303
Scope note 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.
Preferred term Clinical Trials, Phase I as Topic
Entry term(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
Evaluation Studies, FDA Phase I - Narrower
Concept UI M0026302
Preferred term Evaluation Studies, FDA Phase I
Entry term(s) Evaluation Studies, FDA Phase 1
Microdosing Trials, Human - Narrower
Concept UI M0487906
Scope note 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.
Preferred term Microdosing Trials, Human
Entry term(s) Human Microdosing Trial
Human Microdosing Trials
Microdosing Trial, Human
Trial, Human Microdosing
Trials, Human Microdosing
Drug Evaluation, FDA Phase I as Topic - Narrower
Concept UI M0026301
Preferred term Drug Evaluation, FDA Phase I as Topic
Entry term(s) Drug Evaluation, FDA Phase 1
Drug Evaluation, FDA Phase I



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