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Descriptor English: Clinical Trials, Phase IV as Topic
Descriptor Spanish: Ensayos Clínicos Fase IV como Asunto
Descriptor ensayos clínicos en fase IV como asunto
Scope note: Obras sobre estudios poscomercialización planificados de medicamentos, dispositivos o técnicas para diagnóstico, tratamiento o prevención aprobados para su venta en el mercado. Estos estudios a menudo se realizan para obtener datos adicionales sobre la seguridad y la eficacia de un producto. Este concepto incluye los ensayos de fase IV efectuados en Estados Unidos y otros países.
Descriptor Portuguese: Ensaios Clínicos Fase IV como Assunto
Descriptor French: Essais cliniques de phase IV comme sujet
Entry term(s): Clinical Trials, Phase 4 as Topic
Drug Evaluation, FDA Phase 4 as Topic
Drug Evaluation, FDA Phase IV as Topic
Evaluation Studies, FDA Phase 4 as Topic
Evaluation Studies, FDA Phase IV as Topic
Tree number(s): E05.318.372.250.250.230
E05.337.800.200
N05.715.360.330.250.250.230
N06.850.520.450.250.250.230
RDF Unique Identifier: https://id.nlm.nih.gov/mesh/D017327
Scope note: Works about planned post-marketing studies of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques that have been approved for general sale. These studies are often conducted to obtain additional data about the safety and efficacy of a product. This concept includes phase IV studies conducted in both the U.S. and in other countries.
Annotation: for general design, methodology, economics, etc. of phase IV clinical trials; a different heading CLINICAL TRIAL, PHASE IV is used for reports of a specific phase IV 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)
Public MeSH Note: 2008; see CLINICAL TRIALS, PHASE IV 1993-2007; for DRUG EVALUATION, FDA PHASE IV see CLINICAL TRIALS 1981-1992; for EVALUATION STUDIES, FDA PHASE IV see CLINICAL TRIALS 1982-1992
History Note: 2008(1993)
Related: Drug-Related Side Effects and Adverse Reactions MeSH
DeCS ID: 30781
Unique ID: D017327
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: 2019/07/05
Clinical Trials, Phase IV as Topic - Preferred
Concept UI M0026314
Scope note Works about planned post-marketing studies of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques that have been approved for general sale. These studies are often conducted to obtain additional data about the safety and efficacy of a product. This concept includes phase IV studies conducted in both the U.S. and in other countries.
Preferred term Clinical Trials, Phase IV as Topic
Entry term(s) Clinical Trials, Phase 4 as Topic
Drug Evaluation, FDA Phase IV as Topic - Related but not broader or narrower
Concept UI M0026313
Preferred term Drug Evaluation, FDA Phase IV as Topic
Entry term(s) Drug Evaluation, FDA Phase 4 as Topic
Evaluation Studies, FDA Phase 4 as Topic
Evaluation Studies, FDA Phase IV as Topic



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