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DeCS
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Descriptor English:
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Clinical Trials, Phase IV as Topic
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Descriptor Spanish:
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ensayos clínicos en fase IV como asunto
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Descriptor Portuguese:
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Ensaios Clínicos Fase IV como Assunto
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Synonyms English:
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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
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Tree Number:
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E05.318.372.250.250.230
E05.337.800.200
N05.715.360.330.250.250.230
N06.850.520.450.250.250.230
VS2.002.003.001.003.004
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Definition English:
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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. |
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Indexing Annotation English:
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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
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See Related English:
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Drug-Related Side Effects and Adverse Reactions
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History Note English:
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2008(1993)
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Allowable Qualifiers English:
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Record Number:
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30781
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Unique Identifier:
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D017327
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Occurrence in VHL:
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Similar:
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DeCS
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