TERMIUM Plus®

The Government of Canada’s terminology and linguistic data bank.

phase IV trial [1 record]

Filter results by subject field Alphabetical list of terms

Filter results by subject field

Alphabetical list of terms

Record 1 2014-01-23

English

Subject field(s)
  • Scientific Research
  • General Medicine, Hygiene and Health
DEF

A post-marketing pharmacovigilance study to monitor a drug’s long-term effects and provide additional information on the drug’s safety and efficacy, including for patient groups with different dosing regimens.

OBS

phase IV trial: term and definition standardized by the Health Technology Assessment (HTA) Glossary English Editorial Board and the Translation Bureau.

Key term(s)
  • phase 4 trial

French

Domaine(s)
  • Recherche scientifique
  • Médecine générale, hygiène et santé
DEF

Étude de pharmacovigilance menée après la mise sur le marché (post-AMM [autorisation de mise sur le marché]) et visant à surveiller les effets à long terme d'un médicament ainsi qu'à fournir des informations supplémentaires sur son innocuité et son efficacité, y compris pour des groupes de patients qui suivent des schémas posologiques différents.

OBS

essai de phase IV : terme et définition normalisés par l'Institut national d'excellence en santé et en services sociaux (INESSS) et le Bureau de la traduction.

Key term(s)
  • essai de phase 4

Spanish

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TERMIUM Plus®, the Government of Canada's terminology and linguistic data bank
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