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PHASE III 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 large controlled trial to determine a drug’s efficacy and monitor adverse events during longer-term use ...

OBS

... these trials are sometimes divided into phase IIIa trials, conducted before the marketing authorization application, and phase IIIb trials, conducted after the marketing authorization application, but before approval.

OBS

These trials are designed to verify information gathered in phase I and II trials and involve up to several thousand volunteers. Phase III trials may compare the drug being tested to other therapies or to [a] placebo.

OBS

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

Key term(s)
  • phase 3 trial

French

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

Essai de grande envergure avec groupe témoin visant à déterminer l’efficacité d’un médicament et à surveiller l’apparition d’événements indésirables à plus long terme [...]

OBS

[...] ces essais sont parfois divisés en essais de phase IIIa, menés avant la demande d’autorisation de mise sur le marché (AMM), et essais de phase IIIb, menés après la demande d’autorisation de mise sur le marché mais avant l’homologation.

OBS

essai de phase III : 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 3

Spanish

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