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Centre for the Evaluation of Radiopharmaceuticals and Biotherapeutics [1 record]

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Record 1 2011-12-12

English

Subject field(s)
  • Federal Government Bodies and Committees (Canadian)
  • Pharmacology
OBS

The Centre for the Evaluation of Radiopharmaceuticals and Biotherapeutics (CERB) is responsible for reviewing the quality and clinical data of radiopharmaceutical drug submissions and clinical trial applications; conducting on-site evaluations of manufacturing facilities; and conducting laboratory analysis of products, both pre- and post approval in Canada. Examples of products assessed by this Centre include, hormones and enzymes used for diagnostic or treatment purposes, as well as monoclonal antibodies and recombinant DNA products.

Key term(s)
  • Center for the Evaluation of Radiopharmaceuticals and Biotherapeutics

French

Domaine(s)
  • Organismes et comités fédéraux (Gouvernement canadien)
  • Pharmacologie
OBS

Le Centre d'évaluation des produits radiopharmaceutiques et biothérapeutiques (CEPRB) est chargé d'examiner la qualité et les données cliniques des présentations de médicaments radiopharmaceutiques et des demandes d'essais; de procéder à des évaluations sur place des installations de fabrication et d'effectuer des analyses en laboratoire de produits, avant et après leur homologation au Canada. À titre d'exemples de produits évalués par le Centre, il convient de mentionner les hormones et les enzymes utilisés à des fins de diagnostic et de traitement, ainsi que les anticorps monoclonaux et les produits dérivés de la technologie de l'ADN recombinant.

Spanish

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