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Aspects méthodologiques de l’évaluation des médicaments tératogènes dans l’espèce humaine

Teratogenic risk assessment of drugs in humans: Methodological aspects

  • Article De Synthèse / Review Article
  • Published:
Revue de médecine périnatale

Résumé

La détection de nouveaux agents tératogènes est une préoccupation constante des pouvoirs publics, des professionnels de santé et des futurs parents depuis la tragédie du thalidomide. Plusieurs méthodologies ont été développées depuis afin de mesurer le potentiel tératogène des médicaments, approches qui ont toutes leurs forces et leurs faiblesses. Leur complémentarité et la synthèse de leurs résultats permettent de cerner au plus près le rapport bénéfice/risque en cours de grossesse sur la base des données cliniques et précliniques existantes.

Abstract

Detection of new teratogenic agents in humans is a constant concern among public authorities, health care providers, and future parents since the thalidomide tragedy. Different methodological approaches have then been set up in order to measure the potential effect drugs, each of them having its own weaknesses and strengths. Complementarity and synthesis of their designs and results allow to approach as close as possible the updated benefit/risk ratio during pregnancy on the basis of preclinical and clinical available data.

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  1. Centre de référence sur les agents tératogènes (CRAT), hôpitaux universitaires Est-Parisien (AP-HP), hôpital Armand-Trousseau, 26, avenue du Docteur-Arnold-Netter, F-75571, Paris cedex 12, France

    E. Elefant

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Elefant, E. Aspects méthodologiques de l’évaluation des médicaments tératogènes dans l’espèce humaine. Rev. med. perinat. 6, 3–11 (2014). https://doi.org/10.1007/s12611-014-0265-9

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  • DOI: https://doi.org/10.1007/s12611-014-0265-9

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