[Developmental and reproductive toxicology: interest and interpretation].

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  • Author(s): Stadler J
  • Source:
    Therapie [Therapie] 2014 Jan-Feb; Vol. 69 (1), pp. 25-30. Date of Electronic Publication: 2014 Apr 04.
  • Publication Type:
    English Abstract; Journal Article
  • Language:
    French
  • Additional Information
    • Transliterated Title:
      Toxicologie de la reproduction : intérêt et interprétation.
    • Source:
      Publisher: Elsevier Masson Country of Publication: France NLM ID: 0420544 Publication Model: Print-Electronic Cited Medium: Print ISSN: 0040-5957 (Print) Linking ISSN: 00405957 NLM ISO Abbreviation: Therapie Subsets: MEDLINE
    • Publication Information:
      Publication: 2016- : Paris : Elsevier Masson
      Original Publication: Paris : Doin
    • Subject Terms:
      Reproduction/*drug effects ; Toxicity Tests/*methods ; Toxicology/*methods; Drug Design ; Drug and Narcotic Control ; Female ; Humans ; Male ; Pregnancy ; Risk ; Risk Assessment/methods
    • Abstract:
      Developmental and reproduction toxicology studies (DART) are an essential part of the non-clinical dossier for a regulatory submission. They are performed according to internationally recognized and regulatory protocols. They allow a reasonable risk evaluation when a drug is given at any stage of the reproduction cycle. They study impact of the test compound on reproductive functions of both sexes, on pregnancy and embryo/fetal development, parturition and postnatal development of the progeny. The data interpretation and the establishment of safety margins lead to the edition of specific recommendations in the summary of product characteristics (SPC) and directly to the prescribers.
      (© 2014 Société Française de Pharmacologie et de Thérapeutique.)
    • Publication Date:
      Date Created: 20140405 Date Completed: 20140513 Latest Revision: 20140404
    • Publication Date:
      20221213
    • Accession Number:
      10.2515/therapie/2014010
    • Accession Number:
      24698185