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Assessment of the Immunotoxic Potential of Human Pharmaceuticals: A Workshop Report

  • Esther Putman
  • Henk van Loveren
  • Gerd Bode
  • Jack Dean
  • Kenneth Hastings
  • Kazuichi Nakamura
  • François Verdier
  • Jan-Willem Van Der Laan
Article

Abstract

The assessment of the immunotoxic potential of human pharmaceuticals has drawn considerable attention worldwide in the past few years. In Europe, the Committee for Proprietary Medicinal Products released its immunotoxicity guidance documents. The Food and Drug Administration’s Center for Drug Evaluation and Research in the United States and the Japanese Ministry of Health, Labor, and Welfare are in the process of finalizing similar guidance documents.

This report summarizes the discussions on drug immunotoxicity assessment held at a November 2001 DIA workshop held in Noordwijk, The Netherlands. This workshop revealed that an important issue for company attendees was the timing of the immunotoxicity

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Copyright information

© Drug Information Association, Inc 2002

Authors and Affiliations

  • Esther Putman
    • 1
  • Henk van Loveren
    • 2
  • Gerd Bode
    • 3
  • Jack Dean
    • 4
  • Kenneth Hastings
    • 5
  • Kazuichi Nakamura
    • 6
  • François Verdier
    • 7
  • Jan-Willem Van Der Laan
    • 1
  1. 1.Preclinical Assessment Group of the Medicines Evaluation Board, Laboratory for Medicines and Medical DevicesNational Institute for Public Health and the EnvironmentBilthovenThe Netherlands
  2. 2.Section of Immunobiology and HaematologyNational Institute for Public Health and the EnvironmentBilthovenThe Netherlands
  3. 3.Byk Gulden GmbHHamburgGermany
  4. 4.Sanofi-SynthelaboMalvernUSA
  5. 5.Food and Drug AdministrationRockvilleUSA
  6. 6.Shionogi & Co., Ltd.OsakaJapan
  7. 7.Aventis-Pasteur FranceMarcy l’EtoileFrance

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