Assessment of the Immunotoxic Potential of Human Pharmaceuticals: A Workshop Report
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0092-86 15/2002 Copyright 0 2002 Drug Information Association Inc.
ASSESSMENT OF THE IMMUNOTOXIC POTENTIAL OF HUMAN PHARMACEUTICALS: A WORKSHOP REPORT ESTHERPUTMAN,PHD* Preclinical Assessment Group of the Medicines Evaluation Board, Laboratory for Medicines and Medical Devices, National Institute for Public Health and the Environment, Bilthoven, The Netherlands
HENKVAN LOVEREN, PHD Section of Immunobiology and Haematology, National Institute for Public Health and the Environment, Bilthoven, The Netherlands
GERDBODE,PHD Byk Gulden GmbH, Hamburg, Germany
JACK DEAN,PHD Sanofi-Synthelabo, Malvem, Pennsylvania
KENNETHHASTINGS, DRPH** Food and Drug Administration, Rockville, Maryland
KAZUICHI NAKAMURA, PHD Shionogi & Co., Ltd., Osaka, Japan
FRANCOIS VERDIER, PHD Aventis-Pasteur France, Marcy l’Etoile, France
VAN DER LAAN,PHD* JAN-WILLEM Preclinical Assessment Group of the Medicines Evaluation Board, Laboratory for Medicines and Medical Devices, National Institute for Public Health and the Environment, Bilthoven, The Netherlands
The assessment of the immunotoxicpotentialof human pharmaceuticals has drawn considerable attentionworldwide in the past few years. In Europe, the Committeefor Proprietary Medicinal Products released its immunotoxicity guidance documents. The Food and Drug Administration’s Centerfor 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 issuefor company attendees was the timing of the immunotoxicity Reprint address: Dr. J. W. van der Laan, Laboratory for Medicines and Medical Devices, National Institute for Public Health and the Environment, PO Box 1, 3720BA, Bilthoven, The Netherlands. *The views presented in this paper are those of the authors and should not be understood or quoted as being made on behalf of the European Medicine Evaluation Agency or its scientific committees. **The opinions expressed in this paper do not reflect official support or endorsement by the Food and Drug Administration.
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Putman, van Loveren, Bode, Dean, Hastings, Nakamura, Verdier, and van der Laan studies during the drug development process. The Committee for Proprietary Medicinal Products requires that immunotoxicity endpoints be monitored for all new compounds. Industry has interpreted this requirement, and the expectation that these endpoints be studied in a 28-day repeated dose study in rats, as obligatory immunotoxicity testing for all new compounds, regardless of the stage of development. The Committee for Proprietary Medicinal Products requirements, howevec are applicable only at the stage of the marketing application. Workshop participants agreed that immunotoxicity screening should preferably be carried out prior or parallel to Phase 2 development. This will substantially reduce the number of co
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