Immunotoxicity of Pharmaceuticals: Current Knowledge, Testing Strategies, Risk Evaluation & Consequences for Human H
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Drug Information J o u m l . Vol. 31. pp. 1301-1305, 1997 Rintcd in thc USA. All rights reserved.
IMMUNOTOXICITY OF PHARMACEUTICALS: CURRENT KNOWLEDGE, TESTING STRATEGIES, RISK EVALUATION & CONSEQUENCES FOR HUMAN HEALTH JAN
WILLEM VAN DER
LAAN
Reclinical Assessment Group, Medicines Evaluation Board of the Netherlands, Laboratory for Medicines and Medical Devices, National Institute of Public Health and the Environment, Bilthoven. The Netherlands
HENKVAN LOVEREN AND JEFF G . VOS Laboratory for Pathology and Immunobiology, National Institute for Public Health and the Environment, Bilthoven, The Netherlands
JACK H. DEAN Sanofi Research, Sanofi Pharnyeuticals, Inc., Malvern, Pennsylvania
KENNETH L .
HASTINGS”
Division of Antiviral Drug Products, Office of Drug Evaluation 11, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland
This paper provides an overview of the DIA workshop on immunotoxicity of p h a m c e u t i cals held on October 2 4 , 1996, in Montreux, Switzerland. The importance of immunotoxicity testing, and its current status, are discussed. The workshop’s agenda: current animal tests and clinical efforts for which preclinical immunotoxicity assays need to be developed, are highlighted. Conclusions from the meeting are provided. Key Words: Immunotoxicity; Allergenicity; Autoimmunity; Pharmaceuticals
Presented at the DIA Workshop “Immunotoxicity of Pharmaceuticals: Current Knowledge, Testing Strategies, Risk Evaluation & Consequences for Human Health.” October 2-4, 1996, Montreux, Switzerland. Reprint address: Dr.J. W. van der Laan, Reclinical Assessment Group of the Medicines Evaluation Board of the Netherlands, Laboratory for Medicines and Medical Devices, National Institute for Public Health and the Environment. P.O. Box 1. NL-3720 BA Bilthoven, The Netherlands. *This article was coauthored by KLH in his private capacity. No official support or endorsement by the Food and Drug Administration is intended or should be inferred.
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J. Willern van der Laan, et al.
INTRODUCTION? IMMUNOTOXICITY TESTING IS AN important topic in the pharmaceutical field. Although most immunotoxicologicaltests were originally developed primarily for the evaluation of environmental chemicals and food additives, these methods are easily adapted for use in pharmaceutical evaluation. Ongoing research in both Europe and the United States has focused on immunotoxicity testing in rodents with particular emphasis on detecting immunosuppression. Immunotoxicology, however, also includes testing for direct immunostimulation and indirect immunotoxicity. Immunotoxicology is the study of the interactions of chemicals and pharmaceuticals with the immune system. See Table 1. Direct immunotoxicitymay occur when the immune system is the target of chemical insults, resulting in altered immune function; this in turn can result in decreased resistance to infection, certain forms of neoplasia, or immune dy
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