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


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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Correspondence to Dr. Jan-Willem Van Der Laan PhD.

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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, E., van Loveren, H., Bode, G. et al. Assessment of the Immunotoxic Potential of Human Pharmaceuticals: A Workshop Report. Ther Innov Regul Sci 36, 417–427 (2002).

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