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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