Establishment of Immunotoxicology Evaluation Procedures for Pharmaceuticals

  • Nakamura, Kazuichi (Immunotoxicology Working Group. Preclinical Evaluation Subcommittee. Drug Evaluation Committee. Japan Pharmaceutical Manufacturers Association)
  • Published : 2001.07.01

Abstract

The Japan Pharmaceutical Manufacturers Association. with the cooperation of the Japan Association of Contract Laboratories for Safety Evaluation. launched a collaborative study with 38 companies aimed at elucidating the correlation between histopathological/hematological findings and immune function. Seven substances were individually administered to Crj : CD (SD)IGS rats for 14 or 28 days. Their immunotoxicity was assessed by histopathology. hematology. plaque-forming cell assay. enzyme-linked immunosorbent assay of serum antibody to sheep red blood cells. and flow cytometry. Appropriate procedures for immunotoxicology evaluation of pharmaceuticals were considered.

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