国际性杂志“毒理学与工业卫生”(Toxicology and lndustrial Health)1988年9月份刊出专号登载美国政府毒理学家协会举行的“农药毒理学及登记近展”(Recent Development in Pesticide Toxicology and Registration)会议录。及时地报道...国际性杂志“毒理学与工业卫生”(Toxicology and lndustrial Health)1988年9月份刊出专号登载美国政府毒理学家协会举行的“农药毒理学及登记近展”(Recent Development in Pesticide Toxicology and Registration)会议录。及时地报道了这次会议。介绍了一般毒理学、免疫毒理学、神经毒理学及行为、生物工程的新进展。提出了对于管理要求的评议和不久将来要进行的一些改变,特别是将增添对于免疫毒理学方面的测试项目。现将摘译部分陆续刊登,以飨读者。展开更多
Guidance for immunotoxicology studies has been intensively discussed.The European Medicnes Evaluation Agency published the draft guidance on immunotoxicity on December 16,1999 and finalized it on July 27,2000.In the m...Guidance for immunotoxicology studies has been intensively discussed.The European Medicnes Evaluation Agency published the draft guidance on immunotoxicity on December 16,1999 and finalized it on July 27,2000.In the meantime,the US Food and Drug Administration (FDA) published the draft guidance on May 11,2001.The Japanese Ministry of Health,Labor and Welfare and the Japan Pharmaceutical Manufactures Association submitted their interim draft guidance to the International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use(ICH) for discussion of Decemeber 20,2001.The approaches are taken in these(draft) guidance documents.A major difference among the guidance of the three regions is that only the EU guidance requires some immune function tests for all new medicinal products.The informal expert working proup meeting held in the ICH on February 7,2002 resched the conchusion that the guidelines should be eventually hamonized after collecting more data.A scientific session on immunotoxicity testing will be included in the ICH6,Osake,November 2003.展开更多
文摘国际性杂志“毒理学与工业卫生”(Toxicology and lndustrial Health)1988年9月份刊出专号登载美国政府毒理学家协会举行的“农药毒理学及登记近展”(Recent Development in Pesticide Toxicology and Registration)会议录。及时地报道了这次会议。介绍了一般毒理学、免疫毒理学、神经毒理学及行为、生物工程的新进展。提出了对于管理要求的评议和不久将来要进行的一些改变,特别是将增添对于免疫毒理学方面的测试项目。现将摘译部分陆续刊登,以飨读者。
文摘Guidance for immunotoxicology studies has been intensively discussed.The European Medicnes Evaluation Agency published the draft guidance on immunotoxicity on December 16,1999 and finalized it on July 27,2000.In the meantime,the US Food and Drug Administration (FDA) published the draft guidance on May 11,2001.The Japanese Ministry of Health,Labor and Welfare and the Japan Pharmaceutical Manufactures Association submitted their interim draft guidance to the International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use(ICH) for discussion of Decemeber 20,2001.The approaches are taken in these(draft) guidance documents.A major difference among the guidance of the three regions is that only the EU guidance requires some immune function tests for all new medicinal products.The informal expert working proup meeting held in the ICH on February 7,2002 resched the conchusion that the guidelines should be eventually hamonized after collecting more data.A scientific session on immunotoxicity testing will be included in the ICH6,Osake,November 2003.
