Toxicokinetics in Japan  

作　　者：HakuH 

机构地区：[1]DaiichiPharmaceuticalCo.,LTD.,DrugMetabolism＆PhysicochemicalPropertyResearchLaboratory,Tokyo,Japan／Ka

出　　处：《中国药理学与毒理学杂志》2002年第6期412-413,共2页Chinese Journal of Pharmacology and Toxicology

摘　　要：The word ‘toxicokinetics’ is a comparatively new word,but it was being generally practiced in Japanese pharmaceutical industry over 6 years ago.Note for guidance on toxicokinetics(ICH S3A):the assessment of systemic exposure in toxicity studies was harmonized internationally and was essential as the data package for the NDA of a new drug in Japan since 1996.Toxicokinetics is a combination of toxicology and pharmacokinetics.It was to develop a tool which could be most helpful in the interpretation of toxicity data.Using “exposure” as indicated by AUC and/or cmax for parent drug or major metabolite in laboratory animals and man,one can calculate a human safety margin.This human safety margin is the ratio of the AUC of the “no effect dose” in animals in the toxicology studies to the AUC to the therapeutic dose in man.I would like to introduce the actual practice of toxicolinetics in Japan.

关 键 词：毒物动力学 日本 研究进展 

分 类 号：R992[医药卫生—毒理学]