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MEDICINE DEVELOPMENT METHOD AND MEDICINE DEVELOPMENT SUPPORTING INFORMATION DISSEMINATION SERVICE SYSTEM

机译:药物开发方法和药物开发支持信息传播服务系统

摘要

PROBLEM TO BE SOLVED: To discover nonconforming elements of new medicine candidate compound as a new medicine at an early date.;SOLUTION: In medicine development method consisting of clinical trials and nonclinical trials, at least part of a new medicine candidate compound is labeled by observable radioactive isotope with AMS and PET inspections, blood concentration and disposition of the new medicine candidate compound labeled are inspected through AMS and PET inspections, effectiveness of the new medicine candidate compound is tested from the relationship of blood concentration and disposition with target regions, particularly the new medicine candidate compound labeled is administered to healthy individuals, blood concentration and disposition of the new medicine candidate compound are investigated widely to healthy individuals, and finally the data are put to practical uses as a basic data of evaluation and decision of clinical trials.;COPYRIGHT: (C)2008,JPO&INPIT
机译:解决的问题:尽早发现新药候选化合物作为新药的不合格成分;解决方案:在由临床试验和非临床试验组成的药物开发方法中,至少有一部分新药候选化合物用标记通过AMS和PET检查可观察到的放射性同位素,通过AMS和PET检查来检查标记的新药候选化合物的血药浓度和处置,并根据血药浓度和处置与目标区域之间的关系来检验新药候选化合物的有效性将标记的新药物候选化合物施用于健康个体,广泛研究血液浓度和新药物候选化合物对健康个体的作用,最后将这些数据作为评估和临床试验决策的基础数据付诸实践。 ;版权:(C)2008,日本特许厅和INPIT

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