[关键词]
[摘要]
对比了《药物非临床药代动力学研究技术指导原则》和ICH S3B,包括组织分布开展条件、研究设计和实施等内容,分析了我国指导原则和ICH S3B的内容差异和技术差异,并为S3B的具体实施提出建议。
[Key word]
[Abstract]
“Guidance for Nonclinical Pharmacokinetics of Medicinal Products” and ICH S3B were compared, including the conditions for the development of tissue distribution, study design and implementation, and the differences in contents and technology between China's guidance and ICH S3B were analyzed. The suggesstion for impementation of S3B were also made in this paper.
[中图分类号]
[基金项目]