摘要
ICHE5指导原则是为评价药物在不同种族人群的差异,并帮助将一个地区的临床资料合理外推至新的地区,而药代动力学是评价药物种族差异的主要因素之一。本文探讨种族差异对药物吸收、分布、代谢和排泄的影响。
The objective of the ICH E5 guidance is to develop strategies for determining whether a drug is likely to be 'ethnically sensitive', and to reasonably extrapolating clinical data from one region to another. One of the major concerns in evaluating ethic differences is the potential impact of ethnicity on a drug's pharmacokinetics. Supported by the available literature, the purpose of this review is to discuss whether the effects of race or ethnicity on pharmacokinetics can be predictable by major pharmacokinetic proce- sses, such as bioavailability (absorption), distribution, metabolism and renal elimination.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2005年第3期225-228,共4页
The Chinese Journal of Clinical Pharmacology
关键词
药物
种族差异
药代动力学
drug
ethnic differences
pharmacokinetics
