HE Chunyuan, SHEN Bingxiang, XIE Haitang. Population Pharmacokinetic Research Method and its Research Progress[J]. 2020,20(12):1532-1536. DOI: 10.14009/j.issn.1672-2124.2020.12.031.
Since the US Food and Drug Administration approved the method of population analysis to be applied to the pharmacokinetic and pharmacodynamic evaluation of new drug clinical trials with special physiological and pathological subjects in 1998
and the "Guiding Principles for Population Pharmacokinetic Research Technology" was issued in 1999
population pharmacokinetics(PPK) has been widely studied in pharmacy.This article has briefly summarized the basic principle
research method and progress of PPK
and focuses on the nonlinear mixed effects modelling(NONMEN) method
which is currently " the gold standard" for PPK analysis.The research method of PPK has great guiding significance for clinical rational medication
research and evaluation of new drugs.Compared with traditional pharmacokinetic research methods
PPK can explain the variation caused by various factors more conveniently and provide an important reference for clinical individualized medication.
关键词
群体药动学NONMEM法新药临床试验
Keywords
Population pharmacokineticsNONMEMNew drug clinical trials