The value and general consideration of pharmacometric study in new drug development

doi:10.12092/j.issn.1009-2501.2018.09.001

Abstract

Abstract:

Pharmacometrics is a discipline to quantitatively investigate information, such as pharmacokinetics, pharmacodynamics, physiology, disease progression, and clinical trial, to produce knowledge using modeling and simulation methods. It supports new drug development since early phase in a life cycle, which forms a model-informed drug development mode to improve efficiency of drug development and regulatory administration, save development costs, and accelerate approval of new drug.This article illustrates the values and investigates the properties, application assumptions, and standard operation procedures of pharmacometrics during new drug development based on consensus of experts in domestic and overseas. We hope this white paper could standardize and improve the application of pharmacometrics in new drug development in China.

Key words: new drug development, pharmacometric study, expert consensus

CLC Number:

R965

LIU Dongyang,WANG Kun,MA Guangli,XIANG Xiaoqiang,LIU Jiang,ZHAO Ping,CHEN Rui,CHEN Yuancheng,HUANG Xiaohui, LI Li,LI Lujin,NIE Jing,WANG Yuzhu,WEI Chunmin,LU Wei,SHI Jun, ZHENG Qingshan. The value and general consideration of pharmacometric study in new drug development[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, doi: 10.12092/j.issn.1009-2501.2018.09.001.

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