General considerations of population pharmacokinetic/pharmacodynamic study in new drug development

doi:10.12092/j.issn.1009-2501.2019.11.001

Abstract

Abstract:

Population pharmacokinetic/pharmacodynamic (PopPK/PD) study and so derived exposure-response study are key components in new drug development and regulatory decision making. Integrating such studies into new drug development will facilitate new drug development and regulatory decision-making processes. As an expert consensus, this document provides the areas of applications, clinical trial designs, modeling analysis methods, quality control concerns and study reporting formats of PopPK/PD studies in new drug development/regulatory submissions. The authors expect this document can be a valuable reference to those scientists and regulatory reviewer who wish to adapt PopPK/PD studies into new drug development and drug approval processes in China.

Key words: new drug development, pharmacometrics, population pharmacokinetics, pharmacodynamics, exposure-response, expert consensus

CLC Number:

R969.1

MA Guangli, XU Ling, CHEN Rui, CHEN Yuancheng, ZHAO Wei, LIU Dongyang, JIAO Zheng, LI Jian, JI Shuangmin, LI Li, LI Liang, WANG Yuzhu, YANG Jinbo, WANG Yaning, SUN He, HU Pei, ZHENG Qingshan, LU Wei. General considerations of population pharmacokinetic/pharmacodynamic study in new drug development[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, doi: 10.12092/j.issn.1009-2501.2019.11.001.

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