Open AccessRegulatory utility of pharmacometrics in the development and evaluation of antimicrobial agents and its recent progress in China
Author(s) -
Zhao Ming,
Chen Yuancheng,
Yang Dong,
Lyu Cheng,
Bian Xingchen,
Li Xin,
Qiu Weiyi,
Huang Zhiwei,
Hu Zijian,
Zhang Jing
Publication year - 2021
Publication title -
cpt: pharmacometrics and systems pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 37
ISSN - 2163-8306
DOI - 10.1002/psp4.12716
Subject(s) - antimicrobial , drug development , regulatory agency , risk analysis (engineering) , agency (philosophy) , regulatory science , medicine , clinical trial , intensive care medicine , drug , pharmacology , political science , biology , philosophy , public administration , epistemology , pathology , microbiology and biotechnology
Pharmacometrics is an emerging science that interprets drug, disease, and trial information in a mathematical fashion to inform and facilitate efficient drug development and/or regulatory decisions. Pharmacometrics study is increasingly adopted in the regulatory review of new antimicrobial agents. We summarized the 31 antimicrobial agents approved by the US Food and Drug Administration (FDA) and the 26 antimicrobial agents approved by European Medicines Agency (EMA) from January 2001 to May 2019. We also reviewed recent examples of utilizing pharmacometrics to support antimicrobial agent’s registration in China, including modeling and simulation methods, effects of internal/external factors on pharmacokinetic (PK) parameters, safety and efficacy evaluation in terms of exposure‐response analysis, refinement of the wording of product labeling and package leaflet, and possible postmarketing clinical trial. Ongoing communication among regulator, academia, and industry regarding pharmacometrics is encouraged to streamline and facilitate the development of new antimicrobial agents. The industry can maximize its benefit in drug development through continued pharmacometrics education/training.