PHARMACOMETRICS INTEGRATED INTO THE R&D OF ANTIMICROBIAL AGENTS IN CHINA
Pharmacometrics, as an emerging discipline, started relatively later in China. The application of pharmacometric approaches in new drug development is inadequate in depth and extent. Among the antimicrobial agents receiving regulatory evaluation, only a few drugs such as nemonoxacin have a full set of pharmacometric studies.
Nonetheless, in recent years, China scientists have participated in more and more international multi-center clinical trials. A number of innovation-based pharmaceutical companies are emerging. It is encouraging to note the buy-in of pharmacometric concepts by the industry due to vigorous promotion by the regulator and academia. China has made great progress in new drug R&D partly thanks to the application of pharmacometrics. However, the knowledge gap and misunderstanding still exist among drug manufacturers about the advantages, role, and application of pharmacometrics in new drug development. Consistently integrating pharmacometric methods into new drug development still requires concerted efforts of the regulator, academia, and industry in China.