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.