Advances in quantitative pharmacology

Abstract

Abstract: Quantitative pharmacology, also termed as pharmacometrics, is the scientific discipline that uses mathematical and statistical methods to quantify the interactions between therapeutic drugs and patients.It increasingly plays a critical role in drug development and pharmacotherapy.Model-based drug development (MBDD)is a paradigm and a mindset which promotes the use of modeling to delineate the path and focus of drug development.The utilization of MBDD remains at an early stage in China, but it is clear that Chinese scientists embrace the discipline, and are keen to apply this methodology to drug development.In this review, we first introduce the definition and developmental history of quantitative pharmacology.Furthermore, we discuss the major areas that the present research focuses and the technological advances in the filed, such as population pharmacokinetics/pharmacodynamics, exposure-response (PK-PD)modeling, clinical trial simulation, novel clinical trial designs, biomarker, disease model, trial model, and M&S methodology.Following that, we give a brief introduction to MBDD.Finally, some challenges that pharmacometrican are currently facing, and the possible solutions are discussed.

Key words: quantitative pharmacology (pharmacometrics), drug development, model-based drug development, modeling and simulation

CLC Number:

R311

HUANG Xiao-hui, XIE Hai-tang, SHI Jun, SONG Jian-guo, ZHENG Qing-shan. Advances in quantitative pharmacology[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2009, 14(6): 601-612.

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