Evolving role of modeling and simulation in drug development
10.12793/tcp.2019.27.1.19
- Author:
Hyeong Seok LIM
1
Author Information
1. Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan, Seoul 05505, Republic of Korea. mdhslim@gmail.com
- Publication Type:Review
- Keywords:
Language;
Mathematical formula;
Pharmacokinetic-pharmacodynamic model;
Predictive model
- MeSH:
In Vitro Techniques;
Pharmacology
- From:Translational and Clinical Pharmacology
2019;27(1):19-23
- CountryRepublic of Korea
- Language:English
-
Abstract:
Pharmacokinetic-pharmacodynamic model is a kind of language that quantitatively describes the drug-related outcomes in the form of mathematical formula. Various outcomes can be subjected to modeling analysis if they can be expressed in numbers. Empirical models have been widely and successfully applied in drug development and research. However, a more competitive drug development environment requires more accurate and predictive models in the early stages of drug development. Accordingly, the subjects of PK-PD modeling have been extended from clinical data to preclinical and in vitro data in the discovery stage. More mechanistic and predictive models, such as physiologically based pharmacokinetic and quantitative system-based pharmacology models, are being increasingly used owing to the growing need to characterize drugs more accurately at the earliest. This tutorial briefly introduces the essential concepts of PK-PD modeling and simulation and describes the recent changing roles of PK-PD model for application in novel drug development process.
