Pharmacokinetics-pharmacodynamics during drug development--an example from Servier: ivabradine.
A short introduction to the principles of pharmacokinetic-pharmacodynamic (PK-PD) modelling and population approaches is provided in this article. The importance of implementing these techniques in the drug development process is illustrated by an example from experience at the Servier International Research Institute. This example demonstrates how the use of PK-PD modelling can rationalise the development process and save valuable time. Population approaches significantly contribute to the integration of PK-PD modelling into the different drug development phases by expanding the possibilities of application.
Laveille
Christian
C
Institut de Recherches Internationales Servier, Courbevoie, France. christian.laveille@fr.netgrs.com
Jochemsen
Roeline
R
D000787:Angina Pectoris / Q000188:drug therapy; D001552:Benzazepines / Q000493:pharmacokinetics* / Q000494:pharmacology*; D002316:Cardiotonic Agents / Q000493:pharmacokinetics* / Q000494:pharmacology*; D017322:Clinical Trials, Phase II as Topic; D003198:Computer Simulation; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D000077550:Ivabradine; D008954:Models, Biological; D011153:Population
D001552:Benzazepines; D002316:Cardiotonic Agents; D000077550:Ivabradine