Current Edition

Use of Concentration-effect Modelling for Cardiac Safety ECG Assessments

Robert B. Kleiman, MD, Chief Medical Officer at ERT, shares
his knowledge of concentration-effect modelling (CEM), a
method of data evaluation which is also commonly referred
to as pharmacokinetic-pharmacodynamic (PK-PD) modelling
or exposure-response (ER) modelling. It uses time-matched
pairs of a PK measurement (usually plasma concentration
of a compound or its metabolite) and some type of
“pharmacodynamic” outcome. The purpose is to determine if
there is a relationship between the concentration of whatever
drug is being evaluated and the specific effect of interest.…pdf