Population pharmacokinetics

A pharmacokinetic cross-study analysis can be performed by population pharmacokinetics to characterize the PK of the candidate drug in the target population. The relationship between pharmacokinetics and covariates like age, weight and genotype, can be explored to explain parameter variability and to facilitate dose adjustment decisions in the target patient population. For future clinical studies certain outcomes can be explained by the covariates indicated in the modeling exercise. Also simulations can be performed to explore the impact of the different covariates on the PK profile. Finally the model can be used to support label claims in the target patient population. Similar analysis can be done for PK/PD evaluations. Nowadays population pharmacokinetics is widely applied in all stages of drug development and is an integral part of the regulatory dossier. Our Scientific Publications section contains some examples of population pharmacokinetic analysis projects.

back

 

Consultants in drug development

Consultant in drug development

Print this page