Pharmacometrics & PK/PD Modelling
Applying pharmacometrics in drug development
During drug development pharmacometrics is applied to facilitate selection of compounds to enter clinical development, to support optimisation of drug formulations and CMC processes, and to optimise clinical study designs (including dose selection). Through PK / PD modelling and simulation, these techniques are also used to bridge different study populations (e.g. from healthy volunteers to pediatrics) and to facilitate strategic project decisions (go – no go).
Nowadays pharmacometrics is widely applied in all stages of drug development and is an integral part of the regulatory dossier. Guidelines to perform such analysis including population pharmacokinetics have been released by the FDA and EMA. At Venn/Kinesis Pharma BV the PK PD modelling and simulation group has the expertise to assist sponsors with all relevant pharmacometric and biometric services. WinNonLin®, NONMEM®, the R software and our in-house developed and validated “Modeling Platform” is used for the different M&S projects.
Clinical pharmacokinetics (PK) and toxicokinetics (TK) are also part of our biometric services.
- Allometric scaling
- Exploratory PK/PD analysis
- Population pharmacokinetics
- Programming NONMEM datasets
- Modelling and simulation software
Jan Noukens, M.Sc
Group Leader Clinical Pharmacokinetics / Consultant Clinical Development