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 optimization of drug formulations and CMC processes, and to optimize 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 Kinesis Pharma 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. Our Scientific Publications section contains some examples of pharmacometric projects.

Clinical pharmacokinetics (PK)  and toxicokinetics (TK)  are also part of our biometric services.

 

 

"Nowadays Modeling and Simulation is widely applied in all stages of drug development and is an integral part of the regulatory dossier"

Contact details:

Johan te Koppele, Ph.D.
Managing Director
Tel: +31 76 54 80 671
Mob: + 31 6  44 53 86 37
Email: Johan.teKoppele@Kinesis-Pharma.com
   

 

Consultants in drug development

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