POPULATION PK/PD MODELING

Kinesis offers through its subsidiary LAP&P Consultants BV, Leiden, The Netherlands, advanced population pharmacokinetic (PK), pharmacodynamic (PD) or PK/PD analyses of pre-clinical and clinical studies. The spectrum of analyses includes but is not limited to: =characterisation of complex absorption processes, =physiologically-based pharmacokinetic (PB/PK) modeling and interspecies extrapolation, =population pharmacokinetic modeling including covariate analysis, =population PK/PD modeling of continuous, categorical and ‘time-to-event’ data, =mechanism-based pharmacodynamic modeling, and =modeling of disease progression. In addition LAPP Consultants BV has extensive experience with clinical trial modelling and simulation. Internal validation (according to FDA guidelines i.e. bootstrap, posterior predictive check) and, if possible, also external validation are an integral part of all data analyses.

At LAPP Consultants BV all data analyses and model simulations are performed by expert population PK/PD modeling scientists at the PharmD and PhD level. It has a unique software infrastructure for these analyses based on interfacing of the NONMEM and the S-Plus programs. All analyses are performed according to high quality standards using a dedicated quality management system that ensures a reproducible and traceable analysis process.

Data analysis results are reported according to our report template or according to the template provided by the sponsor. In addition LAP&P Consultants offers also regulatory submission support (i.e. expert opinions/reports, hearings).

Another possibility to support your advanced PK and PK/PD data analysis and clinical trial simulations is by supervision of projects conducted within your company.

Address:

Lage Mosten 29
4822 NK Breda
The Netherlands
+31(0)76 54 80 666
+31(0)76 54 21 777 (Fax)

(c) 2003-2004 Kinesis, the Netherlands
info@kinesis-pharma.com