Services
Many questions arise during the discovery and development phases of pharmaceutical or biotech products. We offer pharmacometric consultancy services to answer these questions in a quantitative fashion. Specifically, we apply Modelling and Simulation (M&S) techniques to understand the Pharmacokinetic (PK) and Pharmacodynamic (PD) properties of a drug, and quantify drug effects including variability and uncertainty in projected outcomes. These M&S results can support decision making in different stages of the discovery and development process. We believe that clear and regular communication with the client is crucial for a successful project. Therefore, we prefer having regular teleconferences to give project updates and to jointly decide on next steps in an M&S project. This way we offer maximal flexibility and keep the focus on the most important and relevant questions to be answered. We perform our work according to our professional Quality Management System. Reporting of the modelling and simulation results is done according to relevant regulatory guidance documents.
M&S
We offer model-based analyses:
- Population PK, PK-PD, Disease modelling
- Mechanism-based modelling
- Quantitative Systems Pharmacology (QSP)
- Physiologically-based PK (PBPK) modelling
- Covariate analysis and interpretation of the results
- Meta-analysisbased on data from various sources:
- Continuous, categorical, binary, time-to-event data
- Pharmacology, Safety Pharmacology, Toxicology
- Preclinical and Clinical trials
- Small and large molecules
- Disease progression
- Literature data
With the developed models, we offer in silico , in vivo and in vitro simulations and development of modelling tools to aid decision making for:
- Translational modelling: in vitro-in vivo, preclinical to clinical, interspecies, adults to paediatrics, short to long term
- Sampling scheme optimisation
- Clinical Trial Simulation to optimise the design of planned trials
- Risk-Benefit Analysis
- Automated data analysis from preclinical experiments
Courses
We offer training courses on various topics within the field of M&S. These include theoretical and hands-on modules. We can tailor the course to meet your specific wishes and goals of the training, as a course is most effective with real-life examples and a close link with practise of the participants.
Examples of course modules are:
- Population PK
- PK-PD modelling using turnover models
- Time- and dose-dependent PK
- Modelling circadian cycles
- Modelling tolerance
- Target-mediated drug disposition (TMDD)
- Modelling disease progress