M&S

We offer model-based analyses

• Population-type (nonlinear mixed-effects) modelling
• PK, PK-PD, disease modelling
• Mechanism-based modelling
• Physiologically-based PK (PBPK) modelling
• Continuous, categorical, binary responses, time-to-event data
• Covariate analysis and interpretation of the results
• Meta-analysis

based on data from various sources:

• Pharmacology, Safety Pharmacology, Toxicology
• Preclinical and Clinical trials (phase 0 - 4)
• Small and large molecules
• Disease progression
• Literature data

With the developed models, we offer in silico simulations to aid decision making in the drug development process:

• Translational modelling: in vitro-in vivo , preclinical to clinical, interspecies, adults to paediatrics (allometry)
• Sampling scheme optimisation
• Clinical Trial Simulation (CTS) to optimize planned trials
• Computer Assisted Trial Design (CATD)
• Use results for risk-analysis, Clinical Utility Index, Health Economics