(Clinical Study Design) ---> Bioanalysis ---> Pharmacometrics (PMX) --- > Actionable insights
Johan Van Daele
Specific areas of activity
What do we do?
1/ Our Bioanalysis expertise for your pharma and biotech needs
- Quantitative determination of (a) drugs and their metabolites, (b) biomarkers and endogeneous compounds.
- Metabolite identification (MetID)
- Biological and non-biological matrices (e.g. in vitro, wastewater)
- Custom method development and routine
2/ Our Pharmacometrics (PMX) expertise for your pharma and biotech needs
- Data exploration and visualization (scoping) prior to modeling
- Non-compartmental PK analysis and allometric scaling
- Physiology-based Pharmacokinetics (PBPK) and PBPK-based scaling
- Population Pharmacokinetic/Pharmacodynamic modeling (popPK/PD)
- Dose-finding in special populations (e.g. neonatal, pediatric, geriatric), a.k.a. Model Informed Precision Dosing (MIPD)
- Clinical Study design
- Project management of the PMX parts of drug development
For what type of studies?
Preclinical till late Phase IV
Toxicokinetic and Pharmacokinetic studies (ADME(T))
Randomized Controlled Trials
Cohort Studies (Prospective Observational Studies)
Case Reports and Series
Animal Research Studies
Test-tube Lab Research
Who are our clients?
BioEquivalence Data Management Early Clinical Phases Laboratory Late phase IV Medical Writing Pharmacometrics (Modeling&Simulation) Preclinical Regulatory Statistics Other