bionotus
Niel 2845
Belgium
Core business
(Clinical Study Design) ---> Bioanalysis ---> Pharmacometrics (PMX) --- > Actionable insights
Legal Representative

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
Bioequivalence studies
Toxicokinetic and Pharmacokinetic studies (ADME(T))
Meta-Analysis
Systematic Reviews
Randomized Controlled Trials
Cohort Studies (Prospective Observational Studies)
Case-control Studies
Cross-sectional studies
Case Reports and Series
Animal Research Studies
Test-tube Lab Research
Who are our clients?
CROs
Biotech companies
Pharmaceutical Industry
Academia
University hospitals
IMI
...
BioEquivalence Data Management Early Clinical Phases Laboratory Late phase IV Medical Writing Pharmacometrics (Modeling&Simulation) Preclinical Regulatory Statistics Other