Physiologically Based Pharmacokinetic (PBPK) Modeling Services
Solutions to support drug development, chemical risk assessment, and regulatory submissions.
- Custom compound-specific model development
- Rapid PBPK (HT-PBPK) for early discovery and prioritization
- Dose, route, and species extrapolation
- Early life and other sensitive populations
- Reverse dosimetry and exposure reconstruction to estimate likely human exposures
In Vitro-to-In Vivo Extrapolation (IVIVE) Services
Translate in vitro toxicity findings into in vivo dose– response relationships.
- Quantitative IVIVE of cell-based toxicity assay results
- High-throughput IVIVE (HT IVIVE) of in vitro screening assays
- Derivation of Oral Equivalent Dose (OED) and Activity-to-Exposure Ratio (AER) from HT in vitro data
In Vitro Metabolism Study Design & Implementation
Design, place, and monitor in vitro metabolism studies to inform pharmacokinetics, safety, and risk assessment.
- Intrinsic clearance (Clint) and saturable metabolism (Vmax and Km)
- Metabolite identification
- Studies for cross-species comparison to support interspecies extrapolation
In Silico Models to Predict Physicochemical Parameters and Metabolites
Use of in silico tools to support drug development, safety assessment, and regulatory submissions.
- OPERA modeling of physicochemical parameter
- Meteor Nexus to predict likely metabolites and metabolic pathways
- Integration with in vitro and in vivo experimental data to improve in silico predictions