Following the selection of preclinical candidates, Presude scientists can help you with a variety of in vitro and in vivo studies for DMPK, toxicity and bioanalytical validation.
DMPK
Solution Properties
- Solubility - Kinetic and Equilibrium
- Log D 7.4
- Chemical stability
- Protein binding
Drug Metabolism
- Metabolic stability (microsomes/S9)
- CYP450 inhibition
Transporters
- PAMPA
- Caco-2 permeation
- PgP binding
In Vivo PK
- Bioavailability
- Plasma-brain ratio
- Tissue Distribution
- Excretion
- Analysis in CSF (Rat)
Bioanalytical
- Method development and validation on HPLC/LC-MS/MS. Ability to achieve sensitivity upto picogram level.
- Bioanalytical support for GLP and regulated studies.
- Fit-for purpose method development for N-GLP analysis.
- Derivatization approach for poorly ionizable compounds.
- Quantitation of analyte/ metabolites indifferent matrices plasma, serum, blood etc.
- Method development in other matrices like urine, feces, bile, CSF, cell lysate and tissue homogenates.
- PD marker identification for small molecules (Target based approach).
- Development and validation of desired biomarkers for PK/PD
- Quantitation of marker compounds in plasma of animals administered with plant extract for PK parameter evaluation.
Metabolite Identification
- Metabolite generation using liver microsomes and plasma incubations
- Metabolite generation using protocols of metabolic stability in liver
- Microsomes and plasma stability at accelerated conditions
- Chromatographic optimization for separation of all metabolites
Toxicology
In Vivo Toxicity Studies
- Single Dose & MTD Range Finding Studies – Rat & Mice
- Genotoxicity
- Dermal Irritation Study
- Ocular Irritation Study
Managed at partner site
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