Eurofins Advinus offers a wide range of DMPK services to support lead optimization and preclinical development. Eurofins Advinus capabilities and track record include:
Highly qualified scientists trained in premier universities in India and abroad
Performed over 500 PK studies, 5000 in vitro studies; supported over 200 Toxicology studies for regulated bioanalysis and toxicokinetics
Bioanalytical team has developed over 120 validated methods for NCEs, supported over 70+ complete IND packages
A list of the studies that can be performed are provided below:
In Vitro Assays:
Physiochemical Properties
Permeability
P-gp Substrate and inhibition potential
Metabolic Stability
Plasma Protein Binding
Tissue Homogenate binding
CYP Reaction Phenotyping
Metabolite Identification
Drug-Drug Interaction
Cytotoxicity
In Vivo PK Study Analysis:
Species (rodent and non-rodent*)
Absolute and relative bioavailability assessment
Cannulation techniques used: Jugular vein, femoral vein, carotid artery, portal vein and bile duct
Dosing techniques: IV, Oral, IM, SC, intranasal instillation, endotracheal intubation, dermal application, intradermal etc.
Brain penetration in vivo, supplemented with P-gp assessment in vitro
Validated WinNonlin Phoenix software is used for PK data analysis
*exclusive partner lab for in-life phase only
In-vivo-14-C-labeled-DMPK-Studies-in-rodents:
Mass Balance / Excretion balance
Tissue distribution
Ocular PK study in rabbits
Biliary excretion study
Metabolite profiling
Toxicokinetics:
Toxicokinetic data analysis and report preparation to support IND enabling studies
Allometric scaling: FIH dose projections and human PK predictions
Validated Phoenix WinNonlin software
Formulation Development for PK studies:
Development of solution formulation for IV and PO studies of low solubility lipophilic compounds for conduct of preclinical PK studies using
pH adjustment
Co-solvents
Inclusion complexes (cyclodextrins)
Attempts are made to achieve formulation using excipients acceptable for use in repeated dose studies
The prepared formulations are assessed for accuracy using HPLC or LC/MS/MS method
If necessary, salt forms or pro-drugs can be considered for improving the bioavailability of lead compound along with micronization of compound
Formulation Development and Validation and Sample Analysis for Toxicology studies:
Formulation method development and validation for preclinical dose formulation sample analysis
