Drug Metabolism and PharmacoKinetics Services

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 PropertiesPermeabilityP-gp Substrate and inhibition potentialMetabolic StabilityPlasma Protein Binding
Tissue Homogenate bindingCYP Reaction PhenotypingMetabolite IdentificationDrug-Drug InteractionCytotoxicity

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