PRECLINICAL STUDIES

ADME

ADME studies are conducted to examine the Absorption, Distribution, Metabolism, and Excretion of new chemical entities that have been radiolabeled with either 14C or 3H.

  • Mass balance (collection of excreta)
  • Pulmonary excretion.
  • Blood and plasma kinetics.
  • Biliary excretion.
  • Enterohepatic recirculation.
  • Tissue distribution.
  • Protein binding.

Eurofins ADME BIOANALYSES has experience on multiple routes of administration, both routine (e.g., oral gavage) and non-routine (e.g.,sublin in single or multiple dosing).

Toxicokinetics

Systemic exposure during toxicology studies:

  • Bioanalytical method development and validation (according to FDA and EMA Guidelines)
  • Bioanalysis (GLP when appropriate)
  • Toxicokinetic parameters calculation and interpretation using fully validated software
  • Extrapolation to predict First-In-Man dosage

Benefits:

  • Strong expertise in bioanalysis and DMPK regulation
  • Advice in case of unexpected DMPK results

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