Bioequivalence (BE) Studies for Small Molecules

Our DMPK and bioanalytical teams provide comprehensive solutions for assessing bioequivalence, from in vitro studies to human clinical trials. This can be provided as part of an integrated service with formulation development.

  • Classification of drug substance according to the BCS (Biopharmaceutics Classification System)
    • Solubility determination (USP)
    • Dissolution determination (USP)
    • in vitro intestinal permeability determination (Caco-2 cell model)
    • in vivo permeability determination (human mass balance PK and absolute bioavailability studies)
    • PK analysis by WinNonlin to support clinical BE studies
  • LC-MS/MS bioanalytical support for 2-period cross-over clinical designs for BE (bioequivalence)

 

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