GoingToMeet

In vitro-in vivo correlations and the parameters that should be correlated are defined, as well as conditions that must be met before attempting to establish correlations and their place in drug development are discussed and illustrated by examples. Correlations are examined from a biopharmaceutical point of view and their application for dissolution limits and as an in vivo experimental surrogate are also compared between US and EU.

Overview of In Vitro & In Vivo Methods

• Biopharmaceutical approach, BCS (Biopharmaceutical Classification System), permeability-solubility
• In Vitro methods to access permeability and dissolution: apparatus, media
• Establishment of in vivo studies, calculation of Pharmacokinetics and dissolution parameters
• How to access pharmacokinetic parameters and in vivo dissolution/absorption curves : Deconvolution, Wagner- Nelson, PK parameters, Limits and use