Invitro Be Studies (Phosphate And Bile Salt Binding Study)

Conventional BE studies do not allow to characterize the bioequivalence of Phosphate binding drugs. In view of the above facts, FDA has developed a set of In vitro BE guidelines for bile acid and phosphate binding drugs to compare the extent and rate of binding across Test and Reference formulations.

FDA has published guidance for the products e.g., Sevelamer carbonate tablets, Colesevelam HCl tablets, Cholestyramine PFOS, Ferric citrate tablets, Lanthanum Carbonate tablets, Calcium acetate tablets and Sucralfate solution.

FDA recommended the below mentioned studies for demonstrating the In vitro Bioequivalence

  • Kinetic binding study
  • Equilibrium binding study (Considered for the bioequivalence)

Data shall be presented with Langmuir calculation for binding constants

IVBE studies are governed by well-designed protocols as per the BE guidelines. All activities including dispensing of dosage units and retention of samples will be executed as per defined SOPs under a GMP environment