Bioequivalence and Bioavailability Forum

Dear All,

I have a query regarding In-vitro study (Equilibrium binding & Kinetic binding). Equilibrium binding study is considered the pivotal bioequivalence study for FDA submission. As per FDA, drug content of test and reference product cannot differ from that of reference listed product by more than 5 percent. Is this criteria is applicable for in-vitro study? However, analytes to measure (in-vitro study) is unbound bile salts in filtrate.

Thanks
VM