Bioequivalence and Bioavailability Forum

Hi everyone,

Suppose you run a 4-way crossover study for IVIVC development. The treatments are 3 Test ER formulations with different release rates and an IR Tablet. The dose of the IR is lower than the test formulations due to safety issues. When you carry out the IVIVC development, you normalize the IR dose to that of the test ER formulations assuming the kinetic is linear.

Question...What if AUC from the IR after dose normalization, is smaller than the AUC from the 3 test formulations? Can you still do an IVIVC? If you try to generate in-vivo absorption profiles of the ER based on deconvolution using the IR data to serve as the unit impulse function, then the in-vivo absorption profile would go beyond 100%.

Thanks,
John