Bioequivalence and Bioavailability Forum

Dear Luvblooms

❝ "An open label, balanced, randomized, Four-treatment, four-period, four-sequence, single oral dose, four way crossover bioequivalence study of four formulations of XXX extended release tablets in healthy, adult, human subjects under fasting conditions."

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❝ In the study, we will be using 3 test formulation, with slow, medium and fast release against reference product.

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❝ Whether this design is sufficient enough for IVIVC?

Yes, for Unit impulse response (UIR) calculation, one more arm with IR/IV is required. But data from literature or any previous study for IR/IV can also be used in calculations, if available.


Regards,
GSTATS