Bioequivalence and Bioavailability Forum

Dear All

Regards

We are planning for an IVIVC study for a Extended release formulation of BCS class I drug.

And the designed what we are thinking of is like this

"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."

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

Whether this design is sufficient enough for IVIVC?
Or we have to add one more arm (Oral solution/IV) as Internal validation?

Kindly help me out!!



Luv