Bioequivalence and Bioavailability Forum

Dear all,

Could you guide me regards the biostudy design for Rivastigmine 6.0 mg capsules. It has some complicating factors. The FDA has no draft recommendations. It shows linear pharmacokinetics up to 3 mg BID, but is non-linear at higher doses. The innovator has conduted the bioavailabiltiy study upto 3.0 mg stating that it is very dangerous to conduct study with higher dose of 6 mg. So should I use patients for determining the bioequivalence. Alternatively should I do it at 3.0 mg and submit biowaiver for 6.0 mg. I want to have a EU submission. Please suggest

Regards,
Venkat