Bioequivalence and Bioavailability Forum

Hi Helmut and Ohlbe,

❝ Yes, but it must be clear that here BE is based on a more tough assumption. Genrally (well, outside of Canada) we are not allowed to perform a dose-correction at the same strengths even if we know that actual contents differ.

Actually, the latest Canadian draft guidance (Jan 2010, line 84) implies removal of the dose correction and the inclusion of the 5% similarity requirement (like the rest of the world!) - not sure when the final will be released.

❝ Hhm, but how? If we dose-normalize your example we get e.g. 90.00-111.11%. If we don’t normalize, we get 112.50–138.89%.

I was thinking of the case where the sponsor wants to show their formulation (eg: 10 mg capsule) is bioequivalent to another formulation of different strength (eg: 8 mg tablet). Here, dose normalization would not be necessary because we actually want to show the capsule of this strength is BE to the tablet. Moreover, it would not be appropriate since different formulations = potentially diff f.


sciguy