Corrections for Potency [Regulatives / Guidelines]

posted by Shatha – 2022-03-20 14:51 (68 d 02:04 ago) – Posting: # 22844
Views: 618


My question is related to Health Canada guidance for industry: Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part B: Oral Modified Release Formulations:

For the data mentioned in Table 11-T, I performed the potency correction calculations for Cmax and AUCT.
The results were identical except for Cmax 90% CI Upper limit (my calculations: 91%, guidance: 99%). I think that the value " 99%" isn't correct in the guidance itself.

Any feedback on this issue, please.

The calculations related to uncorrected data were identical to table 11-L and 11-I.

Thank you.

Complete thread:

UA Flag
 Admin contact
22,108 posts in 4,630 threads, 1,567 registered users;
online 8 (0 registered, 8 guests [including 5 identified bots]).
Forum time: Friday 17:55 CEST (Europe/Vienna)

We absolutely must leave room for doubt
or there is no progress and no learning.
There is no learning without having to pose a question.
And a question requires doubt.
People search for certainty.
But there is no certainty.    Richard Feynman

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz