Corrections for Potency [Regulatives / Guidelines]

posted by Shatha – 2022-03-20 15:51 (254 d 16:53 ago) – Posting: # 22844
Views: 925


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
22,418 posts in 4,693 threads, 1,598 registered users;
14 visitors (0 registered, 14 guests [including 9 identified bots]).
Forum time: 08:44 CET (Europe/Vienna)

Intellect distinguishes between the possible and the impossible;
reason distinguishes between the sensible and the senseless.
Even the possible can be senseless.    Max Born

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