Corrections for Potency [Regulatives / Guidelines]

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

Hello

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.

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