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RegisterCorrections for Potency [Regulatives / Guidelines]
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.
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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Ing. Helmut Schütz