Bioequivalence and Bioavailability Forum

Dear All,

For Product X (IR tablets), full replicated BE study was performed on 56 volunteers under fasting state (EU submission).

When data for first half subjects (N: 28) was analysed, we got following results.
Cmax ratio: 87 (CI: 80.88-95.13)
AUC ratio: 87 (CI: 81.85-94.18)

Analysis of full data set (N: 56)
Cmax ratio: 84.32 (CI: 79.89-89.00)
AUC ratio: 86.9 (CI: 83.02-90.96)

%ISCV Cmax: 25
%ISCV AUC: 20
Power ~100
No outlier detected.

Is there any possibility to get through by any means or study to be repeated?
Or we should go ahead with the reformulation??
PROC GLM is used for stat calculation

Kindly advice.
Thanks!

Regards,
Samaya.

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Edit: Category changed. [Helmut]