Bioequivalence and Bioavailability Forum

Dear All,

I had done my home work prior to this post.

We refer the data from product monographs available in this website http://webprod5.hc-sc.gc.ca/dpd-bdpp/ while preparing protocols for canadian submissions. I had observed that the health canada accepted the generic submissions even though the results are outside the normal BE limits(i.e. 80-125%).

For eg. Nabilone and Omeprazole,

Omeprazole Cmax 90% CI are -71.93 to 121.63 % http://webprod5.hc-sc.gc.ca/dpd-bdpp/info.do?code=79591&lang=eng
and the limits are out side the 80 - 125%.

Nabilone Cmax 90 % CI are 77.56 - 100.45%, http://webprod5.hc-sc.gc.ca/dpd-bdpp/info.do?code=87819&lang=eng

I had gone through the canadian guidelines (1992 to till date) to maximum extent; in any of them i haven't found that the BE limits can be exapanded in certain cases or for some products or a related sentence for acceptability beyond the normal limits.

Can any one let me know what could be the possible reason for accepting the generics which were not in BE limits with the reference product?

Regards,
Naveen Kumar.SR