Bioequivalence and Bioavailability Forum

Hi,
Can anybody clarify me about Health Canada regulations for below.

1) if we do group study (two groups) is it required to report group effect
2) how to proceed for any subject if predose concentrations are present more than 5% of Cmax with respect to inclusion and exclusion in PK ans stat analysis
3) For if AUCinf 90& CI is failing (i.e. <80) will regulatort accepts the submission

as the above points are not clear in Health Canada guideline, kindly help me for the same.