Bioequivalence and Bioavailability Forum

Dear Hiren,

your #1 is correct. The study's sample size was calculated based on an assumed T/R-ratio (i.e, being able to demonstrate BE with a given power); you've got approval by the EC according to this assumption. If the T/R-ratio is not supported by the CoAs, the power will be lower.
Such a requirement is also reflected in EMA's current BE-guideline: formulations must not differ by more than 5 % in their actual contents.*

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* Unless a larger difference is justified: For some products it might not be possible to select from different reference batches, because at any given time there's just one on the market.