Bioequivalence and Bioavailability Forum

Are there exact requirments from the batch that is submitted to bio-equivalence studies?
concerning:
1. Stability data before study takes palce
2. stability data after study completed
3. does one required to show (or include in the registration file in EU ) comperative dissolution profile (with reference) in various mediums (in immidiate release)?
4. What can be done if bio batch does not meet sepc after study is finished , but additional batches of the same formulation does meet specifications?

These are issues we are struggeling in the company and we wonder what will the authorities in EU will required once the drug will be submitted with the BE studies documentation