Bioequivalence and Bioavailability Forum

Dear bharathi!

Only answering your first question (have to think about the others). Since you can justify an expected difference of more than 5% (ten batches of the reference documented) you can plan for a content-corrected BE assessment. Show also data of different batches of the test product to document content uniformity.
Covered by the GL Section 4.1.8:

“[…] in exceptional cases where a reference batch with an assay content differing less than 5% from test product cannot be found (see section 4.1.2) content correction could be accepted. If content correction is to be used, this should be pre-specified in the protocol and justified by inclusion of the results from the assay of the test and reference products in the protocol.”