Bioequivalence and Bioavailability Forum

❝ The test product used in the study should be representative of the product to be marketed for oral solid forms for systemic action:

❝ The test product should usually originate from a batch of at least 1/10 of production scale or 100,000 units, whichever is greater, unless otherwise justified."

The question is :

If we prepare a Qty of granules of bio-batch equivalent to 100 000 finished product units and compress only about 30 % of the final blend of granules Qty ( means to get about 30 000 to 35 000 tablets without completing the compression stage with continuing the film coating and the other QC testing for the produced tablets )

Can we consider this compressed Qty as a representative batch and justified to be used in the Bio-Equivalency study ?

Thanks

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]