Bio Batch Size [Design Issues]

posted by Imadov – Saudi Arabia, 2019-05-11 11:43 (619 d 20:57 ago) – Posting: # 20278
Views: 2,389

» 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 ?


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]

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