Bio Batch Size [Design Issues]

posted by Imadov – Saudi Arabia, 2019-05-11 09:43  – Posting: # 20278
Views: 1,827

» 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


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]

Complete thread:

Activity
 Admin contact
20,793 posts in 4,353 threads, 1,445 registered users;
online 5 (0 registered, 5 guests [including 3 identified bots]).
Forum time: 18:20 UTC (Europe/Vienna)

Genius is that which forces
the inertia of humanity to learn.    Henri Bergson

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5