Bio Batch Size [Design Issues]

posted by fedesalas – Costa Rica, 2018-09-12 17:46  – Posting: # 19279
Views: 852

Dear all,

The EMA says about the bio batch:

"Test product
The test product used in the study should be representative of the product to be marketed and this
should be discussed and justified by the applicant.
For example, for oral solid forms for systemic action:
a) 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."


But if the bio batch used in the BE study was lower than 100 000 tablets, in what way we can justify this?

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