Bio Batch Size [Design Issues]

posted by fedesalas – Costa Rica, 2018-09-12 17:46 (949 d 18:23 ago) – Posting: # 19279
Views: 3,905

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?

Complete thread:

Activity
 Admin contact
21,419 posts in 4,475 threads, 1,510 registered users;
online 5 (0 registered, 5 guests [including 1 identified bots]).
Forum time: Monday 12:10 CEST (Europe/Vienna)

There is one certainty in drug development
and statistics that one can depend on:
the data are always late.    Scott Patterson and Byron Jones

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