Bioequivalence and Bioavailability Forum 19:44 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Bio Batch Size [Design Issues]

posted by fedesalas - Costa Rica, 2018-09-12 17:46  - Posting: # 19279
Views: 436

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
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,855 posts in 4,020 threads, 1,269 registered users;
online 26 (0 registered, 26 guests [including 24 identified bots]).

We must be careful not to confuse data with the abstractions
we use to analyze them.    William James

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed