inter-batch variability? [Regulatives / Guidelines]

posted by Pavidus – 2010-08-04 11:57 (3965 d 02:38 ago) – Posting: # 5714
Views: 13,612

Dear Dr_Dan & all,

Allow me one general remark:
IMHO BE studies are definitely not suitable to assess inter-batch variability of any product.

I am not saying, that this remark will "save" your product .... discussion with 'assessors' is always difficult... :-(

(btw. nice figures for a highly-variable drug)

Kind regards, P.

Complete thread:

Activity
 Admin contact
21,518 posts in 4,498 threads, 1,523 registered users;
online 12 (0 registered, 12 guests [including 9 identified bots]).
Forum time: Saturday 14:36 CEST (Europe/Vienna)

If I find 10,000 ways something won’t work, I haven’t failed.
I am not discouraged, because every wrong attempt discarded
is another step forward.    Thomas Alva Edison

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