inter-batch variability? [Regulatives / Guidelines]

posted by Pavidus – 2010-08-04 13:57 (4955 d 06:07 ago) – Posting: # 5714
Views: 15,106

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:

UA Flag
 Admin contact
22,912 posts in 4,806 threads, 1,636 registered users;
22 visitors (0 registered, 22 guests [including 11 identified bots]).
Forum time: 19:04 CET (Europe/Vienna)

It is the peculiar and perpetual error of the human understanding
to be more moved and excited by affirmatives than negatives.    Francis Bacon

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