Bio-waiver for Pregabalin Capsules [Dissolution / BCS / IVIVC]

posted by Maitri – India, 2017-11-16 12:41 (2643 d 07:01 ago) – Posting: # 17984
Views: 6,903

❝ In few cases FDA has not at all accepted the published literature information (even the Clinical Pharmacology and biopharmaceutics data of Inovator) so one need to be very cautious about that.


Dear luvblooms,

Can you just mentioned the few probable reasons for not accepting the published literature information? If the Clinical Pharmacology and biopharmaceutics data of Innovator clearly demonstrated a validated permeability study conducted using all the standards (low permeable, moderate permeable, high permeable, zero permeable) will it be acceptable in your opinion? :confused:

Thank You in advance! :-)
Maitri


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
23,379 posts in 4,913 threads, 1,661 registered users;
254 visitors (0 registered, 254 guests [including 16 identified bots]).
Forum time: 19:43 CET (Europe/Vienna)

Science is what you know.
Philosophy is what you don’t know.    Bertrand Russell

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