SUPAC level 3 changes for MR formulations [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-10-22 21:31 (264 d 16:35 ago) – Posting: # 20715
Views: 1,338

Hi,

» 1. IR product if we change the manufacturing site, do we need to perform BE study as suggested in SUPAC guidance for IR? or it would be okay to justify based on in vitro data?

Did you read the SUPAC guidance for IR?

» 2. For MR product SUPAC MR guidance is not clear for any requirement of conducting BE study. where as we do perform Fasting for such changes in manufacturing site change. are we doing correct?

I dont follow. Are you asking if the study should be a fasted study?

J

Complete thread:

Activity
 Admin contact
20,827 posts in 4,358 threads, 1,449 registered users;
online 31 (3 registered, 28 guests [including 19 identified bots]).
Forum time: 14:06 CEST (Europe/Vienna)

The analysis of variance is not a mathematical theorem,
but rather a convenient method of arranging the arithmetic.    R.A. Fisher

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