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

posted by Mithu – India, 2019-10-23 07:21  – Posting: # 20716
Views: 1,288

Hi,

» Did you read the SUPAC guidance for IR?

Yes.

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

Yes. If you see guidance for Food effect, under SUPAC title (for site change), states fasting study is needed and fed generally not needed.

Regards,

Mithu

Complete thread:

Activity
 Admin contact
20,778 posts in 4,351 threads, 1,444 registered users;
online 24 (0 registered, 24 guests [including 14 identified bots]).
Forum time: 08:39 UTC (Europe/Vienna)

All we know about the world teaches us that the effects of A and B
are always different—in some decimal place—for any A and B.
Thus asking “are the effects different?” is foolish.    John W. Tukey

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