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

posted by Mithu – India, 2019-10-23 09:21 (733 d 00:04 ago) – Posting: # 20716
Views: 2,063

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
21,756 posts in 4,548 threads, 1,544 registered users;
online 10 (1 registered, 9 guests [including 4 identified bots]).
Forum time: Monday 09:26 CEST (Europe/Vienna)

The plural of anecdote is data.    Raymond Wolfinger

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