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

posted by Mithu – India, 2019-10-23 09:21 (492 d 13:52 ago) – Posting: # 20716
Views: 1,831

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
21,357 posts in 4,459 threads, 1,492 registered users;
online 7 (0 registered, 7 guests [including 3 identified bots]).
Forum time: Friday 22:13 CET (Europe/Vienna)

Those who make no mistakes are making the biggest mistakes of all 
they are attempting nothing new.    Anthony de Mello

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