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

posted by Mithu – India, 2019-10-23 09:21 (976 d 03:17 ago) – Posting: # 20716
Views: 2,185

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:

UA Flag
Activity
 Admin contact
22,165 posts in 4,645 threads, 1,572 registered users;
online 4 (0 registered, 4 guests [including 2 identified bots]).
Forum time: Saturday 12:39 CEST (Europe/Vienna)

Absolute certainty is a privilege of uneducated minds  and fanatics.
It is, for scientific folk, an unattainable ideal.    Cassius J. Keyser

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