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

posted by Mithu – India, 2019-10-23 11:21 (1587 d 08:24 ago) – Posting: # 20716
Views: 2,413

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
22,912 posts in 4,806 threads, 1,635 registered users;
22 visitors (1 registered, 21 guests [including 4 identified bots]).
Forum time: 18:46 CET (Europe/Vienna)

[…] an inappropriate study design is incapable of answering
a research question, no matter how careful the subsequent
methodology, conduct, analysis, and interpretation:
Flawless execution of a flawed design achieves nothing worthwhile.    J. Rick Turner

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