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

posted by jag009  – NJ, 2019-10-24 07:34 (2081 d 06:55 ago) – Posting: # 20717
Views: 3,547

Hi,

❝ ❝ Did you read the SUPAC guidance for IR?

❝ Yes.


Then you should know which level of SUPAC change requires a biostudy. It's in there.

❝ ❝ 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.


Fasting study is the one which SUPAC requires for a site change application.

J

Complete thread:

UA Flag
Activity
 Admin contact
23,427 posts in 4,929 threads, 1,684 registered users;
43 visitors (0 registered, 43 guests [including 13 identified bots]).
Forum time: 14:29 CEST (Europe/Vienna)

In the field of observation,
chance favors only the mind that is prepared.    Louis Pasteur

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