Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

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

posted by Mithu – India, 2019-10-23 09:21 – Posting: # 20716
Views: 271

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:

SUPAC level 3 changes for MR formulations Mithu 2019-09-30 07:42 [Regulatives / Guidelines]
- SUPAC level 3 changes for MR formulations jag009 2019-10-22 21:31
  - SUPAC level 3 changes for MR formulations Mithu 2019-10-23 09:21
    - SUPAC level 3 changes for MR formulations jag009 2019-10-24 05:34

Bioequivalence and Bioavailability Forum | Admin contact
19,977 posts in 4,228 threads, 1,373 registered users;
online 6 (0 registered, 6 guests [including 5 identified bots]).
Forum time (Europe/Vienna): 15:53 CET

The fundamental cause of trouble in the world today is
that the stupid are cocksure
while the intelligent are full of doubt. Bertrand Russell

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC

Ing. Helmut Schütz