Fasting and fed [Regulatives / Guidelines]

posted by Ohlbe – France, 2018-11-16 12:09 (744 d 23:40 ago) – Posting: # 19639
Views: 2,399

Dear Mayur,

» As per these statements we are going for only fasting BE study. Please provide opinion on this topic.

The draft guidances for diclofenac capsules and diclofenac potassium capsules both recommend to do fasting and fed studies. Only doing a fasting study for your powder for oral solution could be risky. I would suggest to initiate a controlled correspondence with the FDA.

Regards
Ohlbe

Complete thread:

Activity
 Admin contact
21,223 posts in 4,427 threads, 1,481 registered users;
online 21 (1 registered, 20 guests [including 15 identified bots]).
Forum time: Monday 11:50 CET (Europe/Vienna)

It’s difficult to work in a group
when you are omnipotent.    John de Lancie (as Q)

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