Fasting and fed [Regulatives / Guidelines]

posted by Ohlbe – France, 2018-11-16 12:09 (1038 d 05:56 ago) – Posting: # 19639
Views: 2,808

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
21,691 posts in 4,534 threads, 1,541 registered users;
online 5 (0 registered, 5 guests [including 5 identified bots]).
Forum time: Sunday 19:05 CEST (Europe/Vienna)

If you want to get people to believe
something really, really stupid,
just stick a number on it.    Charles Seife

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