Fasting and fed [Regulatives / Guidelines]

posted by Ohlbe – France, 2018-11-16 13:09 (2278 d 07:25 ago) – Posting: # 19639
Views: 4,128

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:

UA Flag
Activity
 Admin contact
23,379 posts in 4,913 threads, 1,661 registered users;
168 visitors (0 registered, 168 guests [including 12 identified bots]).
Forum time: 20:35 CET (Europe/Vienna)

Science is what you know.
Philosophy is what you don’t know.    Bertrand Russell

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