Diclofenac Potassium Powder for Oral Solution [Regulatives / Guidelines]

posted by Ahmed Al Habashi – UAE, 2014-08-16 05:08 (2438 d 00:39 ago) – Posting: # 13394
Views: 5,199

I would like to get your advice on the following important matter:

I have received a query from one of MOHs requesting us to justify the absence of BE study for our product “Diclofenac Potassium Powder for Oral Solution” due to presence of Mannitol (890 mg) in the formula.

They mentioned that as per the European BE guidelines, we must conduct a BE study for this product.

Hence, I request you to kindly share your experience related to this matter.

Your response will be highly appreciated.

Complete thread:

 Admin contact
21,419 posts in 4,475 threads, 1,510 registered users;
online 11 (0 registered, 11 guests [including 4 identified bots]).
Forum time: Monday 05:47 UTC (Europe/Vienna)

There is one certainty in drug development
and statistics that one can depend on:
the data are always late.    Scott Patterson and Byron Jones

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