Diclofenac Potassium Powder for Oral Solution [Regulatives / Guidelines]

posted by Ahmed Al Habashi – UAE, 2014-08-16 07:08 (2594 d 21:29 ago) – Posting: # 13394
Views: 5,422

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.

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