Bioequivalence and Bioavailability Forum • Diclofenac Potassium Powder for Oral Solution

Diclofenac Potassium Powder for Oral Solution [Regulatives / Guidelines]

posted by Ahmed Al Habashi – UAE, 2014-08-16 09:08 (3535 d 02:32 ago) – Posting: # 13394
Views: 6,277

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:

Diclofenac Potassium Powder for Oral SolutionAhmed Al Habashi 2014-08-16 07:08 [Regulatives / Guidelines]
- Diclofenac Potassium Powder for Oral Solution Dr_Dan 2014-08-16 09:47
  - Diclofenac Potassium Powder for Oral Solution Helmut 2014-08-16 13:00
    - Diclofenac Potassium Powder for Oral Solution mayur661 2018-11-16 09:02
      - Diclofenac Potassium Powder for Oral Solution Ohlbe 2018-11-16 10:01
        
        Diclofenac Potassium Powder for Oral Solution mayur661 2018-11-16 10:08
        
        Fasting and fed Ohlbe 2018-11-16 12:09
        
        Fasting and fed mayur661 2018-11-16 12:27