Bioequivalence and Bioavailability Forum • How to show similarity if solubility is low?

How to show similarity if solubility is low? [Dissolution / BCS / IVIVC]

posted by Dr_Dan – Germany, 2015-03-17 17:28 (3320 d 12:57 ago) – Posting: # 14572
Views: 10,164

Dear all
How can I show similarity for a formulation of a BCS class IV substance if dissolution testing shows that at pH x and pH y only 5 to 10% is dissolved from a formulation within 45 min.? The BE-Guideline does not describe this situation and f2 value calculation is not possible. Any idea?
Looking forward to your replies.
Kind regards
Dr_Dan

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Kind regards and have a nice day
Dr_Dan

Complete thread:

How to show similarity if solubility is low?Dr_Dan 2015-03-17 16:28 [Dissolution / BCS / IVIVC]
- How to show similarity if solubility is low? nobody 2015-03-17 16:37
- How to show similarity if solubility is low? luvblooms 2015-03-19 09:42
  - How to show similarity if solubility is low? ElMaestro 2015-03-19 10:07
    - How to show similarity if solubility is low? luvblooms 2015-03-20 04:26
- How to show similarity if solubility is low? nobody 2015-03-19 11:00
  - How to show similarity if solubility is low? luvblooms 2015-03-20 04:34
    - How to show similarity if solubility is low? Dr_Dan 2015-03-23 09:14