Bioequivalence and Bioavailability Forum • locally acting / diss. similarity mandatory

locally acting / diss. similarity mandatory [Dissolution / BCS / IVIVC]

posted by Helmut – Vienna, Austria, 2017-06-25 14:48 (3276 d 14:00 ago) – Posting: # 17503
Views: 9,720

Hi Kiran,

❝ […] the thing is the dissolution method in which my generic product is faster is given in the FDA guidance and I am bound to meet f2 value w.r.t to that of the reference product.

❝

❝ One more thing is that the drug shows local action in the gut so invitro profile is more relevant to show comparison with that of the reference product.

OK, if you are bound to one of the FDA’s guidance (e.g., mesalamine where additionally to fasting/fed BE dissolution similarity is mandatory), there is nothing you can do. Find another supplier of the API.

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Helmut Schütz

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Complete thread:

Dissolution profie matching Kiran 2017-06-24 18:25
- in vivo data before tweaking in vitro Helmut 2017-06-24 19:30
  - in vivo data before tweaking in vitro Kiran 2017-06-24 20:19
    - locally acting / diss. similarity mandatoryHelmut 2017-06-25 12:48
      - locally acting / diss. similarity mandatory Kiran 2017-06-25 16:40
- Dissolution profie matching ElMaestro 2017-06-25 20:21
  - Dissolution profie matching Kiran 2017-06-26 05:11