Bioequivalence and Bioavailability Forum • Solubility based Biowaiver

Solubility based Biowaiver [Dissolution / BCS / IVIVC]

posted by Amalia – Greece, 2018-10-02 08:59 (1089 d 21:34 ago) – Posting: # 19360
Views: 4,841

Dear Obinoscopy,

what I guess I should have clarified is that the reason we are trying to use this justification is because the lower strength is not proportional in terms of excipients.

» The advise was given by an "external clinical expert".

I presume this is why we were advised to follow the solubility path for a biowaiver? That is why we are wondering whether we should perform the solubility tests at the API or the final formulation.
What do you think?

Kind Regards,

Amalia

Complete thread:

Solubility based Biowaiver Amalia 2018-10-01 11:04 [Dissolution / BCS / IVIVC]
- Solubility based Biowaiver Obinoscopy 2018-10-01 15:03
  - Solubility based Biowaiver Amalia 2018-10-01 15:59
    - Solubility based Biowaiver Obinoscopy 2018-10-01 19:05
      - Solubility based Biowaiver wienui 2018-10-02 04:52
      - Solubility based BiowaiverAmalia 2018-10-02 08:59
        
        Solubility based Biowaiver The Outlaw Torn 2018-10-02 09:51
        
        Solubility based Biowaiver Amalia 2018-10-02 10:35
        
        Solubility based Biowaiver Obinoscopy 2018-10-06 19:59
    - Solubility based Biowaiver The Outlaw Torn 2018-10-02 08:56
- Solubility based Biowaiver lukamar 2018-10-05 09:30