Bioequivalence and Bioavailability Forum • Solubility based Biowaiver

Solubility based Biowaiver [Dissolution / BCS / IVIVC]

posted by The Outlaw Torn – Europe, 2018-10-02 10:56 (2170 d 08:13 ago) – Posting: # 19359
Views: 6,510

Do as others have said, Amalia.

Follow section 4.2 of the Guideline. When it points you to appendix III, ignore the BCS-biowaiver stuff. Focus on the first third of the information on page 27 only (about experimental conditions). In other words, don't think BCS or solubility or permeability or API or anything else. Do the standard comparative dissolution testing at 3 pH values for your finished drug product at all strengths, etc.

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 Biowaiver Amalia 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 BiowaiverThe Outlaw Torn 2018-10-02 08:56
- Solubility based Biowaiver lukamar 2018-10-05 09:30