Bioequivalence and Bioavailability Forum • Solubility based Biowaiver

Solubility based Biowaiver [Dissolution / BCS / IVIVC]

posted by The Outlaw Torn – Europe, 2018-10-02 11:51 (2812 d 12:08 ago) – Posting: # 19361
Views: 9,311

❝ 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".

Where is the difference coming from?

Is the API less than 5% of the total weight of the tablet?

Take a look at the General biowaiver criteria on page 12 of the guideline. If you don't meet the conditions stated in c), you'll need to conduct a BE study at the lower strength too.

Complete thread:

Solubility based Biowaiver Amalia 2018-10-01 11:04
- 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 BiowaiverThe 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