Bioequivalence and Bioavailability Forum • Solubility based Biowaiver

Solubility based Biowaiver [Dissolution / BCS / IVIVC]

posted by Amalia – Greece, 2018-10-02 12:35 (1641 d 18:11 ago) – Posting: # 19362
Views: 5,396

❝ Where is the difference coming from?

None of the excipients are proportional.

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

The API of the lowest strength is less than 5%. But not of the highest strength for which a BE study was performed.

❝ 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.

I Know. The most probable scenario is that we will perform a BE study. We are just trying to see if a justification can be made.

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! Please follow the Forum’s Policy. [Helmut]

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 BiowaiverAmalia 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