Bioequivalence and Bioavailability Forum • Solubility based Biowaiver

Solubility based Biowaiver [Dissolution / BCS / IVIVC]

posted by wienui – Germany/Oman, 2018-10-02 06:52 (2026 d 23:45 ago) – Posting: # 19358
Views: 6,012

Dear Amalia & Scopy,

I agree with Scopy only an important point to mention that the dissolution tests of the lower strength must be conducted against the same Biobatch (the batch which approved via BE study) of the higher strength, otherwise it will not be accepted from the regulatory.

Best regards,

Osama

—
Cheers,
Osama

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