Bioequivalence and Bioavailability Forum • Proportionality-based biowaiver ≠ IVIVC

Proportionality-based biowaiver ≠ IVIVC [Software]

posted by Helmut – Vienna, Austria, 2012-10-03 18:13 (5006 d 17:58 ago) – Posting: # 9305
Views: 9,824

Hi John & Sam,

❝ You want to claim biowaiver on the lower strength (5mg) with an IVIVC from 10mg? I don't think that is acceptable (not sure but others might have experience in this aspect).

No, that’s not acceptable. IVIVC is only applicable to MR formulations with identical strengths. A proportionality-based biowaiver is a different cup of tea.

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Complete thread:

WinNonlin – IVIVC Toolkit sam 2012-09-28 13:28
- WinNonlin – IVIVC Toolkit jag009 2012-10-01 17:41
  - WinNonlin – IVIVC Toolkit sam 2012-10-03 09:18
    - WinNonlin – IVIVC Toolkit jag009 2012-10-03 16:06
      - Proportionality-based biowaiver ≠ IVIVCHelmut 2012-10-03 16:13
- in vivo first Helmut 2012-10-03 15:46
  - in vivo first sam 2012-10-04 12:08
    - RTFM Helmut 2012-10-04 14:17
    - in vivo first jag009 2012-10-04 16:10
      - in vivo first sam 2012-10-05 07:32
        
        in vivo first jag009 2012-10-05 22:51
        
        in vivo first Helmut 2012-10-06 01:23
        
        in vivo first jag009 2012-10-08 18:13
        
        OT Helmut 2012-10-08 19:19