Bioequivalence and Bioavailability Forum • WinNonlin

WinNonlin – IVIVC Toolkit [Software]

posted by jag009 – NJ, 2012-10-03 18:06 (4992 d 01:49 ago) – Posting: # 9304
Views: 9,666

Hi Sam,

You need in-vivo data for each of the three batches.
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).

John

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 Toolkitjag009 2012-10-03 16:06
      - Proportionality-based biowaiver ≠ IVIVC Helmut 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