Bioequivalence and Bioavailability Forum • in vivo first

in vivo first [Software]

posted by Helmut – Vienna, Austria, 2012-10-03 17:46 (4584 d 20:31 ago) – Posting: # 9303
Views: 8,142

Dear Sam!

❝ I have gone through the examples and manual guidance of the winnonlin. From there I did practice on their provided data. But I am bit confused …

Consider registering at Pharsight’s Extranet and post your question there.

❝ I have three batches with invitro data and one invivo data batches.

❝ I have IR profile to generate UIR.

To establish an IVIVC you need in vivo data for all (!) batches. This seems not to be case. As Jean Michel always preaches, start with in vivo and then (!) try to find in vitro conditions which are discriminatory/predictive. If your dissolution medium is Earl Grey tea with milk and sugar, fine.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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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 ≠ IVIVC Helmut 2012-10-03 16:13
- in vivo firstHelmut 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