Bioequivalence and Bioavailability Forum • in vivo first

in vivo first [Software]

posted by jag009 – NJ, 2012-10-06 00:51 (5007 d 11:38 ago) – Posting: # 9322
Views: 9,508

Hi Sam

❝ If I understand you in right way then I think that Target formulation is the previously approved formulation or the formulation for which I have to show the bioequivalent to the reference (for ANDA).

Correct

❝ For the External validation the data from a formulation which will be not involved in developing the IVIVC model to test the IVIVC model for its predictability. So tell me from where I can this data, means I have to run this separate batch or I can the data from internet.

Yes, meaning you need another batch. You can't just grab something from the internet. For example, you vary the coating (alter the release rate) to generate 4 formulations, 3 of them you use for IVIVC, the 4th one for validation.

From the book, "The ideal situation is that the formulations not used in the model development should be different enough in release rate to appropriately evalute the predictability of the model."¹

_{1. Young D, Devane JG, Butler J. In Vitro-In VIvo Corrlations. Advance in Experimental and Medicine and Biology, Vol 423, page 89.}

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 Toolkit jag009 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 firstjag009 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