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Hi Sam,
Don't bother with how Pharsight selects CR01, CR02, CR03, CR04 for their IVIVC example... It is just an example. Target formulation is your target formulation, you know... Formulation which is bioequivalent to the reference (for ANDA).
In short, internal validation means to determine the predictability of the IVIVC model by testing it with data that was used in its development: The Fast, Medium, slow formulation data.
External validation means you use data from a formulation which is not involved in developing the IVIVC model to test the IVIVC model for its predictability.
In both validation, the predictability is to compare the IVIVC predicted in-vivo profile to the observed (real data) in-vivo profile. Comparison is based on AUC and Cmax. Refer to FDA guidance for predictability formula and criteria.
See if you can get access to a book "In-vitro In-vivo correlatons" written by Young, Devane and Butler. Read that book and you will have all your answers.
Almost forgot, Pharsight gives online webinar demonstration of their IVIVC software. Contact Pharsight for their next demo and you will get most of your answers there.
John
Don't bother with how Pharsight selects CR01, CR02, CR03, CR04 for their IVIVC example... It is just an example. Target formulation is your target formulation, you know... Formulation which is bioequivalent to the reference (for ANDA).
In short, internal validation means to determine the predictability of the IVIVC model by testing it with data that was used in its development: The Fast, Medium, slow formulation data.
External validation means you use data from a formulation which is not involved in developing the IVIVC model to test the IVIVC model for its predictability.
In both validation, the predictability is to compare the IVIVC predicted in-vivo profile to the observed (real data) in-vivo profile. Comparison is based on AUC and Cmax. Refer to FDA guidance for predictability formula and criteria.
See if you can get access to a book "In-vitro In-vivo correlatons" written by Young, Devane and Butler. Read that book and you will have all your answers.
Almost forgot, Pharsight gives online webinar demonstration of their IVIVC software. Contact Pharsight for their next demo and you will get most of your answers there.
John
Complete thread:
- WinNonlin – IVIVC Toolkit sam 2012-09-28 13:28
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
- WinNonlin – IVIVC Toolkit jag009 2012-10-03 16:06
- WinNonlin – IVIVC Toolkit sam 2012-10-03 09:18
- 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 firstjag009 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
- in vivo first jag009 2012-10-08 18:13
- in vivo first Helmut 2012-10-06 01:23
- in vivo first jag009 2012-10-05 22:51
- in vivo first sam 2012-10-05 07:32
- in vivo first sam 2012-10-04 12:08
- WinNonlin – IVIVC Toolkit jag009 2012-10-01 17:41
Ing. Helmut Schütz