3 replies to this topic

[Umamaheshwar]

Dear Forum Members,

 

We have just purchased WinNonLin with and IVIVC Toolkit license. I am novice to the software. To establish correlation, i have in-vitro dissolution and corresponding in-vivo data of 3 formulations (tablets) and i want to predict the in-vivo behavior of the 4th formulation (also a tablet), for which i have the in-vitro data.

 

I would like to know if the available oral data is sufficient for using the IVIVC toolkit and to approximate the in-vivo behavior of 4th formulation.

 

I tried following the demo examples provided. However, it is confusing, in that the examples have the data on the IV route but we do not select the data while computing the values. Running the IVIVC software, gave error messages, even when i took utmost care to arrange the data in the similiar way as in the examples, but without IV data. So is the IV data mandatory to establish IVIVC. Please guide.

 

Best Regards,

 

Umamaheshwar

[Simon Davis]

Umamaheshwar wrote:

To establish correlation, i have in-vitro dissolution and corresponding in-vivo data of 3 formulations (tablets) and i want to predict the in-vivo behavior of the 4th formulation (also a tablet), for which i have the in-vitro data.

Umamaheshwar, Theoretically you have sufficient formulations to start to build your correlation.

The example uses IV as a reference, but in the correlation tab you can set one of your oral formulations e.g. innovator as a reference if you prefer, but make sure you set the reference type correctly.

It is mandatory to have some reference set so that the program can deconvolve that profile to get the UIR, IV bolus is typically the 'gold standard' reference, then infusion, then oral solution, immediate release etc. The reason being that if you have an oral reference it's harder to get a 'pure' estimate of elimination.

If you still have a problem with how your data is set up then please Zip up the .IVC project and email the whole project including data files and settings to Support@pharsight.com together with your contact/ company details.

Best Regards,
Simon

[RosyMtz]

Dear SiI am novice to the software too. I try to run an IVIVC but i just have two ER formulations and a third one to predict. But when runs IVIVC, the software shows a error message for all the subjects at deconvolution.

 

Error occurred in processing.  See ASCII output file.
*** ERROR 10203 *** AN ERROR OCCURRED DURING CURVE STRIPPING.
*** ERROR 10201 *** INITIAL ESTIMATES CANNOT BE DETERMINED FOR THIS MODEL.

 

Please help me to find the error.

 

Best regards,

 

Rosy

Edited by RosyMtz, 23 August 2016 - 04:54 PM.

[Simon Davis]

Hi Rosy,  

 

  If you can post your project here or send it to support then we can guide you further.  In the IVIVC, you don't necessarily need your own IV formulation data but you will need some sort of Reference (perhaps literature) to have the UIR to perform the deconvolution. 

 

   If you are have a non-IV reference for this UIR you may also need to strip Ka and/or include a time lag

 

   Simon.

Edited by Simon Davis, 25 August 2016 - 10:55 AM.