3 replies to this topic

[weidsoncs]

Dear all,

 

I am studying this tool for a possible purchase. So, I need help for understanding more kit ivivc logic.

 

In the dissolution data window (the first windon from ivivc kit) it is mentioned that the users should indicate the "target formulation" so that the predictions can be made with the dissolution data of the new formulations.

 

My question: From a theoretical and practical point of view how should I understand this "target formulation"? Is the innovator drug (defined by regulatory authorities as the reference drug) or is it the target formulation being developed?

 

In the example provided in the users folder I noticed that the data of the target formulation and the new test formulation data are exactly the same. This confused my mind. Is this information important in the process of creating the IVIVC model or is it only used at the end when the model is validated internally and externally?

Edited by weidsoncs, 03 September 2018 - 07:31 PM.

[Simon Davis]

Carlos - it would be the Innovator that is the Target.  Your 'test' will then try to match the innovator [Target].

 

And yes, you are correct the example is not 'real' and for simplicity in constructing this demonstration set, the test article e.g. what would correspond to your generic, has the same values as the innovator.  feel free to make a copy of this profile in the worksheet and change the name to e.g. Test2 and change the values a little.  Then you will see predicted profiles.

 

The 'test' data is only used in the final prediction step, it is not used in building the model or in internal or external validation.

 

 Simon

 

PS might be useful to watch a few of the IVIVC webinars on the Certara channel.

[weidsoncs]

Dear Simon,

 

 

 

Thank you very much for fast response!!!

 

I just have more a question: I can not understand why is it necessary provide dissolutions data of the target formulation since the dissolution data of the new test formulation is that will be convolve...

 

At what time are the dissolution data of the target formulation will be use in the workflow from ivivc kit? I have verified that the in vivo data of the target formulation being used to calculate AUC mean, Cmax mean and the error of the prediction of the new test formulation in relative the target formulation. However I can not understand what was the programmers's intention to request entry of dissolution data from the target formulation at begin the process. Could you coment this? Are these data important for generate the model ?

 

best regards

 

Weidson - matematician

[Simon Davis]

Dear Weidson,

   Apologies for the delay,

 

  You're correct that scientifically it should not be required to provide dissolution data of the target formulation since it is the dissolution data of the new test formulation is that will be convolved.

 

   However it's just the way the IVIVC toolkit has been written and there are a few areas where the internal crosschecks are perhaps not the most logical. 

 

  Another example would be that when you get to the Predict PK option, if there is no Target in Dissolution, you will not be able to proceed further.  It should be looking at the In Vivo data instead it reads the Formulation  name from In Vitro data

sheet.   This is noted and when we next update the IVIVC we will look to streamline some of these requirements, in the mean time you cna supply a dummy profile if you don't have real data in order to proceed.

 

  Simon