Edited by weidsoncs, 03 September 2018 - 07:31 PM.
Undersand more kit ivivc logicimput target formulation
Posted 03 September 2018 - 02:58 PM
Posted 03 September 2018 - 03:10 PM
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.
PS might be useful to watch a few of the IVIVC webinars on the Certara channel.
Posted 03 September 2018 - 06:28 PM
Posted 19 September 2018 - 12:06 PM
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.
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