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duplicating the data


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#1 shikha rawat

shikha rawat

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Posted 08 August 2012 - 06:09 AM

dear all forum members,

Aim is to predict the PK data of my test product (2)(T2).I have the in vivo as well as in vitro data for my test(1)(T) & innovator product ®. I had taken both the test as well as the innovator data in the internal field but since i wanted to take the innovator data in the reference field for generating UIR i duplicated the innovator data set and named it as R1. Now i am able to run the model successfully.

My doubt is whether this approach is correct ?
& how can i predict the in vivo data for my test(2).? should i use the correlation plot output (Fdiss vs F abs ,r-square 0.98 and slope 1.2529 ) ,is this the classical plot we get when we do regression analysis in any other software ? i tried using the prediction option but got an error message .

regards
stats 06

#2 Simon Davis

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Posted 08 August 2012 - 12:53 PM

I seem to remember seeing that it was recommended to use the innovator as an EXTERNAL reference, perhaps someone with more commercial/regulatory experience can comment?

 

The Levy plots you mention help you identify possible factors to incorporate into your Correlation model e.g. if the Tdiss and Tabs plot does not intercept at 0 you may have to introduce a lag,either form one of the built in models or in your own custom model.

 

If you got an error when trying the prediction tab, what was it - most likely you didn't map in a work sheet with your NEW formulation for which you only have dissolution data.

 

 Simon.






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