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The Pharsight validation package only checks whether or not the
WinNonlin has successfully been installed on your PC, that is, does it
operate as expected? Is the output as expected given the test data,
are the data filed as expected and are they accessible? It does not
validate whether or not the algorithms in WinNonlin are correct. The
FDA regards WinNonlin as an acceptable program (software) for PK
evaluation, all the user has to do is demonstrate that it works as
expected on your PC or central computer. The validation package
contains test data and automatically carries out the whole range of
functionalities available in WinNonlin. It is a very time consuming
and tedious job to do manually, and with each update you have to do it
again and for each new Laptop or PC you have to do it again.
It would be good to know the FDA's view on the use of the validation
package, does anyone have any information on that?
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