Bioequivalence and Bioavailability Forum

Dear Raja, Jaime,

I would just like to qualify your comment as an 'individual'.

❝ I would not rely on the validation kit provided by Pharsight (see here about the 2×2=5 problem).

Firstly to my knowledge there is not an error where 2x2 = 5, in WNL or VS; I think Helmut's point is that if you use the Validation Suite and IF there were actual calculation errors in the Reference sets then these would not be identified. I think this would be a common problem of Vendor supplied Validation kits, however I would stress that Pharsight takes considerable care to validate the original calculations against other Software for consistency and quality before either product is released.

However many of our users have requested a Validation Suite to assist in speeding up their IQ etc. so that is what we have provided. I would state that the next version which will run against Phoenix has several enhancements including continuously monitoring the installation files to ensure they have not be been changed, even after the actual Validation run has been executed.

I would certainly concur with Jaime that I would write in my own Validation plan my assumptions about using Validation Suite and state those extra checks that I might consider necessary to reassure myself that in a reasonable risk-based approach these are sufficient.

If you feel this is a conversation that would be useful with other Pharsight software users then I recommend discussing it on http://www.pharsight.com/extranet as discussed in my post last month.

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Edit: URL linked. [Helmut]