Bioequivalence and Bioavailability Forum

Hi Lucas,

❝ […] they may lose market due to that. I do think Phoenix is a great software for BA/BE and use it now for many years, but IMHO this is a very risky strategy for them.

Agree. I use it since the DOS-version (PCNONLIN 1) back in 1986 and WinNonlin 1 (1998). The license-fee increased expo­nentially (I have no earlier data in my files: from USD 949 in 2004 to 2,444 this year).

Even if I take the US’ inflation into account that’s +7.2% / year. Nice business model. Maybe I should seriously reconsider my consultancy fees…

❝ […] And also, don't know how they'll account for the studies conducted, …

I guess small CROs – which will not jump ship – will opt for the lowest fee (still an amazing cost increase of 75% from the 2014 fee of 2,254 USD). Then what?

[…] you will be asked to submit a certification document to reconcile the # of actual studies completed to those you purchased.

A “certification document”? Oh yes, I performed 100, but state 5. Will Certara hire a private dick sneaking into my office and check? C’mon! Or is there a hidden counter in the software which phones home every time I execute a workflow?

❝ … but CROs sometimes uses the software with investigational non commercial purposes... I wonder if those will count.

Yep. I regularly recalculate stuff posted here (~10/year). Apart from Pharsight’s employees I’m the top-poster in Certara’s Phoenix-Forum. Similar over there. Shall I pay for sumfink I do in my spare time at no costs? Gimme a break!

❝ May be time to improve my R "almost non-existing" skills!

Why not? Many companies use PHX/WNL for NCA only (and run the stats in SAS). Package bear is an alternative for NCA in R.
Have your heard about RapidNCA? Seems that only the bloody linear trapezoidal method is implemented.