Bioequivalence and Bioavailability Forum

Hi again,

❝ It's a pitty that we don't know a counter example.

❝ In my gut feeling there must be some! Remenber our discussion that Kinetica is Number three?

There are tons of studies evaluated with Kinetica. Usually CROs write that stuff on their homepage. But with the publications by the Dynamic Trio CROs seem to be less enthusiastic about mentioning Kinetica. And it does take some time to decide to buy another package.

❝ Any body out there used Kinetica in unbalanced studies? I promise you full anonymity .

Difficult for a CRO to come forward possibly? But Sponsors might if they had failed studies that could be potentially passing?! Remains to be seen.
Couldn't it be simulated? I think we know the equations used normally and by TFS. We could simulate some scenarios and count the frequency by which the wrong decision is taken. I could write this stuff in a few days. You could probably do it quicker. But I have no good idea on how to use the result?

❝ ElMaestro: Let us be informed if you could identify some "Why's". Scientifically!

I like the idea but must admit I simply don't know how to get answers to those why's. I feel I am not well-connected to the extent that I can ask.

❝ Some insight from Helmut's presentation in Prague?

Helmut's talk was about validation and served as great inspiration. It did not touch so much on Kinetica but contained a wealth of other info.

While we are at it:
When I audit CROs I often ask if they rely on automated IQ/OP/PQ. They usually say they validate formally with a plan and approvals and signatures and coffee and cake and IQ/OQ/PQ scripts. When I ask them if they have checked if some of those scripts contain anything relevant to BE the answer is no. Always.
You can look up in ICH E6 that software must perform for the intended purpose (clause 5.5.3.)
If you buy a pair of shoes you check that they fit your feet, right?