Dear All,
We want to perform the deconvultion method for two way crossover study design, Its possible to perform in Phoenix WinNonlin 6.3, what are the minimum information is required and how to perform.
Please guide me.
Thanks
Dear Karthik, have you looked at the Deconvolution chapter in the Phoenix WinNonlin Examples guide page 116 in the 6.3 documentation. If you can work through that example (datasets are included) I think you will able to see clearly what is necessary, and why, to perform deconvolution.
I am not entirely clear though what your objective/needs are from your question;
If as I am guessing you have two formulations you have tested in vivo and you want to analyse these profiles by deconvolution to better understand their release and absorption characteristics__*__ then the minimum extra information you need is the UIR (unit impulse response). This information is entered into the deconvolution tool to ‘subtract’ the elimination element of the curve, so the best source for this are the modelling parameter estimates frm an IV bolus i.e. A and Alpha in a drug that displays single compartment kinetics for a single unit of the dose (i.e. divide the intercept (A) by 50 if it came from a dose of 50ug), the slope (alpha) of course is constant.
Where do you get these values ? Well you either perform the experiment yourself to get them, and the desirability would be IV bolus as best, but if that is unavailable IV infusion, then oral soluton, oral suspension, immediate release and so on.
Alternatively if you have a literature reference you could use that, if it hasn’t given the you the values as these macro constants then you’ll have to do a little more work to simulate from the literature references and request the macro constants (intercepts and slopes) as secondary parameters in your output.
So if you have your data already go ahead and load it up into a PHXPROJ and try, if you get stuck you can post the project here for comments/clarification - alternatively if you feel it is too urgent or confidential then you can contact Certara directly for an estimate of how much it would cost for a consulting project on your data, these can start from just a couple of billable hours for a simple project.
Simon.
* if you have the dissolution data from these two formulations as well then you can start to think about building and IVIVC (in vivo in vitro correlation) as well, either yourself or via our consulting services and then you have a much better chance of predicting which new formulations might be successful for BE with a dissolution experiment, with the usual caveats of BCS classifications.
Dear Sir,
Thank you for your response.
We are not having any IV or IR data for the molecule but mean Kel and VD is available. With Kel and VD how
to calculate A and Alpha Value. Its possible to calculate.
Please guide me.
Karthik, I already answered this on my previous response
the macro constants are A and alpha for a 1 compartment model, which if you’ve give the drug as a bolus (in your simulation means Cmax and K10.
Simon.