Bioequivalence and Bioavailability Forum

Dear all!

Hopefully you can help me regarding the analysis of serial sampling PK data in WinNonlin 6.3.

Usually I am analyzing such data using R package 'PK' (Jaki and Wolfsegger, 2011) which conveniently provides asymptotic SEs for the most important PK parameters in serial sampling design. For PK modeling, I am using a bootstrap approach to quantify the uncertainty in PK estimates.

Using NCA in WinNonlin doesn't provide SEs for most of the PK estimates (I think only for AUC to infinity and Cmax) which is undesirable as the uncertainty plays an important role in serial sampling designs and adds substantial value to interpretation of estimates. To avoid this drawback, one can switch to compartment modeling for which WinNonlin provides SEs. But I am not sure how these SEs were calculated (no hint in the manuals) and if they are appropriate in serial sampling designs?! Can anybody help?

Thanks a lot and I am looking forward to read your opinions!
All the best,
Alex

Jaki T and Wolfsegger MJ (2011). Estimation of pharmacokinetic parameters with the R package PK. Pharmaceutical Statistics, 10(3):284-288. R package version 1.2-4. URL: http://CRAN.R-project.org/package=PK