Re: Absorption

From: Justin . Wilkins Date: September 04, 2007 technical Source: mail-archive.com
Dear Adithya, Your problem has attracted some good advice from the list, but if you are still interested in trying out the transit model, perhaps we could help, if you were able to furnish some more details about what exactly went wrong with your implementation of it in NONMEM V - posted code snippets and precise error messages would be of particular use. It ought to be possible to make it work under NMV, although the richer the data, the better, and NMV is known to be less robust at working with differential equations than NMVI. Problems can often be resolved with some minor tweaking, given sufficient information in the data to support the model - how many observations per individual are you working with, and how well covered is the absorption phase? You might also try hard-coding the transit compartments, i.e. not estimating the number as a model parameter, but fixing it to different values until you find an optimum. You might also want to take a look at some previous work on the subject, in which the method was established for single dosing: Savic R, Jonker DM, Kerbusch T, Karlsson MO. PAGE 13 (2004) Abstr 513 [www.page-meeting.org/?abstract=513] Have you tried normalizing the concentrations by dose and plotting them on the same axes? That should give you information with respect to whether you have any dose-related nonlinearity - if the curves for each dose levels are roughly superimposed, kinetics are linear, and if not, the relative positions of the curves should provide some useful clues about what is going on. Best regards Justin Justin Wilkins Novartis Pharma AG PH346, MODELING & SIMULATION CHBS, WSJ-027.1.084 Novartis Pharma AG Lichtstrasse 35 CH-4056 Basel Switzerland Phone: +41 61 324 6549 Fax: +41 61 324 3039 Mobile: +41 76 561 0949 Email : [EMAIL PROTECTED] "Adithya Muralidharan" <[EMAIL PROTECTED]> Sent by: [EMAIL PROTECTED] 03.09.2007 19:10 To [email protected] cc Subject [NMusers] Absorption Dear nmusers, I am working on a rising single dose study, with 5 cohorts (10, 25, 50, 100 and 200 mg dose groups). This is a oral drug. There are a total of 45 subjects in the study, 9 subjects in each cohort. The data fits well to a two compartment model, but at higher doses 100 and 200mg dose groups the concentrations leading to Cmax is overpredicted significantly that the model seems to be completely ineffecient in explaining the absorption phase at higher doses. I have tried using a Mixture model assuming that there is a sub population with a totally different absorption, this seemed to work but visual predictive check failed. Used a cobination zero and first order absorption model which couldn't fix the issue at higher doses Transit compartment model (A flexible approach to modeling variable absorption in the context of repeated dosing: illustrated with rifampicin, J. Wilkins, Page 2007). This approach did not work with NONMEM V. i assumed that the drug at higher doses has saturable absorption but even that does not help much. Can someone please comment on this. Thanks Adithya
Sep 03, 2007 Adithya Muralidharan Absorption
Sep 04, 2007 Malaz Abutarif RE: Absorption
Sep 04, 2007 Justin . Wilkins Re: Absorption
Sep 04, 2007 Adithya Muralidharan Re: Absorption
Sep 04, 2007 Mouksassi Mohamad-Samer RE: Absorption
Sep 05, 2007 Juan Jose Perez Ruixo RE: Absorption
Sep 05, 2007 Adithya Muralidharan Re: Absorption
Sep 05, 2007 Murad Melhem Re: Absorption