RE: Getting rid of correlation issues between CL and volume parameters

From: Matt Hutmacher Date: November 26, 2013 technical Source: mail-archive.com
Hi Jacob, and everyone, Sorry to be unclear and if I have added any confusion. My derivation was for the oral/SC administration (into a depot compartment) case with no IV data and with no extra CL/V correlation. If there were extra correlation, the OMEGA matrix would look like V11+VFF VFF+COV(eta1,eta2) VFF+COV(eta1,eta3) VFF+COV(eta1,eta4) VFF+COV(eta2,eta1) V22+VFF VFF+COV(eta2,eta3) VFF+COV(eta2,eta4) VFF+COV(eta3,eta1) VFF+COV(eta3,eta2) V33+VFF VFF VFF+COV(eta3,eta4) VFF+COV(eta4,eta1) VFF+COV(eta4,eta2) VFF+COV(eta4,eta3) V44+VFF which would not be identifiable without the IV data. In my opinion, if there is no IV data, the F is really just conceptual. It is a a way of thinking about certain covariates that affect both CL and V etc in an identical way. Parameterization using covariates (which I do often) and an eta on F is just a trick (in the no-IV data case) to get the OMEGA matrix as previously defined and to avoid having to specify eg, CL=THETA(1)/(1+THETA(2)*FOOD) V=THETA(3)/(1+THETA(2)*FOOD), in the model (which is equivalent). In this case, I am concerned about adding the extra eta on F to constrain the OMEGA matrix because of the whole identifiability issue. Plots would certainly be affected (there really aren't 3 etas in the non-IV data case). In there is no extra-correlation, and F is inducing a high degree of correlation, one might consider putting the eta's on V, K, K12 and K21. The variability of F would be lumped into V, and this would cancel from the K's allowing a diagonal matrix (note that one would need to be careful how one parameterized this and it does not preclude evaluating and estimating fixed effects on CL, V, etc.) Best, Matt (I have trimmed some of the earliest emails from this note to ensure delivery).
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-----Original Message----- From: [email protected] [mailto:[email protected]] On Behalf Of Ribbing, Jakob Sent: Tuesday, November 26, 2013 05:46 To: Mueller-Plock, Nele; Leonid Gibiansky; 'nmusers' Cc: Ribbing, Jakob Subject: RE: [NMusers] Getting rid of correlation issues between CL and volume parameters Hi Nele, I believe Matt's point was more to the situation where any remaining correlation between CL and V random components can not be accounted for by covariates, so that both eta on F and block2 on CL and V is used? If eta on F and covariates takes care of the correlation between CL and V: I would say that you may get even more informative diagnostics with this implementation. For example, if you have not yet taken dose/formulation into account and this affects only F, it would come out as a clearer trend on the eta1 (relative F). This would help in interpretation (but I would highlight Nick's earlier point that eta on F may capture other nonlinearities that are shared between CL and V; like degree of protein binding for a low-extraction drug). Best Jakob -----Original Message----- From: [email protected] [mailto:[email protected]] On Behalf Of Mueller-Plock, Nele Sent: 26 November 2013 08:21 To: Leonid Gibiansky; 'nmusers' Subject: RE: [NMusers] Getting rid of correlation issues between CL and volume parameters Dear all, Thanks for picking up this discussion, and bringing in so many points of view. When I started the discussion I had in mind the physiological viewpoint, from which we know that if there is between-subject variability in F1, this must result in a correlation between volume and CL parameters. From the discussions I would conclude that the group would favor to account for this correlation via inclusion of ETA on F1 and then a coding of FF1=EXP(ETA(1)) CL=THETA()*EXP(ETA())/FF1 V=THETA()*EXP(ETA())/FF1 whereas this does not mean that there is no additional correlation between the parameters which needs to be accounted for in the off-diagonal OMEGA BLOCK structure? Also, I am afraid I was not able to completely follow Matt's argumentation, but would also be interested to hear if implementing the code above might lead to misleading plots. Thanks and best Nele