Re: Indirect response model

From: Jurgen Bulitta Date: May 15, 2007 technical Source: mail-archive.com
Dear Nishit, If I understand correctly, you are using concentration (COP) of your drug as a time dependent covariate which is then used as forcing function for your PD model. As concentrations change over time, you probably need the CALLFL = 0 option ($PK CALLFL=0) to read in the concentration at every new time. I would write out COP in $TABLE in order to check, if COP changes over time as it should. This should work much better, but it will still give you a piecewise constant concentration profile. This may cause numerical problems. Instead, I would include the differential equations for your PK model. This should give you better numerical stability and more correct concentration predictions. You could start with reading in the individual PK parameters (IPP approach, see reference below) and then go to more complex PKPD analyses. You might try the MATRIX=S statement in $COV, if you like to get the covariance step to work. Hope some of this works. Best regards Juergen Reference: Zhang, L., S. L. Beal, and L. B. Sheiner. 2003. Simultaneous vs. sequential analysis for population PK/PD data I: best-case performance. J Pharmacokinet Pharmacodyn 30:387-404. ----------------------------------------------- Juergen Bulitta, PhD, Post-doctoral Fellow Pharmacometrics, University at Buffalo, NY, USA Phone: +1 716 645 2855 ext. 281, [EMAIL PROTECTED] ----------------------------------------------- -----Ursprüngliche Nachricht----- Von: "Modi, Nishit [ALZUS]" <[EMAIL PROTECTED]> Gesendet: 15.05.07 18:31:57 An: [EMAIL PROTECTED] CC: [email protected] Betreff: [NMusers] Indirect response model I am conducting a sequential pharmacokinetic-pharmacodynamic model. The pharmacokinetic fits look good and I was using an indirect response model. The PD model is that the drug inhibits clearance of the analyte (PD response), thus one expects that the response increases with increasing drug (Model II). There is a baseline measured (=Kfor/Kcl) and a dummy dose=1 unit given. It seems despite trying various permutations of the model, eta1 seems to be very small and no covariance step is conducted. The model and data for the first 3 subjects are reproducted below. Any assistance would be appreciated. Note that since conc (COP) are read in, the model only requires a single differential equation. Any insight would be appreciated. Nishit $PROBLEM PD - ADVAN6 $DATA C:\PDDATA.CSV $INPUT ID TIME DV AMT=DOSE COP MDV ; data are subject ID, Time, DV=PD response, Amt (dummy dose of 1 inserted), COP=plasma conc which drive PD model, MDV $SUBROUTINES ADVAN6 TOL=6 $MODEL COMP=(EFFECT, DEFDOSE, DEFOBS) $PK KFOR = THETA(1) KCL = THETA(2)*EXP(ETA(1)) IC50 = THETA(3) IMAX = THETA(4) F1 = KFOR/KCL COEF = IMAX*COP/(IC50+COP) $DES DADT(1) = KFOR-KCL*(1-COEF)*A(1) $ERROR W = F Y = F*EXP(ERR(1)) IPRED = F IRES = DV-IPRED IF (W.LE.0.) W=1 IWRES = IRES/W $THETA (0,0.3) $THETA (0, 0.003) $THETA (0,10) $THETA (0, 0.3, 1) $OMEGA 0.01 $SIGMA 0.5 $ESTIMATION METHOD=1 MAXEVAL=5000 PRINT=20 $COVR $TABLE ID TIME PRED IPRED IRES KFOR KCL IC50 IMAX NOPRINT ONEHEADER FILE=C:\PD.TAB 1001 0 . 1 0 1 1001 0 98.3 . 0 0 1001 168 90.6 . 122.44 0 1001 840 92.8 . 183.69 0 1002 0 . 1 0 1 1002 0 105.1 . 0 0 1002 840 88.5 . 61.253 0 1002 842 106.7 . 106.8 0 1002 844 122.1 . 116.4 0 1002 1848 129.1 . 121.46 0 1002 1850 160.4 . 212.63 0 1002 1852 157.1 . 231.89 0 1101 0 . 1 0 1 1101 0 68.1 . 0 0 1101 840 88.1 . 0.13884 0 1101 842 105.5 . 0.12987 0 1101 844 108.8 . 0.12147 0 1101 1848 113.3 . 227.79 0 1101 1850 62.6 . 379.54 0 1101 1852 138.7 . 412.18 0
May 15, 2007 Nishit Modi Indirect response model
May 15, 2007 Jurgen Bulitta Re: Indirect response model
May 15, 2007 Sunny Chapel RE: Indirect response model
May 16, 2007 David H Salinger Re: Indirect response model
May 17, 2007 Jakob Ribbing RE: Indirect response model
May 28, 2007 Alison Boeckmann RE: Indirect response model