RE: saturable metabolism of 5FU

From: Martin Bergstrand Date: May 19, 2012 technical Source: mail-archive.com
Dear Markus, First of all it is contradictory to both assume a fix fraction (FM) of substance converted to 5FU-H2 and at the same say that hat pathway is saturable. Given that the alternative pathway isn't saturable in the exact same way the fraction FM will be dependent on the concentration of 5FU. If you leave the FM parameter out of the equation for the linear model you will have the exact same model fit but instead of estimating CL of 5FU-H2 you will estimate a parameter that is equal to CL of 5FU-H2 over FM. This way you do not need to make any assumption about FM. ;[1] Non saturable elimination of 5FU and formation of 5FU-H2 K10 = 0 K12 = CL1/V1 K20 = CL2/V2 This model can be compare to a few alternative models that corresponds to different hypothesis regarding saturable metabolism. These models are not strictly nested hierarchical models but in my mind at least you should still be able to judge them as if they were that (when KM>>C1 the models are highly similar). ;[2] Saturable elimination of 5FU --> 5FU-H2 (alternative elimination path) C1 = A(1)/S1 DADT(1) = -C1*VM/(KM+C1) DADT(2) = C1*VM/(KM+C1)-K20*A(2) ;[3] Saturable metabolism of 5FU --> 5FU-H2 and an alternative non-saturable elimination path for 5FU. CL1A = THETA(6)*EXP(ETA(6)) ; Alternative elimination path CL for 5FU K10 = CL1A/V C1 = A(1)/S1 DADT(1) = -C1*VM/(KM+C1) -K10*A(1) ; Same as: -C1*VM/(KM+C1) -CL1A*C1 DADT(2) = C1*VM/(KM+C1)-K20*A(2) ; FM = (C1*VM/(KM+C1))/(CL1A*C1) ; FM as a function of C1 ;[4] Non-saturable metabolism of 5FU --> 5FU-H2 and an alternative saturable elimination path for 5FU. CL1M = THETA(6)*EXP(ETA(6)) ; CL1M K10 = CL1M/V C1 = A(1)/S1 DADT(1) = -C1*VM/(KM+C1) -K10*A(1) ; Same as: -C1*VM/(KM+C1) -CL1M*C1 DADT(2) = K10*A(1)-K20*A(2) ; FM = (CL1M*C1)/(C1*VM/(KM+C1)) ; FM as a function of C1 ;[5] Non-saturable metabolism of 5FU --> 5FU-H2 and an saturable elimination of 5FU-H2. C2 = A(2)/S2 DADT(1) = -K10*A(1) DADT(2) = K10*A(1) -C2*VM/(KM+C2) The above scenarios [2-5] can further be combined to account for more than I saturable elimination path. For running the differential eq. models I would recommend looking into ADVAN13 that in my experience is the best performing differential eq. solver in NONMEM and settings for TOL, SIGL and SIGN (see NONMEM 7 userguide). Kind regards, Martin Bergstrand, PhD Pharmacometrics Research Group Dept of Pharmaceutical Biosciences Uppsala University Sweden [email protected] Visiting scientist: Mahidol-Oxford Tropical Medicine Research Unit, Bangkok, Thailand Phone: +66 8 9796 7611
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From: [email protected] [mailto:[email protected]] On Behalf Of markus joerger Sent: den 19 maj 2012 04:23 To: [email protected] Subject: [NMusers] saturable metabolism of 5FU dear Community, I am modeling 5FU --> 5FU-H2, that is potentially saturable. The linear model runs smoothly, with a fixed proportion of 85% of the parent going to the metabolite. I wonder how the coding should be if I introduce saturable metabolism from 5FU to 5FU-H2. This model does not minimize. Should the coding for saturable metabolism (again with a 85% proportion going from 5FU to 5FU-H2) look like: ? V1=THETA(1)*EXP(ETA(1)) VM=THETA(2)*EXP(ETA(2)) KM=THETA(3)*EXP(ETA(3)) CL2=THETA(4)*EXP(ETA(4)) V2=THETA(5)*EXP(ETA(5)) S1=V1/1000 S2=V2/1000 FM=0.85 K20=CL2/V2 $DES C1=A(1)/S1 C2=A(2)/S2 DADT(1)=-C1*VM/(KM+C1) DADT(2)=C1*FM*VM/(KM+C1)-K20*A(2) LINEAR MODEL: ---------------------------------------------------------------------------- -------------------------------------------------------- $INPUT C=DROP ID OCC TIME AMT RATE DV CMT MDV EVID AGE SEX HEP OXA IRI BEV WT BSA ECOG A496G DPD4 DPD5 CCL $DATA 08088_6.CSV IGNORE=C $SUBROUTINES ADVAN5 $MODEL COMP=(CENTRAL, DEFDOSE) COMP=(5FUH2) $ABBREVIATED DERIV2=NOCOMMON $PK FLAG1=0 FLAG2=0 IF(OCC.EQ.1) FLAG1=1 IF(OCC.EQ.2) FLAG2=2 TVCL1=THETA(1)*THETA(5)**SEX CL1=TVCL1*EXP(ETA(1)+FLAG1*ETA(2)+FLAG2*ETA(3)) V1=THETA(2)*EXP(ETA(4)) TVCL2=THETA(3)*THETA(6)**SEX CL2=TVCL2*EXP(ETA(5)) V2=THETA(4)*EXP(ETA(6)) S1=V1/1000 S2=V2/1000 FM=0.85 K10=(1-FM)*CL1/V1 K12=FM*CL1/V1 K20=CL2/V2 $ERROR CALLFL=0 IPRE=-3 IF(F.GT.0) IPRE=LOG(F) PROP=0 IF(CMT.EQ.1)PROP=EPS(1) IF(CMT.EQ.2)PROP=EPS(2) Y=LOG(F)+PROP W=LOG(F) IRES=DV-IPRE IWRES=IRES/W $THETA (0, 152) ;CL1 (0, 43.3) ;V1 (0, 144) ;CL2 (0, 122) ;V2 (0,1) ;SEX > CL-5FU (0,1) ;SEX > CL-5FU-H2 $OMEGA 0.04 ;IIV CL1 $OMEGA BLOCK(1) 0.004 ;IOV OCC1; CL-5FU $OMEGA BLOCK(1) SAME ;IOV OCC2; CL-5FU $OMEGA 0.04 ;IIV V1 0.04 ;IIV CL2 0.04 ;IIV V2 $SIGMA 0.329 ;EPS COMP1 0.136 ;EPS COMP2 -- Markus Joerger MD PhD Associate Professor Medical Oncology&Clinical Pharmacology Cantonal Hospital 9007 St. Gallen Switzerland [email protected] [email protected] Phone: +41-765591070 Fax: +41-714946325
May 19, 2012 Nick Holford Re: saturable metabolism of 5FU
May 19, 2012 Martin Bergstrand RE: saturable metabolism of 5FU