RE: Indirect response model

From: Jakob Ribbing Date: May 17, 2007 technical Source: mail-archive.com
Dear all, I agree, implementing the actual PK model (i.e. IPP) or using linear interpolation to describe the individual PK profiles as suggested by Juergen and David is necessary in this example. However, for understanding when input concentrations can be used directly as a reasonable approximation I have the following question: If the input concentrations were to be used, as originally presented by Nishit, wouldn't nonmem use the input concentrations according to last observation carried BACKWARD, rather than forward? In that case, for ID 1101 (the third individual in the dataset): 0 < TIME <= 840 -> COP=0.13884 840 < TIME <= 842 -> COP=0.12987 842 < TIME <= 844 -> COP=0.12147 844 < TIME <= 1848 -> COP=227.79 ... I haven't checked myself that nonmem uses LOCB rather than LOCF, but have been told so by Mats Karlsson which usually makes checking superfluous:>) I think this could be important in other situations as well: The LOCB-rule could induce false covariate relations if the drug affects a potential covariate. For example, disease level/score/stage may falsely appear to affect the drug clearance if investigated within nonmem. To properly quantify such a covariate relation a simultaneous fit of the PK-PD model may be necessary, treating the covariate (biomarker) as an integrated part of the model. Getting back to this thread: Nishit, if using nonmem version 6, the dummy dose into compartment 1 is not needed for initializing the baseline. Dummy-dosing records can be removed from the datafile and this line in the model file: F1 = KFOR/KCL can be replace by A_0(1) = KFOR/KCL Lastly, either fit log-transformed DV:s using an additive error model OR add "INTERACTION" on the $ESTIMATION, to account for the interaction between ETA1 and EPS1 in the current error model. I would prefer the first alternative for several reasons. Kind regards, Jakob $INPUT ID TIME DV AMT=DOSE COP MDV ID 1101 in the dataset: 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
Quoted reply history
-----Original Message----- From: [EMAIL PROTECTED] [mailto:[EMAIL PROTECTED] On Behalf Of David H Salinger Sent: den 16 maj 2007 18:14 To: Jurgen Bulitta Cc: Modi, Nishit [ALZUS]; [EMAIL PROTECTED]; [email protected] Subject: Re: [NMusers] Indirect response model Dear Nishit, Jurgen is correct, you are using concentration (COP) as a forcing function. But, in ID 1101, for example, the COP has a value of 0 from TIME=0 to 840 and then values around 0.12 until TIME 1848. Unless this is what you had in mind, I would suggest two steps: 1. Include more time points for COP. These need not coincide with TIMEs were you have DV values. 2. Create a linear interpolation of COP to be used in the $DES block. One way to do this linear interpolation is to add two columns to your data file: PTME (previous time) and PCOP (previous concentration). Then, compute SLOPE = (COP-PCOP)/(TIME-PTME) and use a linear interpolation of conc: PCOP +SLOPE*(T-PTME) in place of COP in computing your COEF parameter (must be in $DES block). I hope this helps, David Salinger RFPK, Univ. of Washington
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