I found a file named "simulation_official.phxproj" attached by serge guzy in this post ( ). For the Dosing in Setup I just input the MAD regimen? Can I put different regimens at the same time? What file should be mapped to the Main in Setup? My PK data or something else? I should do the simulation in individual mode or pop mode? Which option is more reasonable? I think the option 2 is better. Or 2) to use the pop PK parameter to simulate the MAD for each subject and get a range of MAD concentration. What should I do if I want to simulate the MAD for further trials? I think there are two options:ġ) To use the individual PK parameter to simulate the MAD of each subject to get a range of multiple dose concentration The reason that I added Dose as a covariate is when I plot the AUC/Dose vs Dose for all subjects the plot is not horizontal at the high doses (4 and 8mg). I got a new set of PK parameter for all subjects. So I added these covarites to my pop model and rerun it. Next I checked the effect of covariates (Race, Age, Sex, Dose) with stepwise covariate search and found that Race-V, Race-Cl, Dose-Cl is the scenario to use. So I got one set of PK parameters for all subjects. Then I copied and pasted the individual model and changed it to pop model by checking the population checkbox. First I used individual built-in model (PK, clearance, extravascular, 1) to fit them and tried different residual error model and got the PK parameter for each subject (I chose mixed ratio). What I did to them is to send all the data to Phoenix Modeling. I have the results of several cohorts of SAD trials and the dose range is 0.1, 0.3, 1, 2, 4, 8 mg. My situation and questions are as follows. I searched the forum but still didn't get the answer. I have been stuck for a long time and it is really frustrating.
I have some questions about the simulation of multiple dose (MAD) from single dose (SAD) with NLME.
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