Dear Simon, I have few queries regarding the simulation of plasma concentration profiles in phoenix NLME including variability. Actually in Winnonlin , When PK parameters (like V, CL, Ka ) and dose are defined the plasma concentrations are generated in the output with respect to the time points given as input. If i do it for multiple times in winnonlin I would get the same results as there is no variability included in it. How would i do the same in phoenix NLME ? If done , do we need to run the simulation for every subject each time / can be done for multiple subjects at a time ? Looking forward for your guidance , Thanks with best regards, Raghav,
Dear Raghav, To simulate without variability in Phoenix NLME, set the run mode to Sim/Pred Check and N ITER to 0. Go to the tables tab. Enter the times that you would like and enter the variable “C” in the variables field. If the engine is set to Naive Pooled, the profiles will be identical (unless the doses are different or covariates are present and the covariates are different from subject to subject). Best regards, Emily
Dear Emily, Thankyou for the prompt reply, However i would like to simulate plasma concentration profiles for N no. of subjects with variability in phoenix NLME. Can you provide me some example project / can you guide me through the process. Thanks with best regards, Raghav.
With all model parameters entered into the user interface, use the tables tab of the Sim/Pred Check run option with N ITER set to 0. In the times field, enter times you would like to have simulated. In the variables field, put “CObs”. Concentrations with between and within subject variability will be simulated. Use any of the engines that include random effects (FOCE-LB for example).
Dear Emily, I was trying to simulate plasma concentration profile in single human subject with the final parameters i have. but i couldnt find any simulations. Please find the attached project for your review ! Plz gudie me! Regards, Raghav, [file name=Simulation_.phxproj size=302332]Certara | Drug Development Solutions (295 KB)