Dear Simon, I learned through the new phoenix NLME and found myself impressed by its functionalities. I was trying how to run a simulation with the final population PK parameters and covariates. For example, how to simulate PK curves using parameters from final model in a larger population (eg., set N=500 subjects) with different covariates and stratifications, or simulate on new dose levels, or to steady states. Simon, if you can provide me a example project / procedure to simulate plasma curves using phoenix NLME would be greatful. If not in phoenix NLME 1.1 , is it feasible with newer versions like 1.2 with beste regards, Raghav
Raghav, depending on what you want to achieve there are a few options, I think Emily’ post here on using Predictive Check will be good starting point; Certara | Drug Development Solutions if that isn’t what you want to do please reply specifying your simulation objectives/plan. Simon.
Dear Simon, Thanq for the reply, My objective is as follows in steps: 1. We are using phoenix NLME to estimate pop parameters in preclinical setting. So for rat and dog plasma concentration profiles (both IV and PO data simultaneously) data was fit with 2 compartment model and parameters were obtained (CL, V , CLD, V2, F, Ka). 2.From the animal paramters obtained we obtained human CL and V by allometric scaling. 3. From the human parameters (CL, V CLD, V2 , Ka ) we want to simulate plasma concentration profile. we want to generate parameters like AUC (0- specified timepoint) and Cmax with 90 % CI. Step 1 - achieved with phoenix NLME Step 2 - allometric scaling performed by linear regression using graphpad Step 3 - How to acheive step 3 using NLME or Phoenix winnonlin. Thanks with best regards, Raghav, Drug Metabolism and pharmacokinetics.