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Would appreciate getting your input into what may be a basic modeling and simulation question.
I am trying to determine how the concentration of our drug will be affected in patients with differing clearance. Specifically, I am interested in seeing what the concentration would be before the next dose is administered (q8 h). As a background, the drug is almost exclusively excreted renally, has a short half life (approx 3 hours) and is given as an IV infusion.
I looked at the data from 6 healthy volunteers and fit it to a 2-compartmental model. Then, taking the volume and clearance parameters, I created 5 difference scenarios. I altered the clearance by 10%, 25%, 50% in both directions while keeping the volume constant. Using WinNonlin, I then simulated the concentration vs. time profiles over an 8 hour period in each of these cases to get a range of concentrations at 8 hours.
What do you think of this approach? Anything that I may have missed? I only have acess to WinNonlin so doing the same with NONMEM or any other method will not work. I just want to see if my approach is ok.
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