Hi, can I get someone to verify my project is set up correctly to obtain an estimate for “F” from IV and SC data? I am following the examples guide but the example doesn’t have the F in the model. I’m assuming if bioavailabilty for IV =1, then bioavailabilty for SC = F*1 in the model. But my initial estimates are quite different from my NCA results. for example my NCA suggests F = 0.88 V (from IV) = 48 L/kg CL (from IV) = L/hr/kg this is a small peptide so I’m not surprised NCA doesn’t match up so closely but I’m surprisde by the orders of magnitude they are off by. Can someone double check my logic that my model is set up correctly for an absolute bioavailability model? thanks Elliot [file name=Cyno_IVSC.phxproj size=351242]Certara | Drug Development Solutions (343 KB)
and if I could also add a couple follow-on questions: once I get to my “final” model and I want to qualify the model a VPC and obtain standard errors with the boostrap approach, I’m unclear as to how the software can estimate ka or F if in the boostrap run it draws only IV subjects. (1) Should the dataset be split by Route of administration and bootstrap the two routes independently? (2) If I only want to simulate SC doses at varying levels, how do I do that when I don’t have an IV dose going in? do I include a “0” in the simulation template under IV dose?