Hello all,
My question is related to trial simulation, but for a bioavailability trial, so posting here.
I have a pop PK model for IV and am using it to evaluate a study design for cross-over IV vs. extravascular bioavailability study. It is 1 sequence (first extravascular then IV), 2 formulation, and 2 period study. I am trying to do trial simulations to evaluate power and optimal sampling times.
For evaluation of different sampling schemes, I am doing n trial simulations for each sampling schemes, and then using simulated data to calculate AUC and Lambdaz using NCA and evaluating power (percent of virtual trials to meet CI of geo mean within 60% to 140% of geometric mean criteria). Is this method sound reasonable? or using R based design evaluation method (such as PopED) might be more feasible for sampling time points evaluation?
For cross-over study, using intra-subject variability is recommended. Does this mean to neglect between subject variability completely? Is simply using BSV only okay?
I will appreciate any feedback.
Thanks,
Krina
Edited by krinaj@gmail.com, 02 March 2018 - 01:10 AM.
