Re: Simulations for Bioequivalence testing

From: Jeff Wald <jwald@pharsight.com> Subject: Re: Simulations for Bioequivalence testing Date: Wed, 31 May 2000 15:01:16 -0400 To interested readers - Pharsight's Trial Simulator version2.0 contains all of the elements listed by Dr. Gobburu. The simulator allows one to build a mixed effects model and simulate it based upon a trial design. For analysis of the simulated results the mathematical engine of WinNonlin is available for noncompartmental computations as is WinNonlin's ANOVA module (supporting general linear models and bioequivalence computations). S-Plus is integrated into the product for further statistical and graphical comparisons. In addition the simulator allows one to build up multiple scenarios for simulation and then analyze/compare them together in the same set of results. Scenarios may address different study design issues (sampling schedules, number of subjects....) or different elements of the drug model (within, between, or residual variance, values of fixed effect model parameters, etc). Simulation of different analyses and analysis of the results is automated via the simulator. More information can be obtained at www.pharsight.com. Regards, Jeff