Simulations for Bioequivalence testing

From: Sriram Krishnaswami <ksriram@ufl.edu> Subject: Simulations for Bioequivalence testing Date: Tue, 30 May 2000 18:36:56 -0400 Dear NMusers, I was wondering if it is possible to use monte carlo simulations on NONMEM to test for various measures (Cmax, AUC, Cmax/AUClqc etc.) to differentiate test from the reference compound. From what I gather from a couple of papers, 1) El-Tahtawy et al Pharm Res 15&12& 11, (1998, 1995 and 1994), 2) Bois et al, Pharm Res , 11, 966 and 715 (1994) 3) Tozer et al, Pharm Res, 1995 a very large number of volunteers (something like a million) have been simulated based on various scenarios followed by PK analysis and statistics on them. All of them have used SAS for the simulations as well as follow up stats. Has anybody used NONMEM plus Excel or something for this purpose? Thanks in advance, Sriram -- Sriram Krishnaswami Dept. of Pharmaceutics College of Pharmacy University of Florida Gainesville, FL 32610-0494 Home: 352 846 5968 Lab: 352 846 3257 Fax: 352 392 4447