Re: Simulations for Bioequivalence testing

From: "Jogarao Gobburu 301-594-5354 FAX 301-480-3212" <GOBBURUJ@cder.fda.gov> Subject: Re: Simulations for Bioequivalence testing Date: Wed, 31 May 2000 08:50:35 -0400 (EDT) Dear Sriram, 1. Yes, it is possible to perform monte carlo simulations using NM for your need. 2. You need the following: a. Routine to generate a input dataset for your trial design b. NONMEM for simulations c. Routine to calculate non-compartmental parameters (nca), preferrably that can be invoked from command line d. SAS (or the equivalent) to conduct stat testing. Dr.Nick Holford and I have been using a combination of NONMEM, AWK (nca), and SAS to perform simulations/power-calculations of BE trials. Regards, Joga Gobburu, Pharmacometrics, CDER, FDA.