A SAS/IML program for simulating pharmacokinetic data

Data simulation can be an invaluable tool for optimizing the design of bioequivalence trials. It can be particularly useful when exploring alternative approaches for assessing product comparability especially in the context of encountering various complex experimental situations that can occur in veterinary medicine. With this in mind, we designed a novel SAS/IML program to generate pharmacokinetic datasets that reflect the various kinetic, population, and study design characteristics that complicate the bioequivalence evaluation of animal health products. Developing this simulation program within SAS provides an opportunity to utilize the statistical capabilities of this software platform.