Abstract

GastroPlus™ is a mechanistically based simulation software package that predicts absorption, pharmacokinetics, and pharmacodynamics in humans and animals. GastroPlus modeling and simulation has been used to justify biowaivers for Class I, II, and III active pharmaceutical ingredients. 1-4 Simulations Plus has recently demonstrated that GastroPlus can also be applied for extensions of biowaivers for BCS Class II active pharmaceutical ingredients for which manufacturing process changes have been made. This application of GastroPlus has the potential of streamlining the introduction of reformulated drug products by eliminating bioequivalence studies, where appropriate, while still ensuring necessary drug product performance.

By Viera Lukacova, John Dibella