Simulations Plus, Inc., a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemical, and consumer goods industries, announced a new funded collaboration with a large pharmaceutical company to expand and validate the mechanistic in vitro dissolution models for intravitreal injectable formulations within the DDDPlus™ software.
James Mullin , Senior Principal Scientist and lead programmer on DDDPlus, said: “The DDDPlus software is being utilized by numerous companies and regulatory agencies around the globe to support oral drug product development. Recent enhancements to the tool have focused on improvements to the in vitro analysis of precipitation kinetics and functionality to help establish drug product specification limits. Through this new collaboration, we will expand into the injectable product space and apply our novel approaches to capture dissolution kinetics within in vitro systems designed by our industry partner. We look forward to the fruitful interactions.”
“Our team of scientists and programmers have designed unique workflows between DDDPlus and GastroPlus® to advance innovative in vitro-in vivo extrapolation (IVIVE) methods for dissolution and precipitation modeling,” added Haiying Zhou , Director of Simulation Technologies. “Turning our attention to injectable products, and the special in vitro systems used to measure formulation performance, opens new market opportunities for our IVIVE workflows. Like other collaborations, Simulations Plus will own all improvements made to our software programs, and we look forward to sharing these exciting developments with all users to advance model-informed drug development.”
