According to modeling software company Simulations Plus, the FDA has awarded the company a contract for a project that is intended to improve models of pulmonary absorption of inhaled drugs, with a goal of creating “the foundation of a viable alternative to in vivo studies for the establishment of bioequivalence (BE) for OIDPs.”
The company said that Rodrigo Cristofoletti’s lab at the University of Florida will generate in vitro data that Simulations Plus will use, along with pathophysiology data, to validate the Pulmonary Compartmental Absorption and Transit model in the company’s GastroPlus platform for various inhaled drugs.
Cristofoletti said, “We are very excited about the funding of this FDA contract that allows us to collaborate with Dr. Guenther Hochhaus, Dr. Jürgen Bulitta, and Simulations Plus. Our goal is to allow realization of new models that will bridge the gap between in vitro and human data and guide the development of biopredictive methods to improve the mechanistic understanding of drug performance locally within the lung.”
Simulations Plus Associate Research Fellow James Mullin commented, “Our novel physiologically based biopharmaceutics (PBBM)/PBPK modeling approach within GastroPlus for pulmonary delivery was initiated in 2009 through an industry-funded collaboration, and to date there have been over 25 peer-reviewed journal publications validating the platform across a wide range of drugs and chemicals. This partnership with Dr. Cristofoletti, his team, and the FDA will expand and improve upon our current cutting-edge technology. Ultimately, the strategies that we are outlining and implementing for applying in vitro systems and in silico models hold potential to lower regulatory burden and minimize the need for animal and human studies.”
Read the Simulations Plus press release.
