Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, announced that its GastroPlus™ software for simulation of oral absorption, pharmacokinetics, and pharmacodynamics was the top-rated software in a comparison study performed by Pfizer (NYSE: PFE).
Walt Woltosz, chairman and chief executive officer for Simulations Plus, said: “We attended and exhibited at the Asian International Society for the Study of Xenobiotics meeting inShanghai , China on May 12-13. At that meeting, one of the poster presentations was by a team of scientists at Pfizer. Their poster presented the results of a two-year effort to compare simulation programs that provide physiologically based pharmacokinetics (PBPK) modeling capabilities. All four marketed programs with this capability were involved in the study, which was based on actual data from 21 Pfizer compounds that entered human clinical trials. The goal was to assess the predictive accuracy of the four programs as well as to compare them with the then-current Pfizer methodology used to predict human results from preclinical (laboratory and animal) results for each new compound. The study was divided into two parts, one for intravenous dosing and one for the more difficult oral dosing. The accuracy of the predictions from all five methods (four commercial programs and the Pfizer internal method) was compared in each area.”
Woltosz continued: “We are extremely happy to report that GastroPlus was ranked first in accuracy in both areas, while none of the other methods was ranked second in both areas. The then-current Pfizer method was second in accuracy for predicting the different oral doses, while another commercial package was second for predicting intravenous doses (but the same package was second to last for oral doses). We believe this speaks to the rigorous scientific approach our team has taken as well as the tremendous partnerships we have had with industry scientists who have provided excellent feedback and access to data to enable us to constantly update and improve the mathematical models and the user interface employed in GastroPlus.”