Simulations Plus, Inc. (NASDAQ: SLP), the premier provider of simulation and modeling software and consulting services for pharmaceutical discovery and development, today announced that it has released version 1.0 of PKPlus, its next-generation software for analysis of preclinical and clinical trial data.
Mark Pflieger, product manager for PKPlus, said: “More than two years in the making, we have developed a true next-generation capability for two important types of analysis of preclinical and clinical trial results: noncompartmental analysis (NCA) and compartmental analysis (CA). Following from the PKPlus Module that has been in our GastroPlus™ software since 2000, we designed this new standalone PKPlus from the ground up around a relational database – Microsoft® SQL Server Express – to provide powerful new capabilities and a streamlined workflow that makes many analyses simple point-and-click operations. By eliminating the need to write code for equations, analyses are simplified and errors are minimized, resulting in higher productivity and ease-of-use for analysts. Automatic and custom report generation is provided along with full audit trail and validation, which are required to assist companies in complying with 21 CFR Part 11 for their submissions to the U.S. Food and Drug Administration.”
John DiBella, vice president for marketing and sales for Simulations Plus, added: “Every lead compound which enters preclinical testing warrants some form of non-validated NCA, with promising candidates heading into clinical trials requiring validated NCA as part of the new drug applications submitted to regulatory agencies. CA is also often used to support submissions as well as to understand how various factors affect the absorption, distribution, and elimination of drugs from the body. PKPlus combines sophistication and simplicity, providing the capabilities to meet the needs of scientists across departments at pharmaceutical companies, contract research organizations (CROs), and other non-pharma markets, and with the value pricing and flexible licensing policies we have implemented, we believe it has the potential to become a significant contributor to revenues and earnings going forward.”
Walt Woltosz, chairman and chief executive officer of Simulations Plus, said, “The PKPlus development team, consisting of scientists from both our Lancaster, California, and Buffalo, New York, divisions, has been working diligently to bring this new product to the industry for many months. The result is a testament to their dedication and hard work, and is an excellent example of the continuously developing synergies between the two divisions.”