Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, today announced it is expanding its offerings of best-in-class software for pharmaceutical research and development with PKPlus™, a new program that provides high-quality, user-friendly analysis and reporting of clinical trial data for use in submissions to regulatory agencies.
John DiBella, vice president for marketing and sales for Simulations Plus, said: “We believe PKPlus represents a major addition to our product line with the potential to become one of our leading sources of revenues and earnings. Many in the industry have been under the mistaken impression that there is only one software program that meets the requirements of regulatory agencies for analysis and reporting of noncompartmental analysis results for clinical trial data. We intend to correct that misconception. We have taken the core elements of our PKPlus Module, originally introduced as an optional module in our flagship GastroPlus™ software over 15 years ago, and are turning it into a standalone program that will provide:
- calculation of pharmacokinetic parameters using noncompartmental analysis,
- calculation of pharmacokinetic parameters using compartmental analysis with 1, 2, or 3 compartments,
- support for importing and exporting common data file types,
- data management functions to deal with organizing and examining data,
- highly flexible selection of records to analyze and compare desired subsets of a total data set,
- production of high-quality tables, figures, and listings for export to reporting programs,
- audit trail (saving all software settings) to ensure the ability to duplicate results from submitted analyses in the future.”
Walt Woltosz, CEO of Simulations Plus and its wholly owned subsidiary, Cognigen Corporation, said, “We are designing PKPlus to be a friendly but powerful program to satisfy pharmaceutical researchers’ needs while providing better value than alternative programs. The development of PKPlus is an excellent illustration of the synergies between Simulations Plus and our Cognigen subsidiary. We expect a beta release of PKPlus in November, with full release expected in January, but we are announcing it now in order to be able to discuss it at our annual Japan User Meeting for this year in Tokyo tomorrow as well as at the 2015 American Association of Pharmaceutical Scientists Annual Meeting in Orlando, Florida, starting on October 25.”