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Press Release

Simulations Plus Releases PKPlus™ Version 1.0

Simulations Plus,Inc.
Posted on: 25 Aug 16

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.”

About Simulations Plus, Inc.

Simulations Plus, Inc., is a premier developer of drug discovery and development software as well as a leading provider of both preclinical and clinical pharmacometric consulting services for regulatory submissions. The company is a global leader focused on improving the ways scientists use knowledge and data to predict the properties and outcomes of pharmaceutical and biotechnology agents. Our software is licensed to and used in the conduct of drug research by major pharmaceutical and biotechnology companies and regulatory agencies worldwide. Our innovations in integrating new and existing science in medicinal chemistry, computational chemistry, pharmaceutical science, biology, and physiology into our software have made us the leading software provider for physiologically based pharmacokinetic modeling and simulation. For more information, visit our website at

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Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995 – With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. Words like “believe,” “expect” and “anticipate” mean that these are our best estimates as of this writing, but that there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, our ability to identify and close acquisitions on terms favorable to the Company, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports as filed with the U.S. Securities and Exchange Commission.

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Last updated on: 25/08/2016

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