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Simulations Plus Software Used in Regulatory Submittals

Published: Wednesday, May 15, 2013
Last Updated: Wednesday, May 15, 2013
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US FDA, UK MHRA, and European EMA accept simulation results in applications.

Simulations Plus, Inc. announced that results of simulations using its GastroPlus™ software have been submitted to major regulatory agencies as part of applications by its customers.

John DiBella, vice president of marketing and sales for Simulations Plus, noted, “The first submittal to a regulatory agency was reported by Pfizer in 2008, which resulted in Pfizer being allowed to forego a human trial after GastroPlus simulations showed that it would not be necessary. In the past 12 months, four additional customers have submitted simulation results to the U.S. Food and Drug Administration (FDA), the European Medical Agency (EMA), and the British Medical Health Regulatory Agency (MHRA). Each of these involved a consulting contract with Simulations Plus to assist the sponsor with the GastroPlus simulations and model development. Simulations Plus also provided assistance in preparation of the submittals to the regulatory agencies. The acceptance of simulation results by these agencies is an indication of the growing importance of simulation and modeling technology in pharmaceutical research and development.”

Walt Woltosz, chairman and chief executive officer of Simulations Plus, added: “The four submittals John describes resulted in:
1.    Eliminating a clinical trial to demonstrate that fasted and fed states would not produce significantly different results for the absorption of the drug candidate.
2.    Identifying the particle size specification for a re-engineered product to ensure bioequivalence to an existing product.
3.    Explaining the variations observed in different formulations.
4.    Scaling complex processes involving metabolism and carrier-mediated transport from adult to pediatric/neonate populations.

These four submissions signal a developing trend for the use of simulation and modeling results to reduce the cost and time to bring new drug products to market. Note that these four involved Simulations Plus consulting services. A number of other submittals have been made by sponsors on their own. Regulatory agencies in the U.S., Europe, China, and Japan all have GastroPlus for their internal use, so sponsors can submit GastroPlus input files to these agencies to make evaluation of results fast and convenient. In time, we believe other sponsors will increasingly utilize powerful simulation software to help streamline the regulatory process and provide regulators with accurate data for evaluation purposes.”

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