Simulations Plus Wins Cooperative Agreement With FDA

LANCASTER, Calif.--(BUSINESS WIRE)--Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of consulting services and software for pharmaceutical discovery and development, today announced that it has been notified by the U.S. Food and Drug Administration (FDA) that the company has been awarded a $200,000 cooperative agreement to develop improved modeling and simulation capabilities for dosage forms designed to be applied to the eye. The initial award provides support for the first year of the project. Funding for a second and third year of effort, at $200,000 per year, is subject to the availability of funds and satisfactory progress of the project.

Dr. Michael Bolger, chief scientist at Simulations Plus and principal investigator for the cooperative agreement, stated: “We are very pleased to have this opportunity to work with the FDA on this project. Our GastroPlus™ software program captures the best current understanding of the complex interplay between drug product attributes and human physiology. The improvements to our ocular model to be developed under this agreement will aid the FDA in developing regulatory science and policies in the area of absorption of drugs applied to the eye, and it will aid the generic pharmaceutical industry in designing high quality products that meet public expectations for effectiveness.”

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