FDA Purchases Bundle of ADMET Predictor® Licenses
April 30 2019 - 8:30AM
Business Wire
Center for Tobacco Products incorporates
machine learning platform to assist toxicology research
Simulations Plus, Inc. (Nasdaq:SLP), the leading provider of
modeling and simulation solutions for the pharmaceutical,
biotechnology, chemicals, and consumer goods industries, today
announced that it has received an order from the U.S. Food and Drug
Administration (FDA) for a 15-user license to its ADMET Predictor®
software suite. The purchase was made by the Center for Tobacco
Products to support research projects aimed at informing regulatory
decision making.
John DiBella, Lancaster division president for Simulations Plus,
said: “For many years, the FDA has utilized our software across
various departments, including the Office of Clinical Pharmacology,
Office of Generic Drugs, and Office of Pharmaceutical Quality. We
are thrilled to now see the Center for Tobacco Products incorporate
our machine learning technology to support their risk assessment
activities as they evaluate tobacco products and ingredients. We
look forward to interactions with the FDA staff to understand model
performance on their chemicals and identify future advances to
ADMET Predictor’s functionality and workflow.”
Views expressed in this press release do not necessarily reflect
the official policies of the Department of Health and Human
Services; nor does any mention of trade names, commercial
practices, or organizations imply endorsement by the United States
Government.
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 and quantitative systems pharmacology models
for drug-induced liver injury, drug-induced kidney injury, and
nonalcoholic fatty liver disease. The company is a global leader
focused on improving the ways scientists use knowledge and data to
predict the properties and outcomes of pharmaceutical,
biotechnology, and chemical agents. Our software is licensed to and
used in the conduct of drug research by major pharmaceutical,
biotechnology, chemical, and consumer goods 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
www.simulations-plus.com.
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
and filed with the U.S. Securities and Exchange Commission.
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Simulations Plus Investor
RelationsMs. Renee
Bouche661-723-7723renee@simulations-plus.com
Hayden IRMr. Cameron
Donahue651-653-1854cameron@haydenir.com
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