Simulations Plus Enters into New Research Collaboration Agreement with the FDA
July 16 2019 - 7:30AM
Business Wire
Center for Veterinary Medicine to apply
GastroPlus® to assess product bioequivalence in canines
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 entered into a new five-year Research
Collaboration Agreement with the U.S. Food and Drug
Administration’s (FDA) Center for Veterinary Medicine to evaluate
alternative approaches for determining product bioequivalence (BE)
for locally-acting drugs in animals.
“It is always exciting to announce ground-breaking
collaborations with the FDA and reinforce our partnership as we
advance science in new areas,” said Viera Lukacova, director of
Simulation Sciences for Simulations Plus and principal investigator
on the project. “Under this agreement, the FDA, using GastroPlus
with in vitro and in vivo data, will investigate how BE of
non-systemically absorbed products can be evaluated in canines
without the need for clinical endpoint trials. Ideally, through
verification of the methods and results, a framework can be
provided to support these approaches for other drugs.”
John DiBella, Lancaster division president for Simulations Plus,
added, “Our technology is already assisting companies and
regulatory agencies with the ‘3 Rs’: reducing, replacing, and/or
refining animal use. We look forward to these interactions with the
FDA staff to better understand model performance on additional
veterinary medicines and identify further advances to the
GastroPlus platform to support biowaiver applications.”
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 organization imply endorsement by the United States
Government.
About Simulations Plus, Inc.
Simulations Plus, Inc., is a premier developer of drug
discovery/development software and 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. Our software is used to conduct
drug research by major pharmaceutical, biotechnology, chemical,
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
provider for physiologically based pharmacokinetic modeling and
simulation. Visit us online 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 Relations
Ms. Renee Bouche 661-723-7723 renee@simulations-plus.com
Hayden IR Mr. Cameron Donahue
651-653-1854 cameron@haydenir.com
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