Research project with NIEHS includes focus
on qualification of in silico methods for prioritization,
assessment of risk, and identification of safety margins for
chemical use
Simulations Plus, Inc. (Nasdaq: SLP)
(“Simulations Plus”), a leading provider of modeling and simulation
solutions for the pharmaceutical, biotechnology, chemicals, and
consumer goods industries, today announced an extension to the
formal agreement with the Translational Toxicology Division at the
National Institute of Environmental Health Sciences (NIEHS) to
support the rapid safety assessment of chemicals in animals and
humans.
“At NIEHS, we seek to expand scientific knowledge and approach
methods linking the environment and human health. The Division of
Translational Toxicology (DTT) at NIEHS provides health effects
research to federal, state and local health agencies to identify
emerging public health issues and support the conduct of formal
risk assessments and decision-making,” said Stephen Ferguson,
Ph.D., scientific lead for the NIEHS project. “The agreement with
Simulations Plus provides computational tools that support
investigations of environmental chemicals and their potential
health effects.”
Computational model predictions from ADMET Predictor® and
GastroPlus® enable in vitro to in vivo extrapolation (IVIVE) that
relates biologically-active exposure levels to environmental
exposure scenarios. This enables more accurate estimates of
chemical safety margins (Sipes et al. 2017. Environ Sci Technol,
Sep 19;51(18):10786-10796. doi: 10.1021/acs.est.7b00650) and a
framework for integration of various types of toxicology data
(e.g., mechanistic data, in vivo & in vitro toxicology studies)
for decision-making (e.g., risk assessments, safer product
formulation).
“Importantly, these tools are being investigated for their
potential to address a critical gap in toxicology research for
understanding and modeling human bioactivation of environmental
chemicals through xenobiotic metabolism,” Ferguson added.
“It’s critical to understand how chemicals may react in the
body, and that can vary depending on whether they are inhaled or
absorbed through the skin, whether the person was an adult or
child, and if there are other health conditions present,” said
Michael Lawless, Sr. Principal Scientist in the Cheminformatics
Solutions team at Simulations Plus. “As in vivo testing becomes
more and more limited, the application of our software to support
new approach methodologies (NAMs) to predict those outcomes becomes
more crucial, and we are proud to be working with DTT/NIEHS to
support their environmental health and safety research
activities.”
GastroPlus is a mechanistically based modeling and simulation
software that simulates intravenous, oral, intraoral (oral cavity),
pulmonary (respiratory), ocular, dermal (topical and subcutaneous),
intramuscular, and intraarticular routes of administration, as well
as biopharmaceutics, pharmacokinetics, and drug-drug interactions
in humans and animals. It is the leading physiologically based
pharmacokinetic/physiologically based biopharmaceutics modeling
(PBPK/PBBM) platform, built and refined over 25 years on the most
up-to-date scientific research.
ADMET Predictor is a machine learning (ML) platform that
predicts the absorption, distribution, metabolism, excretion, and
toxicity (ADMET) of new molecules. It incorporates more premium and
extensively curated data from pharmaceutical and agrochemical
partners than any other cheminformatics platform, which provides
enhanced predictive accuracy and wider applicability of its
models.
Learn more about GastroPlus and ADMET Predictor.
About Simulations Plus, Inc.
Serving clients worldwide for more than 25 years, Simulations
Plus is a leading provider in the biosimulation market providing
software and consulting services supporting drug discovery,
development, research, and regulatory submissions. We offer
solutions that bridge artificial intelligence (AI)/machine
learning, physiologically based pharmacokinetics, quantitative
systems pharmacology/toxicology, and population PK/PD modeling
approaches. Our technology is licensed and applied by major
pharmaceutical, biotechnology, and regulatory agencies worldwide.
For more information, visit our website at
www.simulations-plus.com. Follow us on LinkedIn | X | YouTube.
Environmental, Social, and Governance (ESG)
We focus our Environmental, Social, and Governance (ESG) efforts
where we can have the most positive impact. To learn more about our
latest initiatives and priorities, please visit our website to read
our 2023 ESG update.
Forward-Looking Statements
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
Renee Bouche 661-723-7723 renee.bouche@simulations-plus.com
Financial Profiles Lisa Fortuna
310-622-8251 slp@finprofiles.com
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