Simulations Plus Releases GastroPlus® Version 9.8.1
February 09 2021 - 8:30AM
Business Wire
Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of
modeling and simulation solutions for the pharmaceutical,
biotechnology, chemical, and consumer goods industries, today
announced that it has released version 9.8.1 of its flagship
physiologically based biopharmaceutics (PBBM) / pharmacokinetics
(PBPK) modeling program, GastroPlus®. For over 20 years,
Simulations Plus has been dedicated to improving state-of-the-art
software tools, educating scientists worldwide with the best and
most innovative science, and advancing in silico modeling and
simulation.
Key improvements in this version include:
- More mechanisms, verification, and guidance for our validated
drug-drug interaction (DDI) models
- A “Validated” column in the DDI perpetrator table to clearly
identify the values that have been validated by our DDI experts for
use in simulations
- A new option to include variability in lung deposition in the
Population Simulator
- New enhancements when importing chemical structures
- Updated probability contour outputs for the Population
Simulator
- Added units for Cmax, AUC0-inf and AUC0-t in .beq files for
both individual crossover trials and virtual bioequivalence (VBE)
summaries
- Added metabolite Cmax, AUC0-inf and AUC0-t in .beq files for
both individual crossover trials and VBE summaries
- Bug fixes reported by our scientists and users
Dr. Michael Bolger, Founding Scientist of Simulation Plus, said:
“Understanding DDI is the first step towards safety for drug
combination therapies which can deliver promising strategies for
complex diseases. The newly enhanced DDI models increase this
capability to identify and predict likely challenges, and the
supporting documentation outlining model development and
verification activities streamlines the use of GastroPlus
simulations to inform regulatory decision making. Special thanks to
the Simulations Plus DDI task force and our government and
commercial collaborators for their efforts and counsel.”
“The theme of this release is ‘improving efficiency for
regulatory reviewers,’” added Neil Miller, Vice President of
Simulation Sciences. “Both the expanded reporting of VBE results
and improved DDI model documentation will facilitate better
communication between health authorities and sponsor companies and
accelerate the time to market for new drug products. The underlying
science and dedication to detail with these refinements further
establishes GastroPlus as the “gold standard” PBPK software
platform from discovery through post-approval.”
About Simulations Plus, Inc.
Simulations Plus, Inc., is a leading provider of modeling and
simulation software and consulting services supporting drug
discovery, development research, and regulatory submissions. With
our subsidiaries, Cognigen, DILIsym Services, and Lixoft, we offer
solutions which bridge 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, chemical,
consumer goods companies and regulatory agencies worldwide. 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 Relations
Ms. Renee Bouche 661-723-7723 renee@simulations-plus.com
Hayden IR Mr. Cameron Donahue
651-653-1854 slp@haydenir.com
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