Press release

Simulations Plus Upgrades Flagship GastroPlus

Sponsored by Businesswire

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
released version
of its flagship physiologically based pharmacokinetic (PBPK)
modeling platform, GastroPlus®.

Key improvements in this version include:

  • Ability to add lysosomal trapping effects to PBPK tissues for more
    accurate systemic calculations
  • New mechanistic pregnancy PBPK model with integrated population
  • Options to define multiple solubility inputs for different drug forms
  • Expanded fed state simulation conditions based on defined meal types
  • Validated models of standard compounds added to the drug-drug
    interaction (DDI) Module
  • PK/PD model extensions added to the PDPlus™
  • Improved population groups for extensive, intermediate, and poor
    metabolizers based on specific genotypes
  • Updates to the dermal
    absorption (TCAT™) model
    through the Cosmetics
    Europe collaboration
  • Novel effects of immune response added to the intramuscular injection
  • And more…

“Special populations modeling continues to be a key component of
GastroPlus with numerous companies applying the results to support
regulatory interactions,” said Dr.
Viera Lukacova
, director of Simulation Sciences for Simulations
Plus. “With this release, we have added several new groups, including a
validated mechanistic pregnancy model, which will greatly enhance the
understanding of drug exposure and assist with dose selection decisions.
Special thanks to the dedicated scientific team at Simulations Plus and
our collaboration partners for all their outstanding efforts.”

, Lancaster division president for Simulations Plus, added:
“GastroPlus continues to provide researchers, including chemists, DMPK
scientists, pharmaceutical developers, and clinical pharmacologists, a
proven and flexible PBPK software to support safety and efficacy
decisions, first-in-human estimations, formulation optimization, and
drug-drug interaction assessments. For over twenty years, Simulations
Plus has been dedicated to improving our state-of-the-art tools, and the
significant enhancements that are integrated in version 9.7 are just a
preview of exciting advancements that will be the foundation for next
year’s entirely new platform release of GastroPlus.”

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
for regulatory submissions and quantitative
systems pharmacology models
for drug-induced liver 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 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

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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