Press release

Cognigen Launches KIWI Version 4.0

Sponsored by Businesswire

Cognigen Corporation, a Simulations Plus company (Nasdaq: SLP) and a
leading provider of population
pharmacokinetic and pharmacodynamic
modeling and simulation
services, today announced that it has released Version 4.0 of its KIWI™
Pharmacometric Communication and Collaboration Platform.

KIWI is a private cloud-based, validated platform to efficiently and
consistently organize, process, visualize, evaluate, and communicate
modeling and simulation results. Since the introduction of KIWI 1.0 in
2011, our mission has been to provide pharmacometricians with the most
efficient analysis environment possible. The release of KIWI version 4.0
continues that mission with the introduction of the Model Wizard and the
Covariate Analysis toolset.

A pharmacometric analysis is an evolutionary process – one that often
results in the creation of hundreds of new program files and code
changes to hundreds more due to common typographical and programmatic
errors. The Model Wizard and the Covariate Analysis toolset aim to
significantly reduce the time spent creating models, correcting errors,
and replicating program files for performing stepwise covariate
analyses, allowing pharmacometricians to focus on advancing science.
With continued feedback from KIWI license holders, various
visualizations within KIWI 4.0 and the pharmacometric-specific Data
Repository will continue to be updated with new
features and functionality

KIWI has been specifically designed to recognize the dynamic nature of
the model building effort in an ongoing drug development program. KIWI
provides the functionality to meet the scientist’s need for extensive
documentation of the analysis pathway and collateral results,
management’s need for summaries of modeling and simulation highlights,
and the regulatory agencies’ needs for transparency and reproducibility.
KIWI continues to bring user experience to a new level through efficient
and decisive model building. KIWI demonstrations will be available
through Cognigen personnel attending the PAGE
this week in Stockholm, Sweden.

Dr. Sebastien Bihorel, director of Pharmacometrics and KIWI
Applications, said: “Our team continues to introduce exciting
functionality into KIWI. The new Wizards greatly decrease the time and
effort required to create model codes for 3 different industry-standard
modeling platforms: NONMEM®, mrgsolve, and Berkeley Madonna.
They will significantly lower the learning curve for modelers who are
new to these platforms while providing consistent coding standards to
more experienced users.”

Dr. Ted Grasela, president of Cognigen, added: “Over the course of a
typical drug development program, fit-for-purpose (F4P) models based on
the current facts and available data are used to inform development
decision making and aid in the design of clinical trials. These F4P
models represent an important repository of knowledge which can be
expanded as new knowledge emerges. The cloud-based KIWI platform serves
a key role in this process by tracking the model refinement process and
capturing development team insights and suggested improvements.”

KIWI was featured at a NONMEM workshop held as part of the University of
Buffalo’s annual PK/PD course held this past May, with international
attendance from both academia and industry. Another workshop is now
planned for September 23-25, 2019, at Johannes Gutenberg University in
Mainz, Germany. Attendance is limited. Contact Jill Harlach (
for further information.

About Cognigen Corporation

Cognigen Corporation is well-recognized as providing insightful analysis
and reports that guide regulatory decision making and minimize follow-up
questions from regulators, saving sponsors considerable time and money
in getting new pharmaceutical products to market. Cognigen Corporation
deployed KIWI in 2011 to provide pharmacometricians and clinical teams
lead access to a dynamic modeling and simulation platform for population
analyses. More information is available on the Cognigen
of the Simulations Plus website.

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
kidney injury
, and nonalcoholic
fatty liver disease
. 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

Safe Harbor Statement Under the Private Securities Litigation Reform
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– 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,”
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