Now available! The next-generation software which easily generates high-quality, custom analysis and reporting of pharmacokinetic data for both validated and non-validated purposes.
How does PKPlus™ help you?
Every lead compound which enters preclinical testing
warrants some form of non-validated noncompartmental analysis (NCA), with
promising candidates heading into clinical trials requiring validated NCA as
part of the new drug applications submitted to regulatory agencies. Compartmental
PK analysis (CA) is also often used to support submissions as well as to
understand how various factors affect the absorption, distribution, and
elimination of drugs from the body. If you decide not to write your own
source code or create validation data sets to confirm results, you may depend
on commercial software to help with these processes.
When considering a commercial program, is it important to
you to utilize a PK modeling platform which offers:
Value pricing and flexible
If you answered yes to any of the above questions, then we
can help. Simulations Plus, the developers of the industry-leading GastroPlus™ modeling platform,
is pleased to introduce PKPlus, a new program that provides high-quality,
user-friendly pharmacokinetic data analysis and reporting for validated and
PKPlus combines sophistication and simplicity, providing the
capabilities to meet the needs of scientists across departments at
pharmaceutical companies, contract research organizations (CROs), and other
non-pharma markets, all with the value pricing and flexible licensing policies to
make it the best choice for cost-conscious organizations.
What can it do?
The underlying mathematics behind NCA or CA models is
relatively straightforward. The key features that must be met when providing a
commercial package are: validation, automation, and workflow. PKPlus, designed
in collaboration with our clinical pharmacology/pharmacometric consulting
experts, meets all requirements:
A validation procedure to confirm PKPlus is
giving you the correct results on your systems
An automated process for fitting NCA and/or CA
models, with subsets of data you select, without the need for writing any
A simple ‘point-and-click’ streamlined workflow
to minimize errors
All of this is available through a flexible licensing model
at a fraction of the cost of competing
tools, with excellent customer support included.
What are the key features?
Automatic and custom report generation is
provided, along with full audit trail and validation, which are required to
assist companies in complying with 21 CFR Part 11 for their submissions to the U.S.
Food and Drug Administration
Calculation of pharmacokinetic parameters using industry-standard NCA methods
Generation of pharmacokinetic parameters using compartmental analysis with 1-, 2-, or 3- compartments - you decide which model(s) to solve in an automated fashion!
Support for importing and exporting common data file types
Fast and easy Exploratory Data Analysis (EDA) - data management functions to deal with organizing and examining data
'Knowledge-based' selection of groups: PKPlus learns from your data input fields and intelligently creates groups of data without any user interaction!
Relational database infrastructure - highly flexible selection of records to analyze and compare desired subsets of a total data set
Unique tracking of exclusions or outliers: define reasons for exclusions which can be included in reports
Production of high-quality tables, figures, and listings for export to reporting programs – designed in accordance with PhUSE
View PK profiles, statistics, and model parameters from a single screen - can easily select point(s) to exclude and quickly recalculate the outputs
Audit trail (saving all software settings) to ensure the ability to duplicate results from submitted analyses in the future
Validation data sets to confirm PKPlus is giving the correct results on your system
Flexible licensing options: you decide whether to install each license on a standalone machine or treat each one as a floating seat - no difference in license fees!
Value pricing - all these features AND still less expensive than similar tools
Who should be using it?
PK study representatives looking to quickly calculate both
non-validated NCA model parameters and generate report-quality output
Clinical pharmacologists analyzing & handling large amounts of PK data, assembling groups, and creating custom plots, figures, and tables (especially in accordance with PhUSE)
Modelers needing to produce parameter estimates for inputs into GastroPlus PBPK or NONMEM® population PK/PD models
CROs doing PK modeling work for sponsor companies and wanting to avoid paying premiums to software vendors based on the volume of studies performed or on the number of user licenses required*
* Remember, our license fees are the same regardless of how you use PKPlus.
Ready to move forward?
There is a choice when deciding on a PK modeling software package. If convenience, validation, workflow, automation, and value are important to you, then check out PKPlus. Ask for an evaluation copy by filling out our simple request form. Or, if you are ready to explore your choices for noncompartmental PK analysis/compartmental PK modeling & reporting, ask us for pricing information.