Simulations Plus





Coming soon... a new program which provides high-quality, user-friendly analysis and reporting of pharmacokinetic data for internal reports or use in submissions to regulatory agencies.


What is PKPlus™?

 
The calculation of pharmacokinetic (PK) parameters using a noncompartmental analysis (NCA) approach is required when preparing internal PK study reports and submitting applications to regulatory agencies. If you decide not to write your own source code or create a validation data set to confirm results, you may depend on commercial software to help with this process. Many in the industry have been under the mistaken impression that there is only one software program that meets internal guidelines and the requirements of regulatory agencies. We intend to correct that misconception.

Simulations Plus, the developers of the industry-leading GastroPlus™ modeling platform, is pleased to introduce PKPlus, a validated program that quickly automates the process of generating NCA and/or compartmental PK modeling reports which can be utilized internally or in submission packages.


What can it do?

The underlying mathematics behind noncompartmental or compartmental PK 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 subsidiary company Cognigen Corporation, a leading CRO focused on pharmacometric services, 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 compartmental PK models, with subsets of data you select, without the need for writing any equations, and an easy-to-use interface, designed by clinical pharmacology scientists who perform these analyses on a routine basis. All of this is available through a flexible licensing model at a fraction of the cost of competing tools.

What are the key features?
  • 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 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 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
  • 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

Ready to move forward?

Remember, 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. Reserve your evaluation slot by filling out our request form. Or, if you are ready to explore your choices for NCA/compartmental PK modeling & reporting, ask us for pricing information.