NCA & compartmental PK modeling for
regulatory submissions

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The validation you require… the value you deserve.

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. Is it important to you to utilize a PK modeling platform which offers:

  • Convenience?
  • Validation?
  • Automation?
  • Value pricing and flexible licensing?

If you answered yes to the above, then we can help. Simulations Plus is pleased to introduce PKPlus™, a new program which provides high-quality, user-friendly analysis and reporting of pharmacokinetic data for validated and non-validated purposes.

What are we providing with PKPlus?

From the beginning, a conscious decision has been made to carefully implement the best theories and design an intuitive workflow to eliminate many of the potential errors (human or otherwise) which can be introduced when preparing your NCA PK reports:

  • Simple user interface
  • 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
  • High-quality tables, lists, plots & figures for reporting purposes
  • Excellent customer support
  • Flexible licensing models – you decide whether to install each license on a standalone machine or treat as a floating seat… no difference in license fees!

The methods & features we’ve introduced into PKPlus are too numerous to list here – instead, take a peek at the PKPlus datasheet for more details.

Who should be using PKPlus?
  • PK study representatives looking to quickly calculate validated/non-validated NCA model parameters and generate report-quality output
  • Clinical pharmacologists analyzing & handling large amounts of PK data, assembling groups, and creating custom tables, lists, plots, and figures (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 number of user licenses required

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.

What's new in PKPlus v2.5?

New features & enhancements of PKPlus 2.5 include:

· Optimized for 64-bit systems

· Streamlined auto-reports

· Improved command line

· Import CDISC SEND packages with PC domain as source data

· Additional workflow refinements

· … and more!

How do I move forward from here?

Join your peers around the world and begin working with PKPlus to automate your PK modeling activities.

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