AutoPilot Toolkit

AutoPilot Tookit for Phoenix: Automate TLF Generation from WinNonlin

The AutoPilot Toolkit™ for Phoenix® is a configurable PK automation software package that is integrated with Phoenix WinNonlin® and Phoenix Knowledgebase Server™ (PKS™) workflows.

It generates report-quality tables, listings, and figures (TLFs) for regulatory submissions and interim reports and presentations and automates key study types including:

  • Bioequivalence and bioavailability
  • Drug-drug and food-drug interactions
  • First-in-man
  • Dose-proportionality
  • Single dose and multiple ascending dose
  • Cross-over studies
  • Special populations (eg, renal, hepatic, age)
  • IV- or PO-based non-compartmental analysis
  • Comparisons between analytes, dosing regimen, or other conditions

Benefits

  • Saves time spent generating reports: Reduce the cycle time to complete interim and final pharmacokinetic (PK) reports by up to 75%.
  • Empowers researchers: Automation of routine TLF generation frees PK scientists to focus their time on critical drug development research.
  • Improves quality of PK reports: AutoPilot helps ensure quality and consistency of reports leading to reduced effect in QA and regulatory affairs groups.
  • Implements best practices: AutoPilot can be configured to capture and implement best practices and business rules for PK study reports within a department and across organizations.

Functionality

AP Automation Object

  • Users send the results of Phoenix WinNonlin non-compartmental analysis (NCA) objects to AutoPilot objects to generate the TLFs required for regulatory or interim reports.
  • The runtime in AutoPilot Toolkit 2.2 has been reduced to less than 40% of that in previous versions so that users can create TLFs for PK studies faster than ever before!
  • Users can customize TLFs within the constraints of the administrator-defined settings.
  • The integrated file explorer allows users to browse through the generated TLFs and select which ones to include in a Microsoft® Word® document or PowerPoint® presentation.

AP Comparison Object

  • It compares the results from multiple studies, i.e., from multiple NCA objects, in a single run.
  • Users can compare different dosing routes (bioavailability of IV vs. PO), different dosing regimens (accumulation of steady-state vs. single-dose), different matrices (plasma vs. urine), and multiple analytes (parent vs. metabolite).

Administration Module

  • AutoPilot Toolkit includes a predefined set of TLFs, formatting settings, and business rules.
  • The Administration Module allows extensive configuration of formatting, nomenclature, and business rules to reflect the organization’s requirements and standard operating procedures (SOPs).
  • Users can save the customized settings to a file and share it with other users.

Contact us to learn more about how the AutoPilot Toolkit for Phoenix can accelerate generating PK reports at your organization!

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