AutoPilot Tookit for Phoenix: Automate TLF Generation from WinNonlin
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
- Single dose and multiple ascending dose
- Cross-over studies
- Special populations (e.g., renal, hepatic, age)
- IV- or PO-based non-compartmental analysis
- Comparisons between analytes, dosing regimen, or other conditions
- 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.
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).
- 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!