AutoPilotTookit for Phoenix: Automate TLF Generation from WinNonlin

The AutoPilot Toolkit^TM for Phoenix^® is a configurable PK automation software package that is integrated with Phoenix WinNonlin®  and  Phoenix Knowledgebase ServerTM  (PKSTM) 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 (e.g., 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 usto learn more about how the AutoPilot Toolkit for Phoenix can accelerate generating PK reports at your organization! Call or email sales@4amsoftware.com.au

Disclaimer : The information on this Certara product line including names of other Software products/companies and brands, customers, customer statements and application labels are information taken from the original developer's website. 4am Software makes no additional claims to the information contained. Furthermore 4am Software Pty Ltd., does not make any claims of performance of the products, links with other related products or industry standards limited to PK/PD analysis or beyond. The sole purpose of information is to provide customers complete details in making a decision to purchase the products.