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Certara offers predictive science and informatics solutions that enable cross-disciplinary and translational approaches to drug development.

PK/PD Modeling and Simulation

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Autopilot Features Tour

Learn about key features that enable PK automation

AutoPilot Object in Phoenix workflow

Just by adding one or multiple AutoPilot objects to the project's workflow and by connecting it to the results of NCA objects, a user can generate a multitude of standard tables and graphs that are required for regulatory or interim reporting.

Extensive User Control

The User Interface of the AutoPilot object provides the user with extensive control over the generated tables and graphs. Of course, this control is limited by the settings provided by the company's AutoPilot administrator, who sets the boundaries using the Administration Module, so that corporate report policies and requirements are met.

Integrated File Explorer

An easy to use tool - accessible in the Reporting tab of the AutoPilot object - helps to browse through the generated output and to transfer selected tables and graphs into a Word document or a PowerPoint presentation.

PK Output integrated in Phoenix Project

Because the generated tables and graphs are stores as results of the AutoPilot object, all relevant data are together in the Phoenix project: study data, NCA analysis, and PK tables and graphs.

Administration Module

The Administration Module allows customers to configure AutoPilot with respect to business rules and output content and formatting. The settings are stored in files that can be shared across an organization, so that corporate policies and reporting requirements are easily implemented.

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AutoPilot Tookit for Phoenix

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

System Requirements

Autopilot Toolkit for Phoenix is supported for both 32-bit and 64-bit versions of Windows® 7 SP1 and Windows 8.1. The following server operating systems are supported: Windows Server 2008 R2 SP1 64 Bit and Windows Server 2012 R2 64 bit.

Minimum Hardware Requirements:

  • Processor:  Intel® Core 2.0 Duo 2.0 GHz, or a CPU of EQUIVALENT processing power

  • RAM:  2 gigabytes RAM

  • Hard drive space:  300 megabytes free

Detailed system requirements, including international language support.