How Certara's Phoenix WinNonlin Software used for PK/PD Analysis

What is Phoenix WinNonlin?

Phoenix WinNonlin is the industry standard for the analysis of pharmacokinetic and pharmacodynamic data. The integrated tools for data processing, non-compartmental analysis (NCA), PK/PD modeling, toxicokinetic analysis, post-analysis statistics, table creation, and graphics create an all-in-one collaboration workbench for analysts, reviewers, medical writers, and quality assurance team members.  Phoenix winNonlin with  intuitive graphical user interface which allows users to spend less time learning the software and managing data and more time to model, interpret, and understand the data. For more information, visit www.certara.com

Top 5 reasons why experts choose Phoenix WinNonlin as their preferred software for NCA and PK/PD modeling in studies ranging from preclinical and toxicokinetic (TK) studies to clinical and first in human studies.

1. Save Time with Integrated Tools

PK/PD and non-compartmental analyses can be time consuming, requiring detailed attention to every step from data preparation to report generation.  Phoenix WinNonlin™’s integrated tools for data processing, graphing & charting, report generation, and compliance create an efficient, all-in-one collaboration workbench.

Phoenix WinNonlin is used by over 10,000 scientists at more than 1,500 establishments in 60 countries. It is the industry standard for non-compartmental analysis (NCA), pharmacokinetic/pharmacodynamic (PK/PD), and toxicokinetic (TK) modeling with a proven 30-year history.

Regulatory agencies, including the US FDA, Japan Pharmaceutical and Medical Device Agency (PMDA), China Food and Drug Administration (CFDA), and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), all use Phoenix WinNonlin to evaluate drug submissions.

2. Easily validated

The enhanced Phoenix® WinNonlin® Validation Suite is integrated into Phoenix and provides software validation in less than 30 minutes with non-editable PDF reports containing links to saved reference files, user output files, and difference files. Updated validation template documents are aligned with the latest regulatory guidance computer system validation such as ICH E6 Good Clinical Practice (GCP) R2 and can be readily modified to fit individual user/organizational policies and procedures.

3. User-friendly graphics engine and table generator

The integrated graphics engine in Phoenix WinNonlin automatically creates publication-quality plots, figures and tables to create standardized PK/PD reports.

The Phoenix Platform’s charting capabilities provide the ability to utilize the offset function, change font size and style, change the order and presentation of categorical axes, and more. The outputs can be quickly attached to a PK/PD report for communicating results internally and to regulatory agencies.

4. Widely Used and Respected

More than 6,500 researchers at 1,500 pharmaceutical companies and academic institutions worldwide rely on Phoenix WinNonlin. Indeed, 100% of leading pharma companies as surveyed and published in the January 2015 IQ Consortia report on preclinical PK/PD modeling rely on Certara’s software. In addition, Phoenix has a strong reputation in academia. This is reflected in the approximately 15,000 publication and academic references to the use of WinNonlin using Google Scholar – far more than any competing software.

5. Extensively Utilized by Regulators

Part of the reason Phoenix WinNonlin is considered the industry gold standard software for PK/PD and NCA analysis is because of Certara’s relationships with regulatory agencies such as the US (United States) FDA (Food and Drug Administration), EMA (European Medicines Agency), and Japan PMDA (Pharmaceutical and Medical Devices Agency). The FDA alone is using more than 250 licenses across six of its centers, including drugs, biologics, and generics. Certara provides these agencies with WinNonlin, onsite training courses, and opportunities for FDA and others to have direct input about the features added to future releases of the product. This means that any regulatory submissions that include WinNonlin results can be easily received and processed by the FDA and other regulatory agencies.

Certara is providing the drug development community with recent and relevant information regarding COVID-19 and facilitating professional development with on-demand resources. For More Information Visit: https://blog.akthealth.com/certaras-phoenix-winnonlin-usage-in-covid-19-studies

About AKT Health Analytics

AKT Health is a Healthcare & Life Science Strategy Consulting firm. AKT Health partners with life science companies and health systems to develop a market-leading strategy for long-term top performance, engagement, growth, and sustainability.

Our consultants evaluate data, apply analytical models, study systems, and dissect workflows to unlock opportunities to improve performance through technology enablement and engagement planning. We collaborate with healthcare providers to implement improved processes and create efficiencies that can withstand changes within the industry.

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