Certara’s Phoenix WinNonlin usage in COVID-19 studies

About Certara

Certara optimizes R&D productivity, commercial value, and patient outcomes through its unique end-to-end platform of model-informed drug development, regulatory science, and market access solutions. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com.

What is Phoenix WinNonlin?

Phoenix WinNonlin is the industry standard for the analysis of pharmacokinetic and pharmacodynamics data. The integrated tools for data processing, non-compartmental analysis (NCA), PK/PD modeling, post-analysis statistics, table creation, and graphics create an all-in-one collaboration workbench for analysts, reviewers, medical writers, and quality assurance team members.

Usage of Certara’s Phoenix WinNonlin in COVID Studies

Certara is providing the drug development community with recent and relevant information regarding COVID-19 and facilitating professional development with on-demand resources.

Severe acute respiratory syndrome coronavirus 2 (SARS- COV-2) is a newly identified pathogen causing the coronavirus disease 2019 (COVID-19) pandemic. Hydroxychloroquine (HCQ), an antimalarial and anti-inflammatory drug, has been shown to inhibit SARS-COV-2 infection in vitro and tested in clinical studies. However, the achievement of lung concentrations predicted to have in vivo antiviral efficacy might not be possible with the currently proposed oral dosing regimens. Further, high cumulative doses of HCQ raise concerns of systemic toxicity, including cardiotoxicity.

PK parameters of HCQ were calculated by a noncompartmental method using Phoenix WinNonlin (version 8.0). PK parameters for tissue/organ were calculated using the sparse‐sample option available in Phoenix WinNonlin.

In addition to using Phoenix WinNonlin and Phoenix NLME, the FDA also uses Certara’s Trial Simulator, IVIVC Toolkit, and PK Submit. Certara recognizes the impact COVID-19 is having on our daily personal and business lives. Certara continues to support our customers' discovery and drug development efforts during this Pandemic time with scientific informatics, modeling and simulation, and regulatory software tools and platforms to inform, improve and accelerate the process of bringing therapies to patients.

Certara works with many biopharmaceutical companies and regulatory agencies to accelerate drug development because our software can be used to test a wide. “Our bio-simulation software is routinely relied upon to support the development of complex therapies, such as cell and gene therapies, and medicines for much-needed areas, including pediatrics, rare diseases, and COVID-19.”