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Global Regulatory Agencies Increase Adoption of Phoenix PK/PD M&S Software for Drug Reviews

PRINCETON, NJ – Apr. 4, 2019 – Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that Brazil’s National Health Surveillance Agency – ANVISA, Japan’s Pharmaceuticals and Medical Device Agency (PMDA), and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) are increasing their adoption of Certara’s Phoenix® software to evaluate drug regulatory submissions.

Phoenix is the most advanced and widely-used validated software for pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) modeling and simulation (M&S) worldwide. It is used by more than 6,000 researchers at 1,500 biopharmaceutical companies and academic institutions in 60 countries. Underscoring Phoenix’s pivotal role in the drug approval process – 90% of novel drugs approved by the US Food and Drug Administration (FDA) are from companies that leverage Phoenix in their R&D programs.

Certara is also providing Phoenix training for the aforementioned regulatory agencies through Certara University that includes in-person, hands-on training, and/or online training delivered via a new certification program.

“Certara’s mission is to improve decision making throughout the drug development continuum from helping sponsors to select the best drug candidate and determine the most appropriate dosing regimen, through to assisting them in making the strongest case for regulatory approval, formulary inclusion, and payer coverage,” said Michael Eckstut, senior vice president, pharmacometrics software at Certara. “We are very proud of Phoenix’s level of adoption and success, which we attribute to in-depth technical and industry knowledge and to continually listening to our clients and ensuring that this family of products evolves to meet their needs whether it be to improve M&S productivity and workflows or to demonstrate virtual bioequivalence.”

In addition to licensing Phoenix WinNonlin® for non-compartmental PK analysis and Phoenix NLME™ for PK/PD and population PK analysis, the agencies are licensing Phoenix IVIVC for In vitro-in vivo correlation. IVIVC is used in drug development and formulation optimization to describe the relationship between an in vitro property of a drug dosage form and an in vivo PK response. Most important, IVIVC is a surrogate for in vivo bioavailability and can be used to demonstrate virtual bioequivalence and support applications for regulatory biowaivers.

Phoenix is also employed by Australia’s Therapeutic Goods Administration (TGA), the China National Products Administration (NMPA), European Medicines Agency (EMA), and 11 divisions of the US FDA for submittal review.


Certara について

Certara enables superior drug development and patient care decision-making through model-informed drug development, regulatory science, real-world evidence solutions and knowledge integration. As a result, it optimizes R&D productivity, commercial value and patient outcomes. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com.


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