Its clients include more than 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries.
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The FDA uses Certara’s Phoenix software including WinNonlin, NLME and In Vitro-In Vivo Correlation (IVIVC) toolkit as well as the company’s Trial Simulator software.Ĭertara accelerates medicines using proprietary biosimulation software and technology to transform traditional drug discovery and development.
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Phoenix is used extensively to perform data analyses for new drug and biologics license applications by drug developers, including 37 of the top 40 global pharmaceutical companies by R&D spend. “We are pleased that more scientists at the FDA are using our biosimulation software to support the development of safe and effective medicines.”Īdditionally, the FDA has renewed and expanded its user licenses of Certara’s Phoenix Software, which is widely used for pharmacokinetic, pharmacodynamic, and toxicokinetic modeling and simulation. “It is a privilege to continue providing software that global regulatory agencies can rely on to inform their reviews of regulatory submissions,” said William F. The FDA has renewed its licenses for the Simcyp Simulator, Simcyp Paediatric and Simcyp Cardiac Safety Simulator, which the agency uses to independently analyze, verify, and review investigational therapies, new drug applications, and generic drug applications. In total, there are 12 divisions and offices of the FDA using Certara’s software for internal research and to independently analyze, verify, and review regulatory submissions.Ĭertara’s Simcyp Simulator, an industry-leading platform for physiologically based pharmacokinetic (PBPK) modeling and simulation, is used throughout the drug development process to evaluate new drug formulations, determine first-in-human dosing, optimize clinical study design and predict drug-drug interactions. WinNonlin SAS Phoenix WinNonlin’s advanced reporting capabilities are very useful when compiling stand-alone PK reports, facilitating rapid illustration of PK data through workflows and templates however, when results are integrated into a large CSR, it is often preferable to generate TLFs in SAS for consistency with the remainder of the clinical report (e.g. (Nasdaq: CERT), a global leader in biosimulation, recently announced the US FDA has renewed and expanded its licenses of Certara’s proprietary biosimulation software, with more than 400 user licenses of Simcyp and Phoenix software. Its clients include more than 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries.Certara, Inc. Ĭertara accelerates medicines using proprietary biosimulation software and technology to transform traditional drug discovery and development. The FDA uses Certara’s Phoenix software including WinNonlin, NLME and In Vitro-In Vivo Correlation (IVIVC) toolkit as well as the Company’s Trial Simulator software.įor more information on Certara’s software platforms, please visit.
“We are pleased that more scientists at the FDA are using our biosimulation software to support the development of safe and effective medicines.”Īdditionally, the FDA has renewed and expanded its user licenses of Certara’s Phoenix Software, which is widely used for pharmacokinetic, pharmacodynamic and toxicokinetic modeling and simulation. The FDA has renewed its licenses for the Simcyp Simulator, Simcyp Paediatric and Simcyp Cardiac Safety Simulator, which the agency uses to independently analyze, verify and review investigational therapies, new drug applications and generic drug applications. In total, there are 12 divisions and offices of the FDA using Certara’s software for internal research and to independently analyze, verify and review regulatory submissions.Ĭertara’s Simcyp Simulator, an industry-leading platform for physiologically-based pharmacokinetic (PBPK) modeling and simulation, is used throughout the drug development process to evaluate new drug formulations, determine first-in-human dosing, optimize clinical study design and predict drug-drug interactions.
Food and Drug Administration (FDA) has renewed and expanded its licenses of Certara’s proprietary biosimulation software, with more than 400 user licenses of Simcyp and Phoenix software. (Nasdaq: CERT), a global leader in biosimulation, today announced that the U.S. 21, 2021 (GLOBE NEWSWIRE) - Certara, Inc. Phoenix is the most advanced and widely-used validated software for PK, PD, and toxicokinetic modeling and simulation worldwide.
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PDF Version FDA holds more than 400 Simcyp™ and Phoenix™ software licenses across 12 divisions and offices