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Year: 2015

FDA Equips its Pharmacometrics Teams with Certara’s Phoenix Software

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Partnership provides pharmacometric biosimulation solutions for multiple FDA centers PRINCETON, NJ – Nov. 2, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced that the United States Food and Drug Administration (FDA) has outfitted its pharmacometrics teams with Certara’s Phoenix® software. Phoenix is the industry’s premier software platform for managing, analyzing and reporting … Continued

Interplay of Metabolism and Transport in Determining Oral Drug Absorption and Gut Wall Metabolism: A Simulation Assessment Using the “Advanced Dissolution, Absorption, Metabolism (ADAM)” Model

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Bioavailability of orally administered drugs can be influenced by a number of factors including release from the formulation, dissolution, stability in the gastrointestinal (GI) environment, permeability through the gut wall and first-pass gut wall and hepatic metabolism. Although there are various enzymes in the gut wall which may contribute to gut first pass metabolism, Cytochrome … Continued

Pharmacokinetics of Tramadol and O-Desmethyltramadol Enantiomers Following Administration of Extended-release Tablets to Elderly and Young Subjects

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Tramadol is frequently used in geriatric patients; however, pharmacokinetic (PK) publications on tramadol and O-desmethyltramadol (ODM) in elderly patients are rare. Our objective was to characterize the PK of tramadol and ODM, including absorption processes and covariates for tramadol, in elderly and young subjects after single-dose administration of 200-mg extended-release tablets. We conducted a PK … Continued

Certara Scientists to Give 22 Presentations at the AAPS Annual Meeting

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Their contributions include workshops, symposia, roundtables, posters, and a sunrise session PRINCETON, NJ – Oct. 23, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced that its scientists are giving 22 presentations at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition being held in Orlando, FL from Oct. 25-29. … Continued

How to Optimize Your Drug Label Using Biosimulation Methodology

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従来よりモデリング&シミュレーション (M&S) は、医薬品開発において重要な役割を果たしてきただけでなく、過去18カ月間では医薬品添付文書の最適化に対して非常に大きな影響を与えています。Specifically, FDA’s acceptance of Physiologically-Based Pharmacokinetic (PBPK) modeling and simulation has impacted key label elements in more than a dozen cases, driving down R&D costs and timelines, … Continued

Japanese Medical Research and Development Agency Selects Phoenix WinNonlin Software

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PRINCETON, NJ – Oct. 20, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced that Japan’s new Agency for Medical Research and Development (AMED) has selected Certara’s Phoenix®WinNonlin® software for pharmacokinetic/pharmacodynamic (PK/PD) modeling and non-compartmental analysis of new drug candidates. AMED was launched on 2015年4月1日 and fulfills a similar role … Continued

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