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Month: 2015年10月

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

Certara Scientists Participate in 9 Presentations at the North American ISSX Meeting

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Diverse agenda underscores the widespread adoption of PBPK approaches throughout the drug development process PRINCETON, NJ – Oct. 19, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced that its scientists are presenting 9 seminars and poster sessions at the twentieth International Society for the Study of Xenobiotics (ISSX). This annual ISSX … Continued

Certara Joins EU-ToxRisk – A Program Driving Mechanism-based Toxicity Testing and Risk Assessment

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In a large (30 Million €) H2020-supported collaborative project, academia joins forces with small and medium-sized enterprises (SMEs), large industry, contract research organizations (CROs) and regulatory bodies to achieve a paradigm shift in toxicology towards a more efficient and animal-free chemical safety assessment. PRINCETON, NJ, Oct. 12, 2015 An international consortium of 39 partner organizations … Continued

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