October 2015

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

10월 27, 2015

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

Application of Physiologically-based Absorption Modelling in the Development of an In Vitro-In Vivo Correlation (IVIVC) for Topiramate Controlled Release Matrix Tablets

10월 25, 2015

By webdev

Application of the “MechPeff” Model to Predict Passive Regional Effective Intestinal Permeability in Rat using Drug Physicochemical Parameters as Inputs

10월 25, 2015

By webdev

In Silico Prediction of Regional Passive Intestinal Permeability in Cynomolgus Monkey using ‘MechPeff’: A Mechanistic Model with Drug Physicochemical and In Vitro Parameters as Inputs

10월 25, 2015

By webdev

Certara Scientists to Give 22 Presentations at the AAPS Annual Meeting

10월 23, 2015

By webdev

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

10월 21, 2015

By webdev

While biosimulation has been an important element in drug development for some time, its impact over the past 18 months with regard to label optimization has been profound. 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

10월 20, 2015

By webdev

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 4월 1, 2015 and fulfills a similar role … Continued

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

10월 19, 2015

By webdev

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

10월 12, 2015

By webdev

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

CLIP—A Command-line Interface to Certara’s Phoenix NLME

10월 4, 2015

By webdev

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Month: October 2015