2015 | 第 2 页，共 15 页

FDA Equips its Pharmacometrics Teams with Certara’s Phoenix Software

2015 年 11 月 2 日

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

Population PK & Dosing Implications for Cobimetinib in Cancer Patients

2015 年 11 月 1 日

By webdev

A population pharmacokinetic model was developed for cobimetinib in cancer patients. Covariates had minimal impact on steady-state exposure, suggesting no need for dose adjustments and supporting the recommended dose for all patients.

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

2015 年 11 月 1 日

By webdev

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

2015 年 10 月 27 日

By webdev

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

2015 年 10 月 25 日

By webdev

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

2015 年 10 月 25 日

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

2015 年 10 月 25 日

By webdev

Certara Scientists to Give 22 Presentations at the AAPS Annual Meeting

2015 年 10 月 23 日

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

2015 年 10 月 21 日

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

2015 年 10 月 20 日

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 2015 年 4 月 1 日 and fulfills a similar role … Continued

第 2 页，共 15 页

Year: 2015