Using Modeling and Simulation to Support Approvals for Orphan Drugs

Rare diseases affect fewer than 1 in 2000 people. Each one affects only a small number of patients. Yet, there are over 7000 rare diseases. And, there are no treatments for 95 percent of them. Thus, many patients suffer from these diseases. The treatments for rare diseases are often referred to as “orphan drugs.” Orphan … Continued

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

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

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

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

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 April 1, 2015 and fulfills a similar role … Continued

How Modeling and Simulation Technology Could Save Us from the Zombie Apocalypse

Skeptical at the idea of ravenous brain-eating undead? You don’t have to take my word for it. The Centers for Disease Control and Prevention (CDC) Office of Public Health Preparedness and Response recognizes this threat. Their Zombie Preparedness website provides information on getting ready for all kinds of disasters. Modeling and simulation (M&S) technology can … Continued

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

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