Certara Launches Its Simcyp In Vitro Analysis Toolkit to Improve Drug Discovery & Development

This new standalone solution is designed to meet the needs of early-stage drug discovery and development researchers. PRINCETON, NJ – July 29, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced the launch of its Simcyp In Vitro (Data) Analysis (SIVA) Toolkit, version 1.0. The SIVA Toolkit is designed to enable the … Continued

100 Articles That Will Help You Understand PBPK Modeling & Simulation

As a company with a strong academic foundation, our scientists actively publish the results of their research in the form of conference abstracts and peer-reviewed papers. We’re proud to announce that our PBPK modeling and simulation group has hit a milestone of having published more than 100 papers since 2007. In this blog post, I’ll discuss … Continued

Population Pharmacokinetic Modeling of Motesanib and Its Active Metabolite, M4, in Cancer Patients

Motesanib is a small molecule and potent multikinase inhibitor with antiangiogenic and antitumor activity. Population pharmacokinetic (POPPK) modeling of motesanib and M4, an active metabolite, was performed to assess sources of variability in cancer patients. The analysis included data collected from 451 patients from 8 clinical trials with oral doses of motesanib ranging from 25 … Continued

How to Revamp Your Approach to Conventional IVIVC Models

An IVIVC (in vitro-in vivo correlation) is a predictive mathematical model describing the relationship between the in vitro properties of a dosage form and the in vivo responses. Drug developers frequently find IVIVCs useful for a number of reasons: They can use dissolution tests as a surrogate for human bioequivalence (BE) studies. They can support … Continued

Certara Appoints Tristen Herrstrom as Senior Vice President of Human Resources

Ms. Herrstrom will focus on enhancing talent acquisition, leadership development, and other key growth initiatives. PRINCETON, NJ – July 16, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced that it has appointed Tristen Herrstrom to the newly-created position of senior vice president of human resources. With responsibility for establishing the strategic … Continued

What NASA’s New Horizons has in Common with Regulatory Writing

Today, NASA’s New Horizons spacecraft will pass by Pluto in the outer solar system after a journey of more than 7.8 million miles (12.5 million kilometers). That is, if everything goes well. After a 6-year journey and a cost of $728 million dollars, mission managers are hoping to avoid a mission ending error caused by … Continued