The Highlights in Model-based Drug Development for 2014

As the end of the year draws near, I want to thank all of our customers for letting us be your biosimulation and model based drug development solution provider. We feel honored to be able to play a small, but crucial role in your success in bringing safe and effective drugs to patients. 2014 has … Continued

Certara VP and Lead Scientist Evaluates Pivotal Study at Cardiac Safety Research Consortium Meeting

Study results support replacing the expensive and time-consuming TQT study with QT assessment in early clinical development PRINCETON, NJ – Dec. 23, 2014 – Certara®, the leading global technology-enabled drug development and drug safety consultancy, today announced that its Vice President and Lead Scientist Christine Garnett, PharmD, was session chair at the Dec.12 Cardiac Safety … Continued

A Change of Heart at the Cardiac Safety Research Consortium

The ICH E14 guidance recommends that all new drugs with systemic bioavailability are assessed for the ability to delay cardiac repolarization as measured by the QT/QTc interval on the surface ECG. For most drugs, this evaluation is performed in the Thorough QT/QTc (TQT) study. Could using model-based approaches during routine early studies influence the current … Continued

Onartuzumab with or without Bevacizumab in Combination with Weekly Paclitaxel Does Not Prolong QTc or Adversely Affect Other ECG Parameters in Patients with Locally Recurrent or Metastatic Triple-negative Breast Cancer

The purpose of this study was to examine the potential effect of onartuzumab, when administered with or without bevacizumab in combination with weekly paclitaxel, on the corrected QT interval (QTc) and other electrocardiogram (ECG) parameters, was investigated in a randomized, phase 2 study OAM4861g of first- or second-line therapy in patients with locally recurrent or … Continued

5 Updates to the Simcyp Simulator You’ll Be Psyched About

The Simcyp™ Population-based Simulator streamlines drug development through the modelling and simulation of physiologically-based pharmacokinetics (PK) and pharmacodynamics (PD) in virtual patient populations. It incorporates numerous databases containing human physiological, genetic and epidemiological information. By integrating this information with in vitro or clinical data, the Simulator can predict PK/PD behavior in ‘real-world’ populations. It can be used to select … Continued

Pharmacokinetics of Vancomycin in Critically Ill Patients in Thailand

The pharmacokinetics and pharmacodynamics of drugs in critically ill patients are difficult to predict due to complex pathophysiological changes. Vancomycin is an antibiotic commonly used to treat serious gram positive bacterial infections in critically ill patients and the treatment goal is to rapidly achieve and maintain therapeutic concentrations. We assessed the pharmacokinetics of vancomycin in … Continued