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
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
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
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
Muse Invent enables researchers not only to design dream molecules, but it also shows how to produce them in the lab TOKYO, JAPAN and PRINCETON, NJ – December 9, 2014 – Certara®, the leading global technology-enabled drug development and drug safety consultancy, today announced the launch in Japan of Muse® Invent, its molecular design workflow … Continued
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
Medical-product development has become increasingly challenging and resource-intensive. In 2004, the Food and Drug Administration (FDA) described critical challenges facing medical-product development by establishing the critical path initiative. Priorities identified included the need for improved modeling and simulation tools, further emphasized in FDA’s 2011 Strategic Plan for Regulatory Science. In an effort to support and … Continued
We predicted vigabatrin dosages for adjunctive therapy for pediatric patients with refractory complex partial seizures (rCPS) that would produce efficacy comparable to that observed for approved adult dosages.
