New biosimulation solution addresses drug candidates’ cardiotoxicity risk PRINCETON, NJ – Apr. 2, 2015 – Certara®, the global biosimulation technology-enabled consultancy, today announced the launch of version 2.0 of its Cardiac Safety Simulator (CSS), which has become a standalone product for the first time. CSS is currently being used by several leading pharma companies, two … Continued
Historically, toxicity testing has been conducted by giving lab animals high doses of chemicals and observing them for adverse events. But quantifying the risks chemicals pose to humans based on animal studies is problematic as the chemical doses are often orders of magnitude higher than environmental levels. Moreover, this process is slow, expensive, and ethically … Continued
Monoclonal antibodies (mAbs) and their derivatives are a rapidly growing segment of the pharmaceutical industry’s pipeline. In fact, more than 40 mAbs and derivatives have been approved for a variety of therapeutic applications; around 500 mAbs and derivatives are currently in different stages of development. Monoclonal antibodies have pharmacokinetic (PK) properties that are quite distinct from that … Continued
Rostami is recognized for his scientific leadership, original thinking, and commitment to knowledge sharing with his colleagues and students PRINCETON, NJ – Jan. 29, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced that it has promoted Amin Rostami, Pharm.D., Ph.D. to senior vice president (SVP) of R&D … 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
Simcyp Simulator advances drug development and regulatory approval for majority of top 40 pharma companies PRINCETON, NJ – Nov. 19, 2014 – Certara®, the leading global technology-enabled drug development and drug safety consultancy, today announced that it has released version 14 of its Simcyp™ Population-based Simulator, which enables biopharmaceutical researchers to predict drug-drug interactions and … Continued
I recently got the chance to attend the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition in San Diego, California. It was a valuable opportunity to see some truly innovative scientific approaches to the toughest challenges in drug development. Pediatric drug development, in particular, remains a top challenge for the pharmaceutical industry as … Continued
Enhanced solution will be able to model additional populations, and diseases, and also consider new mechanisms that impact dermal absorption. ST. LOUIS, MO – Oct. 23, 2014 – Certara®, the leading global technology-enabled drug development and drug safety consultancy, today announced that it has received a Food and Drug Administration (FDA) Office of Generic Drugs … Continued
