Skip to main content

1 Size Doesn’t Fit All: PBPK M&S for Individual Risk of Complex DDIs

Drug-drug interactions (DDIs) are a primary threat to the safety and efficacy of clinical practice. Clinically relevant drug interactions are primarily due to drug-induced alterations in the activity and quantity of metabolic enzymes and transporters. Indeed, DDIs that cause unmanageable, severe adverse effects have led to restrictions in clinical use and even, drug withdrawals from … Continued

Certara Launches its Cardiac Safety Simulator V2.0

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

Personalized Toxicology: A New Paradigm for Chemical Risk Assessment

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

5 Certara Posters You Should Have Seen at ASCPT 2015

I attended and contributed to the recent annual meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT) in New Orleans. This is a meeting that I have attended regularly in the past. It was a valuable opportunity to see some truly innovative scientific approaches to the toughest challenges in drug development. If I … Continued

Predicting mAb Pharmacokinetics in Humans with a Minimal PBPK Model

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

Positive Stats About PK/PD Modeling in the Pharmaceutical Industry

Pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation (M&S) is an important tool that can help researchers gain a better understanding of their drug’s efficacy— especially at the early stages of drug development. In this blog post, I’ll discuss some positive statistics uncovered in a recent IQ Consortium survey that examined the current landscape for preclinical PK/PD modeling … Continued

Certara Promotes Prof. Amin Rostami to Senior Vice President of R&D and Chief Scientific Officer

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

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

Certara Updates its Simcyp Simulator Used to Predict Drug Behavior in Virtual Patient Populations

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

29 of 35