Certara Experts to Host Two Workshops and Present Ten Posters at PAGE 2015

Certara also contributes to a student scholarship fund to ensure that aspiring pharmacometrics researchers can attend the conference PRINCETON, NJ – May 28, 2015 – Certara®, the global biosimulation technology-enabled drug development consultancy, today announced that it will be presenting two workshops and 10 posters at the 2015 Population Approach Group in Europe (PAGE) Annual … Continued

Why Using In Silico Modeling for Cardiac Safety is the Next Big Thing

The sky high cost of drug development means that late stage drug attrition is especially devastating. Thus, the ability to assess potential drug safety issues early— using in vitro data— would be very beneficial. The current paradigm for cardiac safety pharmacology is rooted in the preclinical ICH S7B and clinical ICH E14 guidelines. There have … Continued

Dosing for Two: How Pharmacometrics Supports Drug Safety in Pregnancy

According to the US Census Bureau, there is a birth every eight seconds in the United States. Women frequently take prescription and over-the-counter drugs during pregnancy. Given the ubiquity of pregnancy and births, you’d think that there would be a robust understanding of the safety and efficacy of drugs in pregnant women. However, the vast … Continued

WCG and Certara Co-sponsor Lasker Leadership Events for International Medical Research Students

Support will include the inaugural Lasker Lessons in Leadership series in the US and NIH Global Doctoral Partnerships Annual Research Colloquium in the UK PRINCETON, NJ – May 19, 2015 – WIRB-Copernicus Group (WCG), the world’s largest provider of regulatory and ethical review services and software to support clinical research, and Certara®, the global biosimulation … Continued

A Clearer Crystal Ball: A Meta-regression Model Predicts TB Relapse

What would you guess is the world’s most neglected disease? I bet that you wouldn’t pick tuberculosis (TB)— a disease that causes an estimated 9 million new cases and 1.3 million deaths annually. This infectious disease is caused by the bacterium Mycobacterium tuberculosis. TB usually attacks the lungs, but can attack any part of the body. … Continued

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

Does Age Affect Gastric Emptying Time? A Model-based Meta-analysis

Gastric emptying (GE) is often reported to be slower and more irregular in premature neonates than in older children and adults. The aim of this study was to investigate the impact of age and other covariates on the rate of GE. The effect of age on the mean gastric residence times (MGRT) of liquid and solid food was assessed by analyzing 49 … Continued

Population Pharmacokinetic Analysis of Thrombomodulin Alfa to Support Dosing Rationale in Patients with Renal Impairment

Thrombomodulin alfa is a soluble recombinant human thrombomodulin that was reported to enhance the reversal of disseminated intravascular coagulation (DIC) in subjects with sepsis or hematologic malignancy and reduce mortality in subjects with sepsis and DIC. Population pharmacokinetic (PK) analysis of thrombomodulin alfa was performed based on rich samples collected in 24 healthy subjects (0.02 … Continued

Prediction of Voriconazole Non-linear Pharmacokinetics Using a Pediatric Physiologically-based Pharmacokinetic Modeling Approach

We read with interest the report by Zane and Thakker entitled ‘‘A PBPK model for voriconazole disposition predicts intestinal first-pass metabolism in children’’. We believe the authors should be congratulated for tackling the complex case of voriconazole, as this is a drug with non-linear pharmacokinetics where clinical trials have shown a marked difference between adults … Continued