Certara also contributes to a student scholarship fund to ensure that aspiring pharmacometrics researchers can attend the conference PRINCETON, NJ – 5월 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
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
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
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 – 5월 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
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
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
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
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
PURPOSE: To characterize dose and response for intraocular pressure (IOP) reduction and incidence of hyperemia using a model-based meta-analysis of IOP-lowering monotherapy studies to evaluate new ocular antihypertensive therapies for glaucoma. METHODS: Published randomized controlled trials, regulatory documents, and sponsor reports of IOP-lowering monotherapies were used to develop dose-response models to characterize efficacy (IOP change … Continued
