A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.
PRINCETON, NJ – June 6, 2017 – Certara today launched its Clinical Outcomes Database Explorer (CODEx). An intuitive, web-based platform, CODEx enables drug development teams to easily visualize, explore, analyze and communicate content from Certara’s Clinical Trial Outcomes Databases and assess a given compound’s probability of success against competitor drugs.
A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.
In vitro-in vivo extrapolation of clearance, embedded in a clinical trial simulation, was used to investigate differences in the pharmacokinetics and pharmacodynamics of dextromethorphan between CYP2D6 poor and extensive metabolizer phenotypes. Information on the genetic variation of CYP2D6, as well as the in vitro metabolism and pharmacodynamics of dextromethorphan and its active metabolite dextrorphan, was … 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
Meropenem is frequently prescribed in children receiving continuous renal replacement therapy (CRRT). Fluid overload is often present in critically ill children and affects drug disposition. The purpose of this study was to develop a pharmacokinetic model to 1) evaluate target attainment of meropenem dosing regimens against P. aeruginosa in children receiving CRRT and 2) estimate … Continued
Effective medications are a mainstay of modern pediatric medicine. Yet, ethical concerns about conducting clinical trials in pediatric patients are a major challenge in pediatric drug development. Learn how Dr. Samer Mouksassi and his team at Certara Strategic Consulting have overcome these challenges through the use of pharmacometrics.
Clinical trial simulation (CTS) and model-based meta-analysis (MBMA) can increase our understanding of small, first-in-patient (FIP) trial design performance to inform Phase 2 decision making. In this work, we compared dose-ranging designs vs. designs testing only placebo and the maximum dose for early decision making in psoriasis. Based on MBMA of monoclonal antibodies in the … Continued
Phenylbutyric acid (PBA), which is approved for treatment of urea cycle disorders (UCDs) as sodium phenylbutyrate (NaPBA), mediates waste nitrogen excretion via combination of PBA-derived phenylacetic acid with glutamine to form phenylactylglutamine (PAGN) that is excreted in urine. Glycerol phenylbutyrate (GPB), a liquid triglyceride pro-drug of PBA, containing no sodium and having favorable palatability, is … Continued
Teduglutide, a synthetic glucagon-like peptide-2 (GLP-2) analog with activity relating to the regeneration, maintenance, and repair of the intestinal epithelium, is currently being evaluated for the treatment of short-bowel syndrome (SBS), Crohn’s disease, and other gastrointestinal disorders. On the basis of promising results from teduglutide studies in adults with SBS and from studies in neonatal … Continued
