Computer simulation provides an effective means for evaluating whether a clinical trial design is efficient and optimally informative with a high likelihood of success. Many variables affect the likelihood of success of a trial, and genetic variation in the population is being evaluated with increasing frequency for its impact on trial outcomes.
Anticipate risks and preview the range of expected results before millions in R&D dollars are spent and human subjects are exposed to experimental therapies.
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 – 2017年6月6日 – 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.
If you have ever argued, as we have, for the resources and time needed for model-based drug development (MBDD), you have likely encountered that irritating accountant in the room who says, “Sure, this modeling stuff sounds interesting, but how much MONEY will this save us?”My answer: $97M of savings per New Drug Application (NDA). … Continued
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.
