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Using Realistic Covariates with New Trial Simulator to Optimize Meropenem Dosing in Renally-impaired Children

On-Demand Webinar

In this webinar, see the new Trial Simulator v2.3 in action as Dr. Edward Nehus of Cincinnati Children’s Hospital and Dr. Mark Lovern, VP of Integrated Drug Development at Certara, evaluate target attainment of meropenem in various age groups and fluid overload in children receiving continuous renal replacement therapy (CRRT), reconstructing a previously published Trial Simulator model.  Meropenem is often prescribed in children receiving CRRT, but fluid overload can be present in ill children, affecting drug disposition.

Trial Simulator provides a powerful and efficient approach to computer-assisted trial design, balancing ease-of-use with robust tools for defining study design attributes, conducting statistical and sensitivity analysis, and creating graphical summaries to plan effective trials for every phase of clinical drug testing. While it provides an intuitive user interface to help new users learn trial simulation, Trial Simulator also has the flexibility and versatility to be applied to the most complex trial situations and now connects directly with R and ggplot for custom plotting capabilities.

Join this webinar to learn how to use trial simulation to anticipate risks and preview the range of expected results before millions in R&D dollars are spent, and subjects are exposed to experimental therapies.

About Our Speakers

Mark Lovern  |  Dr. Mark Lovern joined Certara (then Quantitative Solutions) in 2012 with 14 years of experience in applying modeling and simulation tools and techniques toward optimally informing drug development decision-making. Since joining Certara, Dr Lovern has led and contributed to numerous consultancy projects involving population PK, PK/PD, and model-based meta-analysis. In June 2014, Dr Lovern assumed leadership of the Eastern US division of Quantitative Solutions, and continues in this capacity within Certara Strategic Consulting (CSC). His previous work history has been split between biopharmaceutical companies (GSK and UCB) and companies that support the biopharmaceutical industry (Quintiles and Pharsight). In addition to modeling pharmacokinetic and pharmacodynamic data across a wide variety of compounds and therapeutic areas, Mark has also taught over 50 technical training workshops on modeling tools and methodology. His most recent therapeutic area experience has been with therapies for infectious disease, metabolic, and autoimmune disorders.

Edward Nehus  |  Dr. Edward Nehus is a Pediatric Nephrologist in the Division of Nephrology at the Cincinnati Children’s Hospital Medical Center and an Assistant Professor at the University of Cincinnati, Department of Pediatrics. Edward conducted and published a cross-sectional study which investigated the association of serum resistin with cardiovascular risk factors in children with chronic kidney disease. In addition, he recently published a study evaluating the outcomes steroid-avoidance protocols in pediatric kidney transplant recipients. He continues to be the primary investigator for ongoing studies that explore pharmacokinetic alterations in critically ill children receiving continuous renal replacement therapy. (Photo courtesy of Cincinnati Children’s Hospital Medical Center: www.cincinnatichildrens.org)

In this webinar, see the new Trial Simulator v2.3 in action as Dr. Edward Nehus of Cincinnati Children’s Hospital and Dr. Mark Lovern, VP of Integrated Drug Development at Certara, evaluated target attainment of meropenem in various age groups and fluid overload in children receiving continuous renal replacement therapy (CRRT), reconstructing a previously published Trial Simulator model. Meropenem is often prescribed in children receiving CRRT, but fluid overload can be present in ill children, affecting drug disposition.

Trial Simulator provides a powerful and efficient approach to computer-assisted trial design, balancing ease-of-use with robust tools for defining study design attributes, conducting statistical and sensitivity analysis, and creating graphical summaries to plan effective trials for every phase of clinical drug testing. While it provides an intuitive user interface to help new users learn trial simulation, Trial Simulator also has the flexibility and versatility to be applied to the most complex trial situations and now connects directly with R and ggplot for custom plotting capabilities.

Watch this webinar to learn how to use trial simulation to anticipate risks and preview the range of expected results before millions in R&D dollars are spent, and subjects are exposed to experimental therapies.

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