Fostering Pediatric Oncology Drug Development
Our speakers will discuss the pediatric oncology regulatory landscape and how modeling and simulation is used in pediatric oncology drug development.
Tag: Pediatrics
The Research to Accelerate Cures and Equity (RACE) for Children Act: Changing the Landscape of Pediatric Cancer Drug Development
3 key tips to set your pediatric program up for success with the RACE for Children Act by Lynne Georgopoulos, RN, MSHS, RAC, Vice President, Regulatory Strategy at Certara On August 18, 2020, the Research to Accelerate Cures and Equity (RACE), which amends the Pediatric Research and Equity Act (PREA) comes into effect. With the … Continued
Certara Nurture Pediatric Program
Use of Modeling and Simulations to Determine Raltegravir Dosing in Neonates: A Model for Safely and Efficiently Determining Appropriate Neonatal Dosing Regimens: IMPAACT P1110
Maternal-Neonatal Raltegravir Population Pharmacokinetics Modeling: Implications for Initial Neonatal Dosing
Maternal-Neonatal Raltegravir Population Pharmacokinetics Modeling: Implications for Initial Neonatal Dosing
Certara’s Best of the Blog 2019
A selection of short essays from our blog, written to empower our clients with modeling and simulation (M&S), regulatory science, and real-world value assessment solutions to help them solve the toughest drug development problems. In the Best of the Blog, Certara’s scientists and regulatory experts share their learnings, technological advances, and thought leadership.
Using PK/PD M&S for Pediatric Drug Development: Regulatory Insights into Practical Issues
This webinar addressed some of the challenges associated with pediatric drug development and the advantages (and limitations) that pediatric population PK modeling can provide.
Pharmacodynamics of rituximab on B cells in paediatric post-HSCT patients with EBV
Using Realistic Covariates with New Trial Simulator to Optimize Meropenem Dosing in Renally-impaired Children
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.