促进儿科肿瘤药物开发
Our speakers will discuss the pediatric oncology regulatory landscape and how modeling and simulation is used in 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.
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 2020 年 8 月 18 日, the Research to Accelerate Cures and Equity (RACE), which amends the Pediatric Research and Equity Act (PREA) comes into effect. With the … Continued
Maternal-Neonatal Raltegravir Population Pharmacokinetics Modeling: Implications for Initial Neonatal Dosing
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.
This webinar addressed some of the challenges associated with pediatric drug development and the advantages (and limitations) that pediatric population PK modeling can provide.
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.