With the long-anticipated ignition of the Research to Accelerate Cures and Equity (RACE) for Children Act on Tuesday (August 18) this week, stakeholders in the development of oncology drugs—ranging from patients and their families to clinical research sponsors and practitioners—have new hopes for advancements in more effective therapies for pediatric cancers. According to Lynne Georgopoulos, … Continued
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
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.
The astronomical cost of conducting clinical drug trials means that a suboptimal trial design adds significant risk to a drug program. Clinical trial simulation allows drug developers to test different trial designs in silico before exposing patients to an experimental drug. In this blog post, I’ll explain how Certara’s Trial Simulator balances ease-of-use with robust … Continued
As a pediatric nephrologist, I help care for some very sick kids. And because our young patients are so ill, it’s a challenge to recruit them into clinical studies. Of course, we want to provide our patients with the best care; getting the dose right on their medications is a big part of that. However, … Continued