Understanding Drug Effects in Children
Pediatric drug development continues to be a vexing challenge, yet pediatric research is increasingly being mandated by regulators and patients alike. Traditional development methods can be problematic for ethical and logistical reasons. Children are a heterogeneous population, especially neonates and infants, as organ maturation affects drug exposure and response.
Leveraging Model-informed Drug Development
Regulatory agencies worldwide encourage modeling and simulation to “get the dose right” and reduce risk in pediatric product development. Certara’s methods leverage sparse data and prior information from pre-clinical studies, adult trials, literature data, and pediatric studies of related indications or drug actions. We build that knowledge into models of patient physiology, drug actions and trial characteristics that enable us to develop and iterate clinical trial design, explore alternative dosing scenarios, in silico patient responses, drug-drug interactions, and whole trial outcomes. The “learn and apply” approach is repeated for each cohort, with additional modeling and simulation approaches used throughout the cycle. Our consultants also leverage the Simcyp® Pediatric Simulator, the industry’s most sophisticated PBPK technology for modeling drug performance and assessing drug-drug interactions in neonates, infants, and children.
Regulatory Strategy, Writing and Submission – PIP and PSP
The Synchrogenix® division of Certara is the largest, global regulatory/medical writing consultancy, employing more than 200 professionals. Its expertise in pediatrics spans more than 15 therapeutic areas with core competencies including regulatory consulting, writing, preparing and managing documents. The recent addition of GlobalSubmit™ clinical trial operations technology now facilitates the eCTD submittal process, providing scalability and consistency for sponsors.
Learn and Apply Framework
Regardless of size or complexity, your pediatric drug development program will benefit from working with Certara.