Leveraging Biosimulation for Pediatric Drug Development Success
Historically, most medications given to children had not been evaluated in pediatric clinical trials due to logistical and ethical challenges. Without an approved clinical process, physicians are left with inaccurate dosing and therapeutic approaches for children.
Both the U.S. Food and Drug Administration (F.D.A) and the European Medicines Agency (E.M.A) have legislated that pharmaceutical companies must develop label guidelines for pediatric drug development. These guidelines also must include proper dosing for children of all ages. These agencies have also recommended the use of biosimulation methods. Biosimulation leverages information from preclinical studies, adult trials, peer-reviewed literature, and pediatric studies of related indications or drug actions.
Certara has developed technologies and strategies for pediatric drug development to inform dose selection. These technologies include pharmacokinetic/pharmacodynamic PK/PD simulations using sparse data analysis and its Simcyp® Pediatric Simulator. The Simulator captures developmental changes in physiology and enzyme/transporter ontogeny. These changes are particularly prominent in children from birth to two years of age. Certara’s solutions provide the most advanced strategy for neonatal drug development.
Certara also offers regulatory strategy for pediatrics. The strategy includes creation of regulatory documents such as the Pediatric Study Plan (PSP) and Pediatric Investigation Plan (PIP). Our role enhances the understanding of regulations and drug development challenges, to maximize the impact of your data set to create a comprehensive plan to deliver new and safer therapies to children of all ages.