Home

EMA

Assessing Innovative Specialized Models for Pediatrics and Neonatal Patients

Since the recent signing of the FDA Safety and Innovation Act, that will expedite pediatric drug approval, more pharmaceutical companies are taking pediatric pharmacology and drug development into consideration. Before these companies can execute a pediatric clinical research strategy, they must conduct pharmacokinetic and pharmacodynamic studies to evaluate the differences between how children and adults react to and metabolize drugs, as well as address the efficacy and safety issues prior to a clinical trial.