Clinical Pharmacology – Biomolecular
2019 PharmSci 360
Quick access to pediatric population after drug approval in adults is critical. Industries, regulators and pediatricians have different understanding on what is needed and how to accelerate the drug development in pediatrics. Clinical pharmacology played an important role in expediting the drug development in the pediatric population by leveraging M&S approach and extrapolation strategy to identify the appropriate dose(s) to be tested in phase III pediatric clinical trial.My presentation will cover how extrapolation strategy and M&S approach will be applied to accelerate the drug development in pediatric population of inflammatory bowel disease.