Director of Clinical Pharmacology & Pharmacometrics Agios Pharmaceuticals
The development of medications for pediatrics are always problematic because of different physical development stages and this difference cannot be ignored. Those physiological difference/condition is influenced drug absorption and metabolism. In this session, focus on the age specific modeling (pediatrics), formulation development for pediatrics, clinical study design for pediatrics, PK study and smooth transition from preclinical to clinical, and regulatory aspects will be focused on and the newest in vitro methods technology for pediatric population. The information and newer findings are shared in this symposium. in this particular presentation, the view of regulatory agencies for the drug development in pediatrics will be presented. this program idea is supported by OBAM community.
Learning Objectives:
Participants will gain the idea of new drug development, formulation, modeling for pediatric space and potentially new evaluation, prediction method and way.
Participants will understand the movement and the whole picture of drug development from discovery, to preclinical and, potentially, clinical studies for pediatrics.
Participants will be able to build the knowledge what to expect and what will be the next wave of new drug development for pediatrics.
