Accelerating Pediatric Drug Development and the Role of Clinical Pharmacology - an Industry Perspective

抄録

In this presentation, the International Consortium for Innovation and Quality (IQ) Clinical Pharmacology Pediatric Workgroup (CPLG-PWG) will be introduced. The continuous challenges in pediatric drug development and approval, and the evolving global regulations on pediatric drug development will be presented. IQ CPLG-PWG's perspective on when, what and how to plan for an efficient pediatric program will be discussed, with special focus on clinical pharmacology applications. Published examples of using exposure matching and biomarker for pediatric extrapolation, natural history/external control/single-arm study in rare diseases, combined adolescent and adult trials and the use of RWE in innovative and efficient pediatric drug development, as well as Clinical Pharmacology's role in age-appropriate pediatric formulation will also be presented.