Global Harmonization of Pediatric Drug Development: Critical for Progress for Developing Safe and Effective Therapeutic Agents for Children
oleh: Andrew E. Mulberg, MD, FAAP, Timothy Cripps, MSc
| Format: | Article |
|---|---|
| Diterbitkan: | Elsevier 2019-01-01 |
Deskripsi
ABSTRACT: The article, ''Questionable Industry-Sponsored Studies in Children and Adolescents in Slovenia'' provides an opportunity to discuss evolving US and EU legislative measures to improve the available clinical trial-derived pediatric data and provide coherent labeling for pediatric providers in dosing of drugs for children. Keywords: Pediatric drug development, PIP, BPCA, PREA