Clinical data required for the approval of pediatric pharmaceuticals in Japan
The appropriateness or sufficiency of the clinical data package can refer to the PMDA. By considering joining a multinational study and determining the required number of Japanese patients, a path toward the approval of pediatric drugs in Japan can be identified.
Authors
- Mayumi Shikano
- Kenji Matsuda (ORCID: https://orcid.org/0000-0002-7579-1690)
- Hisamitsu Haigo
Institutions
- Tokyo University of Science (JP)
- The University of Tokyo (JP)
Publication Details
- Journal
- BMC Pediatrics
- Published
- 2025-04-13
- DOI
- https://doi.org/10.1186/s12887-025-05646-0
- Primary Topic
- Pharmaceutical studies and practices
- Type
- article
- Field-Weighted Citation Impact
- 0.00