Clinical data required for the approval of pediatric pharmaceuticals in Japan
Abstract Background In Japan, the number of pharmaceuticals with pediatric indications is low, and some are approved only in Europe or the USA but not in Japan. As the approval review report by the Japanese health authority contains any detailed items considered for drug approval, this study aimed t...
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| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2025-04-01
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| Series: | BMC Pediatrics |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12887-025-05646-0 |
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