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Extent of safety database in pediatric drug development: types of assessment, analytical precision, and pathway for extrapolation through on-target effects

Autor: Margaret Gamalo, Yihua Zhao, Aijun Gao, Jingjing Ye, Junjing Lin, Eiji Eshida, YounJeong Choi, Robert Nelson

Publikováno v: Journal of Biopharmaceutical Statistics. :1-16

Pediatric patients should have access to medicines that have been appropriately evaluated for safety and efficacy. Given this goal of revised labelling, the adequacy of the pediatric clinical development plan and resulting safety database must inform

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e7ce8da3a3c5df424d057f6225e7c572
https://doi.org/10.1080/10543406.2023.2172425

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