EMA perspective on the value of model-informed drug development for labeling recommendations regarding medicine use during pregnancy and breastfeeding.
作者信息
Manolis Efthymios, Musuamba Flora Tshinanu, de Vries Corinne S, Colin Pieter J, Oleksiewicz Martin B
机构信息
European Medicines Agency, Amsterdam, The Netherlands.
Federal Agency for Medicines and Health Products, Brussel, Belgium.
出版信息
CPT Pharmacometrics Syst Pharmacol. 2024 Nov;13(11):1820-1823. doi: 10.1002/psp4.13214. Epub 2024 Aug 13.
Abstract
摘要
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