EMA perspective on the value of model-informed drug development for labeling recommendations regarding medicine use during pregnancy and breastfeeding

CPT Pharmacometrics Syst Pharmacol. 2024 Nov;13(11):1820-1823. doi: 10.1002/psp4.13214. Epub 2024 Aug 13.

Authors

Efthymios Manolis¹, Flora Tshinanu Musuamba^{2

3}, Corinne S de Vries¹, Pieter J Colin^{1

4}, Martin B Oleksiewicz⁵

Affiliations

¹ European Medicines Agency, Amsterdam, The Netherlands.
² Federal Agency for Medicines and Health Products, Brussel, Belgium.
³ University of Namur, Namur, Belgium.
⁴ University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
⁵ Danish Medicines Agency, Copenhagen, Denmark.

No abstract available