Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective

por Manolis, Efthymios, García‐Arieta, Alfredo, Lindahl, Anders, Kotzagiorgis, Evangelos, Limberg, Jobst, Holte, Øyvind, Paixao, Paulo, Versantvoort, Carolien, Tshinanu, Flora Musuamba, Blake, Kevin, Van Den Heuvel, Michiel
Publicado 2023

Sex Proportionality in Pre-clinical and Clinical Trials: An Evaluation of 22 Marketing Authorization Application Dossiers Submitted to the European Medicines Agency

por Dekker, Marieke J. H. J., de Vries, Sieta T., Versantvoort, Carolien H. M., Drost-van Velze, Ellen G. E., Bhatt, Mansi, van Meer, Peter J. K., Havinga, Ineke K., Gispen-de Wied, Christine C., Mol, Peter G. M.
Publicado 2021