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TITLE: Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective
AUTHORS: Manolis, Efthymios; Garcia Arieta, Alfredo; Lindahl, Anders; Kotzagiorgis, Evangelos; Limberg, Jobst; Holte, Oyvind; Paixao, Paulo; Versantvoort, Carolien; Tshinanu, Flora Musuamba; Blake, Kevin; Van den Heuvel, Michiel;
PUBLISHED: 2023, SOURCE: CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY
INDEXED IN: Scopus WOS
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TITLE: Model-Informed Drug Development: Steps Toward Harmonized Guidance
AUTHORS: Marshall, Scott; Ahamadi, Malidi; Chien, Jenny; Iwata, Daisuke; Farkas, Pavel; Filipe, Augusto; Frey, Nicolas; Greene, Erin; Kawai, Norisuke; Li, Jian; Lippert, Jorg; Tshinanu, Flora Musuamba; Manolis, Efthymios; Peterson, Mark C.; Sarem, Sarem; Shebley, Mohamad; Tegenge, Million; Tsai, Chia Hsun; Tu, Chien Lung; Otsubo, Yasuto; Wei, Jiawei; Zhang, Lucia; Zhu, Hao; Karlsson, Kristin E.; ...More
PUBLISHED: 2023, SOURCE: CLINICAL PHARMACOLOGY & THERAPEUTICS
INDEXED IN: Scopus WOS