Search Results - Efthymios Manolis

EMA perspective on the value of model‐informed drug development for labeling recommendations regarding medicine use during pregnancy and breastfeeding by Efthymios Manolis, Flora Tshinanu Musuamba, Corinne S. deVries, Pieter J. Colin, Martin B. Oleksiewicz

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Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective by Efthymios Manolis, Alfredo García‐Arieta, Anders Lindahl, Evangelos Kotzagiorgis, Jobst Limberg, Øyvind Holte, Paulo Paixao, Carolien Versantvoort, Flora Musuamba Tshinanu, Kevin Blake, Michiel Van Den Heuvel

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Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs, Gaps, and Challenges by Flora T. Musuamba, Roberta Bursi, Efthymios Manolis, Kristin Karlsson, Alexander Kulesza, Eulalie Courcelles, Jean‐Pierre Boissel, Raphaëlle Lesage, Cécile Crozatier, Emmanuelle M. Voisin, Cécile F. Rousseau, Thierry Marchal, Rossana Alessandrello, Liesbet Geris

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Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility by Flora T. Musuamba, Ine Skottheim Rusten, Raphaëlle Lesage, Giulia Russo, Roberta Bursi, Luca Emili, Gaby Wangorsch, Efthymios Manolis, Kristin E. Karlsson, Alexander Kulesza, Eulalie Courcelles, Jean‐Pierre Boissel, Cécile F. Rousseau, Emmanuelle M. Voisin, Rossana Alessandrello, Nuno Curado, Enrico Dall'ara, Blanca Rodriguez, Francesco Pappalardo, Liesbet Geris

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