Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility

• Main Authors: Flora T. Musuamba (Author), Ine Skottheim Rusten (Author), Raphaëlle Lesage (Author), Giulia Russo (Author), Roberta Bursi (Author), Luca Emili (Author), Gaby Wangorsch (Author), Efthymios Manolis (Author), Kristin E. Karlsson (Author), Alexander Kulesza (Author), Eulalie Courcelles (Author), Jean‐Pierre Boissel (Author), Cécile F. Rousseau (Author), Emmanuelle M. Voisin (Author), Rossana Alessandrello (Author), Nuno Curado (Author), Enrico Dall'ara (Author), Blanca Rodriguez (Author), Francesco Pappalardo (Author), Liesbet Geris (Author)
• Format: Book
• Published: Wiley, 2021-08-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract The value of in silico methods in drug development and evaluation has been demonstrated repeatedly and convincingly. While their benefits are now unanimously recognized, international standards for their evaluation, accepted by all stakeholders involved, are still to be established. In this...