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A Combined 3D Tissue Engineered In Vitro/In Silico Lung Tumor Model for Predicting Drug Effectiveness in Specific Mutational Backgrounds
Published on: April 6, 2016
The acceptance of in silico models for REACH: Requirements, barriers, and perspectives
Emilio Benfenati1, Rodolfo Gonella Diaza, Antonio Cassano
1Istituto di Ricerche Farmacologiche "Mario Negri", Via La Masa 19, 20156, Milano, Italy. emilio.benfenati@marionegri.it.
Abstract:
In silico models have prompted considerable interest and debate because of their potential value in predicting the properties of chemical substances for regulatory purposes. The European REACH legislation promotes innovation and encourages the use of alternative methods, but in practice the use of in silico models is still very limited. There are many stakeholders influencing the regulatory trajectory of quantitative structure-activity relationships (QSAR) models, including regulators, industry, model developers and consultants. Here we outline some of the issues and challenges involved in the acceptance of these methods for regulatory purposes.
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