The Role of Machine Learning in Centralized Authorization Process of Nanomedicines in European Union.

Journal: Current topics in medicinal chemistry
Published Date:

Abstract

BACKGROUND: Machine Learning (ML) has experienced an increasing use, given the possibilities to expand the scientific knowledge of different disciplines, such as nanotechnology. This has allowed the creation of Cheminformatic models capable of predicting biological activity and physicochemical characteristics of new components with high success rates in training and test partitions. Given the current gaps of scientific knowledge and the need for efficient application of medicines products law, this paper analyzes the position of regulators for marketing medicinal nanoproducts in the European Union and the role of ML in the authorization process.

Authors

  • Ricardo Santana
    DeustoTech-Fundation Deusto, Bilbao, Spain. ricardo.santana@opendeusto.es.
  • Enrique Onieva
  • Robin Zuluaga
  • Aliuska Duardo-Sanchez
    Department of Public Law, Chair on Human Genome and Law, University of the Basque Country (UPV/EHU), 48940, Leioa, Spain.
  • Piedad Gañán