Digital Therapeutics: An Integral Component of Digital Innovation in Drug Development.

Autor: Sverdlov O; Early Development Biostatistics, Novartis Pharmaceuticals, East Hanover, New Jersey, USA., van Dam J; Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, USA., Hannesdottir K; Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, USA., Thornton-Wells T; Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, USA.
Jazyk: angličtina
Zdroj: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2018 Jul; Vol. 104 (1), pp. 72-80. Date of Electronic Publication: 2018 Feb 23.
DOI: 10.1002/cpt.1036
Abstrakt: Digital therapeutics represent a new treatment modality in which digital systems such as smartphone apps are used as regulatory-approved, prescribed therapeutic interventions to treat medical conditions. In this article we provide a critical overview of the rationale for investing in such novel modalities, including the unmet medical needs addressed by digital therapeutics and the potential for reducing current costs of medical care. We also discuss emerging pathways to regulatory approval and how innovative business models are enabling further growth in the development of digital therapeutics. We conclude by providing some recent examples of digital therapeutics that have gained regulatory approval and highlight opportunities for the near future.
(© 2018 American Society for Clinical Pharmacology and Therapeutics.)
Databáze: MEDLINE
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