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The Manufacturers’ Perspective on World Health Organization Prequalification of In Vitro Diagnostics

In vitro diagnostic devices (IVDs) help clinicians determine specific conditions, monitor therapeutic efficacy, and prevent drug resistance development. While stringent regulatory authorities (SRAs) regulate IVDs in most high-income countries, regulatory authorities in many low- and middle-income co...

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Detalles Bibliográficos
Autores principales: Morin, Sébastien, Bazarova, Nelli, Jacon, Philippe, Vella, Stefano
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5848238/
https://www.ncbi.nlm.nih.gov/pubmed/29020182
http://dx.doi.org/10.1093/cid/cix719