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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...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2018
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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 |