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Spectrometric Assessment of Generic and Brand Drug Quality for a Sentinel Screening Network

  • James T. Isaacs
  • , Philip J. Almeter
  • , Bradley S. Henderson
  • , Aaron N. Hunter
  • , Thomas L. Platt
  • , Robert A. Lodder

Producción científica: Articlerevisión exhaustiva

1 Cita (Scopus)

Resumen

The U.S. Food and Drug Administration (FDA) is a worldwide leader among analogous regulatory organizations in other countries. The FDA uses current good manufacturing practices to regulate the processes that produce drugs. Nevertheless, investigative journalists have pointed out problems in the drug supply, and pharmacies are not required to test the drugs they receive. The University of Kentucky Drug Quality Study does perform screening on the sterile injectable drugs that it receives and regularly reports new findings to FDA, practitioners, and the public. A Sentinel Screening Network of academic health systems could provide independent data on drug quality to FDA not available through manufacturers.

Idioma originalEnglish
Páginas (desde-hasta)915-927
Número de páginas13
PublicaciónApplied Spectroscopy
Volumen77
N.º8
DOI
EstadoPublished - ago 2023

Nota bibliográfica

Publisher Copyright:
© The Author(s) 2023.

Financiación

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The project described was supported in part by NSF ACI-1053575 allocation number BIO170011 and the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant no. UL1TR001998.

FinanciadoresNúmero del financiador
National Science Foundation (NSF)ACI-1053575, BIO170011
National Institutes of Health (NIH)UL1TR001998
National Center for Research Resources
National Center for Advancing Translational Sciences (NCATS)

    ASJC Scopus subject areas

    • Instrumentation
    • Spectroscopy

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