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

doi:10.1177/00037028231184478

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

Research output: Contribution to journal › Article › peer-review

Abstract

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.

Original language	English
Pages (from-to)	915-927
Number of pages	13
Journal	Applied Spectroscopy
Volume	77
Issue number	8
DOIs	https://doi.org/10.1177/00037028231184478
State	Published - Aug 2023

Bibliographical note

Funding Information:
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.

Publisher Copyright:
© The Author(s) 2023.

Keywords

NIR spectrometery
Near-infrared spectrometry
Raman spectrometry
sterile pharmaceuticals

ASJC Scopus subject areas

Instrumentation
Spectroscopy

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AU - Lodder, Robert A.

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

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

Access to Document

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