TY - JOUR
T1 - Spectrometric Assessment of Generic and Brand Drug Quality for a Sentinel Screening Network
AU - Isaacs, James T.
AU - Almeter, Philip J.
AU - Henderson, Bradley S.
AU - Hunter, Aaron N.
AU - Platt, Thomas L.
AU - Lodder, Robert A.
N1 - Publisher Copyright:
© The Author(s) 2023.
PY - 2023/8
Y1 - 2023/8
N2 - 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.
AB - 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.
KW - NIR spectrometery
KW - Near-infrared spectrometry
KW - Raman spectrometry
KW - sterile pharmaceuticals
UR - http://www.scopus.com/inward/record.url?scp=85165593276&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85165593276&partnerID=8YFLogxK
U2 - 10.1177/00037028231184478
DO - 10.1177/00037028231184478
M3 - Article
C2 - 37475201
AN - SCOPUS:85165593276
SN - 0003-7028
VL - 77
SP - 915
EP - 927
JO - Applied Spectroscopy
JF - Applied Spectroscopy
IS - 8
ER -