Journal article
Transforming an Academic Radiochemistry Facility for Positron Emission Tomography Drug cGMP Compliance
Abstract
In light of the United States Food and Drug Administration (FDA) requirement of 21 CFR 212 current Good Manufacturing Practice (cGMP) for FDA-approved position emission tomography (PET) drugs, the University of California Los Angeles (UCLA) Biomedical Cyclotron (BMC) transformed from a pre-cGMP era academic cyclotron and radiochemistry facility to a current cGMP-compliant PET drug manufacturer. In this article, we share the financial and …
Authors
Zhu S; Mosessian S; Kroeger K; Sadeghi S; Slavik R; Kinloch S; Moore M; Allen-Auerbach M; Czernin J; Phelps M
Journal
Molecular Imaging and Biology, Vol. 22, No. 2, pp. 256–264
Publisher
Springer Nature
Publication Date
4 2020
DOI
10.1007/s11307-019-01395-6
ISSN
1536-1632