Document Detail


Instrumentation and radiopharmaceutical validation.
MedLine Citation:
PMID:  19834450     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Although the promise of new positron emission tomography (PET) imaging agents is great, the process of bringing these agents to commercialization remains in its infancy. There are no PET products today that have gone through the full clinical and chemistry development process required to gain marketing approval by the US Food and Drug Administration (FDA). The purpose of this paper was to review validation from the perspective of the chemistry, manufacturing and controls (CMC) section of an FDA filing, as well as the validation requirements described in FDA good manufacturing practice (GMP) regulations, guidance documents and general chapters of the US Pharmacopeia (USP). The review includes discussion of validation from development to commercial production of PET radiopharmaceuticals with a special emphasis on equipment and instrumentation used in production and testing. The goal is to stimulate a dialog that leads to the standardization of industry practices and regulatory requirements for validation practices in PET.
Authors:
S S Zigler
Publication Detail:
Type:  Journal Article; Validation Studies    
Journal Detail:
Title:  The quarterly journal of nuclear medicine and molecular imaging : official publication of the Italian Association of Nuclear Medicine (AIMN) [and] the International Association of Radiopharmacology (IAR), [and] Section of the Society of Radiopharmaceutical Chemistry and Biology     Volume:  53     ISSN:  1824-4785     ISO Abbreviation:  Q J Nucl Med Mol Imaging     Publication Date:  2009 Aug 
Date Detail:
Created Date:  2009-10-16     Completed Date:  2010-03-24     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101213861     Medline TA:  Q J Nucl Med Mol Imaging     Country:  Italy    
Other Details:
Languages:  eng     Pagination:  402-10     Citation Subset:  IM    
Affiliation:
PETNET Solutions, Inc., Knoxville, TN 37932, USA. steve.zigler@petnetsolutions.com
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MeSH Terms
Descriptor/Qualifier:
Drug Approval / legislation & jurisprudence*
Drug Evaluation, Preclinical / instrumentation*,  methods
Equipment Design
Government Regulation*
Isotope Labeling / instrumentation*,  standards*
Nuclear Medicine / standards*
Radiopharmaceuticals / standards*
United States
Chemical
Reg. No./Substance:
0/Radiopharmaceuticals

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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