| Instrumentation and radiopharmaceutical validation. | |
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MedLine Citation:
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PMID: 19834450 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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S S Zigler |
Publication Detail:
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Type: Journal Article; Validation Studies |
Journal Detail:
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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:
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Created Date: 2009-10-16 Completed Date: 2010-03-24 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101213861 Medline TA: Q J Nucl Med Mol Imaging Country: Italy |
Other Details:
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Languages: eng Pagination: 402-10 Citation Subset: IM |
Affiliation:
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PETNET Solutions, Inc., Knoxville, TN 37932, USA. steve.zigler@petnetsolutions.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Drug Approval
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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:
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0/Radiopharmaceuticals |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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