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FASCICOLI E ARTICOLI   I PIÙ LETTI   eTOC

ULTIMO FASCICOLOTHE QUARTERLY JOURNAL OF NUCLEAR MEDICINE AND MOLECULAR IMAGING

Rivista di Medicina Nucleare e Imaging Molecolare

A Journal on Nuclear Medicine and Molecular Imaging
Affiliated to the Society of Radiopharmaceutical Sciences and to the International Research Group of Immunoscintigraphy
Indexed/Abstracted in: Current Contents/Clinical Medicine, EMBASE, PubMed/MEDLINE, Science Citation Index (SciSearch), Scopus
Impact Factor 2,413

Periodicità: Trimestrale

ISSN 1824-4785

Online ISSN 1827-1936

 

The Quarterly Journal of Nuclear Medicine and Molecular Imaging 2009 Agosto;53(4):402-10

LATEST ADVANCES IN RADIOPHARMACOLOGY AND RADIOPHARMACY 2009 

 REVIEWS

Instrumentation and radiopharmaceutical validation

Zigler S. S.

PETNET® Solutions, Inc., Knoxville, TN, USA

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.

lingua: Inglese


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