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Cyclotron Produced Radionuclides: Guidance on Facility Design and Production of [{sup 18}F]Fluorodeoxyglucose (FDG)

Abstract

Positron emission tomography (PET) has advanced rapidly in recent years and is becoming an indispensable imaging modality for the evaluation and staging of cancer patients. A key component of the successful operation of a PET centre is the on-demand availability of radiotracers (radiopharmaceuticals) labelled with suitable positron emitting radioisotopes. Of the hundreds of positron labelled radiotracers, 2-[{sup 18}F]-fluoro-2-deoxy-D-glucose (FDG) is the most successful and widely used imaging agent in PET today. While FDG is utilized largely in oncology for the management of cancer patients, its applications in neurology and cardiology are also steadily growing. A large number of PET facilities have been established in Member States over the past few years, and more are being planned. The design and operation of a facility for the production of FDG requires attention to detail, in particular the application of good manufacturing practices (GMP) guidelines and quality assurance. The product must conform to the required quality specifications and must be safe for human use. This book is intended to be a resource manual with practical information for planning and operating an FDG production facility, including design and implementation of the laboratories, facility layout, equipment, personnel and FDG quality assessment. GMP and quality management  More>>
Authors:
"NONE"
Publication Date:
Jan 15, 2012
Product Type:
Book
Report Number:
STI/PUB-1515
Resource Relation:
Other Information: Figs., tabs., refs.; Related Information: Series: IAEA Radioisotopes and Radiopharmaceuticals Series; no. 3
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CYCLOTRONS; FLUORINE 18; FLUORODEOXYGLUCOSE; GLUCOSE; HUMAN POPULATIONS; POSITRON COMPUTED TOMOGRAPHY; POSITRONS; RADIOPHARMACEUTICALS; TRACER TECHNIQUES
OSTI ID:
22092467
Research Organizations:
International Atomic Energy Agency, Division of Physical and Chemical Sciences, Vienna (Austria)
Country of Origin:
IAEA
Language:
English
Other Identifying Numbers:
Other: ISBN 978-92-0-117310-2; ISSN 2077-6462; TRN: XA13R0155050733
Availability:
Also available on-line: http://www-pub.iaea.org/MTCD/Publications/PDF/Pub1515_Web.pdf; Enquiries should be addressed to IAEA, Marketing and Sales Unit, Publishing Section, E-mail: sales.publications@iaea.org; Web site: http://www.iaea.org/books
Submitting Site:
INIS
Size:
172 page(s)
Announcement Date:
May 03, 2013

Citation Formats

Cyclotron Produced Radionuclides: Guidance on Facility Design and Production of [{sup 18}F]Fluorodeoxyglucose (FDG). IAEA: N. p., 2012. Web.
Cyclotron Produced Radionuclides: Guidance on Facility Design and Production of [{sup 18}F]Fluorodeoxyglucose (FDG). IAEA.
2012. "Cyclotron Produced Radionuclides: Guidance on Facility Design and Production of [{sup 18}F]Fluorodeoxyglucose (FDG)." IAEA.
@misc{etde_22092467,
title = {Cyclotron Produced Radionuclides: Guidance on Facility Design and Production of [{sup 18}F]Fluorodeoxyglucose (FDG)}
abstractNote = {Positron emission tomography (PET) has advanced rapidly in recent years and is becoming an indispensable imaging modality for the evaluation and staging of cancer patients. A key component of the successful operation of a PET centre is the on-demand availability of radiotracers (radiopharmaceuticals) labelled with suitable positron emitting radioisotopes. Of the hundreds of positron labelled radiotracers, 2-[{sup 18}F]-fluoro-2-deoxy-D-glucose (FDG) is the most successful and widely used imaging agent in PET today. While FDG is utilized largely in oncology for the management of cancer patients, its applications in neurology and cardiology are also steadily growing. A large number of PET facilities have been established in Member States over the past few years, and more are being planned. The design and operation of a facility for the production of FDG requires attention to detail, in particular the application of good manufacturing practices (GMP) guidelines and quality assurance. The product must conform to the required quality specifications and must be safe for human use. This book is intended to be a resource manual with practical information for planning and operating an FDG production facility, including design and implementation of the laboratories, facility layout, equipment, personnel and FDG quality assessment. GMP and quality management are discussed only briefly, since these topics are covered extensively in the IAEA publication Cyclotron Produced Radionuclides: Guidelines for Setting up a Facility (Technical Reports Series No. 471). It should be noted that manufacturing processes and quality specifications for FDG are not currently globally harmonized, and these do vary to some extent. However, there is no disagreement over the need to ensure that the product is manufactured in a controlled manner, that it conforms to applicable quality specifications and that it is safe for human use. Administrators, managers, radiopharmaceutical scientists, production technologists and regulators of radiopharmaceutical manufacturing, especially those required for the establishment of new FDG production facilities, are expected to benefit from this publication.}
place = {IAEA}
year = {2012}
month = {Jan}
}