Title: Radiopharmaceutical production
Authors: HOLZWARTH Uwe
Publisher: Springer
Publication Year: 2011
JRC N°: JRC59482
ISBN: 978-3-642-11326-0
URI: http://publications.jrc.ec.europa.eu/repository/handle/JRC59482
DOI: 10.1007/978-3-642-11327-7_6
Type: Articles in books
Abstract: Radiopharmaceuticals play an increasingly important role in medical imaging especially in oncology for diagnosis and staging of cancer, and for the early assessment of therapy response. Considerable progress has been made in targeted radionuclide therapy and the ¿rst antibody-guided radiophar¬maceuticals obtained FDA approval in 2002 for the treatment of relapsed or refractory B-cell Non-Hodgkin¿s lymphoma. Further progress depends on the availability of radionuclides that meet the radiobiological requirements for a given purpose and can be supplied reliably with high purity and speci¿c activity, in sufficient quantity at reasonable cost. The radioconjugate must preserve the physiological and biochemical properties of the biological vector. This goal is only achievable for favourable combinations of radionuclide, carrier molecule and labelling procedure. Moreover, the production of radiopharmaceuticals, dealing simultaneously with pharmaceuticals and open radioactive sources, requires a demanding quality assurance system in order to meet the legal requirements for drug approval by the regulatory authorities.
JRC Institute:Institute for Health and Consumer Protection

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