2010
DOI: 10.1007/s00259-010-1407-3
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Guidance on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals

Abstract: This guidance is meant as a guidance to Part B of the EANM “Guidelines on Good Radiopharmacy Practice (GRPP)” issued by the Radiopharmacy Committee of the EANM (see www.eanm.org), covering the small-scale “in house” preparation of radiopharmaceuticals which are not kit procedures. The aim is to provide more detailed and practice-oriented guidance to those who are involved in the small-scale preparation of, for example, PET, therapeutic or other radiopharmaceuticals which are not intended for commercial purpose… Show more

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Cited by 113 publications
(78 citation statements)
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“…68 Ga was eluted from a 68 Ge/ 68 Ga generator (Eckert and Ziegler), and DOTANOC (ABX) was labeled with 68 Ga following the procedure described by Zhernosekov et al (19) and according to the recommendations of the European Association of Nuclear Medicine on good radiopharmacy practice in the preparation of radiopharmaceuticals (20). 68 Ga-DOTANOC PET/CT (administered dose, 1.5-2 MBq/kg; uptake time, 50-70 min after injection) was performed on a dedicated hybrid scanner (Discovery STE or Discovery LS; GE Healthcare).…”
Section: Methodsmentioning
confidence: 99%
“…68 Ga was eluted from a 68 Ge/ 68 Ga generator (Eckert and Ziegler), and DOTANOC (ABX) was labeled with 68 Ga following the procedure described by Zhernosekov et al (19) and according to the recommendations of the European Association of Nuclear Medicine on good radiopharmacy practice in the preparation of radiopharmaceuticals (20). 68 Ga-DOTANOC PET/CT (administered dose, 1.5-2 MBq/kg; uptake time, 50-70 min after injection) was performed on a dedicated hybrid scanner (Discovery STE or Discovery LS; GE Healthcare).…”
Section: Methodsmentioning
confidence: 99%
“…A prerequisite to get permission for such studies is the transition of the biomarker from research-grade radiochemical to a radiopharmaceutical, for which higher standards of product quality must be met [269] . Many aspects of radiation safety, toxicology issues, quality control, licensing, and regulatory control need to be considered for the production of radiopharmaceuticals and these have been extensively reviewed elsewhere [5,100,270,271] .…”
Section: Proof-of-concept In Humansmentioning
confidence: 99%
“…As suggest by EANM guidelines [3] and by P. Elsinga et al [4], QC equipment, such as the radiochromatogram scanner, should have sufficient sensitivity and spatial resolution for the intended use. Also, the equipment must be regularly checked and maintained, as recommended by the manufacturer.…”
Section: Introductionmentioning
confidence: 99%