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Guideline
. 2010 May;37(5):1049-62.
doi: 10.1007/s00259-010-1407-3.

Guidance on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals

Philip Elsinga  1 , Sergio Todde, Ivan Penuelas, Geerd Meyer, Brit Farstad, Alain Faivre-Chauvet, Renata Mikolajczak, Gerrit Westera, Tanja Gmeiner-Stopar, Clemens Decristoforo; Radiopharmacy Committee of the EANM
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Guideline

Guidance on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals

Philip Elsinga et al. Eur J Nucl Med Mol Imaging. 2010 May.

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 purposes or distribution.

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References

    1. Food and Drug Administration. Guidance: PET Drugs—Current Good Manufacturing Practice (CGMP). US Department of Health and Human Services, Center for Drug Evaluation and Research (CDER). December 2009. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati...
    1. European Agency for the Evaluation of Medicinal Products. ICH topic Q2B. Validation of analytical procedures: methodology. http://www.emea.europa.eu/pdfs/human/ich/028195en.pdf

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