EANM position on the in-house preparation of radiopharmaceuticals

被引:15
作者
Hendrikse, Harry [1 ]
Kiss, Oliver [2 ]
Kunikowska, Jolanta [3 ]
Wadsak, Wolfgang [4 ]
Decristoforo, Clemens [5 ]
Patt, Marianne [6 ]
机构
[1] Vrije Univ Amsterdam Med Ctr, Dept Clin Pharmacol & Pharm, Dept Radiol & Nucl Med, Amsterdam, Netherlands
[2] Helmholtz Zentrum Dresden Rossendorf, Dept Radiopharmaceut Prod, Inst Radiopharmaceut Canc Res, Dresden, Germany
[3] Med Univ Warsaw, Nucl Med Dept, Warsaw, Poland
[4] Med Univ Vienna, Dept Biomed Imaging & Image Guided Therapy, Div Nucl Med, AKH Wien, Waehringer Guertel 18-20, A-1090 Vienna, Austria
[5] Med Univ Innsbruck, Dept Nucl Med, Innsbruck, Austria
[6] Univ Leipzig, Dept Nucl Med, Leipzig, Germany
关键词
EUROPEAN REGULATIONS; GUIDANCE;
D O I
10.1007/s00259-022-05694-z
中图分类号
R8 [特种医学]; R445 [影像诊断学];
学科分类号
1002 ; 100207 ; 1009 ;
摘要
The EANM herewith clearly expresses its commitment and support to the non-commercial in-house preparation of radiopharmaceuticals for direct use in accordance with European and national regulations.
引用
收藏
页码:1095 / 1098
页数:4
相关论文
共 11 条
[1]   Guidance on current good radiopharmacy practice for the small-scale preparation of radiopharmaceuticals using automated modules: a European perspective [J].
Aerts, Joel ;
Ballinger, James R. ;
Behe, Martin ;
Decristoforo, Clemens ;
Elsinga, Philip H. ;
Faivre-Chauvet, Alain ;
Mindt, Thomas L. ;
Peitl, Petra Kolenc ;
Todde, Sergio C. ;
Koziorowski, Jacek .
JOURNAL OF LABELLED COMPOUNDS & RADIOPHARMACEUTICALS, 2014, 57 (10) :615-620
[2]  
[Anonymous], EUROPEAN PHARMACOPOE, P807
[3]  
Council of Europe European Pharmacopoeia Commission European Directorate for the Quality of Medicines Healthcare, 2020, EUROPEAN PHARMACOPOE
[4]  
Daue, 2017, EUDRALEX
[5]   Emerging Radionuclides in a Regulatory Framework for Medicinal Products - How Do They Fit? [J].
Decristoforo, Clemens ;
Neels, Oliver ;
Patt, Marianne .
FRONTIERS IN MEDICINE, 2021, 8
[6]   European regulations for the introduction of novel radiopharmaceuticals in the clinical setting [J].
Decristoforo, Clemens ;
Penuelas, Ivan ;
Patt, Marianne ;
Todde, Sergio .
QUARTERLY JOURNAL OF NUCLEAR MEDICINE AND MOLECULAR IMAGING, 2017, 61 (02) :135-144
[7]   Guideline on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals [J].
Gillings, Nic ;
Hjelstuen, Olaug ;
Ballinger, Jim ;
Behe, Martin ;
Decristoforo, Clemens ;
Elsinga, Philip ;
Ferrari, Valentina ;
Peitl, Petra Kolenc ;
Koziorowski, Jacek ;
Laverman, Peter ;
Mindt, Thomas L. ;
Neels, Oliver ;
Ocak, Meltem ;
Patt, Marianne ;
Todde, Sergio .
EJNMMI RADIOPHARMACY AND CHEMISTRY, 2021, 6 (01)
[8]   EANM guideline on the validation of analytical methods for radiopharmaceuticals [J].
Gillings, Nic ;
Todde, Sergio ;
Behe, Martin ;
Decristoforo, Clemens ;
Elsinga, Philip ;
Ferrari, Valentina ;
Hjelstuen, Olaug ;
Peitl, Petra Kolenc ;
Koziorowski, Jacek ;
Laverman, Peter ;
Mindt, Thomas L. ;
Ocak, Meltem ;
Patt, Marianne .
EJNMMI RADIOPHARMACY AND CHEMISTRY, 2020, 5 (01)
[9]   Untangling the web of European regulations for the preparation of unlicensed radiopharmaceuticals: a concise overview and practical guidance for a risk-based approach [J].
Lange, Rogier ;
ter Heine, Rob ;
Decristoforo, Clemens ;
Penuelas, Ivan ;
Elsinga, Philip H. ;
van der Westerlaken, Monique M. L. ;
Hendrikse, N. Harry .
NUCLEAR MEDICINE COMMUNICATIONS, 2015, 36 (05) :414-422
[10]   The new Regulation on clinical trials in relation to radiopharmaceuticals: when and how will it be implemented? [J].
Penuelas, Ivan ;
Vugts, Danielle J. ;
Decristoforo, Clemens ;
Elsinga, Philip H. .
EJNMMI RADIOPHARMACY AND CHEMISTRY, 2019, 4 (01)