Literature DB >> 18690437

Guideline to regulations for radiopharmaceuticals in early phase clinical trials in the EU.

Alfons Verbruggen1, Heinz H Coenen, Jean-Robert Deverre, Denis Guilloteau, Bengt Langstrom, Piero A Salvadori, Christer Halldin.   

Abstract

The purpose of this guideline is to help investigators by giving an overview of relevant current EU requirements concerning the quality of starting materials and final drug products (the radiopharmaceuticals), the non-clinical safety studies and dosimetry considerations whilst designing a human clinical trial which includes the use of radiopharmaceutical compounds.

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Year:  2008        PMID： 18690437     DOI： 10.1007/s00259-008-0853-7

Source DB:  PubMed          Journal:  Eur J Nucl Med Mol Imaging        ISSN： 1619-7070            Impact factor:   9.236


  25 in total

Review 1.  Feasibility and availability of ⁶⁸Ga-labelled peptides.

Authors:  Clemens Decristoforo; Roger D Pickett; Alfons Verbruggen
Journal:  Eur J Nucl Med Mol Imaging       Date:  2012-02       Impact factor: 9.236

2.  Radiopharmaceutical clinical trials - dose is more than sieverts and becquerels.

Authors:  James R Ballinger; Stephen J Mather; Michael J O'Doherty
Journal:  Eur J Nucl Med Mol Imaging       Date:  2009-08       Impact factor: 9.236

Review 3.  68Ga-DOTA and analogs: Current status and future perspectives.

Authors:  Krzysztof Kilian
Journal:  Rep Pract Oncol Radiother       Date:  2014-05-19

Review 4.  Using PET for therapy monitoring in oncological clinical trials: challenges ahead.

Authors:  C M Deroose; S Stroobants; Y Liu; L K Shankar; P Bourguet
Journal:  Eur J Nucl Med Mol Imaging       Date:  2017-04-27       Impact factor: 9.236

5.  Biodistribution and radiation dosimetry of the 18 kDa translocator protein (TSPO) radioligand [18F]FEDAA1106: a human whole-body PET study.

Authors:  Akihiro Takano; Balázs Gulyás; Andrea Varrone; Per Karlsson; Nils Sjoholm; Stig Larsson; Cathrine Jonsson; Richard Odh; Richard Sparks; Nabil Al Tawil; Anja Hoffmann; Torsten Zimmermann; Andrea Thiele; Christer Halldin
Journal:  Eur J Nucl Med Mol Imaging       Date:  2011-07-06       Impact factor: 9.236

6.  Radiopharmaceuticals are special, but is this recognized? The possible impact of the new Clinical Trials Regulation on the preparation of radiopharmaceuticals.

Authors:  C Decristoforo; I Penuelas; P Elsinga; J Ballinger; A D Winhorst; A Verbruggen; F Verzijlbergen; A Chiti
Journal:  Eur J Nucl Med Mol Imaging       Date:  2014-11       Impact factor: 9.236

Review 7.  Development of (18)F-labeled radiotracers for neuroreceptor imaging with positron emission tomography.

Authors:  Peter Brust; Jörg van den Hoff; Jörg Steinbach
Journal:  Neurosci Bull       Date:  2014-08-29       Impact factor: 5.203

8.  Fully automated radiosynthesis of 2-[18F]fludarabine for PET imaging of low-grade lymphoma.

Authors:  Stéphane Guillouet; Delphine Patin; Olivier Tirel; Jérôme Delamare; Fabienne Gourand; Jean Bernard Deloye; Michel Leporrier; Louisa Barré
Journal:  Mol Imaging Biol       Date:  2014-02       Impact factor: 3.488

9.  Human biodistribution and dosimetry of the PET radioligand [¹¹C]flumazenil (FMZ).

Authors:  Charles M Laymon; Rajesh Narendran; Neale S Mason; Jonathan P Carney; Brian J Lopresti; Chester A Mathis; James M Mountz; Donald Sashin; W Gordan Frankle
Journal:  Mol Imaging Biol       Date:  2012-02       Impact factor: 3.488

10.  Good manufacturing practice production of [(68)Ga]Ga-ABY-025 for HER2 specific breast cancer imaging.

Authors:  Irina Velikyan; Anders Wennborg; Joachim Feldwisch; Henrik Lindman; Jörgen Carlsson; Jens Sörensen
Journal:  Am J Nucl Med Mol Imaging       Date:  2016-04-24
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