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Literature DB >> 24990405

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

C Decristoforo¹, I Penuelas, P Elsinga, J Ballinger, A D Winhorst, A Verbruggen, F Verzijlbergen, A Chiti.

Abstract

Mesh：

Substances：
Radiopharmaceuticals

Year: 2014 PMID： 24990405 DOI： 10.1007/s00259-014-2838-z

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

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7 in total

1. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

Authors:
Journal: Med Etika Bioet Date: 2002 Spring-Summer

2. Investigative clinical studies with radiopharmaceuticals.

Authors: Keith Harding; Stephen J Mather
Journal: Nucl Med Commun Date: 2007-01 Impact factor: 1.690

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

Authors: Alfons Verbruggen; Heinz H Coenen; Jean-Robert Deverre; Denis Guilloteau; Bengt Langstrom; Piero A Salvadori; Christer Halldin
Journal: Eur J Nucl Med Mol Imaging Date: 2008-11 Impact factor: 9.236

4. The specific case of radiopharmaceuticals and GMP--activities of the Radiopharmacy Committee.

Authors: C Decristoforo; P Elsinga; A Faivre-Chauvet; B Farstad; G Meyer; R Mikolajczak; I Penuelas; P Unak; G Westera
Journal: Eur J Nucl Med Mol Imaging Date: 2008-05-15 Impact factor: 9.236

5. Towards a harmonized radiopharmaceutical regulatory framework in Europe?

Authors: A Decristoforo; I Peñuelas
Journal: Q J Nucl Med Mol Imaging Date: 2009-08 Impact factor: 2.346

6. The qualified person in radiopharmacy.

Authors: Stephen J Mather; Paul Maltby; Bev Ellis; Michael O'Docherty; Val Lewington; Tom Nunan; Sadia Khan; Nigel Hodges
Journal: Nucl Med Commun Date: 2010-03 Impact factor: 1.690

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

Authors: Philip Elsinga; Sergio Todde; Ivan Penuelas; Geerd Meyer; Brit Farstad; Alain Faivre-Chauvet; Renata Mikolajczak; Gerrit Westera; Tanja Gmeiner-Stopar; Clemens Decristoforo
Journal: Eur J Nucl Med Mol Imaging Date: 2010-05 Impact factor: 9.236

7 in total

8 in total

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

2. Investigative clinical studies with radiopharmaceuticals.

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

4. The specific case of radiopharmaceuticals and GMP--activities of the Radiopharmacy Committee.

5. Towards a harmonized radiopharmaceutical regulatory framework in Europe?

6. The qualified person in radiopharmacy.

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

1. Debate: Molecular cardiac imaging is ready for the prime time con between wishful thinking and reality.

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

Review 3. Biomarkers in preclinical cancer imaging.

4. Are we "preparing" radiopharmaceuticals?

5. Position statement on radiopharmaceutical production for clinical trials.

Review 6. 68Ga-Based radiopharmaceuticals: production and application relationship.

Review 7. Clinical translation of theranostic radiopharmaceuticals: Current regulatory status and recent examples.

8. Implementation and validation of an in-house combined fluorescein/media-fill test to qualify radiopharmacy operators.