CLINICAL TRIAL (TOPIC);
DIAGNOSTIC USE;
DRUG STABILITY;
GOVERNMENT REGULATION;
HEALTH CARE ORGANIZATION;
LEGISLATION AND JURISPRUDENCE;
NOMENCLATURE;
NUCLEAR MEDICINE;
PRACTICE GUIDELINE;
QUALITY CONTROL;
STANDARD;
STANDARDS;
CLINICAL TRIALS AS TOPIC;
DRUG STABILITY;
GOVERNMENT REGULATION;
NUCLEAR MEDICINE;
QUALITY CONTROL;
RADIOPHARMACEUTICALS;
REFERENCE STANDARDS;
SOCIETIES, SCIENTIFIC;
TERMINOLOGY AS TOPIC;
Guidelines on current good radiopharmacy practice (cGRPP) in the preparation of radiopharmaceuticals
European Association of Nuclear Medicine Radiopharmacy Committee. Guidelines on current good radiopharmacy practice (cGRPP) in the preparation of radiopharmaceuticals, version 2, 2007. http://www.eanm.org/publications/guidelines/gl_radioph_cgrpp.pdf. Accessed 11 July 2014.
Elsinga P, Todde S, Penuelas I, Meyer G, Farstad B, Faivre-Chauvet A, et al. Guidance on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals. Eur J Nucl Med Mol Imaging 2010;37:1049–62.
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
European Parliament and the Council of the European Union. 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. Off J Eur Union 2001;L(121):34–44.
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
European Parliament and Council of the European Union. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Off J Eur Union 2014;L(158):1–76.
European Medicines Agency Committee for Medicinal Products for Human Use. Guideline on the requirements for quality documentation concerning investigational medicinal products in clinical trials. 2012. EMA/CHMP/BWP/534898/2008
European Medicines Agency Committee for Medicinal Products for Human Use. Guideline on the requirements for quality documentation concerning investigational medicinal products in clinical trials. 2012. EMA/CHMP/BWP/534898/2008.
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European Union Enterprise Directorate-General. Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial. Revision 2. 2005. ENTR/F2/BL D(2003)
European Union Enterprise Directorate-General. Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial. Revision 2. 2005. ENTR/F2/BL D(2003).
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Guideline for good clinical practice
International Conference on Harmonisation. Guideline for good clinical practice. E6(R1). 1996. www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html. Accessed 11 July 2014.
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use
European Parliament and the Council of the European Union. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use. Off J Eur Union 2004;L(311):67–128.
European Directorate for the Quality of Medicines and Healthcare. Radiopharmaceutical preparations. European Pharmacopoeia, 8th edition, 2013. Strasbourg: Council of Europe.
