Riassunto
La normativa vigente definisce “preparazioni estemporanee di radiofarmaci”:
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i radiofarmaci preparati in base a una prescrizione medica destinata a un determinato paziente, detti formule magistrali; sono assimilabili ai preparati magistrali anche le miscelazioni, le ripartizioni, le diluizioni, i dosaggi personalizzati destinati al singolo paziente su indicazione medica;
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i radiofarmaci preparati in base alle indicazioni della European Pharmacopoeia o delle Farmacopee in vigore nell’Unione Europea, detti formule officinali.
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Bibliografia
EudraLex — The rules governing medicinal products in the European Union. Volume 4 — EU Guidelines for good manufacturing practices (GMP) for medicinal products for human and veterinary use Annex 3: Manufacture of radiopharmaceuticals http://ec.europa.eu/health/files/eudralex/vol-4/pdfsen/anx02en200408_en.pdf
Padgett HC, Schmidt DG, Luxen A et al (1989) Computer-controlled radiochemical synthesis: A chemistry process control unit for the automated production of radiochemicals. International Journal of Radiation Applications and Instrumentation. Part A. Applied Radiation and Isotopes 40:433–445
European Pharmacopoeia, 7th edn. Radiopharmaceutical Preparations (0125)
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (2005) ICH Harmonised Tripartite Guideline “Validation of Analytical Procedures: Text and Methodology”, Q2(R1), Step 4
European Pharmacopoeia, 7th edn. L-methionine ([11C]methyl) injection (1617)
European Pharmacopoeia, 7th edn. § 5.4 Residual solvents
European Pharmacopoeia, 7th edn. § 2.6.14 Bacterial Endotoxins
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Todde, S., Bogni, A., Boschi, S. (2011). Produzione e verifiche di qualità dei radiofarmaci estemporanei per PET e terapia. In: La qualità nella preparazione dei radiofarmaci. Imaging & formazione, vol 6. Springer, Milano. https://doi.org/10.1007/978-88-470-2020-7_13
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DOI: https://doi.org/10.1007/978-88-470-2020-7_13
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