Abstract
The increasing use of radiopharmaceuticals for positron emission tomography (PET) has come to the attention of regulatory bodies. In order to help authorities in all aspects, the EANM has formed a task group for licensing PET radiopharmaceuticals; this group has surveyed the use of these compounds in Europe by a questionnaire. The number of PET centres that responded to the questionnaire was 26, which included more than 90% of the larger European PET centres. The survey showed that 2-[18F]fluoro-2-deoxyglucose is by far the most important PET radiopharmaceutical with more than 200 applications per week, followed by [15O]water, [15O]carbonmonoxide, [13N]ammonia, [11C]-l-methionine, andl-6-[18F]fluoro-DOPA. More than 25 other PET radiopharmaceuticals are in regular use, however, at rather low application frequencies. The data were used by the European Pharmacopoeia Commission for its priority rating for requesting the formulation of monographs. Since it is likely that group registrations will be issued by authorities for the PET radiopharmaceuticals, relevant data on toxicity and dosimetry for the formulation of summaries of product characteristics have been collected by the task group as well.
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References
European Pharmacopoeia Commission. Guideline for residual solvent levels in drug substances and excipients used for the preparation of medicinal products. Document (PA/PH/SG (94) 143).
Som P, Atkins HL, Bandoypadhyay D, et al.J Nucl Med 1980; 21: 670–675.
Reivich M, Kuhl D, Wolf A, et al. The [18F]-fluorodeoxyglucose method for the measurement of local cerebral glucose metabolism in man.Circ Res 1979; 44: 127–133.
Bida GT, Satyamurthy N, Barrio J. The synthesis of 2-[F-18]Fluoro-2-deoxy-d-glucose using glucals: a reexamination.J Nucl Med 1984; 25: 1327–1334.
Wienhard K, Pawlik G, Nebeling B, et al.J Cereb Blood Flow Metab 1991; 11: 485–491.
Füchtner F, Steinbach J, Mäding P, Johannsen B. Basic hydrolysis of 2-[18F]fluoro-1,3,4,6-tetra-O-acetyl-d-glucose in the preparation of 2-[18F]fluoro-2-deoxy-d-glucose. Appl. Radiat Isot 1995;in press.
Baudot P, Jaque M, Robin M. Effect of a diaza-polyoxa-macrobicyclic complexing agent on the urinary elimination of lead in lead-poisoned rats.Toxicol Appl Pharmacol 1977; 41: 113–115.
Baumann M, Schäfer E, Grein H. Short-term studies with the cryptating agent hexaoxa-diaza-bicyclo-hexacosane in rats.Arch Toxicol 1984; 55 Suppl 7: 427–429.
Müller WH, Beaumatin J. Distribution of a cryptating agent in excreta and its influence on urinary elimination of Na, K, Mg, Ca, and Zn in the rat.Life Sci 1976; 17: 1815–1820.
Meyer G-J, Coenen HH, Waters SL, et al. Quality assurance and quality control of short-lived radiopharmaceuticals for PET. In Stöcklin G, Pike V, eds. Radiopharmaceuticals for positron emission tomography: methodological aspects. Dordrecht Boston London: Kluwer Academic; 1993: 91–150.
Hunt R. Some effects of quarternary ammonium compounds on the autonomic nervous system.J Pharmacol Exp Ther 1926; 28: 367–388.
Jones SC, Alavi A, Christman D, et al. The radiation dosimetry of 2-[F-18]fluoro 2-deoxy-d-glucose.J Nucl Med 1982; 23: 613–617.
Mejia AA, Nakamura T, Masatoshi I, et al. Estimation of absorbed doses in humans due to intravenous administration of fluorine-18-fluorodeoxyglucose in PET studies.J Nucl Med 1991; 32: 699–706.
ICRP publication 53.Radiation dose to patients from radiopharmaceuticals. Oxford: Pergamon, 1988.
Junker D, Fitschen J. Spezielle Probleme des Strahlenschutzes. In: Hundeshagen H, ed.Handbuch der Medizin. Radiologie vol 15/1b, Heidelberg Berlin New York: Springer, 1988: pp 119–147.
ICRP publication 601990 recommendations of the international commission on radiological protection. Oxford: Pergamon, 1991.
Dowd MT, Chen C-T, Wendel MJ, et al. Radition dose to the bladder wall from 2-[18F]fluoro-2-deoxy-d-glucose in adult humans.J Nucl Med 1991; 32: 707–712.
Huda W, Sandison G A. Estimates of the effective dose equivalent HE, in positron emission tomography studies.Eur J Nucl Med 1990; 17: 116–120.
Johannsson L, Mattsson S, Nosslin B, Leide-Svegborn S. Effective dose from radiopharmaceuticals.Eur J Nucl Med 1992; 19: 933–938.
The Merck Index, 11th edn. Rahway N.J.: Merck; 1989.
Kearfott KJ, Absorbed dose estimates for positron emission tomography (PET): C15O,11CO, CO15OJ Nucl Med 1982; 23: 1031–1037.
Kearfott KJ, Rottenberg DA, Volpe BT. Design of steady-state PET protocols for neurobehavioural studies: CO15O and19Ne.J Comput Assist Tomogr 1983; 7: 51–57.
Bigler RE, Sgouros G. Biological analysis and dosimetry of15O-labelled O2, CO2, and CO gases administered continuously by inhalation.J Nucl Med 1983; 24: 431–437.
Smith T, Tong C, Lammertsma AA, et al. Dosimetry of intravenously administered oxygen 15 labelled water in man: a model based on experimental human data from 21 subjects.Eur J Nucl Med 1994; 21: 1126–1134.
Brihaye C, Depresseux JC, Comar D. Radiation dosimetry for bolus administration of oxygen-15-water.J Nucl Med 1995; 36: 651–656.
Lockwood AH. Absorbed doses of radiation after an intravenous injection of N-13 ammonia in man: concise communication.J Nucl Med 1980; 21: 276–278.
Forth W, Henschler D, Rummel W, eds.Allgemeine und spezielle Pharmakologie und Toxikologie. Zürich: Bibliographisches Institut, 1987.
Clark JC, Crouzel C, Meyer G-J, et al. Current methodology for oxygen-15 production for clinical use.Appl Radiat Isot 1987; 38: 597–600.
Luxen A, Perlmutter M, Bida GT, et al. Remote semiautomated production of 6-[18F]Fluoro-l-DOPA. for human studies with PET.Appl Radiat Isot 1990; 41: 275–281.
Seiler HG, Sigel H.Handbook of toxicity of inorganic compounds. New York: Marcel Dekker; 1988.
Deutsche Forschungsgemeinschaft.BAT Werte DFG, 1994.
United States Pharmacopoeial Convention. Fluorodopa F 18 injection,Pharmacopoeial Forum 1991; 17: 1582–1584.
Luxen A, Barrio JR, Van Moffaert G, et al. Remote semiautomated production of 6-[18F]fluoro-l-DOPA for human studies with PET.J Labelled Comp Radiopharm 1988; 26: 465–466.
Wagner R. Removal of mercury contamination from 6-F-FDOPA preparations.J Labelled Comp Radiopharm 1993; 32: 250.
Lemaire C, Damhaut P, Plenevaux A, Comar D. Enantioselective synthesis of 6-[fluorine-18]fluoro-l-DOPA from no-carrier-added fluorine-18-fluoride.J Nucl Med 1994; 35: 1996–2002.
Sachs C, Jonsson G. Selective 6-hydroxy-DOPA induced degeneration of central and peripheral noradrenalin neurons. Brain Res 1972; 40: 563–568.
Pike VW, Kensett MJ, Turton DR, et al. Labelled agents for PET studies of the dopaminergic system — some quality assurance methods, experience and issues.Appl Radiat Isot 1990; 41: 483–492.
Harvey J, Firnau G, Garnett ES. Estimation of the radiation dose in man due to 6-[18F]Fluoro-l-DOPA.J Nucl Med 1985; 26: 931–935.
Lu E, Meyer E, Kuwabara H, et al. Reduction of radiation absorbed dose in F-18-FDPOA PET studies by hydration induced voiding.J Nucl Med 1995; 36: 98.
Hübner KF, Andrews GA, Buonocore E, et al. Carbon-11-labelled amino acids for the rectilinear and positron tomographic imaging of the human pancreas.J Nucl Med 1979; 20: 507–513.
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Meyer, G.J., Waters, S.L., Coenen, H.H. et al. PET radiopharmaceuticals in Europe: Current use and data relevant for the formulation of summaries of product characteristics (SPCs). Eur J Nucl Med 22, 1420–1432 (1995). https://doi.org/10.1007/BF01791152
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DOI: https://doi.org/10.1007/BF01791152