Appendix 1
Table A.1. Administration of Radioactive Substances Advisory Committee (ARSAC): radiation doses for children
Calculation of administered activity to children based on body weight Body weight (kg) Fraction of adult administered
radioactivity scaling factors (F)
3 (0.1)
a4 (0.1)
a6 (0.1)
a8 0.11
10 0.14
12 0.17
14 0.20
16 0.23
18 0.26
20 0.28
25 0.36
30 0.43
35 0.50
40 0.57
45 0.64
50 0.64
55 0.79
60 0.86
65 1.00
ARSAC ± Administration of Radioactive Substances Advisory Committee; Notes for Guidance on the Administration of Radioactive Substances to Persons for Purposes of Diagnosis, Treatment or Research, January 1993
a
Depending on local techniques and facilities the acceptable minimum administered activity will
vary, regardless of the size of the child. The minimum value of the scaling factor is 0.1, since ac-
tivities below 10% of the value of the adult radioactivity have resulted in poor image quality
Recommended Reading
Textbooks in Radiopharmacy/Radiopharmacology
Bçll U, Schicha H, Biersack H-J, Knapp WH, Reiners Chr, Schober O (eds) (1996) Nuk- learmedizin, 2nd edn. Georg Thieme, Stuttgart
Colombetti LG (ed) (1976±1986) CRC Series in radiotracers in biology and medicine.
CRC Press, Boca Raton:
Colombetti LG (ed) (1979) Principles of radiopharmacology, vol. I±II Colombetti LG (ed) (1982) Biological transport of radiotracers, vol. III Anghileri LJ (ed) (1982) General processes of radiotracer localization, vol. I±II Eckelman WC (ed) (1982) Receptor-binding radiotracers, vol. I±II
Robertson JS (ed) (1983) Compartmental distribution of radiotracers
Table A.2. European Association of Nuclear Medicine (EANM): radiation doses for children (issued by the Pediatric Task Group of the EANM)
Calculation of administered activity to children based on body weight Body weight (kg) Fraction of adult administered
radioactivity scaling factors (F)
3 0.1
4 0.14
6 0.19
8 0.23
10 0.27
12 0.32
14 0.36
16 0.40
18 0.44
20 0.46
22 0.50
24 0.53
26 0.56
28 0.58
30 0.62
32 0.65
34 0.68
36 0.71
38 0.73
40 0.76
42 0.78
44 0.80
46 0.83
48 0.85
50 0.88
52±54 0.90
56±58 0.92
60±62 0.96
64±66 0.98
68 0.99
>70 1.00
Example: To calculate the amount of radioactivity to be administered to a child with a body
weight of 22 kg, the corresponding F=0.5. Accordingly, the amount of radioactivity recommended
for adults is multiplied by 0.5
Fritzberg AR (ed) (1986) Radiopharmaceuticals: progress and clinical perspectives, vol. I±II
Cox PH (ed) (1982) Progress in radiopharmacology 3: selected topics. Martinus Nijhoff, The Hague
Cox PH (ed) (1985) Radiopharmacy and radiopharmacology yearbook. Gordon and Breach, New York
Cox PH, Mather SJ, Sampson CB, Lazarus CR (eds) (1986) Progress in radiopharmacy.
Martinus Nijhoff, Dordrecht, The Netherlands
Hladik WB III, Saha G, Study KT (eds) (1987) Essentials of nuclear medicine science.
Williams & Wilkins, Baltimore
Owunwanne A, Patel M, Sadek S (eds) (1995) Handbook of radiopharmaceuticals.
Chapman & Hall, London
Saha GB (1998) Fundamentals of nuclear pharmacy, 4th edn. Springer, Berlin Heidel- berg New York
Sampson CB (ed) (1994) Textbook of radiopharmacy: theory and practice, 2nd edn.
Gordon and Breach Science, UK
Wagner HNJr, Szabo Z, Buchanan JW (eds) (1995) Principles of nuclear medicine, 2nd edn. Saunders, Philadelphia
Good Radiopharmacy Practice
Kristensen K, Norbygaard E (eds) (1984, 1987) Safety and efficacy of radiopharmaceuti- cals. Martinus Nijhoff, Boston (1984), Dordrecht (1987)
Nordic Council on Medicines (1989) Radiopharmacy: preparation and control of radio- pharmaceuticals in hospitals. Nordic Guidelines. NLN publication no. 26. Nordic Council on Medicines, Uppsala
Quality Control of Radiopharmaceuticals
Brandau W, Hotze L-A, Meyer G-J (1996) Qualitåtskontrolle In: Nuklearmedizin, Bçll U, Schicha H, Biersack H-J, Knapp WH, Reiners Chr, Schober O (eds) 4. Radiochemie, 2nd edn. [in German]. Georg Thieme, Stuttgart, pp 97±104
Frier M, Hesslewood SR (1980) Quality assurance of radiopharmaceuticals: a guide to hospital practice. Nucl Med Comm Special Issue 1980, Chapman and Hall, London Hammermaier A, Reich E, Bægl W (1986) Qualitåtskontrolle von in-vivo Radiopharma-
ka: Ein Handbuch fçr das nuklearmedizinische Labor zur Analytik radiochemischer Verunreinigungen [in German]. Reimers, ISH Heft 94, Bundesgesundheitsamt, Berlin Mallol J, Bonino C (1997) Comparison of radiochemical purity control methods for technetium radiopharmaceuticals used in hospital radiopharmacy. Nucl Med Com- mun 18:419±422
Millar AM (1989) Quality assurance of radiopharmaceuticals In: Theobald AE (ed) Radiopharmaceuticals: using radioactive compounds in pharmaceutics and medi- cine. Horwood, Chichester, pp 83±102
Johannsen B, Narasimhan DVS (eds) (1992) Preparation of kits for
99mTc-radiopharma- ceuticals. International Atomic Energy Agency: IAEA-TECDOC-649. Vienna
Robbins PJ (1985) Chromatography of Tc-99m-radiopharmaceuticals ± a practical guide, 2nd printing. Society Nuclear Medicine, New York
Theobald AE (1990) Quality control of radiopharmaceuticals In: Sampson CB (ed) Text-
book of radiopharmacy: theory and practice. Gordon and Breach, New York, pp
115±148
Webber D, Zimmer AM, Spies SM (1983) Common errors associated with miniaturized chromatography. J Nucl Med Technol 11:66
Zimmer AM, Pavel DG (1977) Rapid miniaturized chromatographic quality control pro- cedures for Tc-99m radiopharmaceuticals. J Nucl Med 18:1230
Physics/Radiological Protection
Administration of Radioactive Substances Advisory Committee (1993) Investigations ± adult patients. In: Notes for guidance on the administration of radioactive sub- stances to persons for purposes of diagnosis, treatment or research, Appendix 1, Part A. Administration of Radioactive Substances Advisory Committee ± ARSAC, Oxon, UK, p 25
Ibidem (1993) Investigations ± children and young persons. In: Notes for guidance on the administration of radioactive substances to persons for purposes of diagnosis, treatment or research, Appendix 1, Part D, pp 34±35
International Commission on Radiation Protection (1987) Annals of the ICRP, radiation dose to patients from radiopharmaceuticals, biokinetic models and data. ICRP pub- lication 53, vol. 18, no. 1±4. Pergamon, Oxford
International Commission on Radiation Protection (1993) Annals of the ICRP, radiolog- ical protection in biomedical research, ICRP Publication 62, vol. 22, no. 3. Perga- mon, Oxford
Saha GB (2000) Physics and radiobiology of nuclear medicine, 2nd edn. Springer, Ber- lin Heidelberg New York
Young MEJ (1983) Radiological Physics, 3rd edn. Lewis, London Official Publications
Council of Europe (2005) European pharmacopoeia 5.0. Maisonneuve, Sainte-Ruffine European Commission (1997) Pharmaceutical legislation ± Eudralex ± the rules govern-
ing medicinal products in the European Union. Good manufacturing practices, vol.
4. European Commission, Luxembourg, pp 70, 81±82
United States Pharmacopeial Convention (2005) United States pharmacopeia (USP) 28 ±
national formulary (NF) 23
Scope of COST B3: WG-1
COST is a European cooperation in the field of scientific and technical research. COST Action B3 was devoted to the development of new radiotracers for nuclear medicine application and methods of quality assurance. The main objectives of the cooperation were defined in a preparatory meeting in Vienna on 12 October 1990. Fifteen partici- pants from six member states worked out a draft of the Memorandum of Understand- ing (MOU), receiving expert advice from the Austrian Ministry of Science and Re- search.
COST Action B3 was enacted in December 1992 and ended in December 1997. Six- teen European states ± Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Italy, The Netherlands, Norway, Slovenia, Spain, Sweden, Switzerland, and the United Kingdom ± signed the MOU; their national institutions participated in five Working Groups.
Chairpersons
1993±1994 Dr. Ilse Zolle, M. Pharm. M. Sc., Department of Nuclear Medicine, AKH, Vienna
1994±1997 Prof. Dr. P.A. Schubiger, Paul Scherrer Institute, Center for Radiophar- maceutical Science, Villigen, CH
Working Group 1 was concerned with the standardization of methods for labeling and quality control:
(a) Quality control of
99mTc-radiopharmaceuticals, Coordinator F. Rakias (Hungary) (b) Standardization of radio-iodinated pharmaceuticals, Coordinator J. Mertens (Bel-
gium)
The scientific goal of Working Group 1(a) has been the development and updating of quality control methods to assure safety of
99mTc radiopharmaceuticals for parenteral application in nuclear medicine. Scientific institutions in 12 European countries have contributed their experience and results for comparison of the available analytical methods. Some results are presented in the monographs.
Participating Institutions in Working Group 1(a) Austria: Department of Nuclear Medicine,
Radiopharmacology, Ludwig-Boltzmann- Institute of Nuclear Medicine AKH Wien, University of Vienna
Ilse Zolle, Rudolf Hæfer
Department of Nuclear Medicine,
University of Innsbruck Clemens Decristoforo Belgium: VUB-Cyclotron Eenheid,
Vrije Universiteit Brussel John Mertens Department of Radiopharmacy,
Katholieke Universiteit Leuven, Leuven Alfons Verbruggen
Appendix 2
France: Service Medecine Nucleaire, Centre Hospitalier,
Regional et Universitaire de Tours, Tours
Denis Guilloteau
Germany: Klinikum Berlin-Buch, Klinik fçr Nuklearmedizin, und Endokrinologie, Berlin-Buch
A.G. Bratouss
Radiologische Klinik, Abt. f. Nuklearmedizin,
Christian Albrechts Universitåt Kiel, Kiel
Heike Wolf
Greece: Radiodiagnostic Products, NCSR±ªDemocritosº,
Radiopharmaceuticals Section, Athens
Efstratios Chiotellis
Hungary: Drug Quality Department, Radiopharmaceutical Section,
National Institute of Pharmacy, Budapest
Ferenc Rakis
Frederic Joliot-Curie National Research Institute for Radiobiology and Radiohygiene, Department of Applied Radioisotopes, Budapest
Gyæzæ A. Jnoki
Italy: Department of Nuclear Medicine,
Universita di Ferrara, Ferrara Adriano Piffanelli Department Scienze Farmaceutiche,
Universita di Padova, Padua Ulderico Mazzi Norway: Institut Energiteknikk, Kjeller Per Bremer Slovenia: Department of Nuclear Medicine,
Division of Radiochemistry, University Medical Centre Ljubljana, Ljubljana
Silvester Kladnik, Tanja Stopar
Spain: Dpto. Technologia Pharmaceutica,
Facultad Pharmacia, Universidad La Laguna, La Laguna, Tenerife
Jesus Mallol
Sweden: Medical Products Agency,
Radiopharmaceuticals, Uppsala Trygve Bringhammar United
Kingdom: Department of Nuclear Medicine,
Addenbrooke's Hospital, Cambridge Charles B. Sampson
Publications Working Group 1
Mallol J, Bonino C (1997) Comparison of radiochemical purity control methods for technetium radiopharmaceuticals used in hospital radiopharmacy. Nucl Med Com- mun 18:419±422
Noll B, Johannsen B, Spies H (1995) Sources of radiochemical impurities in the
99mTc/
S-unprotected MAG
3-system. Presented at the second COST B3 Workshop in Villigen (Switzerland), 6±7 October 1994. Nucl Med Biol 22:1057±1062
Sampson CB (1996) Complications and difficulties in radio-labelling blood cells: a re-
view. Nucl Med Commun 17:648±658
Rakias F, Zolle I (1997) Stannous ion determination: importance and relevance for radiopharmaceutical kits. In: Bergmann H, Kroiss A, Sinzinger H (eds) Radioactive isotopes in clinical medicine and research XXII. Birkhåuser, Basel, Switzerland, pp 401±407
Seifert S, Muth O, Jantsch K, Johannsen B (1995) Radiochemical purity of
99mTc-HM- PAO: critical parameters during kit preparation. Presented at the second COST B3 workshop in Villigen (Switzerland), 6±7 October 1994. Nucl Med Biol 22:1063±1066 Solanki C, Barber R, Sampson CB (1994) Stabilization and multi-dose usage of exame-
tazime for cerebral perfusion studies. Nucl Med Commun 15:718±722 Working Group Meetings
25 June 1993 National Institute of Pharmacy, Radiopharmaceutical Section, Budapest, Hungary
22 March 1994 National Institute of Pharmacy, Radiopharmaceutical Section, Budapest, Hungary
12 May 1995 National Institute of Pharmacy, Radiopharmaceutical Section, Budapest, Hungary
22 March 1996 Dpto. Technologia Pharmaceutica, Facultad Pharmacia, Universidad La Laguna, Tenerife, Spain
Editors' Meetings
In preparation of the Handbook of quality control of
99mTc-radiopharmaceuticals 5 December 1994 Department of Nuclear Medicine, Radiopharmacology, AKH Wien,
Vienna, Austria
14 July 1995 National Institute of Pharmacy, Radiopharmaceutical Section, Budapest, Hungary
8 January 1996 Hotel Elisabethpark, Badgastein, Austria Short-Term Scientific Missions
Jesus Mallol, Ph.D, September 1995: Comparison of radiochemical purity control meth- ods for technetium radiopharmaceuticals used in hospital radiopharmacy. Sorin Bio- medica S.p.A., Radiopharmaceutical Development, Saluggia, Italy
Martina Netter, M.Sc., 3±21 June 1996: Study of methods to enhance the stability of the
99m
