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Quality Assurance of Radiopharmaceuticals

  • T. Bringhammar
  • I. Zolle
Chapter
  • 1.8k Downloads

Abstracts

This chapter deals with neither the efficacy of radiopharmaceuticals nor the radiation protection of patients and workers in connection with the handling of radiopharmaceuticals.

Keywords

Competent Authority Marketing Authorization Good Manufacturing Practice United States Pharmacopeia European Economic Community 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. Council of Europe (2005) European pharmacopeia, 5th edn. Maisonneuve, Sainte-RuffineGoogle Scholar
  2. European Economic Community (1983) Council Directive 83/570/EEC (26 October 1983), Summary of product characteristics. European Economic Community, LuxembourgGoogle Scholar
  3. European Economic Community (1997) Pharmaceutical legislation: good manufacturing practices for medicinal products for human and veterinary use (Directive 91/356/EEC). Eudralex, vol. IV. European Economic Community, LuxembourgGoogle Scholar
  4. European Economic Community (1998a) Notice to applicants: procedures for marketing authorization. Medicinal products for human use. (Directive 75/318/EEC; Regulation (EEC) No 2309/93). Eudralex, vol. IIA. European Economic Community, LuxembourgGoogle Scholar
  5. European Economic Community (1998b) Notice to applicants: presentation and content of the dossier. Medicinal products for human use (Directive 75/319/EEC, resp. Regulation (EEC) No 2309/93; Directive 89/343/EEC). Eudralex, vol. IIB. European Economic Community, LuxembourgGoogle Scholar
  6. European Free Trade Agreement (1992) Guide to good manufacturing practice for pharmaceutical products, the convention for the mutual recognition of inspections in respect of the manufacture of pharmaceutical products, Document 5/92 (PIC guidelines on GMP). European Free Trade Agreement, GenevaGoogle Scholar
  7. United States Pharmacopeial Convention (2005) Official monographs: USP28. United States Pharmacopeia Convention, Rockville, Md.Google Scholar
  8. Kristensen K (1979) Preparation and control of radiopharmaceuticals in hospitals. International Atomic Energy Agency, ViennaGoogle Scholar
  9. Nordic Council on Medicines (1989) Radiopharmacy: preparation and control of radiopharmaceuticals in hospitals. National Library of Norway publication No. 26, UppsalaGoogle Scholar

Copyright information

© Springer Berlin Heidelberg 2007

Authors and Affiliations

  • T. Bringhammar
    • 1
  • I. Zolle
    • 2
  1. 1.Medical Products Agency RadiopharmaceuticalsUppsalaSweden
  2. 2.Department of Medicinal/Pharmaceutical ChemistryUniversity of ViennaViennaAustria

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