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Safety and efficacy of radiopharmaceuticals

  • Knud Kristensen
  • Elisabeth Nørbygaard

Part of the Developments in Nuclear Medicine book series (DNUM, volume 4)

Table of contents

  1. Front Matter
    Pages I-XIV
  2. Development of the Documentation for Efficacy and Safety of Radiopharmaceuticals

    1. Front Matter
      Pages 1-1
    2. Knud Kristensen, Elisabeth Norbygaard
      Pages 3-4
    3. Gopal Subramanian, J. G. McAfee, R. F. Schneider
      Pages 5-43
    4. Jiri Cifka
      Pages 44-65
    5. Gertrude Pfeiffer
      Pages 66-84
    6. Per O. Bremer
      Pages 85-98
    7. Charles Fallais, Francis Smal
      Pages 99-106
    8. Maurizio Villa
      Pages 107-116
    9. Yves Cohen
      Pages 140-157
    10. Hans Detlev Roedler
      Pages 158-178
    11. Harriet Dige-Petersen
      Pages 191-202
    12. Rolf de Jong, Wim B. Huising
      Pages 203-212
    13. David H. Keeling
      Pages 240-250
    14. Bente Pedersen
      Pages 251-262
    15. Hans Detlev Roedler
      Pages 280-292
    16. Bertil Nosslin
      Pages 293-298
  3. Design of Laboratory Facilities for Preparation of Radiopharmaceuticals at Hospitals

    1. Front Matter
      Pages 307-307
    2. Knud Kristensen, Elisabeth Nørbygaard
      Pages 309-310
  4. Quality Control of Radiopharmaceuticals Prepared from Generators and Kits

    1. Front Matter
      Pages 349-349
    2. Knud Kristensen, Elisabeth Nørbygaard
      Pages 351-352
    3. Yves Jean-Baptiste
      Pages 353-355
    4. Sten-Ove Nilsson
      Pages 356-359
    5. Derek E. Lovett
      Pages 360-363
    6. Jørgen Marqversen
      Pages 364-370
  5. Back Matter
    Pages 379-383

About this book

Introduction

Safety and efficacy of radiopharmaceuticals are elements of great importance in nuclear medicine. Since the first meeting in 1965 in Oak Ridge with the title Radiopharmaceuticals tremendous developments have taken place. In 1965 the whole technetium-99m area was just in its very beginning. Safety and efficacy of the non-radioactive pharmaceuticals have attracted great attention during the last 10 years and so have similar aspects of radiopharmaceuticals during the later years. Regulatory agencies are extending their work also to the preparation of radiopharmaceuticals at hospitals and to requirements for registration of radiopharmaceuticals. In a fast developing field there might be tendencies to confrontation between interests and there have certainly been some tendencies to put undue restrictions on the use of radio­ pharmaceuticals due to the lack of understanding between the industry and the regulatory authorities and between regulatory authorities and hospitals. Much of this may have been due to lack of information and certainly is due to the lack of fundamental scientific knowledge in many radiopharmaceutical aspects. A fast and safe introduction of new radio­ pharmaceuticals and the proper handling of these requires a lot of development work, but also an understanding of how general principles from the non-radioactive drug field may be sensibly transformed into the radiopharmaceutical area. It may even require compromises between requirements for safety in different areas such as radiation protection and pharmaceutical aspects.

Keywords

clinical trial dosimetry drug ethics kinetics pharmacokinetics pharmacology radiation research

Editors and affiliations

  • Knud Kristensen
    • 1
  • Elisabeth Nørbygaard
    • 1
  1. 1.The Isotope-PharmacyThe National Board of HealthCopenhagenDenmark

Bibliographic information

  • DOI https://doi.org/10.1007/978-94-009-6753-3
  • Copyright Information Springer Science+Business Media B.V. 1984
  • Publisher Name Springer, Dordrecht
  • eBook Packages Springer Book Archive
  • Print ISBN 978-94-009-6755-7
  • Online ISBN 978-94-009-6753-3
  • Buy this book on publisher's site