Bookedited by Knud Kristensen, Elisabeth Nørbygaard.
Summary: Safety and Efficacy of Radiopharmaceuticals was established as a very important and comprehensive subject at the First Europe an Symposium on Radiopharmacy and Radiopharmaceuticals in Denmark in 1983. The interest in this subject has grown considerably since then due to the growing interest among national authorities to deal with radiopharmaceuticals. The introduction in recent years of nuclear medicine techniques based on radioactive labelled cells and on monoclonal antibodies has stressed the importance of a well functioning approval system for the clinical trial and use of new radiopharmaceuticals. The process of transferring the experience from the non radioactive drug field into the area of radiopharmaceuticals is still ongoing. International organisations such as the World Health Organisation is also including this into their quality assurance programme from both the radiopharmaceutical and the radiation hygiene point of view. In order to give an up-to date survey of these areas, experts were invited to prepare review papers under the following headings: Safety and Efficacy of Radiopharmaceuticals with Emphasis on Biological Products, Radiopharmacy/Radiation Hygiene, Legal Aspects of the Introduction of New Radiopharmaceuticals and some selected aspects of Good Radiopharmacy Practice.
Contents:
Part 1: Safety and Efficacy of Radiopharmaceuticals with Emphasis on Biological Products
1. Design and development of radiopharmaceuticals based on monoclonal antibodies
2. Newer Technetium-99m radiopharmaceuticals
3. Labelling methods with radioactive iodine
4. Labelling with Indium-111
5. Labelling methods with Technetium-99m
6. Animal models for the evaluation of radiopharmaceuticals
7. Models for safety testing of immunoreactive pharmaceuticals
8. A mouse tumour model for screening radiotracer uptake into primary neoplasms and metastatic disease
9. Monoclonal antibodies and their radionuclide conjugates: Practical and regulatory aspects
10. Specifications and quality control methods for labelled cells
11. Radiochemical purity determination of labelled proteins
12. Safety aspects of human use of labelled cells
13. The basis for preliminary clinical trials of monoclonal antibodies for diagnosis and therapy
Part 2: Radiopharmacy / Radiation Hygiene
14. 'Dose' validation
How do we garantee that the patient is given the prescribed activity
15. Daily Practice in radiopharmacy with special reference to therapy
16. Waste disposal
17. Tc-99
A waste problem?
Part 3: Legal aspects of the introduction of new radiopharmaceuticals
18. Report on the WHO workshop for administrators in the field of radiopharmaceuticals
19. Current trends in the requirement for safety and efficacy of new drugs
20. Relationship between industry, hospitals and authorities
21. Relationship between industry, hospitals and authorities
22. Relationship between industry, hospitals and authorities
Part 4: Selected aspects of Good Radiopharmacy Practice
23. Design of a hospital system for production of radiopharmaceuticals (Quality Assurance programme for a labelled biological product)
24. New developments: Laboratory facilities / product quality
25. Process validation
26. The radiopharmacy as an information center
27. Current trends in the training and education of pharmasists in radiopharmacy.