Safety and efficacy of radiopharmaceuticals

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Product Details

  • ISBN-13: 9789400967557
  • Publisher: Springer Netherlands
  • Publication date: 12/31/2013
  • Series: Developments in Nuclear Medicine Series, #4
  • Edition description: Softcover reprint of the original 1st ed. 1984
  • Pages: 336

Table of Contents

1: Development of the documentation for efficacy and safety of radiopharmaceuticals.- 1 Structure/distribution relationship in the design of Tc-99m radiopharmaceuticals.- 2 Physical/chemical description.- 3 Analytical quality control.- 4 Pharmaceutical form - packaging.- 5 Stability of radiopharmaceuticals.- 6 Production design - GMP industry.- 7 The design of radiopharmaceuticals Pharmacology and toxicology.- 8 Animal models for efficacy studies - a practical approach.- 9 Human pharmacology - pharmacokinetics.- 10 Radiation dosimetry.- 11 Clinical trials of radiopharmaceuticals.- 12 Evaluation of clinical information.- 13 Comparative evaluation of drugs.- 14 “The paperwork” with applications for registration of radiopharmaceuticals in Denmark.- 15 Drug-radiopharmaceutical interactions and other possible modifications in radiopharmaceutical biodistribution.- 16 Adverse reactions to radiopharmaceuticals.- 17 Drug defects.- 18 Ethics - responsibility in development, clinical trials and marketing.- 19 United Kingdom regulations relating to the control of safety and efficacy of radiopharmaceuticals.- 20 Regulatory aspects in the Federal Republic of Germany.- 21 Regulatory aspects - examples from Sweden.- 22 Licensing of radiopharmaceuticals in european countries 1982.- 2: Design of laboratory facilities for preparation of radiopharmaceuticals at hospitals.- 23 Design criteria in relation to protection of the product.- 24 Design criteria in relation to protection of the personnel and the environment.- 25 Present status of recommendations for the design of laboratory facilities.- 3: Quality control of radiopharmaceuticals prepared from generators and kits.- 26 Generator quality - industry points of view.- 27 Generator - hospital points of view.- 28 Kit - industry points of view.- 29 Kit - hospital points of view.- 30 United Kingdom Drug control point of view.

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