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Author:   Knud Kristensen ,  Elisabeth Nørbygaard
Publisher:   Kluwer Academic Publishers
Imprint:   Kluwer Academic Publishers
Edition:   1984 ed.
Volume:   4
Weight:   0.860kg
ISBN:  

9780898386097

ISBN 10:   0898386098
Pages:   336
Publication Date:   30 November 1983
Audience:   College/higher education ,  Professional and scholarly ,  Postgraduate, Research & Scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   Out of stock  
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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 pointsof view.- 29 Kit - hospital points of view.- 30 United Kingdom Drug control point of view.

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