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Safety and efficacy of radiopharmaceuticals

  • Book
  • © 1984

Overview

Editors:
  1. Knud Kristensen

    1. The Isotope-Pharmacy, The National Board of Health, Copenhagen, Denmark

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  2. Elisabeth Nørbygaard

    1. The Isotope-Pharmacy, The National Board of Health, Copenhagen, Denmark

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    You can also search for this editor in PubMed   Google Scholar

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

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Table of contents (33 chapters)

  1. Development of the Documentation for Efficacy and Safety of Radiopharmaceuticals

    1. Ethics-Responsibility in Development, Clinical Trials and Marketing

      • Ole Weis-Fogh
      Pages 263-269

    2. United Kingdom Regulations Relating to the Control of Safety and Efficacy of Radiopharmaceuticals

      • Rosemary J. Smith
      Pages 270-279

    3. Regulatory Aspects in the Federal Republic of Germany

      • Hans Detlev Roedler
      Pages 280-292

    4. Regulatory Aspects — Examples from Sweden

      • Bertil Nosslin
      Pages 293-298

    5. Licensing of Radiopharmaceuticals in European Countries 1982

      • Knud Kristensen
      Pages 299-305

  2. Design of Laboratory Facilities for Preparation of Radiopharmaceuticals at Hospitals

    1. Front Matter

      Pages 307-307
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    2. Introduction

      • Knud Kristensen, Elisabeth Nørbygaard
      Pages 309-310

    3. Design Criteria in Relation to Protection of the Product

      • Neil Bell
      Pages 311-325

    4. Design Criteria in Relation to Protection of the Personnel and the Environment

      • Klaus R. Ennow
      Pages 326-332

    5. Present Status of Recommendations for the Design of Laboratory Facilities

      • Colin R. Lazarus
      Pages 333-348

  3. Quality Control of Radiopharmaceuticals Prepared from Generators and Kits

    1. Front Matter

      Pages 349-349
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    2. Introduction

      • Knud Kristensen, Elisabeth Nørbygaard
      Pages 351-352

    3. Generator Quality — Industry Point of View

      • Yves Jean-Baptiste
      Pages 353-355

    4. Generator-Hospital Points of View

      • Sten-Ove Nilsson
      Pages 356-359

    5. Kit — Industry Points of View

      • Derek E. Lovett
      Pages 360-363

    6. Kit — Hospital Points of View

      • Jørgen Marqversen
      Pages 364-370

    7. Quality Control of Radiopharmaceuticals Prepared from Kits and Generators in Hospitals — United Kindgom Drug Control Point of View

      • Rosemary J. Smith
      Pages 371-377

  4. Back Matter

    Pages 379-383
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Keywords

About this book

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.

Editors and Affiliations

  • The Isotope-Pharmacy, The National Board of Health, Copenhagen, Denmark

    Knud Kristensen, Elisabeth Nørbygaard

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