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    Guidance for Preclinical Studies with Radiopharmaceuticals
    Pain Palliation of Bone Metastases: Production, Quality Control and Dosimetry of Radiopharmaceuticals
    Copper-64 Radiopharmaceuticals: Production, Quality Control and Clinical Applications
    Ebook series3 titles

    IAEA Radioisotopes and Radiopharmaceuticals Series

    By IAEA

    ()

    About this series

    Radionuclide therapy using bone targeting radiopharmaceuticals is an effective palliative care option to reduce pain associated with advanced disease with bone metastases. Over the last 20 years, suitable therapeutic radionuclides are more widely available, meaning that the benefits of pain palliation therapy could reach more patients. This publication provides a broad overview on the current status of radiopharmaceuticals for bone pain palliation. It covers production of radionuclides, identification of bone seeking carrier molecules, preparation of stable complexes, in vitro and in vivo evaluations and dosimetry studies which are part of the development of these radiopharmaceuticals for clinical use. Details on production and quality control of the currently available products, provided here will be of use to scientists involved in the development of these radiopharmaceuticals.
    LanguageEnglish
    PublisherInternational Atomic Energy Agency
    Release dateNov 10, 2022
    Guidance for Preclinical Studies with Radiopharmaceuticals
    Pain Palliation of Bone Metastases: Production, Quality Control and Dosimetry of Radiopharmaceuticals
    Copper-64 Radiopharmaceuticals: Production, Quality Control and Clinical Applications

    Titles in the series (3)

    • 7

      Copper-64 Radiopharmaceuticals: Production, Quality Control and Clinical Applications
      Copper-64 Radiopharmaceuticals: Production, Quality Control and Clinical Applications

      Copper-64 Radiopharmaceuticals: Production, Quality Control and Clinical Applications

      IAEA
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      0 ratings

      Positron emission tomography (PET) is an important clinical tool, and with its longer half-life, copper-64 has several unique attributes that make it a multi-purpose radionuclide with many potential applications. Additionally, copper as a trace element plays a pivotal role in several human metabolic and pathologic diseases and is involved in malignant cells biochemistry pathways. This offers the opportunity for scientists to explore the theranostic capabilities of copper-64. This current publication, arising from an IAEA Coordinated Research Project, describes the biochemical and radiopharmaceutical aspects of copper-64, and its clinical applications, with specific guidelines and methods for the production of copper-64 chloride, peptide and monoclonal antibody radiopharmaceuticals. It is expected to be of use to all professionals involved in the field by specifying ideal production, formulation and quality control methods.

      Positron emission tomography (PET) is an important clinical tool, and with its longer half-life, copper-64 has several unique attributes that make it a multi-purpose radionuclide with many potential applications. Additionally, copper as a trace element plays a pivotal role in several human metabolic and pathologic diseases and is involved in malignant cells biochemistry pathways. This offers the opportunity for scientists to explore the theranostic capabilities of copper-64. This current publication, arising from an IAEA Coordinated Research Project, describes the biochemical and radiopharmaceutical aspects of copper-64, and its clinical applications, with specific guidelines and methods for the production of copper-64 chloride, peptide and monoclonal antibody radiopharmaceuticals. It is expected to be of use to all professionals involved in the field by specifying ideal production, formulation and quality control methods.

    • 8

      Guidance for Preclinical Studies with Radiopharmaceuticals
      Guidance for Preclinical Studies with Radiopharmaceuticals

      Guidance for Preclinical Studies with Radiopharmaceuticals

      IAEA
      0 ratings
      0 ratings

      Preclinical or nonclinical evaluation is an integral part of the development of any drug. The process of developing a new radiopharmaceutical includes rigorous testing before it can be cleared for use in humans. There must be in-depth characterization of its behaviour to assess its safety and suitability for the intended clinical application. This publication provides a baseline guide for preclinical evaluation of radiopharmaceuticals that will give its readers a general review of the requirements of a facility and insight into the various scientific activities that constitute this process. The principles and protocols discussed herein will provide guidelines for biological assessment of candidate compounds, which are consistent with the principles of good laboratory practices to generate valid nonclinical scientific data towards approval for clinical translation. This publication is intended not only for researchers engaged in radiopharmaceutical development, but also for the Member States planning to set up or upgrade facilities for radiopharmaceuticals’ research.

      Preclinical or nonclinical evaluation is an integral part of the development of any drug. The process of developing a new radiopharmaceutical includes rigorous testing before it can be cleared for use in humans. There must be in-depth characterization of its behaviour to assess its safety and suitability for the intended clinical application. This publication provides a baseline guide for preclinical evaluation of radiopharmaceuticals that will give its readers a general review of the requirements of a facility and insight into the various scientific activities that constitute this process. The principles and protocols discussed herein will provide guidelines for biological assessment of candidate compounds, which are consistent with the principles of good laboratory practices to generate valid nonclinical scientific data towards approval for clinical translation. This publication is intended not only for researchers engaged in radiopharmaceutical development, but also for the Member States planning to set up or upgrade facilities for radiopharmaceuticals’ research.

    • 9

      Pain Palliation of Bone Metastases: Production, Quality Control and Dosimetry of Radiopharmaceuticals
      Pain Palliation of Bone Metastases: Production, Quality Control and Dosimetry of Radiopharmaceuticals

      Pain Palliation of Bone Metastases: Production, Quality Control and Dosimetry of Radiopharmaceuticals

      IAEA
      0 ratings
      0 ratings

      Radionuclide therapy using bone targeting radiopharmaceuticals is an effective palliative care option to reduce pain associated with advanced disease with bone metastases. Over the last 20 years, suitable therapeutic radionuclides are more widely available, meaning that the benefits of pain palliation therapy could reach more patients. This publication provides a broad overview on the current status of radiopharmaceuticals for bone pain palliation. It covers production of radionuclides, identification of bone seeking carrier molecules, preparation of stable complexes, in vitro and in vivo evaluations and dosimetry studies which are part of the development of these radiopharmaceuticals for clinical use. Details on production and quality control of the currently available products, provided here will be of use to scientists involved in the development of these radiopharmaceuticals.

      Radionuclide therapy using bone targeting radiopharmaceuticals is an effective palliative care option to reduce pain associated with advanced disease with bone metastases. Over the last 20 years, suitable therapeutic radionuclides are more widely available, meaning that the benefits of pain palliation therapy could reach more patients. This publication provides a broad overview on the current status of radiopharmaceuticals for bone pain palliation. It covers production of radionuclides, identification of bone seeking carrier molecules, preparation of stable complexes, in vitro and in vivo evaluations and dosimetry studies which are part of the development of these radiopharmaceuticals for clinical use. Details on production and quality control of the currently available products, provided here will be of use to scientists involved in the development of these radiopharmaceuticals.

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