Safety And Efficacy Of Radiopharmaceuticals


Safety And Efficacy Of Radiopharmaceuticals
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Safety And Efficacy Of Radiopharmaceuticals


Safety And Efficacy Of Radiopharmaceuticals
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Author : Knud Kristensen
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06

Safety And Efficacy Of Radiopharmaceuticals written by Knud Kristensen and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-06 with Medical categories.


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.



Safety And Efficacy Of Radiopharmaceuticals 1987


Safety And Efficacy Of Radiopharmaceuticals 1987
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Author : Knud Kristensen
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06

Safety And Efficacy Of Radiopharmaceuticals 1987 written by Knud Kristensen and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-06 with Medical categories.


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 Organisa tion 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 Radiophar maceuticals with Emphasis on Biological Products, Radiophar macy/Radiation Hygiene, Legal Aspects of the Introduction of New Radiopharmaceuticals and some selected aspects of Good Radiopharmacy Practice.



Progress In Radiopharmacy


Progress In Radiopharmacy
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Author : August P. Schubiger
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06

Progress In Radiopharmacy written by August P. Schubiger and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-06 with Medical categories.


This book is a compilation of the invited papers, which were presented at the Fourth European Symposium on Radiopharmacy and Radiopharmaceuticals, which was held in Baden, Switz- land, 1-4 May, 1991. The First and Third Symposia on Radiopharmacy and Radiopharmaceuticals (Elsinore, Denmark, 1983, 1987) concentrated on the safety and efficacy of radiopharmaceuticals, whereas this Fourth Symposium to some extent followed up the subject of the Second Symposium (Cambridge, UK, 1985): recent developments in radiopharmacy and current research on radiopharmaceuticals. The symposium was organized by the Radiopharmacy Group of the Swiss Society of Medical Radiology (Section Nuclear Medicine) under the auspices of the task group on radiopharmaceu- cals of the European Association of Nuclear Medicine (EANM). The organizing committee consisted of the cochairmen Drs. P.A. Schubiger (Paul Scherrer Institute (PSI), Villigen) and G. Westera (University Hospital, ZiJrich) and the members H.-F. Beer, P. Bl~iuenstein, P. Hasler (all PSI) and H. M~icke (Cantonal Hospital, Basel). The subjects of this Symposium ranged from isotope production to clinical testing of radioph- maceuticals, including the organisational prerequisites. In addition, the development of new radiopharmaceuticals and of PET radiopharmacy, and the concomittant ongoing evolution of regulatory guidelines by national (various European countries, USA) and international (EC) authorities, induced us to honor the vivid interest in this subject and to make it an important part of this symposium.



Guidelines For The Clinical Evaluation Of Radiopharmaceutical Drugs


Guidelines For The Clinical Evaluation Of Radiopharmaceutical Drugs
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Author : United States. Food and Drug Administration. Division of Oncology and Radiopharmaceutical Drug Products
language : en
Publisher:
Release Date : 1981

Guidelines For The Clinical Evaluation Of Radiopharmaceutical Drugs written by United States. Food and Drug Administration. Division of Oncology and Radiopharmaceutical Drug Products and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1981 with Radioisotopes categories.




Guidelines For The Clinical Evaluation Of Radiopharmaceutical Drugs


Guidelines For The Clinical Evaluation Of Radiopharmaceutical Drugs
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Author :
language : en
Publisher:
Release Date : 1977

Guidelines For The Clinical Evaluation Of Radiopharmaceutical Drugs written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1977 with Drugs categories.




Radiation Safety In Nuclear Medicine


Radiation Safety In Nuclear Medicine
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Author : Max H. Lombardi
language : en
Publisher: CRC Press
Release Date : 2006-10-20

Radiation Safety In Nuclear Medicine written by Max H. Lombardi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-10-20 with Law categories.


Recent advances in the field of nuclear medicine (NM) are expanding the role and responsibilities of the nuclear medicine technologist (NMT) to include more complex and detailed tasks. New technologies are making the diagnosis, management, and treatment of illnesses more sensitive, more specific, more accurate, and ultimately safer for both the pat



Quality Control In The Production Of Radiopharmaceuticals


Quality Control In The Production Of Radiopharmaceuticals
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Author : International Atomic Energy Agency
language : en
Publisher:
Release Date : 2018-11-30

Quality Control In The Production Of Radiopharmaceuticals written by International Atomic Energy Agency and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-11-30 with categories.


Advances have led to the production of new radiopharmaceuticals and availability of new production routes. Various new diagnostic agents in the field (such as Ga-68 radiopharmaceuticals and generators) as well as therapeutic agents (such as alpha emitters) have been added to the clinician's menu. It is essential that radiopharmaceuticals are prepared within a robust quality control system encompassing materials and personnel, with adequate documentation, and continuous review of ongoing results. This publication provides guidelines and best practices for the quality control of medical radioisotopes and radiopharmaceuticals. It was written by a group of experts with experience across a range of radiopharmaceuticals and is intended to support professionals in the preparation of good quality and safe products to be used in nuclear medicine procedures.



Fundamentals Of Nuclear Pharmacy


Fundamentals Of Nuclear Pharmacy
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Author : Gopal B. Saha
language : en
Publisher: Springer
Release Date : 2017-11-11

Fundamentals Of Nuclear Pharmacy written by Gopal B. Saha and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-11-11 with Medical categories.


Currently an estimated 17 million nuclear medicine procedures are performed each year in the US and constantly evolving, as new radiopharmaceuticals and imaging techniques are introduced for better diagnosis and treatment of human diseases. In keeping up with new developments, the Seventh Edition of Fundamentals of Nuclear Pharmacy chronicles the advancements in radiopharmaceuticals and their use in clinical applications. It discusses basic concepts such as the atom, radioactive decay, instrumentation and production of radionuclides, and explores the design, labeling, characteristics and quality control of radiopharmaceuticals. Radiation regulations and diagnostic and therapeutic applications of radiopharmaceuticals are detailed. Thoroughly updated, the Seventh Edition includes new topics such as alternative productions of 99Mo; production of 64Cu, 86Y, 89Zr, 177Lu, 223Ra; synthesis and clinical uses of new radiopharmaceuticals such as DaTscan, Xofigo, Amyvid, Neuraceq, Vizamyl, Axumin and 68Ga-DOTATATE; dosimetry of new radiopharmaceuticals; theranostic agents and translational medicine. It features numerous examples, diagrams, and images to further clarify the information and offers end- of-chapter questions to help readers assess their comprehension of the material. Recognized as a classic text on nuclear chemistry and pharmacy and acclaimed for its concise and easy-to-understand presentation, Fundamentals of Nuclear Pharmacy is an authoritative resource for nuclear medicine physicians, residents, students, and technologists.



Advancing Nuclear Medicine Through Innovation


Advancing Nuclear Medicine Through Innovation
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2007-09-11

Advancing Nuclear Medicine Through Innovation written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-09-11 with Medical categories.


Nearly 20 million nuclear medicine procedures are carried out each year in the United States alone to diagnose and treat cancers, cardiovascular disease, and certain neurological disorders. Many of the advancements in nuclear medicine have been the result of research investments made during the past 50 years where these procedures are now a routine part of clinical care. Although nuclear medicine plays an important role in biomedical research and disease management, its promise is only beginning to be realized. Advancing Nuclear Medicine Through Innovation highlights the exciting emerging opportunities in nuclear medicine, which include assessing the efficacy of new drugs in development, individualizing treatment to the patient, and understanding the biology of human diseases. Health care and pharmaceutical professionals will be most interested in this book's examination of the challenges the field faces and its recommendations for ways to reduce these impediments.



Radiation Safety In Nuclear Medicine


Radiation Safety In Nuclear Medicine
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Author : Gopal B. Saha
language : en
Publisher: Springer
Release Date : 2024-04-06

Radiation Safety In Nuclear Medicine written by Gopal B. Saha and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-04-06 with Medical categories.


This new edition is a fully updated guide to radiation safety practice for nuclear medicine professionals, and assists the nuclear medicine technologists in taking their board certifying examination. The NRC requires the appointment of a radiation safety officer (RSO) or an associate radiation safety officer (ARSO) for different uses of radioactive material. Board certified nuclear medicine technologists are eligible to be RSO and ARSO in specific uses of radioactive material after successfully completing a 40-hr or 200-hr course on radiation safety depending on the type of RAM use. This book covers all subject materials in these courses on radiation safety. This guide provides ready-made, handy information on radiation safety as required in the practice of nuclear medicine, presented in a concise form for easy understanding and quick reference related to a given situation and/or incident. The major change in the new edition of the book is the addition of questions at the end of each chapter, to ensure the comprehension of the material by the examinees taking their certifying board examinations. As mentioned in the first edition, the NRC 10CFR20 for Standards for Radiation Protection and the NRC 10CFR35 for Medical Uses of Radioactive Materials are the primary sources of practical information on radiation safety in nuclear medicine. Much of the information is still valid, but many changes and additions have also been made since, which are fully updated here. This is an ideal reference for nuclear medicine physicians, nuclear medicine technologists, and researchers using radioactive materials.