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Sample records for radiopharmaceuticals annual technical

  1. Report on the Technical Meeting on Therapeutic Radiopharmaceuticals

    International Nuclear Information System (INIS)

    2009-01-01

    The purpose of the TM was to provide an experts' platform to facilitate exploring the current status and future directions on therapeutic radiopharmaceuticals. The invited talks and presentations in the TM were in the following topics: - Radionuclide Production; - Production and availability of alpha emitters and their radiopharmaceuticals; - Therapeutic radiopharmaceutical chemistry; - Targets and biological evaluation; - Medical physics and dosimetry; - Clinical applications including radioimmunotherapy and clinical needs; - Peptide receptor mediated therapy Panel discussions: - Radionuclide therapy using alpha emitters; - Regulatory challenges with therapeutic radiopharmaceuticals; - International activities in radionuclide therapy. he technical meeting generated a large interest among scientists and physicians working in the field of targeted therapy using radiopharmaceuticals. Participants from both developed and developing MS reported on recent developments on the research work and clinical studies going on in the field and provided their views on the future developments in this field. The unexpected high number of participants and the high number of presentations with exceptional quality underlines the great interest of scientists and professionals in therapeutic applications using radiolabelled drugs / biomolecules. The intensive discussions including panels specified the challenges in the future on developing novel agents and to finally use them for the benefit of patients. The IAEA can play as vital role in streamlining developments and to provide tools to overcome scientific, professional and regulatory challenges in the field of therapeutic radiopharmaceuticals

  2. Report on the Technical Meeting on Therapeutic Radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2009-07-01

    The purpose of the TM was to provide an experts' platform to facilitate exploring the current status and future directions on therapeutic radiopharmaceuticals. The invited talks and presentations in the TM were in the following topics: - Radionuclide Production; - Production and availability of alpha emitters and their radiopharmaceuticals; - Therapeutic radiopharmaceutical chemistry; - Targets and biological evaluation; - Medical physics and dosimetry; - Clinical applications including radioimmunotherapy and clinical needs; - Peptide receptor mediated therapy Panel discussions: - Radionuclide therapy using alpha emitters; - Regulatory challenges with therapeutic radiopharmaceuticals; - International activities in radionuclide therapy. he technical meeting generated a large interest among scientists and physicians working in the field of targeted therapy using radiopharmaceuticals. Participants from both developed and developing MS reported on recent developments on the research work and clinical studies going on in the field and provided their views on the future developments in this field. The unexpected high number of participants and the high number of presentations with exceptional quality underlines the great interest of scientists and professionals in therapeutic applications using radiolabelled drugs / biomolecules. The intensive discussions including panels specified the challenges in the future on developing novel agents and to finally use them for the benefit of patients. The IAEA can play as vital role in streamlining developments and to provide tools to overcome scientific, professional and regulatory challenges in the field of therapeutic radiopharmaceuticals

  3. Institute of Bioinorganic and Radiopharmaceutical Chemistry. Annual report 2000

    International Nuclear Information System (INIS)

    Johannsen, B.; Seifert, S.

    2001-01-01

    In 2000 the Rossendorf research centre continued and further developed its basic and application-oriented research. Research at the Institute of Bioinorganic and Radiopharmaceutical Chemistry, one of five institutes in the Research Centre, was focused on radiotracers as molecular probes to make the human body biochemically transparent with regard to individual molecular reactions. In this respect the potential for diagnostic application depends on the quality and versatility of radiopharmaceutical chemistry, which is the main discipline in our Institute. Areas in which the Institute was particularly active were the design of new radiotracers, both radiometal-based and natural organic molecules, the elaboration of radiolabelling concepts and procedures and the chemical and pharmacological evaluation of new tracers. This was complemented by more clinically oriented activities in the Positron Emission Tomography Centre Rossendorf. With numerous contributions in the fields of radiopharmaceutical chemistry, tumour agents, tumour diagnosis and brain biochemistry this Annual Report will document the scientific progress made in 2000. (orig.)

  4. Radiopharmaceuticals

    International Nuclear Information System (INIS)

    1981-01-01

    The catalogue offers a wide-spread product range which meets the requirements of the international trend of in vivo application of radiopharmaceuticals. It includes: (1) conditions of sale and delivery, (2) delivery schedule for radiopharmaceuticals, (3) technical information, (4) product specifications, and (5) the complete delivery programme

  5. Forschungszentrum Rossendorf, Institute of Bioinorganic and Radiopharmaceutical Chemistry. Annual report 1995

    International Nuclear Information System (INIS)

    Johannsen, B.

    1996-02-01

    Research at the Institute of Bioinorganic and Radiopharmaceutical Chemistry of the Research Center Rossendorf is focused on radiotracers as molecular probes for diagnosis of disease. The research effort has two main components: -Positron emission tomography (PET) - technetium chemistry and radiopharmacology. The research activities of the Institute have been performed in three administratively classified groups. A PET tracer group is engaged in the chemistry and radiopharmacy of 11 C and 18 F compounds and in the setup of the PET center. A SPECT tracer group deals with the design, synthesis and chemical characterization of metal coordination compounds, primarily rhenium and technetium complexes. A biochemical group is working on SPECT and PET-relevant biochemical and biological projects. This includes the characterization and assessment of new compounds developed in the two synthetically oriented groups. The annual report presented here covers the research activities of the Institute of Bioinorganic and Radiopharmaceutical Chemistry in 1995. (orig.)

  6. Report of a Technical Meeting on ''Alpha emitting radionuclides and radiopharmaceuticals for therapy''

    International Nuclear Information System (INIS)

    2013-01-01

    Considering the high potential of α-emitters for future development of radionuclide therapy, the International Atomic Energy Agency (IAEA) organized a Technical Meeting on ‘Alpha Emitting Radionuclides and Radiopharmaceuticals for Therapy’, from June 24 to 28, 2013, at IAEA Headquarters in Vienna with the purpose of gathering eminent Experts in the field and discuss with them the status and future perspectives of the field. Sixteen Experts and two External Observers from ten different countries, and four IAEA Technical Officers attended this meeting. Outstanding lectures have been presented covering all relevant aspects of α-therapy, which were followed by extensive discussions and analysis. Selected arguments encompassed production methods and availability of alpha-emitting radionuclides, labelling chemistry of alpha-emittting radioelements, design and development of target-specific radiopharmaceuticals, physical principles of alpha-particle dosimetry and advanced dosimetric models, biological effects of alpha radiation at the cellular level, on-going preclinical and clinical studies with new radiopharmaceuticals, results of clinical trials on the use of radium-223 chloride solutions for the treatment of metastatic bone cancer. The broad scientific background of invited components of the Experts’ panel conferred a strong interdisciplinary trait to the overall discussion and stimulated a critical analysis of this emerging unexplored field. Results of this comprehensive overview on alpha therapy, including recommendations to the Agency on suitable initiatives that may help to promote and spread the knowledge to Members States on this emerging therapeutic modality, are summarized in the present Report

  7. Technical artifacts in chromatographic analysis of Tc-99m radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kowalsky, R.J.; Creekmore, J.R.

    1982-01-01

    Technical artifacts produced during chromatographic analysis of technetium radiopharmaceuticals were investigated. Such artifacts are, we found, caused by improper spotting and drying techniques; these in turn produce spuriously high impurities in Tc-99m complexes of DTPA, MDP, PPi, and GH. The ITLC-SG/acetone system produces considerable streaking of Tc-complex if the applied spot is large and not dried before development. This results in activity in the solvent front portion of the chromatographic strip indicating falsely high levels of pertechnetate impurity. Proper drying of the applied spot eliminates the artifact. The ITLC-SG/saline system yields falsely high, hydrolyzed-reduced technetium impurities if the spot is allowed to enter the solvent during development. Correct spot placement and size eliminate this problem. Strips that are allowed to dry in room air for several minutes may indicate considerable pertechnetate impurity on the chromatogram; yet this may not actually be present in the radiopharmaceutical vial. Drying spots rapidly with hot air or in a nitrogen atmosphere before development eliminates this problem

  8. Teaching and research in radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Wiebe, L I [Noujaim Institute for Pharmaceutical Oncology Research, University of Alberta, Edmonton (Canada)

    1998-08-01

    Radiopharmaceuticals comprise a critical element of diagnostic and therapeutic clinical nuclear medicine. As well they contribute to more basic pre-clinical and clinical diagnostic studies such as the evaluation of new drugs and new drug formulations. Their development and utilization is based on the complex interaction of a number of disciplines including medicine, pharmacy, biochemistry, pharmacology, chemistry, physics and engineering. This technically-complex multidisciplinary base has impeded the development of a uniform curriculum of training for basic scientists and professionals who work with radiopharmaceuticals. the range of technical knowledge required is very broad; it ranges from chemical synthesis and radiolabelling, through a maze of biochemistry, pharmacology and now molecular biology, to GMP manufacture, dispensing and clinical consultation concerning use and interpretation of data. Clearly, no single discipline can (nor should) be expected to undertake in-depth training of radiopharmaceutical scientists, but equally clearly, there is need for the development of curricula that will develop specific components of the essential knowledge base. The `radiopharmaceutical` or `product` orientation of both teaching and research can be used to provide a focus for academic and professional organizations to develop `radiopharmacy` curricula that effectively train radiopharmaceutical practitioners for specific roles within the clinical, academic, government and industrial interests of radiopharmaceutical scientists. Currently, there is a plethora of segmented training programs, many of which are inadequately positioned to be of great value to the field or its practitioners. Efforts to re-focus radiopharmacy programs and to build professional recognition for them are bringing about harmonization of performance objectives, and leading to didactic and experiential curricula. The impact and evolution of regulatory processes will demand new and better

  9. Teaching and research in radiopharmaceuticals

    International Nuclear Information System (INIS)

    Wiebe, L.I.

    1998-01-01

    Radiopharmaceuticals comprise a critical element of diagnostic and therapeutic clinical nuclear medicine. As well they contribute to more basic pre-clinical and clinical diagnostic studies such as the evaluation of new drugs and new drug formulations. Their development and utilization is based on the complex interaction of a number of disciplines including medicine, pharmacy, biochemistry, pharmacology, chemistry, physics and engineering. This technically-complex multidisciplinary base has impeded the development of a uniform curriculum of training for basic scientists and professionals who work with radiopharmaceuticals. the range of technical knowledge required is very broad; it ranges from chemical synthesis and radiolabelling, through a maze of biochemistry, pharmacology and now molecular biology, to GMP manufacture, dispensing and clinical consultation concerning use and interpretation of data. Clearly, no single discipline can (nor should) be expected to undertake in-depth training of radiopharmaceutical scientists, but equally clearly, there is need for the development of curricula that will develop specific components of the essential knowledge base. The 'radiopharmaceutical' or 'product' orientation of both teaching and research can be used to provide a focus for academic and professional organizations to develop 'radiopharmacy' curricula that effectively train radiopharmaceutical practitioners for specific roles within the clinical, academic, government and industrial interests of radiopharmaceutical scientists. Currently, there is a plethora of segmented training programs, many of which are inadequately positioned to be of great value to the field or its practitioners. Efforts to re-focus radiopharmacy programs and to build professional recognition for them are bringing about harmonization of performance objectives, and leading to didactic and experiential curricula. The impact and evolution of regulatory processes will demand new and better

  10. Radiopharmacy and radiopharmaceutical products

    International Nuclear Information System (INIS)

    Galy, Gerard; Fraysse, Marc; Hammadi, Akli; Tafani, Mathieu

    2012-01-01

    Written by two radio-pharmacist doctors, this book presents all the theoretical and practical knowledge necessary to radio-pharmacists in charge of the management, the preparation, the control and the delivery of radiopharmaceutical medicines. It presents the scientific, regulatory and technical foundations for the implementation and operation of radiopharmacy in hospitals, addressing themes such as the fundamentals and theories about nuclear physics and radioactivity (production of artificial radionuclides, detectors and measuring instruments, radio-chemistry), radio-biology and radiation protection (biological effects of ionizing radiations, radioprotection, regulations concerning the use of radiopharmaceutical products by medical personnel), the application domains of radiopharmaceutical medicines and products (diagnosis, therapy, biological assessment), and the management of radiopharmacy in a hospital (design, implementation, organizing, operation)

  11. Annual report 1994 of the Verein fuer Kernverfahrenstechnik und Analytik, Rossendorf

    International Nuclear Information System (INIS)

    Haefele, W.

    1995-05-01

    The annual report 1994 of the VKTA presents reports on the scientific and technical activities and the management activities, and an organigram. The scientific-technical activities focus on the subjects of nuclear facilities, nuclear waste management, radioactivity monitoring and analysis, site decontamination and rehabilititation, radiopharmaceuticals, and safety and radiological protection. (DG) [de

  12. Radiopharmaceuticals

    International Nuclear Information System (INIS)

    Theobald, A.E.

    1989-01-01

    This book is a review of the latest developments in radiopharmaceuticals. It covers the development of radiopharmaceutical compounds, the theory and practice of their synthesis, and examples of their application. Also covers safe handling of radiopharmaceuticals, legislation affecting their use, radiation monitoring, radiochromatography, and computer techniques

  13. Lung radiopharmaceuticals

    International Nuclear Information System (INIS)

    Gonzalez, B.M.

    1994-01-01

    Indication or main clinical use of Lung radiopharmaceuticals is presented and clasification of radiopharmaceuticals as ventilation and perfusion studies. Perfusion radiopharmaceuticals, main controls for administration quality acceptance. Clearence after blood administration and main clinical applications. Ventilation radiopharmaceuticals, gases and aerosols, characteristics of a ideal radioaerosol, techniques of good inhalation procedure, clinical applications. Comparison of several radiopharmaceuticals reflering to retention time as 50% administered dose, percent administered dose at 6 hours post inhalation, blood activity at 30 and 60 minutes post inhalation, initial lung absorbed dose, cumulated activity.Kinetic description of two radiopharmaceuticals, 99mTcDTPA and 99mTc-PYP

  14. Institute of Bioinorganic and Radiopharmaceutical Chemistry. Annual report 1992

    International Nuclear Information System (INIS)

    Johannsen, B.

    1993-04-01

    The Institute of Bioinorganic and Radiopharmaceutical Chemistry of the Rossendorf Research Center (FZR) presents its 1992 anual report in order to in form on research activities in the first year of its existence. This volume contains 27 individual reports devoted to various aspects of radiotracers for nuclear medicine. (BBR)

  15. Hospitable radiopharmaceuticals

    International Nuclear Information System (INIS)

    Gonzalez, M.B.

    1994-01-01

    Two types of hospitalary radiopharmaceutical was given in Nuclear Medicine: the centralized and hospitalary radiopharmaceuticals. The good practice in the use, instrumentation and quality control of radiopharmaceuticals are used in nuclear medicine for diagnostic and therapy diseases

  16. New radiopharmaceuticals

    International Nuclear Information System (INIS)

    Payoux, P.; Esquerre, J.P.; Alonso, M.; Tafani, M.

    2008-01-01

    With the development of positron emission tomography, the significant increase in prescriptions of [ 18 F]F.D.G. has underlined the interest for molecular imaging in many pathologies. Facing the demand of 'new' radiopharmaceuticals (frequently clinically validated in the last century) for more and more specific diagnosis, the nuclear physician is confronted with a sparse offer of the radiopharmaceutical companies and a particularly complicated radiopharmaceutical legislation. This paper briefly reports on the radiopharmaceutical statutes encountered in France nowadays; it emphasizes that is essential to deeply modify the conditions to obtain a marketing authorization for radiopharmaceuticals if we want to propose to our patients the kind of right they have to expect from nuclear medicine. (authors)

  17. Radiopharmaceuticals

    International Nuclear Information System (INIS)

    Ganatra, R.D.

    1992-01-01

    Today there are an estimated ten million nuclear imaging procedures, performed each year, in just the United States, and the number is still growing. More than 30,000 therapy procedures are performed in the USA each year using radiopharmaceuticals. Moreover, while the numbers continue to grow, so also do the variety of the procedures being employed. A weakness of nuclear medicine is related also to one of its strengths. Unlike other types of imaging where only an instrument and the patient are required (e.g., with ultrasonics); nuclear medicine requires a radiopharmaceutical. At the same time, the variety of radiopharmaceuticals offers the ability to trace one or more particular functions of the human body. This provides nuclear medicine with great variety in detecting specific pathologies. Various nuclear medicine studies are possible because of the localization of radiopharmaceuticals in different organs

  18. Lung radiopharmaceuticals; Radioformacos pulmonares

    Energy Technology Data Exchange (ETDEWEB)

    Gonzalez, B M [Instituto Nacional de Pediatroa (Mexico)

    1994-12-31

    Indication or main clinical use of Lung radiopharmaceuticals is presented and clasification of radiopharmaceuticals as ventilation and perfusion studies. Perfusion radiopharmaceuticals, main controls for administration quality acceptance. Clearence after blood administration and main clinical applications. Ventilation radiopharmaceuticals, gases and aerosols, characteristics of a ideal radioaerosol, techniques of good inhalation procedure, clinical applications. Comparison of several radiopharmaceuticals reflering to retention time as 50% administered dose, percent administered dose at 6 hours post inhalation, blood activity at 30 and 60 minutes post inhalation, initial lung absorbed dose, cumulated activity.Kinetic description of two radiopharmaceuticals, 99mTcDTPA and 99mTc-PYP.

  19. Radiopharmaceuticals generalities

    International Nuclear Information System (INIS)

    Leon Cabana, A.S.

    1994-01-01

    Many applications in nuclear medicine used as diagnostic techniques, images methods with direct and indirect labelled compounds in organs. A brief description about scintillator counters or gamma counters SPECT(single photon emission computed tomography) and PECT (positron emission computed tomography), as well as therapeutic proceedings,radiopharmaceutical classification, labell steps,administration form in the body,physical form and the best radiopharmaceutical ideal classification. Two tables was used contain radiopharmaceuticals more used in diagnostic and more used in therapic uses. Tabs

  20. Institute of Bioinorganic and Radiopharmaceutical Chemistry. Annual report 2001

    International Nuclear Information System (INIS)

    Johannsen, B.; Seifert, S.

    2002-01-01

    In 2001 the Forschungszentrum Rossendorf e.V. continued and further developed its basic and application-oriented research. Research at the Institute of Bioinorganic and Radiopharmaceutical Chemistry, one of five institutes in the Research Centre, was focused on radiotracers as molecular probes to make the human body biochemically transparent with regard to individual molecular reactions. As illustrated by the large number of contributions in this report, the Institute is predominantly engaged in the coordination chemistry and radiopharmacology of technetium and rhenium. (orig.)

  1. Report of the consultants meeting on good manufacturing practices and clean room requirements for radiopharmaceuticals

    International Nuclear Information System (INIS)

    2000-07-01

    be carried out in special facilities often with shielding and remote handling to protect the operators from radiation exposure. There are international norms for radiation exposure allowed for radiation workers and strong national organizations for monitoring and implementing radiation protection measures. Being part of the national nuclear programmes, radiopharmaceutical production has been from the very beginning subjected to regulations of radioactive material handling, transportation and use. However, the systems of surveillance and control for pharmaceutical products have not been implemented in many places to the same extent as for radiation protection. There are also technical difficulties in harmonizing the requirements of radiation safety and pharmaceutical safety. Simultaneously, there have been several technical developments in the field of Quality Assurance of pharmaceuticals. The concepts of Good Manufacturing Practices (GMP) and the requirements for clean rooms define quality of air for pharmaceutical production areas. Efforts have been made in recent years to apply these concepts also to radiopharmaceutical production. Significant progress appears to have been made in the developed countries and in the technology needed to fulfil these standards. The technical problems in upgrading the facilities of radioisotope laboratories to conform with the clean air requirements and the cost involved are still to be clearly understood in many developing countries. In many countries the regulatory authorities apply the same set of regulations for radiopharmaceuticals as for other pharmaceuticals. Some guidelines for radiopharmaceuticals have been published, e.g. Scandinavian, US FDA, Australian, Canadian and EU guidelines. No such guidelines are yet available from international agencies such as the International Atomic Energy Agency (IAEA) or World Health Organization (WHO). A guideline from an international body of this nature would be very useful for institutions

  2. Eleventh international symposium on radiopharmaceutical chemistry

    International Nuclear Information System (INIS)

    1995-01-01

    This document contains abstracts of papers which were presented at the Eleventh International Symposium on Radiopharmaceutical Chemistry. Sessions included: radiopharmaceuticals for the dopaminergic system, strategies for the production and use of labelled reactive small molecules, radiopharmaceuticals for measuring metabolism, radiopharmaceuticals for the serotonin and sigma receptor systems, labelled probes for molecular biology applications, radiopharmaceuticals for receptor systems, radiopharmaceuticals utilizing coordination chemistry, radiolabelled antibodies, radiolabelling methods for small molecules, analytical techniques in radiopharmaceutical chemistry, and analytical techniques in radiopharmaceutical chemistry

  3. Eleventh international symposium on radiopharmaceutical chemistry

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-12-31

    This document contains abstracts of papers which were presented at the Eleventh International Symposium on Radiopharmaceutical Chemistry. Sessions included: radiopharmaceuticals for the dopaminergic system, strategies for the production and use of labelled reactive small molecules, radiopharmaceuticals for measuring metabolism, radiopharmaceuticals for the serotonin and sigma receptor systems, labelled probes for molecular biology applications, radiopharmaceuticals for receptor systems, radiopharmaceuticals utilizing coordination chemistry, radiolabelled antibodies, radiolabelling methods for small molecules, analytical techniques in radiopharmaceutical chemistry, and analytical techniques in radiopharmaceutical chemistry.

  4. Medical application of nuclear science: nuclear medicine and production of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Cornet, L.

    1997-01-01

    Nuclear science in attendance on medicine or from Radium to Radiopharmaceuticals. By a brief historical reminder of the evolution of the radioactivity and development of nuclear science, we could see a very early interest and application of the radioactivity in the medical field. Main steps: Detection of natural radioactivity/Discovery of artificial radioactivity/First treatment of leukaemia and thyroid/First nuclear reactor/First radioisotope laboratory in hospital/First scintigraphy/First radiopharmaceutical/First cyclotron and cyclotron products/First immunoscintigraphy/Biotechnology and radioisotope/Evolution of technics [equipment for diagnosis (imaging, scintigraphy) and therapy]/Evolution of production technics and concept of products (generators of Technetium) and machines, reactor, cyclotron/Evolution of importance and interest of nuclear medicine/Creation of international association of nuclear medicine and producers (example ARPR)/Evolution of safety and pharmaceuticals regulation. After the sixties, period extremely rich in invention of products, characterized by a high fertility specially due to a non-restrictive regulation in terms of safety and pharmaceutical consideration, the evolution of technics, the importance of costs (investment, research, healthcare and the evolution of the regulations) have smoothly but continuously transformed the contexts and different actors. Consequences and facts: Rationalization and standardization of the catalogues, total integration of radiopharmaceuticals into the pharmaceutical laws, stop of nuclear research reactors, increase of number of cyclotrons, transformation of size and role of the producers and nuclear centers, risk in supply of some raw materials like Molybdenum, medical nuclear application as a worldwide business

  5. The development of cyclotron radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Yang, Seung Dae; Chun, K. W.; Suh, Y. S.; Lee, J. D.; Ahn, S. H. and others

    1999-03-01

    The purpose of this project is to developthe radiopharmaceuticals and automatic synthetic unit for labelled compounds, and to establish mass production system of radiopharmaceuticals. These will contribute to the early diagnosis of the disease hard to cure. The contents of this project are as follows, the development of the radiopharmaceutical for imaging of cancer, the development of automatic synthesizer for the synthesis of radio-pharmaceuticals, the development of hormone derivatives labelled with {sup 12}'3I, the development of the radiopharmaceuticals for therapy of cancer labelled with cyclotron produced radionuclides, the development of radiopharmaceuticals for therapy of cancer labelled with cyclotron produced radionuclides, the development of radiopharmaceuticals for imaging of myocardial metabolism.

  6. The development of cyclotron radiopharmaceuticals

    International Nuclear Information System (INIS)

    Yang, Seung Dae; Chun, K. W.; Suh, Y. S.; Lee, J. D.; Ahn, S. H. and others

    1999-03-01

    The purpose of this project is to develop the radiopharmaceuticals and automatic synthetic unit for labelled compounds, and to establish mass production system of radiopharmaceuticals. These will contribute to the early diagnosis of the disease hard to cure. The contents of this project are as follows, the development of the radiopharmaceutical for imaging of cancer, the development of automatic synthesizer for the synthesis of radio-pharmaceuticals, the development of hormone derivatives labelled with 12 '3I, the development of the radiopharmaceuticals for therapy of cancer labelled with cyclotron produced radionuclides, the development of radiopharmaceuticals for therapy of cancer labelled with cyclotron produced radionuclides, the development of radiopharmaceuticals for imaging of myocardial metabolism

  7. Fabrication of sterile experimental radiopharmaceuticals: technical and regulatory requirements

    International Nuclear Information System (INIS)

    Briand, S.

    2008-03-01

    The radiopharmaceuticals devoted to the biomedical research were the object of the directive 2001/20/C.E. transposition that defined again the conditions of implementation of biomedical research using drugs at human use, whom authorization is delivered by A.f.s.s.a.p.s.. In an other hand the law 2006-686 of the 13. june 2006 ( called law T.S.N.) has modified the regulatory dispositions relative to the radiation protection norms. These new dispositions allow to the health facilities to realize their research projects without difficulties for experimental drugs supply. (N.C.)

  8. The IAEA Activities on Supporting Development of Therapeutic Radiopharmaceuticals and Capacity Building in Member States

    International Nuclear Information System (INIS)

    Pillai, M.R.A.; Haji-Saeid, M.; Zaknun, J.; Ramamoorthy, N.

    2009-01-01

    The IAEA activities on supporting development of therapeutic radiopharmaceuticals are focused on identified radionuclides that can be produced in large quantities and making use of carrier molecules which can be synthesized locally or procured from commercial sources or already available in MS from other related programs. The main emphasis is on 90 Y and 177 Lu based products, which cover the hard beta energy and soft beta energy range respectively, and also since both these radionuclides can be produced in large quantities with very high specific activity and high radionuclidic purity. The services to MS are provided through implementing Coordinated Research Projects (CRP), Technical Cooperation (TC) projects, technical meetings and regional training courses in addition to documenting practically useful technical information related to these products though IAEA publications. The CRP is a group activity in which nearly 15 participants from as many countries come together to work towards an identified objective. Two of the completed CRPs in this area are: (i) Comparative evaluation of therapeutic radiopharmaceuticals (2002-2005) that focussed on the development of 'in vitro' and 'in vivo' techniques for evaluating new generation therapeutic radiopharmaceuticals; and (ii) Development of generator technologies for therapeutic radionuclides (2004-2007) that addressed technologies for 90 Sr/ 90 Y and 188 W/ 188 Re generators and which can be easily adapted by MS. The participants in the CRP on 'Comparative evaluation of therapeutic radiopharmaceuticals' used the somatostatin analogue, DOTATATE as the lead molecule for developing radiopharmaceuticals and testing the efficacy by in vitro biological assays and animal biodistribution studies. A significant outcome of the CRP was that 177 Lu-DOTATATE therapy is now practised in several of the CRP participating countries including Brazil, India, Italy, and Poland. The major outcome of the CRP on 'Development of generator

  9. The IAEA Activities on Supporting Development of Therapeutic Radiopharmaceuticals and Capacity Building in Member States

    Energy Technology Data Exchange (ETDEWEB)

    Pillai, M R.A.; Haji-Saeid, M; Zaknun, J; Ramamoorthy, N [Department of Nuclear Sciences and Applications, International Atomic Energy Agency, Vienna (Austria)

    2009-07-01

    The IAEA activities on supporting development of therapeutic radiopharmaceuticals are focused on identified radionuclides that can be produced in large quantities and making use of carrier molecules which can be synthesized locally or procured from commercial sources or already available in MS from other related programs. The main emphasis is on {sup 90}Y and {sup 177}Lu based products, which cover the hard beta energy and soft beta energy range respectively, and also since both these radionuclides can be produced in large quantities with very high specific activity and high radionuclidic purity. The services to MS are provided through implementing Coordinated Research Projects (CRP), Technical Cooperation (TC) projects, technical meetings and regional training courses in addition to documenting practically useful technical information related to these products though IAEA publications. The CRP is a group activity in which nearly 15 participants from as many countries come together to work towards an identified objective. Two of the completed CRPs in this area are: (i) Comparative evaluation of therapeutic radiopharmaceuticals (2002-2005) that focussed on the development of 'in vitro' and 'in vivo' techniques for evaluating new generation therapeutic radiopharmaceuticals; and (ii) Development of generator technologies for therapeutic radionuclides (2004-2007) that addressed technologies for {sup 90}Sr/{sup 90}Y and {sup 188}W/{sup 188}Re generators and which can be easily adapted by MS. The participants in the CRP on 'Comparative evaluation of therapeutic radiopharmaceuticals' used the somatostatin analogue, DOTATATE as the lead molecule for developing radiopharmaceuticals and testing the efficacy by in vitro biological assays and animal biodistribution studies. A significant outcome of the CRP was that {sup 177}Lu-DOTATATE therapy is now practised in several of the CRP participating countries including Brazil, India, Italy, and Poland. The major outcome of the CRP

  10. Cyclotron produced radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kopicka, K.; Fiser, M.; Hradilek, P.; Hanc, P.; Lebeda, O.

    2003-01-01

    Some of the cyclotron-produced radionuclides may serve as important materials for the production of radiopharmaceuticals. This lecture deals with basic information relating to various aspects of these compounds. In comparison with radionuclides /compounds used for non-medical purposes, radiopharmaceuticals are subject to a broader scale of regulations, both from the safety and efficacy point of view; besides that, there are both radioactive and medical aspects that must be taken into account for any radiopharmaceutical. According to the regulations and in compliance with general rules of work with radioactivity, radiopharmaceuticals should only be prepared/manufactured under special conditions, using special areas and special equipment and applying special procedures (e.g. sterilisation, disinfection, aseptic work). Also, there are special procedures for cleaning and maintenance. Sometimes the requirements for the product safety clash with those for the safety of the personnel; several examples of solutions pertaining to these cases are given in the lecture. Also, the specific role of cyclotron radiopharmaceuticals is discussed. (author)

  11. Harvard-MIT research program in short-lived radiopharmaceuticals. Technical progress report, 1991

    Energy Technology Data Exchange (ETDEWEB)

    Adelstein, S.J.

    1991-12-31

    This report presents research on radiopharmaceuticals. The following topics are discussed: antibody labeling with positron-emitting radionuclides; antibody modification for radioimmune imaging; labeling antibodies; evaluation of technetium acetlyacetonates as potential cerebral blood flow agents; and studies in technetium chemistry. (CBS)

  12. Universitaet Mainz, Institut fuer Kernchemie. Annual report 2005

    International Nuclear Information System (INIS)

    Kratz, J.V.

    2006-11-01

    Compiled by the employees of the institute, the present 2005 annual report gives an overview of the scientific activities of the working groups of the Institute for Nuclear Chemistry. It is also intended as a account to all those who have promoted us financially and idealistically on the use of what has been not an insubstantial amount of public funds. The report again covers three main fields of research: nuclear chemistry in terms of fundamental problems; radiopharmaceutical chemistry and the use radiochemical methods for medical purposes; and highly sensitive and selective analyses for environmental, technical and biological problems. The report also describes the status of the institute's technical facilities and new technical developments. Finally it gives an account of the institute's output in terms of publications, conference contributions, dissertations, diploma theses, state examination theses and on the contributions of its teaching staff to study and advanced training programs

  13. Radiopharmaceutical licensing

    International Nuclear Information System (INIS)

    Mather, S.J.

    1992-01-01

    Recent health service legislation, and especially the loss of crown immunity has once again focussed attention on the arrangements for licensing of radiopharmaceuticals. The aim of the article is to describe in general terms the UK licensing system and in particular to provide guidance to those responsible for the supply of radiopharmaceuticals in hospitals. (author)

  14. Radiopharmaceutical development

    International Nuclear Information System (INIS)

    Zielinski, F.W.; Robinson, G.D. Jr.; MacDonald, N.S.

    1976-01-01

    Progress is reported in the following areas of research: compact cyclotron production of 123 I iodide for radiopharmaceutical synthesis; synthesis of 123 I-labeled compounds for myocardial imaging and evaluation of kidney and liver functions; 62 Cu: a short-lived, generator-produced, positron emitting radionuclide for radiopharmaceuticals; dry radioaerosols for lung airway imaging; and improved particulate agents for perfusion imaging

  15. Click synthesis of PET radiopharmaceuticals

    International Nuclear Information System (INIS)

    Xu Mei; Kuang Chunxiang

    2009-01-01

    Increasing attention has been focused on synthesis radiopharmaceuticals for positron emission tomography (PET). The recent years witnessed applications of click chemistry to PET radiopharmaceutical synthesis,because of its distinctive advantages including high speed,yield and stereospecificity under mild conditions. Synthesis of 18 F-labeled and 11 C-labeled radiopharmaceuticals and intermediates via click chemistry are reviewed. The future trend of click chemistry for the synthesis of PET radiopharmaceutical is prospected. (authors)

  16. Research laboratories annual report 1993

    International Nuclear Information System (INIS)

    1994-08-01

    The 1993 annual report of the Israel Atomic Energy Commission presents, in brief and concise form, recent results and achievements of the well established program of the basic and applied research carried out by the scientists and engineers of the Israel Atomic Energy Commission in collaboration with colleagues at the other institutions in Israel and abroad. In terms of contents, the report presents the usual combination of topical basic applied research. Much of the work has been published or submitted for publication in the international scientific or technical literature. The main headings in the report are: theoretical physics and theoretical chemistry; optics and lasers; solid states and nuclear physics; materials sciences; chemistry; environmental studies and radiopharmaceuticals; radiation effects, dosimetry and radioprotection; and instrumentation and techniques

  17. Regulatory aspects of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kristensen, K.

    1985-01-01

    Regulatory systems in the field of radiopharmaceuticals have two main purposes: efficacy and safety. Efficacy expresses the quality of the diagnostic and therapeutic process for the patient. Safety involves the patient, the staff, and the environment. The world situation regarding regulations for radiopharmaceuticals is reviewed on the basis of a survey in WHO Member States. The main content of such regulations is discussed. The special properties of radiopharmaceuticals compared with ordinary drugs may call for modified regulations. Several countries are preparing such regulations. Close co-operation and good understanding among scientists working in hospital research, industry and regulatory bodies will be of great importance for the fast and safe introduction of new radiopharmaceuticals for the benefit of the patient. Before introducing new legislation in this field, a radiopharmaceutical expert should analyse the situation in the country and the relationship to the existing regulations. It is expected that the most important factor in promoting the fast introduction of new, safe and effective radiopharmaceuticals will be the training of people working within the regulatory bodies. It is foreseen that the IAEA and WHO will have an important role to play by providing expert advice and training in this area. (author)

  18. Occupational exposure in the production of radiopharmaceuticals in Cuba

    International Nuclear Information System (INIS)

    Amador, Z. H.; Soria, M. A.

    2016-01-01

    The aim of this paper is to show the experiences in controlling occupational exposure production of radiopharmaceuticals in the Isotope Center (CENTIS) of the Republic of Cuba. data corresponding period 1996-2014 to 896 records are processed. The percentage distributions of the annual effective dose (E), the equivalent dose in the hands (Hp (0.07)) and the equivalent dose in crystalline (Hp (3)), are presented. The annual performance of the average values ​​of these dose quantities is plotted. The results of the internal dosimetry are processed. Annual activities manipulated radioisotopes greater contribution and its relation to the distribution of the collective dose directly linked S of staff, they are evaluated. The ALARA principle is implemented and maintained, based on qualitative and quantitative analysis, as appropriate. The (63-98)% of workers are monitored to E and the (80-100)% for Hp (0.07) and Hp (3), receives less than 10% of annual exposure limits. Groups of workers Radiopharmacy and Inspection and Testing are the greatest contribution to the collective dose, whose S to E equal to or greater than 2 mSv is the (9-62)% of total annual S. The maximum value of S is 98.3 mSv recorded man-1 and this occurs in 2011, however the highest value of 99Mo activity is handled in 2012 and a later year for 131I. They are identified as the most effective means for optimizing radiation safety the use of electronic dosimeters, internal shields process in hot cells and glove boxes and shields for collection of radioactive waste. a reduction in personnel exposure between (10-27)% is obtained. It is shown that exposure of workers in the production of radiopharmaceuticals in Cuba is acceptably low. (author)

  19. Verein fuer Kernverfahrenstechnik und Analytik Rossendorf (VKTA). Annual report 1995

    International Nuclear Information System (INIS)

    Haefele, W.

    1996-04-01

    The annual report 1995 presents information from the managing and financial departments and on the activities and achievements of the scientific-technical departments relating to nuclear facilities, radioactive waste management, radioactivity analytics, measurement and management of radioactivity in the environment, radiopharmaceuticals, and safety and radiological protection. The main activities continued to be the management of radwaste resulting from decommissioning of the research reactors and facilities on site; other activities include cooperative activities together with the Siemens company assisting in erection and establishment of isotope production labs in developing countries. There also is an organizational chart of the institution. (DG) [de

  20. Radiopharmaceuticals for neurotransmitter imaging

    Energy Technology Data Exchange (ETDEWEB)

    Oh, Seung Jun [Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of)

    2007-04-15

    Neurotransmitter imaging with radiopharmaceuticals plays major role for understanding of neurological and psychiatric disorders such as Parkinson's disease and depression. Radiopharmaceuticals for neurotransmitter imaging can be divided to dopamine transporter imaging radiopharmaceuticals and serotonin transporter imaging radiopharmaceuticals. Many kinds of new dopamine transporter imaging radiopharmaceuticals has a tropane ring and they showed different biological properties according to the substituted functional group on tropane ring. After the first clinical trials with [{sup 123}I] {beta} -CIT, alkyl chain substituent introduced to tropane ring amine to decrease time for imaging acquisition and to increase selectivity. From these results, [{sup 123}I]PE2I, [18F]FE-CNT, [{sup 123}I]FP-CIT and [{sup 18}F]FP-CIT were developed and they showed high uptake on the dopamine transporter rich regions and fast peak uptake equilibrium time within 4 hours after injection. [{sup 11}C]McN 5652 was developed for serotonin transporter imaging but this compound showed slow kinetics and high background radioactivity. To overcome these problems, new diarylsulfide backbone derivatives such as ADAM, ODAM, AFM, and DASB were developed. In these candidates, [{sup 11}C]AFM and [{sup 11}C]DASB showed high binding affinity to serotonin transporter and fast in vivo kinetics. This paper gives an overview of current status on dopamine and serotonin transporter imaging radiopharmaceuticals and the development of new lead compounds as potential radiopharmaceuticals by medicinal chemistry.

  1. World Radiopharmaceutical Therapy Council: A report on the 5th International Radiopharmaceutical Therapy Colloquium and the Final Planning Meeting of the World Radiopharmaceutical Therapy Council held at Santiago, Chile, 29 September, 2002

    International Nuclear Information System (INIS)

    Turner, J.V.

    2003-01-01

    -stenosis of coronary arteries following balloon angioplasty was presented by Achim Kropp of Dresden, Amalia Peix of Havana, and June-Key Chung from Seoul who also reported encouraging radiation synovectomy results. Hans Biersack described preliminary studies from Bonn with 188Re MAG3 RC-160 and 188Re-DOTATOC radiopeptides and the potential clinical applications of other 188Re radiopharmaceuticals for radiopeptide therapy and radioimmunotherapy were contemplated, given the daily on-site supply of radionuclide from the 188W/188Re generator. The Final Planning Meeting of the World Radiopharmaceutical Therapy Council, chaired by Harvey Turner, was held during the last session of the Colloquium and discussion was facilitated by a panel of members of the International Task Force of the Council comprising Horacio Amaral, Suresh Srivastava and Alan Perkins. A Preliminary Draft Charter of the World Radiopharmaceutical Therapy Council had been prepared by the Task Force with notable contributions from Sandy McEwan and Chaitanya Divgi and had been circulated to all attendees of the Foundation Planning Meeting of the Council held during the Annual Scientific Meeting of the Society of Nuclear Medicine, June 2001 in Toronto. This draft document was presented for detailed discussion at the Final Planning Meeting in Chile and embodied the principles of global cooperation in therapeutic nuclear medicine outlined in the first issue of the Journal. A Consensus Draft Charter subsequently prepared by the International Task Force was then submitted to the Assembly of Delegates of the World Federation of Nuclear Medicine and Biology on 1st October 2002. The proposal that the World Radiopharmaceutical Therapy Council become an affiliated body of the World Federation of Nuclear Medicine and Biology was adopted without dissent, having been proposed by the President, Horacio Amaral and supported by the Incoming President, Myung Chul Lee. The World Radiopharmaceutical Therapy Council will become an

  2. 18F based radiopharmaceuticals and automation of synthesis. New 18F radiopharmaceuticals

    International Nuclear Information System (INIS)

    Garg, P.K.; Garg, S.

    2007-01-01

    Fluorine-18 is one of the most commonly used positron emitting isotopes for clinical and research needs with a physical half-life of 110 min. PET isotopes deposit higher radiation absorbed dose than nuclear medicine isotopes. Because of their relatively short half-life, larger quantities of these isotopes are used at the start of synthesis. Therefore, increased shielding and remote automated synthesis are essential for their safe handling. Unlike other radiopharmaceuticals, it is not practical to produce PET radiopharmaceuticals at a central location for subsequent distribution to clinical and research facilities around the country. This limitation compels various academic and research facilities to manufacture their own PET radiopharmaceuticals for in-house use. For multiple reasons, 18 F fluorodeoxyglucose ([ 18 F]FDG) is one of the most commonly used radiopharmaceuticals. The synthesis of [ 18 F]FDG has been optimized and automated, thus allowing independent laboratories to produce this radiopharmaceutical safely. Nonetheless, these laboratories should acquire resources and expertise to fulfil ever increasing regulatory requirements for the safe production and usage of PET radiopharmaceuticals. In addition to [ 18 F]FDG, a wide array of new and novel radiotracers is being developed to explore various biological processes. This paper emphasizes the fact that it is possible to accomplish research and fulfil clinical needs within an academic setting with modest resources. A careful assessment of the need for due diligence in radiation safety issues is very important for the longevity of any PET research endeavour. (author)

  3. Specific GMP guidelines for radiopharmaceutical products

    International Nuclear Information System (INIS)

    2000-01-01

    These guidelines are intended to complement those provided in ''Good manufacturing practices for pharmaceutical products'', as well as the GMP for sterile pharmaceutical products. The regulatory procedures necessary to control radiopharmaceutical products are in large part determined by the sources of products and methods of manufacture. Manufacturing procedures within the scope of these guidelines include: preparation of radiopharmaceuticals in hospital radiopharmacies, preparation of radiopharmaceuticals in centralized radiopharmacies, production of radiopharmaceuticals in nuclear centres, institutes or industrial manufacturers, preparation and production of radiopharmaceuticals in Positron Emission Tomography (PET) centres

  4. A study of effluent control technologies employed by radiopharmaceutical users and suppliers

    International Nuclear Information System (INIS)

    Leventhal, L.; Slider, J.; Chakoff, E.; Chen, J.I.; Savage, E.

    1980-01-01

    The quantities of radiopharmaceuticals produced for in-vivo diagnostic and therapy procedures has been estimated to be growing at the rate of 16% per year, based on 1978 sales figures. Nuclear medicine facilities are experiencing an average annual growth rate of 5% per year. The principle radionuclides produced and used for nuclear medicine are 131 I, 131 Xe, and sup(9m)Tc. Of particular concern is that amount of these radionuclides which might become airborne and escape into the environment during the process of manufacture or during aliquotting or administration by hospital personnel. Therefore, a study was made of the effluent control technology employed by radiopharmaceutical suppliers and users. Generally, the means used to control airborne radioactive effluents fall into two classes according to function. The controls either dilute and direct the effluent to a specific point of release or hold up the effluent to reduce by decay the amount of radioactivity released. Radiopharmaceutical suppliers and hospitals were contacted, and a survey made of the control technology used. The classes and types of effluent control equipment and their general characteristics, cost and effectiveness were determined. It was concluded that control equipment was readily available, reliable, and effective in reducing radioactive releases from radiopharmaceutical facilities. (author)

  5. Drug-radiopharmaceutical interactions

    International Nuclear Information System (INIS)

    Hladik, W.B.; Ponto, J.A.; Stathis, V.J.

    1985-01-01

    Patients seen in the nuclear medicine department have a wide variety of disorders and, consequently, may be receiving any number of therapeutic drugs. For this reason, nuclear medicine professionals should be aware of the potential effects that these pharmacologic agents may have on the bio-distribution of subsequently administered radiopharmaceuticals, commonly referred to as ''drug-radiopharmaceutical interactions.'' Compared with the quantity of literature written about interactions between various therapeutic drugs, the information available on drug-radiopharmaceutical interactions is scarce. However, there has been increasing interest in this subject, particularly during the past five years. Some of the reported interactions are used intentionally to add a new dimension to the nuclear medicine study and increase its diagnostic capabilities, i.e., pharmacologic intervention. These beneficial ''interactions'' are discussed in detail in several other chapters of this book. Other interactions, however, cause changes in the normal distribution of radiopharmaceuticals, which may interfere with the diagnostic utility of various nuclear medicine procedures. The latter group of interactions is the focus of this chapter

  6. Radiopharmaceutical research: trends and novel concepts

    International Nuclear Information System (INIS)

    Wuest, F.

    2005-01-01

    The efficiency of nuclear medicine in diagnosis, therapy and medicinal research strongly depends on the progress to develop novel suitable radiopharmaceuticals. The selection, preparation, and preclinical evaluation of new radiopharmaceuticals is addressed by the field of radiopharmaceutical chemistry. The rapid developments in the field of biotechnology in the post-genome era combined with the recent advances in the instrumentation of SPECT and PET have directed radiopharmaceutical research into a complex chemical science. Current radiopharmaceutical research comprises novel developments of coordination chemistry with [ 99m Tc]technetium pharmaceuticals, the development of non-standard PET radionuclides and the synthesis of 11 C- and 18 F-labelled radiopharmaceuticals at high specific radioactivity. Further developments deal with an increasing alignment to radiotherapeutics and the implementation of PET into the process of drug development and evaluation. (orig.)

  7. Therapeutic applications of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Baker, W.J.; Datz, F.L.; Beightol, R.W.

    1987-01-01

    Whether a radiopharmaceutical has diagnostic or therapeutic application depends on both the isotope and pharmaceutical used. For diagnostic applications, the isotope should undergo only γ-decay, since usually only γ-radiation is detected by nuclear medicine cameras. The half-life should be just long enough to allow the procedure to be performed. In contrast, the isotope needed for therapeutic purposes should have particulate radiation, such as a β-particle (electron), since these are locally absorbed an increase the local radiation dose. γ-Radiation, which penetrates the tissues, produces less radiation dose than do Β-particles. Several references dealing with radioactive decay, particulate interactions, and diagnostic and therapeutic applications of radiopharmaceuticals are available. Radiopharmaceuticals can legally be used only by physicians who are qualified by specific training in the safe handling of radionuclides. The experience and training of these physicians must be approved by the Nuclear Regulatory Commission or Agreement State Agency authorized to license the use of radiopharmaceuticals. A list of all byproduct material and procedures is available in the Code of Federal Regulations. Of the many radiopharmaceuticals available for diagnostic and therapeutic use, only those commonly used are discussed in this chapter

  8. Quality control of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kristensen, K.

    1981-01-01

    Quality assurance was introduced in the pharmaceutical field long before it was used in many other areas, and the term quality control has been used in a much broader sense than merely analytical quality control. The term Good Manufacturing Practice (GMP) has been used to describe the system used for producing safe and effective drugs of a uniform quality. GMP has also been used for the industrial production of radiopharmaceuticals. For the preparation and control of radiopharmaceuticals in hospitals a similar system has been named Good Radiopharmacy Practice (GRP). It contains the same elements as GMP but takes into account the special nature of this group of drugs. Data on the assessment of the quality of radiopharmaceuticals in relation to present standards are reviewed. The general conclusion is that the quality of radiopharmaceuticals appears comparable to that of other drugs. It seems possible to establish the production of radiopharmaceuticals, generators and preparation kits in such a way that analytical control of the final product at the hospital may be limited provided the final preparation work is carried out in accordance with GRP principles. The elements of GRP are reviewed. (author)

  9. Radiopharmaceuticals 1994. Nil desperandum

    International Nuclear Information System (INIS)

    Cox, P.H.; Meyer, G.J.

    1995-01-01

    On the basis of the discussions at a symposium held in Duesseldorf and attended by representatives of various interested bodies, European legislation as it affects radiopharmaceuticals is reviewed. Due consideration is given to the new, centralised and decentralised, registration procedures, effective since 1 January 1995. The dossier required to support an application for marketing authorisation is discussed, separate consideration being given to single-photon emitters, therapeutic radio-nuclides and positron-emitting radiopharmaceuticals. The role of the European Pharmacopoiea is also considered. It is concluded that the new, modified procedures for the registration of medicinal products in the European Union may actually inhibit free availability of radiopharmaceuticals within the Community, and that there is a strong case for modification of the European Directives so that radiopharmaceuticals are placed in a separate category to therapeutic drugs, with less stringent registration requirements. (orig.)

  10. Radiopharmaceuticals for therapy

    International Nuclear Information System (INIS)

    Lazarus, C.R.; Maisey, M.N.

    1985-01-01

    Several factors influencing the choice of radiopharmaceutical used in the treatment of benign and malignant disease are discussed. A brief review is given of the routine clinical uses of radiopharmaceuticals including treatments for hyperthyroidism, thyroid cancer, polycythaemia rubra vera and intracavitary therapy. Finally clinical situations using radionuclides under evaluation including the treatment of bone disease, adrenal tumours and monoclonal antibodies are discussed. (UK)

  11. Center for Advanced Space Propulsion Second Annual Technical Symposium Proceedings

    Science.gov (United States)

    1990-01-01

    The proceedings for the Center for Advanced Space Propulsion Second Annual Technical Symposium are divided as follows: Chemical Propulsion, CFD; Space Propulsion; Electric Propulsion; Artificial Intelligence; Low-G Fluid Management; and Rocket Engine Materials.

  12. Difficulties and aspects to take into account in the production, use and distribution of new radiopharmaceuticals PET

    International Nuclear Information System (INIS)

    Sanchez, R.; Rayo, J.I.; Serrano, J.; Infante, J.; Luz Dominguez, M.; Garcia, L.; Duran, C.

    2008-01-01

    This article seeks to describe the requirements, legal and technical, for the production, distribution and use of new radiopharmaceuticals PET (other than the 18 F.D.G.), describing the legislative framework in which we find ourselves, the characteristics of a production and types of synthesis and existing modules. A list of susceptible radiopharmaceuticals is presented that are being currently used in nuclear medicine by specifying the real possibilities of their production and use and which are the difficulties we face

  13. Supply of radiopharmaceuticals in Japan

    International Nuclear Information System (INIS)

    Genka, Tsuguo

    2006-01-01

    Detailed statistics of the application of radiopharmaceuticals in nuclear medicine in Japan are summarized. They are the amount of supply in terms of monetary value and radioactivity, categorized usages of in vivo and in vitro, number of facilities using the radiopharmaceuticals for the time span of 5 years (1998-2002). Obvious tendency of decrease for in vitro use can be seen while the total amount of radiopharmaceuticals is almost unchanged. (author)

  14. Radiopharmaceuticals good practices handbook: ARCAL XV radiopharmaceuticals control and production

    International Nuclear Information System (INIS)

    Verdera Presto, Silvia

    1998-01-01

    A safety practice of the therapeutics diagnostic proceeding in nuclear medicine require a permanent provide high quality radiopharmaceuticals manufacture. This work treat to give a guide for all radio pharmacies laboratories that produce,control, fraction and or dispense radiopharmaceuticals products, with attention hospitable radiopharmacy laboratory. Three chapters with recommendations in manufacture good practice in Hospital radiopharmacy, industrial centralized, bibliography and three annexe's about clean area classification,standards work in laminar flux bell, and guarantee and cleaning areas

  15. Annual technical meeting of the NRC cooperative severe accident research program

    International Nuclear Information System (INIS)

    Silver, E.G.

    1993-01-01

    This brief report summarizes the 1992 annual technical meeting of the NRC Cooperative Severe Accident Research Program (CSARP-92) held at the Hyatt Regency Hotel in Bethesda, Maryland, May 4-8, 1992. The report is taken mainly from coverage of the meeting published in the June 5, 1992, issue of Atomic Energy Clearinghouse. Results of this meeting are formalized at the Water Reactor Safety Information Meetings (WRSIM) that are held annually in October. Nuclear Safety summarizes the annual WRSIM meetings and provides a list of the presentations that were given. Interested readers are encouraged to review listed topics to identify specific topic areas in severe accident research. Sessions were held on in-vessel core melt progression; fuel-coolant interactions; fission-product behavior; direct containment heating; and severe accident code development, assessment, and validation. Summaries of the individual technical sessions and the current state of the art in these areas were given by the chairmen

  16. The radiopharmaceutical industry and European Union regulations

    International Nuclear Information System (INIS)

    Fallais, C.J.; Sivewright, S.; Ogle, J.R.

    1997-01-01

    After a brief historical introduction to Council Directives relating to the manufacture of radiopharmaceuticals the work of the Association of Radiopharmaceuticals Producers - Europe (ARPE) is discussed. ARPE has played a significant role as an officially recognized interlocutor with the EEC, influencing decisions on the registration of radiopharmaceuticals and labelling; this role is reviewed and difficulties identified. The future of radiopharmaceuticals is then considered; it is emphasized that harmonization of national laws by the European Council would represent a first step to enabling radiopharmaceutical manufacturers to access the largest possible market for their products. (orig.)

  17. Radiopharmaceuticals and applications; Preparacoes radiofarmaceuticas e suas aplicacoes

    Energy Technology Data Exchange (ETDEWEB)

    Oliveira, Rita [Universidade Fernando Pessoa, Porto (Portugal). Fac. de Ciencias da Saude; Santos, Delfim; Ferreira, Domingos; Coelho, Pedro [Universidade do Porto (Portugal). Fac. da Farmacia; Veiga, Francisco, E-mail: fveiga@ci.uc.pt [Universidade de Coimbra (Portugal). Fac. de Farmacia

    2006-04-15

    Radiopharmaceuticals are substances without pharmacological activity that are used in Nuclear Medicine for diagnosis and therapy for several diseases. Diagnosis radiopharmaceuticals generally emit {gamma} radiation or positrons ({beta}+), because their decay originates penetrating electromagnetic radiation that can cross the tissues and be externally detected. Therapeutic radiopharmaceuticals must include in their composition ionized particles emission nucleus ({alpha}, {beta}{sup -} or Auger electrons), since their action is based in selective tissue destruction. There are two main methods for image acquisition: SPECT (Single Photon Emission Computerized Tomography) that uses {gamma} emission radionuclides ({sup 99m}Tc, {sup 123}I, {sup 67}Ga, {sup 201}Tl) and PET (Positron Emission Tomography) that uses positron emission radionuclides like {sup 11}C, {sup 13}N, {sup 15}O, {sup 18}F. Radiopharmaceuticals can be classified into perfusion radiopharmaceuticals (first generation) or specific radiopharmaceuticals (second generation). Perfusion radiopharmaceuticals are transported in the blood e reach the target organ in the direct proportion of the blood stream. Specific radiopharmaceuticals contain a biologically active molecule that binds to cellular receptors that must remain biospecific after binding to the radiopharmaceutical. For this type of radiopharmaceuticals, tissue or organ uptake is determined by the biomolecule capacity of recognizing receptors in those biological structures. Radiopharmaceuticals are produced ready to use, in cold kits or in autologal preparations. According to the preparation type there is a different quality control procedure. Most of the radiopharmaceuticals used nowadays are of the perfusion type. Research focus in the development of specific radiopharmaceuticals that can provide information, at the molecular level, of biochemical alterations associated to different pathologies. (author)

  18. Radiopharmaceuticals drug interactions: a critical review

    International Nuclear Information System (INIS)

    Santos-Oliveira, Ralph; Smith, Sheila W.; Carneiro-Leao, Ana Maria A.

    2008-01-01

    Radiopharmaceuticals play a critical role in modern medicine primarily for diagnostic purposes, but also for monitoring disease progression and response to treatment. As the use of image has been increased, so has the use of prescription medications. These trends increase the risk of interactions between medications and radiopharmaceuticals. These interactions which have an impact on image by competing with the radiopharmaceutical for binding sites for example can lead to false negative results. Drugs that accelerate the metabolism of the radiopharmaceutical can have a positive impact (i.e. speeding its clearance) or, if repeating image is needed, a negative impact. In some cases, for example in cardiac image among patients taking doxirubacin, these interactions may have a therapeutic benefit. The incidence of drug-radiopharmaceuticals adverse reactions is unknown, since they may not be reported or even recognized. Here, we compiled the medical literature, using the criteria of a systematic review established by the Cochrane Collaboration, on pharmaceutical-drug interactions to provide a summary of documented interactions by organ system and radiopharmaceuticals. The purpose is to provide a reference on drug interactions that could inform the nuclear medicine staff in their daily routine. Efforts to increase adverse event reporting, and ideally consolidate reports worldwide, can provide a critically needed resource for prevention of drug-radiopharmaceuticals interactions. (author)

  19. Radiopharmaceuticals for nuclear cardiology

    International Nuclear Information System (INIS)

    Leon Cabana, Alba

    1994-01-01

    One of the diagnostic technique periodically used in Nuclear Medicine is the angiographic studi e, employee for detect cardiovascular diseases. The radiopharmaceutical more used in the angiographic ones is 99mTc. Between thetopics described in the present work it find: myocardial infarction, radiopharmaceuticals classification for cardiac studies, labelled proceedings, cardiovascular diseases

  20. Development of European regulations on radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kristensen, K.

    1990-01-01

    Separate regulatory systems are being developed on the use of radiopharmaceuticals including radiation protection of patients and personnel and on the quality including safety and efficacy of radiopharmaceuticals. Radiation protection legislation has been introduced in most western European Economic Community (EEC). Within the drug field radiopharmaceuticals have been excepted up till now. However, new EEC directive on radiopharmaceuticals will soon come into force. The work done on the preparation of regulations and guidelines will be discussed. This discussion will focus on the problems faced when radiation protection aspects shall be balanced to traditional requirements of pharmaceutical aspects

  1. Radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kristensen, K.

    1988-01-01

    Different forms of radiopharmaceuticals such as radioactive gases, aerosols and colloids used for diagnostic techniques and radiotherapy and methods of labelling them are discussed. Some reference is made to their documentation, handling and quality control. (U.K.)

  2. KBS Annual Report 1982. Summaries of technical reports issued during 1982

    International Nuclear Information System (INIS)

    1983-07-01

    The purpose of the KBS Annual Report is to inform interested organizations and individuals of the research and development work perfomed by the division KBS within the Swedish Nuclear Fuel Supply Co. (SKBF) on the handling, treatment and final storage of nuclear wastes in Sweden. In the Annual Report for 1982 the summaries of 27 technical reports and other publications issued during the year are listed. (K.A.E.)

  3. 6. Radiopharmaceuticals

    International Nuclear Information System (INIS)

    Schiller, P.; Havranek, E.; Majer, J.

    1981-01-01

    Radionuclides commonly used in medicine are surveyed and their nuclear characteristics are presented. The methods are given of their preparation, most frequent use and detection. The list is given of radiopharmaceuticals included in the Czechoslovak Pharmacopoeia CsL 3 , ie., sodium chromate( 51 Cr), sodium iodide( 131 I), hippuran( 131 I), sodium phosphate( 32 P), colloidal gold( 198 Au), rose bengal sodium salt( 131 I), and sodium pertechnetate(sup(99m)Tc) injections. Characteristics, chemical preparation, identification tests, packaging, storage, application and dosage are shown for each preparation. Also listed are important unofficial radiopharmaceuticals, their main characteristics and data on their preparation and application. (B.S.)

  4. Toxic Hazards Research Unit Annual Technical Report: 1984

    Science.gov (United States)

    1984-09-01

    exposed to TOCP exhibited the classic lesions of delayed neuropathy (Smith and Lillie, 1931; Barnes and Denz, 1953; (avanagh, 1954; and Fenton , 1955...Safety of *.i Chemicals in Food, Drugs, and Cosmetics , The staff of the Divi- sion of Pharmacology of the Federal Food and Drug Administration, Austin...Annual Technical Report: 1967, AMRL-TR-67-137 (AD 834723), Aerospace Medical Research Laboratory, Wright-Patterson Air Force Base, Ohio. Fenton , J. C

  5. Recent advances in radiopharmaceuticals

    International Nuclear Information System (INIS)

    Smith, S.

    2000-01-01

    Full text: Radiopharmaceuticals in Nuclear Medicine may be divided into diagnostic and therapeutic agents. The diagnostic area is perceived to be mature, while the therapeutic side of nuclear medicine is still evolving. There are over 100 diagnostic radiopharmaceutical products available, the greatest number applied in cardiology followed by oncology and neurology. The greatest success in therapeutic nuclear medicine has been achieved in thyroid cancer, hyperthyroidism and bone pain palliation. Those in the field believe the future of nuclear medicine resides in the growth potential of the emerging therapeutic market, hence much of the recent research has been focussed in the development of therapeutic agents for targeting cancers. Radiopharmaceuticals under development or in clinical trials involve the use of radionuclides such as Y-90, Pd-103, Ir-192, Re-188, I-131, Sm-153, Sn-114, Sr-90, Cu-64 and In-111. Advances in cyclotron and camera technology as well as automation has enhanced and widened the potential use of positron emitting radiopharmaceuticals such as F-18 Fluorodeoxyglucose (FDG). However the relationship between FDG uptake and glucose consumption in normal and diseased tissue is still to be defined. Many challenges remain for the nuclear medicine community to apply new knowledge of human biochemistry in the development of new radiopharmaceuticals. A better understanding of effects of radiation and its role in the design of therapeutic agents is undoubtedly pivotal for advancing therapeutic Nuclear Medicine into the future

  6. Radiopharmaceuticals for bone scintillators

    International Nuclear Information System (INIS)

    Rey, A.M.

    1994-01-01

    One of the diagnostic techniques used in nuclear medicine is the bone scintiscanning with labelled compounds for obtain skeletal images. The main sections in this work are: (1) bone composition and anatomy;(2)skeletal radiopharmaceutical development;(3)physical properties of radionuclides;(4)biological behaviour and chemical structures;(5)radiopharmaceuticals production for skeletal scintillation;(6)kits;(7)dosimetry and toxicity.tabs

  7. Radiopharmaceuticals for thrombus detection

    International Nuclear Information System (INIS)

    Knight, L.C.

    1990-01-01

    Most of the components of the thrombotic and fibrinolytic systems have at some time been evaluated as a means of carrying a radiolabel specifically to thrombi, although very few have been promising enough to emerge from investigational status to routine clinical use. New approaches are being explored, including improved methods of labeling platelets, chemically modified forms of previously tested plasma proteins, and new biomolecules, including monoclonal antibodies specific for fibrin and platelets. The current goal is to find one or more radiotracers that bind specifically and rapidly to thrombi, and that also have a rapid blood disappearance rate, permitting a clear diagnosis within a few hours after injection. Because this test may be needed to assess the course of therapy in an anticoagulated patient, the ideal radiopharmaceutical should be able to locate thrombi without interference by anticoagulants. Until a suitable thrombus-specific radiopharmaceutical becomes generally available, many hospitals will continue to attempt to make a diagnosis with nonspecific radiopharmaceuticals that can at best provide blood pool images to indicate filling defects. Several of the new approaches seem likely to provide the radiopharmaceutical sought, although clinical trials are at an early stage.137 references

  8. Audits of radiopharmaceutical formulations

    International Nuclear Information System (INIS)

    Castronovo, F.P. Jr.

    1992-01-01

    A procedure for auditing radiopharmaceutical formulations is described. To meet FDA guidelines regarding the quality of radiopharmaceuticals, institutional radioactive drug research committees perform audits when such drugs are formulated away from an institutional pharmacy. All principal investigators who formulate drugs outside institutional pharmacies must pass these audits before they can obtain a radiopharmaceutical investigation permit. The audit team meets with the individual who performs the formulation at the site of drug preparation to verify that drug formulations meet identity, strength, quality, and purity standards; are uniform and reproducible; and are sterile and pyrogen free. This team must contain an expert knowledgeable in the preparation of radioactive drugs; a radiopharmacist is the most qualified person for this role. Problems that have been identified by audits include lack of sterility and apyrogenicity testing, formulations that are open to the laboratory environment, failure to use pharmaceutical-grade chemicals, inadequate quality control methods or records, inadequate training of the person preparing the drug, and improper unit dose preparation. Investigational radiopharmaceutical formulations, including nonradiolabeled drugs, must be audited before they are administered to humans. A properly trained pharmacist should be a member of the audit team

  9. The current situation and future prospects of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Ando, Atsushi

    2001-01-01

    Radiopharmaceuticals play an important role in nuclear medicine. In this paper, nuclear medicine relating to radiopharmaceuticals was briefly described. And I would like to focus on the current situation and future prospects of radiopharmaceuticals. Nuclear medicine in this century should take the following directions. Firstly, cancer treatment by radionuclides will be one of the promising fields in oncology. Secondly, in order to achieve evidence-based medicine, sensitive, quantitative imaging using the nuclides will be necessary in nuclear medicine. Under these circumstances, it is important to develop radiopharmaceuticals for sensitive, quantitative imaging and therapeutic radiopharmaceuticals. (author)

  10. Radiopharmaceuticals for cerebral studies

    International Nuclear Information System (INIS)

    Leon Cabana, Alba

    1994-01-01

    For obtain good brain scintillation images in nuclear medicine must be used several radiopharmaceuticals. Cerebral studies give a tumors visual image as well as brain anomalities detection and are helpful in the diagnostic diseases . Are described in this work: a cerebrum radiopharmaceuticals classification,labelled compounds proceeding and Tc 99m good properties in for your fast caption, post administration and blood purification for renal way

  11. Radiopharmaceuticals - current state and trends

    International Nuclear Information System (INIS)

    Muenze, R.

    1981-07-01

    The current state as well as the tendencies of modern radiopharmaceutical development and application is reviewed. After an evaluation of the fundamental preconditions of decay characteristics and pharmaceutical properties the problems concerning sup(99m)Tc-radiopharmaceuticals, metabolizable compounds and the use of specific biological interactions are discussed. (author)

  12. Cyclotrons and positron emitting radiopharmaceuticals

    International Nuclear Information System (INIS)

    Wolf, A.P.; Fowler, J.S.

    1984-01-01

    The state of the art of Positron Emission Tomography (PET) technology as related to cyclotron use and radiopharmaceutical production is reviewed. The paper discusses available small cyclotrons, the positron emitters which can be produced and the yields possible, target design, and radiopharmaceutical development and application. 97 refs., 12 tabs

  13. Radiochemical stability of radiopharmaceutical preparations

    International Nuclear Information System (INIS)

    Martins, Patricia de A.; Silva, Jose L. da; Ramos, Marcelo P.S.; Oliveira, Ideli M. de; Felgueiras, Carlos F.; Herrerias, Rosana; Zapparoli Junior, Carlos L.; Mengatti, Jair; Fukumori, Neuza T.O.; Matsuda, Margareth M.N.

    2011-01-01

    The 'in vitro' stability studies of the radiopharmaceutical preparations are an essential requirement for routine practice in nuclear medicine and are an important parameter for evaluating the quality, safety and efficacy required for the sanitary registration of pharmaceutical products. Several countries have published guidelines for the evaluation of pharmaceutical stability. In Brazil, the stability studies should be conducted according to the Guide for Conducting Stability Studies published in the Resolution-RE n. 1, of 29th July 2005. There are also for radiopharmaceutical products, two specific resolutions: RDC-63 regulates the Good Manufacturing Practices for Radiopharmaceuticals and RDC-64 provides the Registration of Radiopharmaceuticals, both published on the 18th December 2009. The radiopharmaceutical stability is defined as the time during which the radioisotope can be safely used for the intended purpose. The radiochemical stability can be affected by a variety of factors, including storage temperature, amount of radioactivity, radioactive concentration, presence or absence of antioxidants or other stabilizing agents. The radiochemical stability studies must be established under controlled conditions determined by the effective use of the product. The aim of this work was to evaluate the radiochemical stability of labeled molecules with 131 I, 123 I, 153 Sm, 18 F, 51 Cr, 177 Lu and 111 In as well as 67 Ga and 201 Tl radiopharmaceuticals. Radiochemical purity was evaluated after production and in the validity period, with the maximum activity and in the recommended storage conditions. The analyses were carried out by thin-layer silica gel plate, paper chromatography and gel chromatography. The experimental results showed to be in accordance with the specified limits for all the analysed products. (author)

  14. Regulatory and technical reports (abstract index journal): Annual compilation for 1987

    International Nuclear Information System (INIS)

    1988-03-01

    This compilation consists of bibliographic data and abstracts for the formal regulatory and technical reports issued by the US Nuclear Regulatory Commission (NRC) Staff and its contractors. It is NRC's intention to publish this compilation quarterly and to cumulate it annually

  15. Regulatory considerations concerning IND radiopharmaceutical drug products

    International Nuclear Information System (INIS)

    Nissel, M.

    1985-01-01

    The Food and Drug Administration is charged by the Food, Drug, and Cosmetic Act, as presently amended, to assure that any drug introduced into interstate commerce is safe and effective for the purposes for which it is labeled. A radiopharmaceutical is, by definition, a new drug unless there is in effect an approved New Drug Application (NDA) for it. Before the data for the NDA are compiled, investigative studies have to be done. Before such studies can be performed in humans, an exemption from the Act is necessary. This exemption, technically the Claimed Exemption for an Investigational New Drug, is termed the IND. Both the scientific and the administrative requirements for an IND are discussed. For radiopharmaceutical drug products (RDP's), the radiation hazards, as well as the pharmacological ones, must be documented. Should the early studies demonstrate a potential for efficacy in a certain condition or disease state, an investigative protocol for an extended clinical trial is presented. The necessary requirements for Institutional Review Board (IRB) approval and consent forms are discussed. For certain research purposes, uniquely for radioactive drugs, an IND is not required for certain specific studies; the requirements for such a research study, conducted under the auspices of an approved radioactive drug research committee, are outlined

  16. Cyclotrons and positron emitting radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Wolf, A.P.; Fowler, J.S.

    1984-01-01

    The state of the art of Positron Emission Tomography (PET) technology as related to cyclotron use and radiopharmaceutical production is reviewed. The paper discusses available small cyclotrons, the positron emitters which can be produced and the yields possible, target design, and radiopharmaceutical development and application. 97 refs., 12 tabs. (ACR)

  17. Considerations and controversies in the selection of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Chilton, H.M.; Cowan, R.J.

    1987-01-01

    When a radiopharmaceutical is selected for a specific study, multiple factors must be considered to ensure that optimum clinical information will be provided with minimum radiation exposure to the patient and laboratory personnel. In this endeavor, certain questions must be considered. What are the nuclear properties of the available radiopharmaceuticals? For the organ to be studied, are there multiple radiopharmaceutical localization pathways? If so, which is best suited to provide the desired diagnostic information? Does the presence of certain clinical factors preclude the use of some radiopharmaceuticals and require the use of others? Do certain radiopharmaceuticals have overriding radiopharmacologic properties which limit their usefulness for the evaluation of certain clinical situations? Finally, how significant are non-clinical properties such as cost, availability, and product formulation? In this chapter, some of these areas and several situations which illustrate the radiopharmaceutical selection process are discussed

  18. KWL Lingen nuclear plant. Technical annual report 2016; KWL Kernkraftwerk Lingen. Technischer Jahresbericht 2016

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2017-07-01

    The technical annual report 2016 for KWL (Lingen nuclear plant) covers the following sections: dismantling project management and operation, monitoring and clearance; waste management, technical qualification, security and safety, central tasks; licensing and supervision procedures, operational data, radiation monitoring, radioactive materials, in-service inspections.

  19. Placental transfer of selected radiopharmaceuticals

    International Nuclear Information System (INIS)

    Wegst, A.V.

    1992-01-01

    This paper reviews animal experiments carried out to determine the transfer of radiopharmaceuticals from mother to fetus. Animal data are compared to any human data available. The radiopharmaceuticals included in the discussion are Tc-99m pertechnetate, Tc-99m DTPA, Ga-67 citrate and Tl-201 chloride. (6 tab., 5 refs.)

  20. Annual report 1979/1980

    International Nuclear Information System (INIS)

    Muenze, R.

    1981-11-01

    The annual report concentrates result of investigations in the field of the production of radioisotopes, the synthesis of radioactive compounds and their characterization. Main topics are the production of 99 Mo and the application of radioactive compounds in nuclear medicine especially as radiopharmaceuticals. A list of publications and lectures is enclosed. (author)

  1. Proceedings of the Efficient Separations and Processing Cross-Cutting Program Annual Technical Exchange Meeting

    International Nuclear Information System (INIS)

    1995-01-01

    This document contains summaries of technology development presented at the 1995 Efficient Separations and Processing Cross-Cutting Program (ESP) Annual Technical Exchange Meeting. The ESP is sponsored by the US Department of Energy's Office of Environmental Management (EM), Office of Technology Development. The meeting is held annually to promote a free exchange of ideas among technology developers, potential users (for example, EM focus areas), and other interested parties within EM. During this meeting, developers of ESP-funded technologies describe the problems and needs addressed by their technologies; the technical approach, accomplishments, and resolution of issues; the strategy and schedule for commercialization; and evolving potential applications. Presenters are asked to address the following areas: Target waste management problem, waste stream, or data need; scientific background and technical approach; technical accomplishments and resolution of technical issues; schedule and strategy for commercializing and implementing the technology or acquiring needed data; potential alternate applications of the technology or data, including outside of DOE/EM. The meeting is not a program review of the individual tasks or subtasks; but instead focuses on the technical aspects and implementation of ESP-sponsored technology or data. The meeting is also attended by members of the ESP Technical Review Team, who have the opportunity at that time to review the ESP as a whole

  2. Center for Space Transportation and Applied Research Fifth Annual Technical Symposium Proceedings

    Science.gov (United States)

    1993-01-01

    This Fifth Annual Technical Symposium, sponsored by the UT-Calspan Center for Space Transportation and Applied Research (CSTAR), is organized to provide an overview of the technical accomplishments of the Center's five Research and Technology focus areas during the past year. These areas include chemical propulsion, electric propulsion, commerical space transportation, computational methods, and laser materials processing. Papers in the area of artificial intelligence/expert systems are also presented.

  3. Clean room installations in a radiopharmaceutical facility

    International Nuclear Information System (INIS)

    2000-01-01

    The standards of radiopharmaceuticals on the facility, working environment and preparation control strategy are yet to be generated. In general, radiopharmaceuticals have short half-lives and emit gamma radiation. Due to its unique characteristics, its preparation has to be made in the fume hood and hot cell to avoid radiation exposure to workers. Considering radiation protection, the working environment has to be maintained under negative pressure so that dispersion of radiopharmaceuticals should be avoided. On the contrary, a positively pressurized working environment gives clean atmosphere and prevents contamination with harmful microorganisms during preparation. Hence, it is required to harmonize for mentioned contradictory conditions in preparation of radiopharmaceuticals for the safety of workers and its quality assurance as well. Therefore, it is reasonable that good manufacturing practice for radiopharmaceutical production facility should be constituted according to the standards for production of biological agents accompanied with a radiation shielding

  4. Technical Support Section annual work plan for FY 1998

    Energy Technology Data Exchange (ETDEWEB)

    Adkisson, B.P.; Allison, K.L.; Effler, R.P.; Hess, R.A.; Keeble, T.A.; Odom, S.M.; Smelcer, D.R.

    1997-12-01

    The Technical Support Section (TSS) of the Instrumentation and Controls (I and C) Division of Oak Ridge National Laboratory (ORNL) provides technical services such as fabrication, modification, installation, calibration, operation, repair, and preventive maintenance of instruments and other related equipment. Because the activities and priorities of TSS must be adapted to the technical support needs of ORNL, the TSS Annual Work Plan is derived from, and is driven directly by, current trends in the budgets and activities of each ORNL division for which TSS provides support. Trends that will affect TSS planning during this period are reductions in the staffing levels of some R and D programs because of attrition or budget cuts. TSS does not have an annual budget to cover operating expenses incurred in providing instrument maintenance support to ORNL. Each year, TSS collects information concerning the projected funding levels of programs and facilities it supports. TSS workforce and resource projections are based on the information obtained and are weighted depending on the percentage of support provided to that division or program. Each year, TSS sets the standard hourly charge rate for the following fiscal year. The Long-Range Work Plan is based on estimates of the affects of the long-range priorities and directions of the Laboratory. Proposed new facilities and programs provide additional bases for long-range planning. After identifying long-range initiatives, TSS planning includes future training requirements, reevaluation of qualifications for new hires, and identification of essential test equipment that will be needed for new work.

  5. Preparation of radiopharmaceutical formulations

    International Nuclear Information System (INIS)

    Simon, J.; Garlich, J.R.; Frank, R.K.; McMillan, K.

    1998-01-01

    Radiopharmaceutical formulations for complexes comprising at least one radionuclide complexed with a ligand, or its physiologically-acceptable salts thereof, especially 153 samarium-ethylenediaminetetramethylenephosphonic acid, which optionally contains a divalent metal ion, e.g. calcium, and is frozen, thawed, and then administered by injection. Alternatively, the radiopharmaceutical formulations must contain the divalent metal and are frozen only if the time before administration is sufficiently long to cause concern for radiolysis of the ligand. 2 figs., 9 tabs

  6. Radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Hunt, F C; Wilson, J G

    1980-03-13

    The claim describes a reducing metal complex of a compound in a suitable form for labelling with technetium-99m for radiopharmaceutical purposes, the compound being a complex derived from an indene heterocycle structure. The indene heterocycle structure is selected from the group consisting of iminodiacetic acid derivates of benzimidazole, benzthiazole and benzoxazole.

  7. Radiopharmaceuticals For Detection Of Inflammation And Infection

    International Nuclear Information System (INIS)

    Nurlaila, Z.

    2002-01-01

    Feeling of pain in the body could be caused by reaction of inflantation and infection as well. One of the methods could be used to detect the reaction is nuclear technique using radiopharmaceutical as radiotracer. Some radiopharmaceuticals having specific accunulation mechanism to diagnose the presence of inflamations and infections with satisfactory results. Among those radiophannaceuticals are technetium-99m-hexamethylpropileneamine-white blood cell ( 99m Tc-HMPAO-WBC), indium-111-oxine-white blood cell ( 111 In-oksin-WBC). technetium-99m-immunoglobuline G ( 99m Tc-lgG) and technetium-99m-infecton ( 99m Tc-infecton). In visualization using this method. the information of a serial previous medical treatment of the patient should be known, because cer1ain medicament, could influence the biological characteristic of radiopharmaceuticals and hence. a missed diagnosis could be resulted. This review discusses several radiopharmaceuticals for inflamation and infection, diagnoses their accumulation, mechanism in the body. Besides, the radiopharmaceuticals interaction with several drugs are also reviewed

  8. Forschungszentrum Rossendorf. Institute of Bioinorganic and Radiopharmaceutical Chemistry. Annual report 2002

    Energy Technology Data Exchange (ETDEWEB)

    Johannsen, B.; Seifert, S. (eds.)

    2003-01-01

    In 2002 the Institute of Bioinorganic and Radiopharmaceutical Chemistry, one of five institutes in the Forschungszentrum Rossendorf e.V., continued and further developed its basic and application-oriented research. Research was focused on radiotracers as molecular probes to make the human body biochemically transparent with regard to individual molecular reactions. While further pursuing and extending our chemical, biological and medical activities in the PET Centre and being engaged in the coordination chemistry and radiopharmacology of technetium, rhenium and other metals, new lines of activity have also been opened up recently. This involves bioactive substances as they are present in food. Such substances may cause a health risk or may exert effects not yet fully understood. New biotechnological procedures in food processing also give rise to new questions that can be addressed by PET. As illustrated by the majority of contributions in this report, the Institute is predominantly engaged in radiopharmaceutical chemistry of both radiometals and the PET nuclides carbon-11 and fluorine-18. The improvement of labelling methods continued to remain an area of considerable endeavour. The review article on radiochemistry with the short-lived positron emitters {sup 11}C and {sup 18}F is meant to emphasize this field of research and to help to classify our contribution to this area. As for the radiometals, our studies agree with the more and more demanding insight that the coordination has a not sufficiently predictable impact on the in vivo behaviour of the molecule into which the chelate unit is integrated. Therefore, attempts to better understand and adjust the in vivo behaviour of the radiotracers are being continued. In order to reflect on and identify trends and perspectives, the Institute organized on March 7-8, 2002, an international conference on advances and perspectives in radiotracer development. The Institute's chemically and radiopharmacologically

  9. Forschungszentrum Rossendorf. Institute of Bioinorganic and Radiopharmaceutical Chemistry. Annual report 2002

    International Nuclear Information System (INIS)

    Johannsen, B.; Seifert, S.

    2003-01-01

    In 2002 the Institute of Bioinorganic and Radiopharmaceutical Chemistry, one of five institutes in the Forschungszentrum Rossendorf e.V., continued and further developed its basic and application-oriented research. Research was focused on radiotracers as molecular probes to make the human body biochemically transparent with regard to individual molecular reactions. While further pursuing and extending our chemical, biological and medical activities in the PET Centre and being engaged in the coordination chemistry and radiopharmacology of technetium, rhenium and other metals, new lines of activity have also been opened up recently. This involves bioactive substances as they are present in food. Such substances may cause a health risk or may exert effects not yet fully understood. New biotechnological procedures in food processing also give rise to new questions that can be addressed by PET. As illustrated by the majority of contributions in this report, the Institute is predominantly engaged in radiopharmaceutical chemistry of both radiometals and the PET nuclides carbon-11 and fluorine-18. The improvement of labelling methods continued to remain an area of considerable endeavour. The review article on radiochemistry with the short-lived positron emitters 11 C and 18 F is meant to emphasize this field of research and to help to classify our contribution to this area. As for the radiometals, our studies agree with the more and more demanding insight that the coordination has a not sufficiently predictable impact on the in vivo behaviour of the molecule into which the chelate unit is integrated. Therefore, attempts to better understand and adjust the in vivo behaviour of the radiotracers are being continued. In order to reflect on and identify trends and perspectives, the Institute organized on March 7-8, 2002, an international conference on advances and perspectives in radiotracer development. The Institute's chemically and radiopharmacologically oriented activities

  10. Universitaet Mainz, Institut fuer Kernchemie. Annual report 1998

    International Nuclear Information System (INIS)

    Denschlag, H.O.

    1999-03-01

    The annual report concentrates on three research activities of major interest: (1) Nuclear chemistry in the sense of approaches to fundamental problems which also relate to nuclear physics (nuclear fission, chemistry of the heaviest elements, excitation of giant dipole resonance, Halo nuclei, radiochemical astrophysics (structure of neutron-rich nuclei, prediction of half-lives and P n -values, elemental abundances), metal clusters in vacuum). (2) Radiopharmaceutical chemistry and applications in nuclear medicine (synthesis of radiopharmaceuticals using 3 H and 18 F, in vitro and in vivo evaluation of radiopharmaceuticals, diagnostics using PET, solid-state target systems, development and test of radiopharmaceuticals using isotopes of As, Y, Nb, Nd, and Re). (3) Environmental analysis (humic acid complexes of actinides and lanthanides, disintegration products of cellulose, ultratrace analysis using RIMS, determination of Th and U in the environment and in urine, AOX determination in waste waters, anthropogenic γ emitters in ground level air). (orig./CB) [de

  11. Radiopharmaceutical drug review process

    International Nuclear Information System (INIS)

    Frankel, R.

    1985-01-01

    To ensure proper radioactive drug use (such as quality, diagnostic improvement, and minimal radioactive exposure), the Food and Drug Administration evaluates new drugs with respect to safety, effectiveness, and accuracy and adequacy of the labeling. The IND or NDA process is used for this purpose. A brief description of the process, including the Chemical Classification System and the therapeutic potential classification, is presented as it applies to radiopharmaceuticals. Also, the status of the IND or NDA review of radiopharmaceuticals is given

  12. The hospital preparation of radiopharmaceuticals

    International Nuclear Information System (INIS)

    The subject is covered in sections: introduction; preparation ((general - sterilization), production areas (laboratories), working methods for injections, working methods for oral preparations and iodination procedures); analytical testing (general, standards common to injections and oral preparations, standards for injections, standards for oral preparations); reliable methods of preparing sup(99m)Tc-radiopharmaceuticals and 51 Cr-red cells; commercial radiopharmaceutical kits. (U.K.)

  13. Radiochemical syntheses further radiopharmaceuticals for positron emission tomography and new strategies for their production

    CERN Document Server

    Kilbourn, Michael R; Kilbourn, Michael R

    2015-01-01

    This book describes methods and procedures for preparing PET radiopharmaceuticals, and highlights new methods for conducting radiochemical reactions with carbon-11 (C11) and fluorine-18 (F18), which are two of the most commonly used radionuclides in positron emission tomography (PET) imaging.     Provides reliable methods for radiochemical syntheses and reactions, including all essential information to duplicate the procedure     Eliminates the time-consuming process of searching journal articles and extracting pertinent details from lengthy experimental sections or supporting information     Focuses on an emerging and important area for pharmaceutical and medical applications     Encompasses technical, regulatory, and application aspects     Includes solid-phase radiochemistry, transition-metal catalyzed radiochemistry, microfluidics, click chemistry, green radiochemistry and new strategies for radiopharmaceutical quality control.

  14. Uncertainty sources in radiopharmaceuticals clinical studies

    International Nuclear Information System (INIS)

    Degenhardt, Aemilie Louize; Oliveira, Silvia Maria Velasques de

    2014-01-01

    The radiopharmaceuticals should be approved for consumption by evaluating their quality, safety and efficacy. Clinical studies are designed to verify the pharmacodynamics, pharmacological and clinical effects in humans and are required for assuring safety and efficacy. The Bayesian analysis has been used for clinical studies effectiveness evaluation. This work aims to identify uncertainties associated with the process of production of the radionuclide and radiopharmaceutical labelling as well as the radiopharmaceutical administration and scintigraphy images acquisition and processing. For the development of clinical studies in the country, the metrological chain shall assure the traceability of the surveys performed in all phases. (author)

  15. Radiochemistry in nuclear medicine. Radiopharmaceuticals

    International Nuclear Information System (INIS)

    Samochocka, K.

    1999-01-01

    Radionuclides and radiopharmaceuticals play a kay role in nuclear medicine, both in diagnostics and therapy. Incorporation of radionuclides into biomolecules, and syntheses of radiolabelled compounds of high biological selectivity are a task for radiochemists working in the multidisciplinary field of radiopharmaceutical chemistry. The most commonly used radionuclide, 99m Tc, owes this popularity to its both nearly ideal nuclear properties in respect to medical imaging, and availability from inexpensive radionuclide generators. Also numerous other radionuclides are widely used for medical imaging and therapy. Labelling of biomolecules with radioiodine and various positron emitters is getting increasingly important. This review describes some chemical and radiochemical problems we meet while synthesizing and using 99m Tc-radiopharmaceuticals and radioiodine-labelled biomolecules. Also represented are the recent developments in the design and use of the second generation radiopharmaceuticals based on bifunctional radiochelates. Several principal routes of fast chemical synthesis concerning incorporation of short-lived positron emitters into biomolecules are outlined as well. The search for chemical structures of high biological selectivity, which would be activated by slow neutrons, is related to the method of Neutron Capture Therapy, an interesting option in nuclear medicine. (author)

  16. Database setup insuring radiopharmaceuticals traceability

    International Nuclear Information System (INIS)

    Robert, N.; Salmon, F.; Clermont-Gallerande, H. de; Celerier, C.

    2002-01-01

    Having to organize radiopharmacy and to insure proper traceability of radiopharmaceutical medicines brings numerous problems, especially for the departments which are not assisted with global management network systems. Our work has been to find a solution enabling to use high street software to cover those needs. We have set up a PC database run by the Microsoft software ACCESS 97. Its use consists in: saving data related to generators, isotopes and kits reception and deletion, as well as the results of quality control; transferring data collected from the software that is connected to the activimeter (elutions and preparations registers, prescription book). By relating all the saved data, ACCESS enables to mix all information in order to proceed requests. At this stage, it is possible to edit all regular registers (prescription book, generator and radionuclides follow-up, blood derived medicines traceability) and to quickly retrieve patients who have received a particular radiopharmaceutical, or the radiopharmaceutical that has been given to a particular patient. This user-friendly database provides a considerable support to nuclear medicine department that don't possess any network management for their radiopharmaceutical activity. (author)

  17. Quality control procedures for iodinated radiopharmaceuticals 131I-Hippuran and 131I-Risa

    International Nuclear Information System (INIS)

    Toledo e Souza, I.T. de; Pereira, N.P.S. de; Silva, C.P.G. da.

    1986-02-01

    A rapid miniaturized chromatography system was developed for fast determination of the proportion of inorganic radioactive iodide from radiopharmaceutical 131 I-Hippuran and 131 I-Risa. The technical parameters associated with miniaturized chromatography system were evaluated. One of the problems found in this system was the movement of the 131 I-Risa from the origin with consequent overestimation of the inorganic iodide. A correct spot placement eliminated this problem. (Author) [pt

  18. Radiopharmaceuticals for diagnosis. Final report

    Energy Technology Data Exchange (ETDEWEB)

    1994-03-01

    In the period 1969-1986, this project was directed to the evolution of target-specific labeled chemicals useful for nuclear medical imaging, especially radioactive indicators suited to tracing adrenal functions and localizing tumors in the neuroendocrine system. Since 1986, this project research has focused on the chemistry of positron emission tomography (PET) ligands. This project has involved the evaluation of methods for radiochemical syntheses with fluorine-18, as well as the development and preliminary evaluation of new radiopharmaceuticals for positron emission tomography. In the radiochemistry area, the ability to predict fluorine-18 labeling yields for aromatic substitution reactions through the use of carbon-13 NMR analysis was studied. Radiochemical yields can be predicted for some structurally analogous aromatic compounds, but this correlation could not be generally applied to aromatic substrates for this reaction, particularly with changes in ring substituents or leaving groups. Importantly, certain aryl ring substituents, particularly methyl groups, appeared to have a negative effect on fluorination reactions. These observations are important in the future design of syntheses of complicated organic radiopharmaceuticals. In the radiopharmaceutical area, this project has supported the development of a new class of radiopharmaceuticals based on the monoamine vesicular uptake systems. The new radioligands, based on the tetrabenazine structure, offer a new approach to the quantification of monoaminergic neurons in the brain. Preliminary primate imaging studies support further development of these radioligands for PET studies in humans. If successful, such radiopharmaceuticals will find application in studies of the causes and treatment of neurodegenerative disorders such as Parkinson`s disease.

  19. Synthesis of the radiopharmaceuticals for positron emission tomography

    International Nuclear Information System (INIS)

    Biricova, V.; Kuruc, J.

    2007-01-01

    In this paper is shown a short overview of the biogenic positron radiopharmaceuticals production and a brief summary of some PET preparation synthesis. At the end the overview of some forward-looking positron radionuclides, which can be used for a preparation of the PET radiopharmaceuticals is said. A short review of diagnostic use of PET radiopharmaceuticals is presented (authors)

  20. Development of an injectable formulation for the preparation of radiopharmaceutical 68Ga-DOTA-Sar gastrin

    International Nuclear Information System (INIS)

    Castillo P, M.

    2015-01-01

    The CCK2 receptor (cholecystokinin) is located in areas of the central and peripheral nervous system and is over expressed in several types of human cancer, as medullar thyroid, lung and ovarian carcinomas. One of the endogenous ligands for the CCK2 receptor is the gastrin, so that radiolabeled peptides analogues to gastrin as Sar gastrin (Gln-Gly-Pro-Trp-Leu-Glu-Glu-Glu-Glu-Glu-Ala-Tyr-Gly-Trp-Nle-Asp-Phe-NH 2 ) have been proposed as potential diagnostic radiopharmaceuticals for obtaining tumors images with CCK2 receptors over expressed. The 68 Ga is an ideal candidate for the peptides radiolabelled and has favorable characteristics to be used for diagnostic purposes by imaging with Positron emission tomography (PET). This work aimed to verify the technical documentation of the production process of radiopharmaceutical 68 Ga-DOTA-Sar gastrin for its sanitary registration before the Comision Federal contra Riesgos Sanitarios (COFEPRIS) in Mexico. For optimization of the production process was assessed a factorial design of two variables with mixed levels (27 combinations), where the dependent variable was the radiochemical purity. The analytical method used for evaluating the content of Sar gastrin peptide in the injectable formulation was also validated by High-performance liquid chromatography. Subsequently the validation of the production process was carried out by manufacturing of lots in single-dose of the optimized injectable formulation of the radiopharmaceutical 68 Ga-DOTA-Sar gastrin and the stability study was conducted at different times to determine the useful life time. The following was established as the optimal pharmaceutical formulation: 185 MBq of 68 Ga, 50 μg de DOTA-Sar gastrin, 14 mg of sodium acetate and 0.5 m L of buffer acetates, 1.0 M, ph 4.22 in 2.5 m L of the vehicle. The analytical method used to determine the radiochemical purity of the formulation satisfied the requirements for the intended analytical application. The lots in

  1. Radiopharmaceuticals in Czechoslovakia

    International Nuclear Information System (INIS)

    Hron, M.; Kronrad, L.; Svoboda, K.; Melichar, F.

    1986-01-01

    The history is briefly described of the production of radiopharmaceuticals in Czechoslovakia for nuclear medicine purposes. 131 I-labelled orthoiodohippurate and rose Bengal were first produced. Currently, 99m Tc is the most frequently requested radionuclide for radiopharmaceutical labelling. The preparation of 99m Tc is described in detail, a flow chart is shown and the network of 99m Tc distribution to hospitals outlined. In addition of 99m Tc and 131 I, UJV Rez produces other radionuclides for nuclear medicine, such as 113m In, 67 Ga, 35 S, 32 P, 203 Hg, 85 Sr. The methods are being developed of the production of 201 Tl, 125 I and 131 I-labelled bromosulfophthalein. (E.S.)

  2. Quality assurance of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Frier, M.; Hesslewood, S.R.

    1980-01-01

    A practical guide has been composed for all persons involved in the preparation and use of radiopharmaceuticals on methods used in quality assurance and their applications. These methods include the calibration of ionization chamber assay calibrators, the determination of radionuclide purity, radiochemical purity and chemical purity, particle size analysis and the measurement of pH. Quality assurance procedures are described for products not described in Compendial Monographs, or where the monograph exists, additional useful information is provided; such radiopharmaceuticals include technetium, indium-labelled and iodine-labelled products. (U.K.)

  3. Exposure of croatian population to radiopharmaceuticals

    International Nuclear Information System (INIS)

    Prlic, I.; Suric Mihic, M.; Marovic, G.; Mestrovic, T.; Mrcela, I.; Cerovac, Z.; Golubovic, D.; Hajdinjak, M.

    2010-01-01

    The aim of this paper is to call attention to the exposure of Croatian population to open sources of ionising radiation used in medical diagnostics, radiopharmaceuticals in particular, whose initial activity is very high. Without proper exposure monitoring, it is not possible to establish the effective dose per capita, but we have estimated it to be between 6.8 μSv and 7.0 μSv for this type of internal exposure, based on a very loose assumption that about 35,000 diagnostic procedures with radiopharmaceuticals are performed in Croatia every year. This calls for further research that would eventually lead to limiting the doses received through exposure to radiopharmaceuticals. (authors)

  4. Radiopharmaceutical scanning agents

    International Nuclear Information System (INIS)

    1976-01-01

    This invention is directed to dispersions useful in preparing radiopharmaceutical scanning agents, to technetium labelled dispersions, to methods for preparing such dispersions and to their use as scanning agents

  5. Application of a small molecule radiopharmaceutical concept to improve kinetics

    International Nuclear Information System (INIS)

    Jeong, Jae Min

    2016-01-01

    Recently, large molecules or nanoparticles are actively studied as radiopharmaceuticals. However, their kinetics is problematic because of a slow penetration through the capillaries and slow distribution to the target. To improve the kinetics, a two-step targeting method can be applied by using small molecules and very rapid copper-free click reaction. Although this method might have limitations such as internalization of the first targeted conjugate, it will provide high target-to-non-target ratio imaging of radiopharmaceuticals. The majority of radiopharmaceuticals belong to small molecules of which the molecular weight is less than 2000 Da, and the molecular size is smaller than 2 nm generally. The outstanding feature of the small molecule radiopharmaceuticals compared to large molecules is with their kinetics. Their distribution to target and clearance from non-target tissues are very rapid, which is the essential requirement of radiopharmaceuticals. In conclusion, the small molecule radiopharmaceuticals generally show excellent biodistribution properties; however, they show poor efficiency of radioisotope delivery. Large molecule or nanoparticle radiopharmaceuticals have advantages of multimodal and efficient delivery, but lower target-to-non-target ratio. Two-step targeting using a bio-orthogonal copper-free click reaction can be a solution of the problem of large molecule or nanoparticle radiopharmaceuticals. The majority of radiopharmaceuticals belong to small molecules of which the molecular weight is less than 2000 Da, and the molecular size is smaller than 2 nm generally. The outstanding feature of the small molecule radiopharmaceuticals compared to large molecules is with their kinetics. Their distribution to target and clearance from non-target tissues are very rapid, which is the essential requirement of radiopharmaceuticals

  6. Application of a small molecule radiopharmaceutical concept to improve kinetics

    Energy Technology Data Exchange (ETDEWEB)

    Jeong, Jae Min [Dept. of Nuclear Medicine, Seoul National University College of Medicine, Seoul (Korea, Republic of)

    2016-06-15

    Recently, large molecules or nanoparticles are actively studied as radiopharmaceuticals. However, their kinetics is problematic because of a slow penetration through the capillaries and slow distribution to the target. To improve the kinetics, a two-step targeting method can be applied by using small molecules and very rapid copper-free click reaction. Although this method might have limitations such as internalization of the first targeted conjugate, it will provide high target-to-non-target ratio imaging of radiopharmaceuticals. The majority of radiopharmaceuticals belong to small molecules of which the molecular weight is less than 2000 Da, and the molecular size is smaller than 2 nm generally. The outstanding feature of the small molecule radiopharmaceuticals compared to large molecules is with their kinetics. Their distribution to target and clearance from non-target tissues are very rapid, which is the essential requirement of radiopharmaceuticals. In conclusion, the small molecule radiopharmaceuticals generally show excellent biodistribution properties; however, they show poor efficiency of radioisotope delivery. Large molecule or nanoparticle radiopharmaceuticals have advantages of multimodal and efficient delivery, but lower target-to-non-target ratio. Two-step targeting using a bio-orthogonal copper-free click reaction can be a solution of the problem of large molecule or nanoparticle radiopharmaceuticals. The majority of radiopharmaceuticals belong to small molecules of which the molecular weight is less than 2000 Da, and the molecular size is smaller than 2 nm generally. The outstanding feature of the small molecule radiopharmaceuticals compared to large molecules is with their kinetics. Their distribution to target and clearance from non-target tissues are very rapid, which is the essential requirement of radiopharmaceuticals.

  7. Trends in radiopharmaceutical dispensing in a regional nuclear pharmacy

    International Nuclear Information System (INIS)

    Basmadjian, G.P.; Barker, K.; Johnston, J.; Stinchcomb, R.; Tarman, B.; Ice, R.D.

    1983-01-01

    In the last five years, the practice of nuclear medicine has undergone changes due to the advent of new imaging technologies and radiopharmaceuticals. These changes have had an impact upon the number and the type of radiopharmaceuticals dispensed in centralized nuclear pharmacies. With the advent of Computerized Axial Tomography Scanners (CAT), sophistication and wider acceptance of the Ultrasound imaging modality, nuclear medicine has had to change directions from utilizing radiopharmaceuticals for static organ imaging to functional type imaging and to resort to the use of new radiopharmaceuticals or to find other uses for the existing radiopharmaceuticals. The following trends in radiopharmaceutical dispensing in a regional nuclear pharmacy are evident: Brain procedures have declined by about 67% while nuclear cardiology studies have increased by over 2000%. Bone scans have increased by 72% while liver, renal and lung studies have shown no significant increase. These changes will continue as the practice of nuclear medicine concentrates more on functional studies and relegates other studies to newer imaging modalities

  8. Rational development of radiopharmaceuticals for HIV-1

    International Nuclear Information System (INIS)

    Lau, Chuen-Yen; Maldarelli, Frank; Eckelman, William C.; Neumann, Ronald D.

    2014-01-01

    The global battle against HIV-1 would benefit from a sensitive and specific radiopharmaceutical to localize HIV-infected cells. Ideally, this probe would be able to identify latently infected host cells containing replication competent HIV sequences. Clinical and research applications would include assessment of reservoirs, informing clinical management by facilitating assessment of burden of infection in different compartments, monitoring disease progression and monitoring response to therapy. A “rational” development approach could facilitate efficient identification of an appropriate targeted radiopharmaceutical. Rational development starts with understanding characteristics of the disease that can be effectively targeted and then engineering radiopharmaceuticals to hone in on an appropriate target, which in the case of HIV-1 (HIV) might be an HIV-specific product on or in the host cell, a differentially expressed gene product, an integrated DNA sequence specific enzymatic activity, part of the inflammatory response, or a combination of these. This is different from the current approach that starts with a radiopharmaceutical for a target associated with a disease, mostly from autopsy studies, without a strong rationale for the potential to impact patient care. At present, no targeted therapies are available for HIV latency, although a number of approaches are under study. Here we discuss requirements for a radiopharmaceutical useful in strategies targeting persistently infected cells. The radiopharmaceutical for HIV should be developed based on HIV biology, studied in an animal model and then in humans, and ultimately used in clinical and research settings

  9. Radiopharmaceuticals for thyroid imaging: a review

    International Nuclear Information System (INIS)

    Nishiyama, H.

    1979-01-01

    A review of radiopharmaceuticals which have been used for thyroid imaging was made with special emphasis on palpable thyroid nodules. An attempt was made to evaluate cold nodules derived from imaging methods using radioiodine or Tc-99m pertechnetate, followed by a successive application of another radiopharmaceutical. An attempt was also made to understand the patho-physiology of various thyroid disorders. The latter was based on the accumulated cases with discordant images between radioiodine and Tc-99m pertechnetate, and also on the iodine content within the gland by means of fluorescent techniques. Better radiopharmaceuticals are anxiously awaited in order to realize the distinction between benign and malignant thyroid disorders at the preoperative decision-making stage

  10. Radiopharmaceutical prescription in nuclear medicine departments

    International Nuclear Information System (INIS)

    Biechlin-Chassel, M.L.; Lao, S.; Bolot, C.; Francois-Joubert, A.

    2010-01-01

    In France, radiopharmaceutical prescription is often discussed depending to which juridical structure the nuclear medicine department is belonging. According to current regulation, this prescription is an obligation in a department linked to hospital with a pharmacy department inside. But situation remains unclear for independent nuclear medicine departments where physicians are not constrained to prescribe radiopharmaceuticals. However, as radiographers and nurses are only authorized to realize theirs acts in front of a medical prescription, one prescription must be realized. Nowadays, computerized prescription tools have been developed but only for radiopharmaceutical drugs and not for medical acts. In the aim to achieve a safer patient care, the prescription regulation may be applied whatever differences between nuclear medicines departments. (authors)

  11. Aptamers as radiopharmaceuticals for nuclear imaging and therapy

    International Nuclear Information System (INIS)

    Gijs, Marlies; Aerts, An; Impens, Nathalie; Baatout, Sarah; Luxen, André

    2016-01-01

    Today, radiopharmaceuticals belong to the standard instrumentation of nuclear medicine, both in the context of diagnosis and therapy. The majority of radiopharmaceuticals consist of targeting biomolecules which are designed to interact with a disease-related molecular target. A plethora of targeting biomolecules of radiopharmaceuticals exists, including antibodies, antibody fragments, proteins, peptides and nucleic acids. Nucleic acids have some significant advantages relative to proteinaceous biomolecules in terms of size, production, modifications, possible targets and immunogenicity. In particular, aptamers (non-coding, synthetic, single-stranded DNA or RNA oligonucleotides) are of interest because they can bind a molecular target with high affinity and specificity. At present, few aptamers have been investigated preclinically for imaging and therapeutic applications. In this review, we describe the use of aptamers as targeting biomolecules of radiopharmaceuticals. We also discuss the chemical modifications which are needed to turn aptamers into valuable (radio-)pharmaceuticals, as well as the different radiolabeling strategies that can be used to radiolabel oligonucleotides and, in particular, aptamers.

  12. Radiopharmaceutical regulation and Food and Drug Administration policy.

    Science.gov (United States)

    Rotman, M; Laven, D; Levine, G

    1996-04-01

    The regulatory policy of the Food and Drug Administration (FDA) on radiopharmaceuticals flows from a rigid, traditional, drug-like interpretation of the FDC Act on the licensing of radiopharmaceuticals. This contributes to significant delays in the drug-approval process for radiopharmaceuticals, which are very costly to the nuclear medicine community and the American public. It seems that radiopharmaceuticals would be better characterized as molecular devices. Good generic rule-making principles include: use of a risk/benefit/cost analysis; intent based on sound science; performance standards prepared by outside experts; a definite need shown by the regulatory agency; to live with the consequences of any erroneous cost estimates; and design individual credential requirements so that additional training results in enhanced professional responsibility. When these common elements are applied to current FDA policy, it seems that the agency is out of sync with the stated goals for revitalizing federal regulatory policies as deemed necessary by the Clinton administration. Recent FDA rulings on positron-emission tomography, Patient Package inserts, and on medical device service accentuate the degree of such asynchronization. Radiopharmaceutical review and licensing flexibility could be dramatically improved by excluding radiopharmaceuticals from the drug category and reviewing them as separate entities. This new category would take into account their excellent record of safety and their lack of pharmacological action. Additionally, their evaluation of efficacy should be based on their ability to provide useful scintiphotos, data, or responses of the physiological system it portends to image, quantitate, or describe. To accomplish the goal of transforming the FDA's rigid, prescriptive policy into a streamlined flexible performance-based policy, the Council on Radionuclides and Radiopharmaceuticals proposal has been presented. In addition, it is suggested that the United

  13. Current directions in radiopharmaceutical research

    Energy Technology Data Exchange (ETDEWEB)

    Mather, S J [Department of Nuclear Medicine, St. Bartholomew` s Hospital, London (United Kingdom)

    1998-08-01

    Much of current radiopharmaceutical research is directed towards the development of receptor-binding tracers which are targeted towards biochemical processes. These may be extra or intracellular in nature and hold promise for an imaging approach to tissue characterisation in-vivo. Many of these products are based on proteins which range in size from large monoclonal antibodies to small neuropeptides and share a radiolabelling chemistry based on the use of bifunctional chelating agents. Although developed initially for use with indium-111, considerations of cost and isotope availability have continued to direct the efforts of many researchers towards the use of technetium-99m. While polypeptide-based radiopharmaceuticals may be useful for imaging peripheral cell-surface receptors, access to sites of interest within the cell, or in the brain, requires the development of small lipophilic molecules with retained ability to interact with intracellular targets. The design and synthesis of these compounds presents a particular challenge to the radiopharmaceutical chemist which is being met through either a pendant or integrated approach to the use of technetium coordination with particular emphasis on technetium (v) cores. Progress continues to be made in the application of targeted radionuclide therapy particularly in the development of radiopharmaceuticals for the treatment of malignant bone disease. methods for labelling antibodies with a great variety of cytotoxic radionuclides have now been refined and their use for radioimmunotherapy in the treatment of haematological malignancies shows great promise. The major medical areas for application of these new radiopharmaceuticals will be in oncology, neurology and inflammation but the increasingly difficult regulatory climate in which drug development and health-care now operate will make it essential for researchers to direct their products toward specific clinical problems as well as biological targets. (author) 36 refs

  14. Current directions in radiopharmaceutical research

    International Nuclear Information System (INIS)

    Mather, S.J.

    1998-01-01

    Much of current radiopharmaceutical research is directed towards the development of receptor-binding tracers which are targeted towards biochemical processes. These may be extra or intracellular in nature and hold promise for an imaging approach to tissue characterisation in-vivo. Many of these products are based on proteins which range in size from large monoclonal antibodies to small neuropeptides and share a radiolabelling chemistry based on the use of bifunctional chelating agents. Although developed initially for use with indium-111, considerations of cost and isotope availability have continued to direct the efforts of many researchers towards the use of technetium-99m. While polypeptide-based radiopharmaceuticals may be useful for imaging peripheral cell-surface receptors, access to sites of interest within the cell, or in the brain, requires the development of small lipophilic molecules with retained ability to interact with intracellular targets. The design and synthesis of these compounds presents a particular challenge to the radiopharmaceutical chemist which is being met through either a pendant or integrated approach to the use of technetium coordination with particular emphasis on technetium (v) cores. Progress continues to be made in the application of targeted radionuclide therapy particularly in the development of radiopharmaceuticals for the treatment of malignant bone disease. methods for labelling antibodies with a great variety of cytotoxic radionuclides have now been refined and their use for radioimmunotherapy in the treatment of haematological malignancies shows great promise. The major medical areas for application of these new radiopharmaceuticals will be in oncology, neurology and inflammation but the increasingly difficult regulatory climate in which drug development and health-care now operate will make it essential for researchers to direct their products toward specific clinical problems as well as biological targets. (author)

  15. Quality assurance considerations related to in-house radiopharmaceutical preparations

    International Nuclear Information System (INIS)

    Finn, R.D.; Boothe, T.E.

    1990-01-01

    The Food and Drug Administration through its interpretation of the Food, Drug and Cosmetic Act with various amendments not only oversees the clinical investigation of new drugs, including short-lived radiopharmaceuticals but also monitors specific basic research protocols through the activities of the approved Radioactive Drug Research Committees. Concurrent with the technical improvements being made with positron emission tomographs is the increased availability of a variety of radiolabeled substrates possessing the unique potential to serve as indicators of in vivo alteration of biochemical processes. The syntheses of certain positron emitting radioligands with specific emphasis on the quality control procedures and current good manufacturing practices are discussed

  16. A new approach to the analysis of radiopharmaceuticals. Final technical report, January 15, 1987--June 30, 1991

    International Nuclear Information System (INIS)

    Jones, A.G.; Davison, A.; Costello, C.E.

    1998-03-01

    The objective of this research was to investigate analytical techniques that could be used in the study of both the basic chemistry and the radiopharmaceutical chemistry of 99m Tc. First funded in 1981, the work focused initially upon the use of high performance liquid chromatography (HPLC) and various forms of mass spectrometry for the identification of technetium species. This funding allowed the authors to combine HPLC and mass spectrometry to identify radiopharmaceuticals which, although in clinical use, had not previously been characterized. Other techniques that have been examined include resonance Raman spectroscopy and, more significantly, 99 Tc nuclear magnetic resonance spectroscopy (NMR), with the latter not only being used in purely chemical experiments but also in biologic studies. In 1985 a grant to the Department of Chemistry at MIT from DOE allowed the purchase of an X-ray diffractometer and access to this instrument has enabled them to broaden the analytical base with routine structural determinations

  17. Physical and Chemical Aspects of PET Radiopharmaceuticals

    International Nuclear Information System (INIS)

    2004-09-01

    On the Workshop 23 contributions were presented. This proceedings includes 21 presentations delivered at the workshop. The topics discussed included: Cyclotron and Target Constructions; Target Chemistry; Radiopharmaceuticals Synthesis; Quality Control of Radiopharmaceuticals; GLP-GMP Design; PET Imaging. Each presentation has been indexed separately

  18. Energy Materials Coordinating Committee (EMaCC): Annual technical report, Fiscal year 1987

    International Nuclear Information System (INIS)

    1988-09-01

    The DOE Energy Materials Coordinating Committee (EMaCC) serves primarily to enhance coordination among the Department's materials programs and to further the effective use of materials expertise within the Department. These functions are accomplished through the exchange of budgetary and planning information among program managers and through technical meetings/workshops on selected topics involving both DOE and major contractors. This annual technical report is mandated by the EMaCC terms of reference. This report summarizes EMaCC activities for FY 1987 and describes the materials research programs of various offices and divisions within the Department

  19. Chirality plays important roles in radiopharmaceuticals

    International Nuclear Information System (INIS)

    Shen Yumei

    2006-01-01

    The paper introduces the basic concept of chirality, target specific selectivity and their relationship in radiopharmaceuticals. If the ligands labeled by radionuclides have chiral center, the enantiomers must be separated, or the target specific selectivity will not be good. Chirality is one of the most important factors which must be considered in the study of the structure-activity relationship of radiopharmaceuticals. (authors)

  20. Applications and development trend of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kim, J.R.

    1978-01-01

    Present status of radiopharmaceuticals applications and the trend of the development are extensively reviewed and discussed. The followings are manifested: a) Among the various radionuclides, those of short lived, accelerator produced, and having moderate radiation energies are becoming popular. b) Diagnosis using various labelled molecules are considered to be the most active field in nuclear medicine. c) Development of radiopharmaceuticals for tumor localization studies is one of the trends. d) The use of various convenient kits of both in-vitro radioligand assay, and in-vivo instant labelling is now an enormous domain in nuclear medicine. A great stride is also made in the development of automation technique. Upon it, an urgent development of some new radiopharmaceuticals having local characteristics is proposed. (author)

  1. Quality control in 99m technetium radiopharmaceuticals

    International Nuclear Information System (INIS)

    Leon Cabana, Alba

    1994-01-01

    This work means about the quality control in Tc radiopharmaceuticals preparation at hospitalary levels. Several steps must be used in a Nuclear Medicine Laboratory, such as proceeding,radiopharmaceuticals kits preparation, and dispensation materials,glasses,stopper,physical aspects,identification,ph control,storage,and reactif kits

  2. Preparation and control of radiopharmaceuticals in hospitals

    International Nuclear Information System (INIS)

    Kristensen, K.

    1979-01-01

    This guidebook covers the work commonly organized as part of the work in the hospital. It does not cover the manufacture of radiopharmaceuticals on an industrial scale. The work is characterized by the small scale on which manufacture and preparation of radiopharmaceuticals take place

  3. Characterization of atmospheric emissions of a radiopharmaceutical' s production unit

    Energy Technology Data Exchange (ETDEWEB)

    Siqueira, Gessilane M.; Barreto, Alberto A.; Maletta, Paulo G.M.; Alves, Thaís A.N., E-mail: gessilane.siqueira@cdtn.br, E-mail: aab@cdtn.br, E-mail: pgmm@cdtn.br, E-mail: aryadnenasc@gmail.com [Centro de Desenvolvimento da Tecnologia Nuclear (CDTN/CNEN-MG), Belo Horizonte - MG (Brazil)

    2017-07-01

    Cyclotrons are radiative facilities capable of synthesizing radioisotopes that will be used for the production of radiopharmaceuticals. The increasing use of these substances in diagnostic therapies and procedures in nuclear medicine implies the need to increase the production of radiopharmaceuticals. In this context, it is fundamental, from the point of view of environmental radioprotection, to characterize atmospheric emissions from this type of production, in order to make feasible studies of radiological impacts, especially with a view to human health and environmental preservation. It is premise that facilities must ensure the radiological safety of exposed individuals through the control of discharges into the environment. This work aims to characterize the atmospheric emissions behavior of a Radiopharmaceutical Research and Production Unit (RRPU). The emission data for the radionuclides C-11, F-18, and N-13, associated to the production of radiopharmaceuticals ({sup 18}F-FES, {sup 18}F-FDG, {sup 18}FCOL, {sup 18}F-FLT, Na{sup 18}F) during the year 2016 were analyzed. Emissions data are collected every 10 seconds from a sensor installed in the unit's exhaust system. The pre-processing of these data was done by spreadsheets (Excel®) and exported to a statistical package (Minitab16®) to characterize the behavior of these emissions. The results of this study aim to contribute: to the study of atmospheric dispersion of radionuclides in the region of interest; to evaluate the operational control measures of the investigated facility; and to evaluate the radiological impacts in the region neighboring the facility. This methodology has been used in atmospheric dispersion modeling studies in the RRPU and the results showed that the annual doses from the emissions are within the limits established by the radioprotection norms of the Brazilian National Nuclear Energy Commission. Additionally, it is believed that the information generated in this study

  4. Radiopharmaceuticals for palliative therapy pain

    International Nuclear Information System (INIS)

    Gaudiano, Javier

    1994-01-01

    Dissemination to bone of various neoplasms is cause of pain with poor response by major analgesics.Indications. Radiopharmaceuticals,description of main characteristics of various β emitter radionuclides.Choose of patients for worm indication of pain palliative therapy with β emitter radiopharmaceuticals is adequate must be careful . Contraindications are recognized.Pre and post treatment controls as clinical examination and complete serology are described.It is essential to subscribe protocols,keep patient well informed,included the physician in charge of the patient as part of the team.Bibliography

  5. Studies of quality control procedures for radiopharmaceuticals

    International Nuclear Information System (INIS)

    Zivanovic, M.; Trott, N.G.

    1983-01-01

    In this paper, a short description is given of a radiopharmaceutical preparation suite set up at the Royal Marsden Hospital and an account is presented of methods used for quality control of radiopharmaceuticals and of the results obtained over a period of about two and a half years

  6. Trends in radiopharmaceutical dispensing in a regional nuclear pharmacy

    International Nuclear Information System (INIS)

    Basmadjian, G.P.; Johnston, J.; Barker, K.; Ice, R.D.

    1982-01-01

    Dispensing trends for radiopharmaceuticals at a regional nuclear pharmacy over a 51-month period were studied. dispensing records of a regional nuclear pharmacy were analyzed with a forecasting procedure that uses univariate time data to produce time trends and autoregressive models. The overall number of prescriptions increased from 3500 to 5500 per quarter. Radiopharmaceuticals used in nuclear cardiology studies increased from less than 0.1% to 17.5% of total prescriptions dispensed, while radiopharmaceuticals used for brain imaging showed a steady decline from 29% to 11% of total prescriptions dispensed. The demand for other radiopharmaceuticals increased in areas such as renal studies, bone studies, lung studies, liver-function studies, and 67 Ga tumor-uptake studies, and declined slightly for static liver studies. Changes in dispensing trends for radiopharmaceuticals will continue as the practice of nuclear medicine concentrates more on functional studies and as newer imaging techniques become used for other purposes

  7. Prenatal radiation doses from radiopharmaceuticals

    International Nuclear Information System (INIS)

    Rojo, A.M.; Gomez Parada, I.M.; Di Trano, J.L.

    1998-01-01

    The radiopharmaceutical administration with diagnostic or therapeutic purpose during pregnancy implies a prenatal radiation dose. The dose assessment and the evaluation of the radiological risks become relevant due to the great radiosensitivity of the fetal tissues in development. This paper is a revision of the available data for estimating fetal doses in the cases of the more frequently used radiopharmaceuticals in nuclear medicine, taking into account recent investigation in placental crossover. The more frequent diagnostic and therapeutic procedures were analyzed according to the radiation doses implied. (author) [es

  8. Quality controls of radiopharmaceuticals used in nuclear medicine

    International Nuclear Information System (INIS)

    Gomez de Castiglia, S.I.; Fraga de Suarez, A.H.; Mitta, A.E.A.

    1981-01-01

    Chromatographic quality controls for Tc-99m; In-113m; I-131; Tl-201 and Ga-67 radiopharmaceuticals are described. Moreover, a chromatographic system which allows to separate different radiopharmaceuticals from In-113m is pointed out. (author) [es

  9. Radiopharmaceuticals for diagnosis of ischemic heart disease

    Energy Technology Data Exchange (ETDEWEB)

    Komarek, P; Chalabala, M [Institut pro Dalsi Vzdelavani Lekaru a Farmaceutu, Prague (Czechoslovakia)

    1982-01-01

    Radiopharmaceuticals used for diagnosing ischemic heart disease in the experimental and clinical practice are reviewed. The mechanism of their retention by the heart muscle is briefly described. The respective radiopharmaceuticals are divided into preparations imaging disorders in the blood supply of the cardiac muscle, diagnosing the myocardial infarction, and evaluating the contractility of the heart.

  10. Radiopharmaceuticals in China. Current status and prospects

    Energy Technology Data Exchange (ETDEWEB)

    Jia, Hong-Mei; Liu, Bo-Li [Beijing Normal Univ. (China). Key Laboratory of Radiopharmaceuticals

    2014-04-01

    The review provides an overview of the current status of radiopharmaceuticals in China for in vivo clinical use and also describes some important advances in the past three decades. Development of the diagnostic and therapeutic radiopharmaceuticals as well as basic research on radiopharmaceutical chemistry are being introduced. The radiotracers developed in China include: (1) Brain perfusion imaging agents and CNS radiotracers for β-amyloid plaques, σ{sub 1} receptors, and dopamine D{sub 2} or D{sub 4} receptors; (2) {sup 99m}Tc- and {sup 18}F-labeled myocardial perfusion imaging agents; (3) tumor imaging agents including integrin-targeting radiotracer, novel sentinel lymph node imaging agents, hypoxia imaging agents, {sup 99m}Tc-labeled glucose derivatives, σ{sub 2} receptor imaging agents, folate receptor imaging agents, and potential radiotracers for imaging of human telomerase reverse transcriptase expression; (4) Potential infection imaging agents; (5) Potential asialoglycoprotein receptor imaging agents; (6) Other imaging agents. Moreover, some prospects of research and development of radiopharmaceuticals in the near future are discussed. (orig.)

  11. A study on bacterial endotoxins test of radiopharmaceuticals with limulus agent

    Energy Technology Data Exchange (ETDEWEB)

    Suozhen, Bai; Kai, Luyu; Cheng, Luo [Academia Sinica, Beijing, BJ (China). Inst. of Atomic Energy; Ruiting, Zhang; Zhenmin, Xia [National Inst. for the Control of Pharmaceutical and Biological Products (China)

    1989-08-01

    The feasibility of endotoxins test of radiopharmaceuticals with limulus agent and the approach to take off the inhibition/enhancement effect of radiopharmaceuticals on limulus agent have been studied. Results of the test for 8 radiopharmaceuticals have been given.

  12. Detection of sentinel nodes with radiopharmaceuticals

    International Nuclear Information System (INIS)

    Yokoyama, Kunihiko; Michigishi, Takatoshi; Kinuya, Seigo; Konishi, Shota; Nakajima, Kenichi; Tonami, Norihisa

    2000-01-01

    Sentinel lymph nodes have been found to be an indicator of lymph node metastasis in breast cancer. In Japan, the theory and concept of sentinel lymph nodes in breast cancer have begun to be applied to carcinomas of the digestive system. Based on clinical experience in the detection of sentinel lymph nodes with radiopharmaceuticals, differences and similarities between the radiopharmaceuticals, methods, and techniques used to detect sentinel lymph nodes have been assessed in relation to breast cancer and carcinomas of the digestive system (including carcinomas of the esophagus and large intestine). The greatest difference between the methods used for breast and digestive cancers is the site of administration of the radiopharmaceutical. In breast cancer, the radiopharmaceutical is administered into a superficial organ (i.e., the mammary gland), whereas in carcinomas of the digestive system, it is administered into a deep organ (i.e., digestive tract). Another obvious difference is in lymph flow, i.e., the flow of the mammary glands is subcutaneous whereas lymph flow in the digestive tract is submucosal. Two radionuclide diagnostic methods are available to detect sentinel lymph nodes: sentinel lymphoscintigraphy with a gamma camera and a method that involves the use of a gamma probe intraoperatively. Radiopharmaceuticals used to detect sentinel lymph nodes must be smoothly transferred from the site of administration into the lymph, and uptake by the sentinel lymph node must continue for a long time without excessive flowing to lower reaches. The optimal particle size remains a matter of controversy, and no radiopharmaceuticals appropriate for lymphoscintigraphy have ever been approved in Japan. The authors compared the pharmacokinetics of three different radiopharmaceuticals used for sentinel lymphoscintigraphy in breast cancer ( 99m Tc-labeled albumin, 99m Tc-labeled tin colloid, and 99m Tc-labeled phytic acid) and founded that the detection rate was lowest with

  13. Regulatory and technical reports (abstract index journal): Annual compilation for 1996, Volume 21, No. 4

    Energy Technology Data Exchange (ETDEWEB)

    Sheehan, M.A.

    1997-04-01

    This compilation is the annual cumulation of bibliographic data and abstracts for the formal regulatory and technical reports issued by the U.S. Nuclear Regulatory Commission (NRC) Staff and its contractors.

  14. Regulatory and technical reports (abstract index journal): Annual compilation for 1996, Volume 21, No. 4

    International Nuclear Information System (INIS)

    Sheehan, M.A.

    1997-04-01

    This compilation is the annual cumulation of bibliographic data and abstracts for the formal regulatory and technical reports issued by the U.S. Nuclear Regulatory Commission (NRC) Staff and its contractors

  15. Kinetic model for the dosimetry of radiopharmaceuticals contaminated by Mo-99

    International Nuclear Information System (INIS)

    Shearer, D.R.; Pezzullo, J.C.

    1986-01-01

    Radiopharmaceuticals tagged with Tc-99m may become contaminated with breakthrough products from the Mo-99/Tc-99m generator. If a fraction of the contaminant becomes bound to the radiopharmaceutical, the dose to the radiopharmaceutical target organ from the contaminant must be considered. The dose to the contaminant target organ may then be calculated as the sum of the doses from a) the initially unbound contaminant, and b) the contaminant later released by degradation of the radiopharmaceutical. This paper presents a model which takes the above processes into account. The model is illustrated with clinical data derived from Mo-99 contaminated radiopharmaceuticals. 5 references, 2 figures, 6 tables

  16. Consequences of radiopharmaceutical extravasation and therapeutic interventions: a systematic review

    Energy Technology Data Exchange (ETDEWEB)

    Pol, Jochem van der; Voeoe, Stefan [Maastricht University Medical Centre (MUMC+), Department of Radiology and Nuclear Medicine, Postbox 5800, Maastricht (Netherlands); Bucerius, Jan; Mottaghy, Felix M. [Maastricht University Medical Centre (MUMC+), Department of Radiology and Nuclear Medicine, Postbox 5800, Maastricht (Netherlands); University Hospital, RWTH Aachen University, Department of Nuclear Medicine, Aachen (Germany)

    2017-07-15

    Radiopharmaceutical extravasation can potentially lead to severe soft tissue damage, but little is known about incidence, medical consequences, possible interventions, and effectiveness of these. The aims of this study are to estimate the incidence of extravasation of diagnostic and therapeutic radiopharmaceuticals, to evaluate medical consequences, and to evaluate medical treatment applied subsequently to those incidents. A sensitive and elaborate literature search was performed in Embase and PubMed using the keywords ''misadministration'', ''extravasation'', ''paravascular infiltration'', combined with ''tracer'', ''radionuclide'', ''radiopharmaceutical'', and a list of keywords referring to clinically used tracers (i.e. ''Technetium-99m'', ''Yttrium-90''). Reported data on radiopharmaceutical extravasation and applied interventions was extracted and summarised. Thirty-seven publications reported 3016 cases of diagnostic radiopharmaceutical extravasation, of which three cases reported symptoms after extravasation. Eight publications reported 10 cases of therapeutic tracer extravasation. The most severe symptom was ulceration. Thirty-four different intervention and prevention strategies were performed or proposed in literature. Extravasation of diagnostic radiopharmaceuticals is common. {sup 99m}Tc, {sup 123}I, {sup 18}F, and {sup 68}Ga labelled tracers do not require specific intervention. Extravasation of therapeutic radiopharmaceuticals can give severe soft tissue lesions. Although not evidence based, surgical intervention should be considered. Furthermore, dispersive intervention, dosimetry and follow up is advised. Pharmaceutical intervention has no place yet in the immediate care of radiopharmaceutical extravasation. (orig.)

  17. Melanin-binding radiopharmaceuticals

    International Nuclear Information System (INIS)

    Packer, S.; Fairchild, R.G.; Watts, K.P.; Greenberg, D.; Hannon, S.J.

    1980-01-01

    The scope of this paper is limited to an analysis of the factors that are important to the relationship of radiopharmaceuticals to melanin. While the authors do not attempt to deal with differences between melanin-binding vs. melanoma-binding, a notable variance is assumed

  18. Gallium and copper radiopharmaceutical chemistry

    International Nuclear Information System (INIS)

    Green, M.A.

    1991-01-01

    Gallium and copper radionuclides have a long history of use in nuclear medicine. Table 1 presents the nuclear properties of several gallium and copper isotopes that either are used in the routine practice of clinical nuclear medicine or exhibit particular characteristics that might make them useful in diagnostic or therapeutic medicine. This paper will provide some historic perspective along with an overview of some current research directions in gallium and copper radiopharmaceutical chemistry. A more extensive review of gallium radiopharmaceutical chemistry has recently appeared and can be consulted for a more in-depth treatment of this topic

  19. Metabolic radiopharmaceutical therapy in nuclear medicine

    International Nuclear Information System (INIS)

    Reguera, L.; Lozano, M. L.; Alonso, J. C.

    2016-01-01

    In 1986 the National Board of Medical Specialties defined the specialty of nuclear medicine as a medical specialty that uses radioisotopes for prevention, diagnosis, therapy and medical research. Nowadays, treatment with radiopharmaceuticals has reached a major importance within of nuclear medicine. The ability to treat tumors with radiopharmaceutical, Radiation selective therapy has become a first line alternative. In this paper, the current situation of the different therapies that are sued in nuclear medicine, is reviewed. (Author)

  20. Tc: chemistry and radiopharmaceuticals: a prospectus

    International Nuclear Information System (INIS)

    Tulip, T.H.

    1987-01-01

    The recent explosion in technetium chemistry evident in this symposium promises to continue unabated. As in the past, radiopharmaceutical applications will lead to new Tc chemistry. In this lecture the author will discuss those areas which appear most fertile based on chemical and radiopharmaceutical criteria. Among these will be new organometallic Tc chemistry (e.g., Tc(CNR) 6 cations), Tc complexes as metabolic tracers (e.g., Tc-analogs to FDG), and peptide-based Tc chelators (e.g., Tc-metallothionein)

  1. Radioisotopes and radiopharmaceuticals catalogue

    International Nuclear Information System (INIS)

    2002-01-01

    The Chilean Nuclear Energy Commission (CCHEN) presents its radioisotopes and radiopharmaceuticals 2002 catalogue. In it we found physical characteristics of 9 different reactor produced radioisotopes ( Tc-99m, I-131, Sm-153, Ir-192, P-32, Na-24, K-42, Cu-64, Rb-86 ), 7 radiopharmaceuticals ( MDP, DTPA, DMSA, Disida, Phitate, S-Coloid, Red Blood Cells In-Vivo, Red Blood Cells In-Vitro) and 4 labelled compounds ( DMSA-Tc99m, DTPA-Tc99m, MIBG-I131, EDTMP-Sm153 ). In the near future the number of items will be increased with new reactor and cyclotron products. Our production system will be certified by ISO 9000 on March 2003. CCHEN is interested in being a national and an international supplier of these products (RS)

  2. Multi-disciplinary collaboration in radiopharmaceutical chemistry

    International Nuclear Information System (INIS)

    Nozaki, Tadashi

    1989-01-01

    Various possibilities often exist in each step of radiopharmaceutical preparation, and multi-disciplinary knowledge and collaboration are necessary for improved choice of the preparation conditions. In the radionuclide production step, proton bombardment of a separated nuclide target usually exceeds other bombardments of natural targets. Isotope separation by laser-chemical method is expected to soon offer several enriched nuclides useful as the target in enough amount and moderate price. The design and preparation of radiopharmaceuticals will be directly influenced by further progress of enzymology and immunology. Nondestructive, continuous observation of chemical changes in vivo is a longing of radiochemists, and may be realized gradually through elaborate examination of chemical effects in Mossbauer absorption, γ-γ angular correlation, EC X-ray properties, and positron annihilation. Present knowledge and techniques in radiopharmaceutical chemistry, on the other hand, can be utilized effectively in other fields of life sciences

  3. The progress on researching method and metabolism of positron radiopharmaceutical

    International Nuclear Information System (INIS)

    Gan Hongmei; Qiao Jinping; Kong Aiying; Zhu Lin

    2010-01-01

    Positron radiopharmaceuticals are mainly used for PET studies, which are used in the field of nuclear medicine as tracers in the diagnosis and treatment of many diseases. They have important position and function in the clinical diagnosis and treatment. Metabolism or biotransformation will happen when PET radio-pharmaceuticals enter into the body. Understanding the metabolic fate of radiopharmaceutical probes is essential for an accurate analysis and interpretation of positron emission tomography imaging. The recent research progress on PET radiopharmaceuticals metabolism was reviewed in this paper, including the metabolism characteristics, research methods, analytical techniques and so on. (authors)

  4. Energy Materials Coordinating Committee (EMaCC): Fiscal year 1996. Annual technical report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-08-01

    The DOE Energy Materials Coordinating Committee (EMaCC) serves primarily to enhance coordination among the Department`s materials programs and to further effective use of materials expertise within the Department. These functions are accomplished through the exchange of budgetary and planning information among program managers and through technical meetings/workshops on selected topics involving both DOE and major contractors. In addition, EMaCC assists in obtaining materials-related inputs for both intra- and interagency compilations. The EMaCC reports to the Director of the Office of Energy Research in his or her capacity as overseer of the technical programs of the Department. This annual technical report is mandated by the EMaCC terms of reference. This report summarizes EMaCC activities for FY 1996 and describes the materials research programs of various offices and divisions within the Department.

  5. Energy Materials Coordinating Committee (EMaCC): Fiscal year 1996. Annual technical report

    International Nuclear Information System (INIS)

    1997-08-01

    The DOE Energy Materials Coordinating Committee (EMaCC) serves primarily to enhance coordination among the Department's materials programs and to further effective use of materials expertise within the Department. These functions are accomplished through the exchange of budgetary and planning information among program managers and through technical meetings/workshops on selected topics involving both DOE and major contractors. In addition, EMaCC assists in obtaining materials-related inputs for both intra- and interagency compilations. The EMaCC reports to the Director of the Office of Energy Research in his or her capacity as overseer of the technical programs of the Department. This annual technical report is mandated by the EMaCC terms of reference. This report summarizes EMaCC activities for FY 1996 and describes the materials research programs of various offices and divisions within the Department

  6. Evaluation of quality control of radiopharmaceuticals in Nuclear Medicine service

    International Nuclear Information System (INIS)

    Tavares, Jamille A. Lopes; Lira, Renata F. de; Santos, Marcus Aurelio P. dos

    2014-01-01

    Radiopharmaceuticals are a type of pharmaceutical preparation associated with radionuclides with purpose of diagnosis and therapy. Nuclear Medicine Services (NMS) should perform quality control of radiopharmaceuticals according to the recommendations of the manufacturer and scientific evidences accepted by the National Agency Sanitary Surveillance ( Brazilian ANVISA). This study evaluated the quality of the main radiopharmaceuticals in a NMS of the state of Pernambuco in relation to pH and radiochemical purity. The results showed that 96.8% of the radiopharmaceuticals showed radiochemical purity and all pH values were within the range recommended by the American pharmacopoeia. The study found that the quality control when inserted into the NMS, provides important data that allows exclusion of radiopharmaceuticals with low radiochemistry purity, favoring a reliable diagnosis and ensuring good radiation protection practices and biosecurity for patient and occupationally exposed individuals

  7. Analytics of radiochmical impurities in radiopharmaceutics. Pt. 4

    International Nuclear Information System (INIS)

    Heide, L.; Stamm, A.; Boegl, W.

    1981-01-01

    The radiopharmaceutics have been compiled in the present volume in the form of a medicament encyclopaedia. The term radiopharmaceutic has been very broadly covered so that one can find pharmaceutics which are applied in clinical routine as well as for veterinary tests or are being or have been tested. Preparates for radio-immuno assays are also recorded. All analysis methods are considered even if these only slightly differ from one another. Methods described in the literature are given which have resulted in a bad or no separation of the radiopharmaceutics from the impurities. (orig./MG) [de

  8. The application of the 'ten-day rule' in radiopharmaceutical investigations

    International Nuclear Information System (INIS)

    Ellis, R.E.; Nordin, B.E.C.; Tothill, P.; Veall, N.

    1977-01-01

    The working party first classified subjects who are investigated using radiopharmaceuticals into three groups, being (a) patients and other subjects who are asked to volunteer as controls for research studies, (b) patients on whom research investigations are being conducted which are relevant to their clinical condition but which are not strictly necessary for their management, and (c) patients on whom investigations are required for their proper management. The application of the 'ten-day rule' in relation to the use of radiopharmaceuticals is complicated by the fact that the total radiation dose is received over a time given by the effective life of the radiopharmaceutical in the organ, which may be a substantial part or even longer of the menstrual cycle. The activities of the radiopharmaceuticals normally administered are tabulted together with their effective half-lives and resulting gonad doses, and those radiopharmaceuticals requiring consideration of the implementation of the 'ten-day rule' for patients in groups (b) and (c) are identified. When the administration of therapeutic quantities of radiopharmaceuticals is being contemplated it is particularly important to take into account the applicability or otherwise of the 'ten-day rule'. It is recommended that the 'ten-day rule' should be strictly applied to all radiopharmaceutical administrations to women of child-bearing age who are volunteers for research purposes (group(a)). (U.K.)

  9. Design and Development of New Radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Wagner, Jr., H. N.; Stern, H. S.; Rhodes, B. A.; Reba, R. C.; Hosain, F.; Zolle, I. [Johns Hopkins Medical Institutions, Baltimore, MD (United States)

    1969-05-15

    The major factors in the design of a new radiopharmaceutical for radioisotope scintigraphy are the photon energy of the radionuclide, the ability to incorporate the radionuclide insuitable chemical and biological form, the radiation dose to the patient, and the cost of production of the radiopharmaceutical. In this laboratory, the radionuclides, indium-113m and ytterbium-169, and technetium-99m, have been incorporated into a variety of radiopharmaceuticals. These include particles suitable for lung and liver studies, chelates for brain and kidney studies, and ionic forms for blood pool imaging. Studies in experimental animals and man indicate that these agents offer certain advantages over previously available radiopharmaceuticals. By providing larger numbers of photons, they permit more precise temporal and spatial resolution. The longer half-life of the tin-113 parent radionuclide from which indium-113m can be eluted makes indium-113m readily available, even at sites distant from the source of production. The tin-indium generator system need be purchased only every five months rather than weekly as in the case of the widely used molybdenum-technetium system. The ytterbium-radionuclide in the chemical form of a chelate is particularly useful as an inexpensive agent that provides high photon yields for renal and brain imaging. The rapid and complete biological excretion results in low radiation dose while the longer physical half-life greatly extends the shelf-life. (author)

  10. Legal aspects of the production and application of radiopharmaceuticals in Germany

    International Nuclear Information System (INIS)

    Kuwert, T.; Prante, O.; Meyer, G.

    2009-01-01

    This article deals with the regulation of the production and use of radiopharmaceuticals in Germany. As in other countries, radiopharmaceuticals may be used when licensed by the German equivalent of the Federal Drug Agency or in clinical trials. Furthermore, non-licensed radiopharmaceuticals can be administered to patients for diagnosis when they are produced in the same institution and not more than 20 doses per week and radiopharmaceutical are given. A prerequisite for these three ways of use is the production of the radiopharmaceutical in question according to the guidelines of the good manufacturing practice (GMP) which creates considerable problems for the usually small PET centers installed in the German university hospitals. German law offers a further possibility to apply non-licensed radiopharmaceuticals for clinical purposes: their administration to patients is not forbidden when performed by a physician who produces the substance himself or is at least responsible for its synthesis. This regulation has, however, been met with criticism by government agencies. (orig.)

  11. KBS Annual Report 1983. Including summaries of technical reports issued during 1983

    International Nuclear Information System (INIS)

    1984-06-01

    The purpose of the KBS Annual Report is to inform interested organizations and individuals of the research and development work performed by the division KBS within the Swedish Nuclear Fuel Supply Co (SKBF) on the handling, treatment and final storage of nuclear wastes in Sweden. The Annual Report normally contains a presentation of the legal and organizational situation followed by an account of the progress within different areas of the R and D-work. This account also includes indications of the activities planned for the future. At the end of the report the summaries of 76 technical reports and other publications issued during the year are listed in special appendices. (K.A.E.)

  12. Good Practice for Introducing Radiopharmaceuticals for Clinical Use

    International Nuclear Information System (INIS)

    2016-02-01

    The use of new radiopharmaceuticals can provide extremely valuable information in the evaluation of cancer, as well as heart and brain diseases. Information that often times cannot be obtained by other means. However, there is a perceived need in many Member States for a useful reference to facilitate and expedite the introduction of radiopharmaceuticals already in clinical use in other countries. This publication intends to provide practical support for the introduction of new radiotracers, including recommendations on the necessary steps needed to facilitate and expedite the introduction of radiopharmaceuticals in clinical use, while ensuring that a safe and high quality product is administered to the patient at all times

  13. The safe and effective use of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Trott, N.G.

    1982-01-01

    In the medical applications of radionuclides, we have to arrange effective radiation protection of patients, staff and general public, maintain high standards of pharmaceutical safety and ensure that the radiopharmaceuticals are effective in use. The influence of the 1976 Council of the European Communities Euratom Directive in producing legislation in the United Kingdom controlling medical work with radioactivity is discussed. Attention is drawn to current studies in the dosimetry of radiopharmaceuticals, and some of the problems that continue to arise in evaluating the dosimetry and possible hazards of isotopes of iodine are discussed. Developments in facilities for preparing radiopharmaceuticals in hospital laboratories are considered and a short report is given of an extensive study of quality control procedures which showed that it was difficult to justify their use as a routine on established products. (Author)

  14. Fetal absorbed doses by radiopharmaceutical administration

    International Nuclear Information System (INIS)

    Rojo, Ana M; Gomez Parada, Ines M.; Di Trano, Jose L.

    2000-01-01

    The radiopharmaceutical administration with diagnostic or therapeutic purpose during pregnancy implies a prenatal radiation dose. The dose assessment and the evaluation of the radiological risks become relevant due to the great radiosensitivity of the fetal tissues in development. This paper is a revision of the available data for estimating fetal doses in the cases of the more frequently used radiopharmaceuticals in nuclear medicine, taking into account recent investigation in placental crossover. The more frequent diagnostic and therapeutic procedures were analyzed according to the radiation doses implied. (author)

  15. Results of quality control studies of technetium 99m labelled radiopharmaceuticals prepared from kits

    International Nuclear Information System (INIS)

    McLean, J.R.; Rockwell, L.J.; Welsh, W.J.

    1978-01-01

    This report summarizes the results of quality control studies of Tc 99m labelled normal serum albumin and macro-aggregated albumin radiopharmaceuticals prepared from commercially available kits. It includes all analyses performed since the inception of the program in 1976 until the end of 1977. The results presented herein were obtained through the application of various in vitro tests and animal (mouse) bio-distribution studies. It is hoped that a similar report will be published annually for the benefit of hospital nuclear medicine departments and kit manufacturers. (auth)

  16. F-18 Radiopharmaceuticals

    International Nuclear Information System (INIS)

    2001-12-01

    This document includes 8 presentations delivered at the symposium. The topics discussed include: optimization of accelerator production of 18 F- and 18 F 2 -fluorodeoxyglucose; radiopharmaceuticals synthesis, synthesis modules, pharmacopoeia and GLP; quality control; radiation safety of production and application; PET imaging in human medicine. Each presentation has been indexed separately

  17. Radiopharmaceuticals for nuclear cardiology; Radiofarmacos para cardiologica nuclear

    Energy Technology Data Exchange (ETDEWEB)

    Leon Cabana, Alba [Universidad de la Republica, Facultad de Quimica (Uruguay)

    1994-12-31

    One of the diagnostic technique periodically used in Nuclear Medicine is the angiographic studi e, employee for detect cardiovascular diseases. The radiopharmaceutical more used in the angiographic ones is 99mTc. Between thetopics described in the present work it find: myocardial infarction, radiopharmaceuticals classification for cardiac studies, labelled proceedings, cardiovascular diseases.

  18. Energy materials coordinating committee (EMACC) Fiscal Year 1982. Annual technical report

    Energy Technology Data Exchange (ETDEWEB)

    None, None

    1983-03-01

    The DOE Energy Materials Coordinating Committee (EMaCC) serves primarily to enhance coordination among the Department's materials programs and to further the effective use of materials expertise within the Department. These functions are accomplished through the exchange of budgetary and planning information among program managers and through technical meetings/ workshops on selected topics involving both DOE and major contractors. In addition, the EMaCC aids in obtaining materials - related inputs for both intra- and interagency compilations. Membership in the EMaCC is open to any Department organizational unit; participants are appointed by Division or Office Directors. The current membership is listed in Table 1. The EMACC reports to the Director of the Office of Energy Research in his capacity as overseer of the technical programs of the Department. This annual technical report is mandated by the EMACC terms of reference. In this report are described 1) EMACC activities for FY 1982; 2) a summary of materials funding in the Department from FY 1978 to the present; and 3) on-going materials programs in the Department.

  19. Molecular design of 99Tcm labelled radiopharmaceuticals. Pt.2

    International Nuclear Information System (INIS)

    Wang Xuebin; Chu Jinfeng

    2003-01-01

    The structure-activity relationship of 99 Tc m labelled radiopharmaceuticals and the correlative contents of computer aided drug design are introduced. Of them, quantitative structure-activity relationship and its application to design 99 Tc m labelled radiopharmaceuticals are narrated on emphases

  20. ANSTO - Annual Report 1996-1997

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-09-01

    Highlights of achievements during 1996-1997 at the Australian Nuclear Science and technology (ANSTO) include: release of the new ANSTO Strategic Plan for the period till June 2000 and the establishment of a Technical Advisory Committee (TAC) of the Board. In accordance with the Strategic Plan, ANSTO has continued to focus its activities in six core business areas. The major outcomes and outputs of this work are outlined. The majority of ANSTO strategic research was directed at several topics launched during the year, including: international cooperative research to enhance safety of nuclear facilities and safeguards for nuclear materials, environmental dynamics, global climate change, radioactive waste management, ecological sustainability of the mining and mineral industries, radionuclides and radiopharmaceuticals for the 21st century and the design and process of novel interfaces. During the year major upgrades were made to he National Medical Cyclotron (NMC) and the Australian National Tandem Accelerator for Applied Research (ANTARES). The Annual Report documents the uses of these facilities by universities, industry, medicine and Government. Details are also provided of the organization development and support which support the core scientific areas. The financial statement for the year under review is also included tabs, ills, figs.

  1. ANSTO - Annual Report 1996-1997

    International Nuclear Information System (INIS)

    1997-09-01

    Highlights of achievements during 1996-1997 at the Australian Nuclear Science and technology (ANSTO) include: release of the new ANSTO Strategic Plan for the period till June 2000 and the establishment of a Technical Advisory Committee (TAC) of the Board. In accordance with the Strategic Plan, ANSTO has continued to focus its activities in six core business areas. The major outcomes and outputs of this work are outlined. The majority of ANSTO strategic research was directed at several topics launched during the year, including: international cooperative research to enhance safety of nuclear facilities and safeguards for nuclear materials, environmental dynamics, global climate change, radioactive waste management, ecological sustainability of the mining and mineral industries, radionuclides and radiopharmaceuticals for the 21st century and the design and process of novel interfaces. During the year major upgrades were made to he National Medical Cyclotron (NMC) and the Australian National Tandem Accelerator for Applied Research (ANTARES). The Annual Report documents the uses of these facilities by universities, industry, medicine and Government. Details are also provided of the organization development and support which support the core scientific areas. The financial statement for the year under review is also included

  2. Radiation Protection, double-blind studies with radiopharmaceuticals

    International Nuclear Information System (INIS)

    Pujadas, M. C.; Camacho, C.; Guasp, M.; Villaescusa, J. I.

    2009-01-01

    In a double-blind randomized controlled clinical trial (RCT) subjects and researchers do not know the assignment to treatment groups to ovoid the appearance of subjective biases of information. The employment of radiopharmaceuticals in double-blind RCTs raises a dilemma from the point ov view of the radiological protection. On the one hand, the obligation to act in cases of contamination and/or risk of irradiation exists, but on the other hand the duty of keeping the blind study also exists. In this paper some of the possible problems that arise when conducting a double-blind RCT with radiopharmaceuticals from the point of view of the radiological protection are presented. We comment our experience with the radiopharmaceutical Alpharadin and, in addition, we propose useful recommendations based on the randomness of the decontamination process. (Author) 7 refs.

  3. Annual meeting on nuclear technology '92. Technical session 'Nuclear energy discussion'

    International Nuclear Information System (INIS)

    1992-05-01

    The report contains the six special papers red at the 1992 annual conference on nuclear engineering at Karlsruhe, all of which are individually retrievable from the database. They deal with the following subjects: historical development of the basic trends of technology criticism; communication problems in connection with the conveying of technical facts; psycho-sociological patterns of technology anxiety-mental infection or risk consciousness; field of tension between technology and journalism; handling of insecurities; ethical justifiability of nuclear energy use. (HSCH) [de

  4. Report of the Task Force on radiopharmaceuticals

    International Nuclear Information System (INIS)

    Lacker, D.K.; Porter, B.J.; Watkins, G.

    1975-01-01

    The procedures for evaluation of IND and NDA applications were reviewed by FDA and the state members of the Task Force believe that there is significant progress being made toward expeditious handling of these items. Progress toward publication of the final rule on radiopharmaceuticals has reduced the need for state regulatory activity in investigational aspects of radiopharmaceutical research to the point that the original concept for the training is no longer valid

  5. Regulatory and technical reports (abstract index journal). Annual compilation for 1984. Volume 9, No. 4

    International Nuclear Information System (INIS)

    1985-01-01

    This compilation consists of bibliographic data and abstracts for the formal regulatory and technical reports issued by the US Nuclear Regulatory Commission (NRC) Staff and its contractors. It is NRC's intention to publish this compilation quarterly and to cumulate it annually

  6. Pain palliative Radiopharmaceuticals

    International Nuclear Information System (INIS)

    Gonzalez, B. M.

    1994-01-01

    A pain relieving agents based on β emitters mainly and in some cases a complex preparation are being given for bone metastasis in relation with breast,prostate and lung carcinoma with good performance in clinical practice.Several radionuclides and radiopharmaceuticals are mentioned giving strength to those newly proposed, 153Sm and 186Re.Bibliography

  7. The role of mathematical models in the optimization of radiopharmaceutical therapy

    International Nuclear Information System (INIS)

    Divgi, C.

    2001-01-01

    Mathematical models have been used in radiopharmaceutical therapy for over five decades. These have served to determine the amount of radioactivity required to treat disease, as in the therapy of hyperthyroidism with iodine-131, or, more frequently, to determine the largest amount of radioactivity that can be safely administered. Mathematical models are especially useful in the determination of fractionated radiopharmaceutical therapy. This review will briefly outline the historical development and current utility of mathematical models in radiopharmaceutical therapy, including thyroid disorders and radioimmunotherapy; and describe the potential of modeling in fractionated therapy. The extended application of such models to currently used radiopharmaceutical therapy based on indices of body mass or surface area, to alleviate toxicity and increase radiation dose to tumour, will be proposed. Finally, future applications of mathematical models in radiopharmaceutical therapy will be outlined. (author)

  8. Quality control of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Verdera, E.S.

    1994-01-01

    The quality control of radiopharmaceuticals is based in physics, physics-chemical and biological controls. Between the different controls can be enumerated the following: visual aspect,side, number of particle beams,activity,purity,ph,isotonicity,sterility,radioinmunoessay,toxicity,stability and clinical essay

  9. International symposium on trends in radiopharmaceuticals (ISTR-2005). Book of extended synopses

    International Nuclear Information System (INIS)

    2005-01-01

    Radiopharmaceuticals, along with imaging instrumentation, are the pillars that support the edifice of clinical nuclear medicine and the former is the major driver enabling investigations of molecular phenomena for better understanding of human disease and developing effective treatments. The growth of nuclear medicine has been intimately linked to availability of new radioisotopes and the discovery of new radiopharmaceuticals. The field of radiopharmaceuticals has witnessed continuous evolution thanks to the immense contributions of scientists from diverse disciplines such as radiochemistry, inorganic chemistry, organic chemistry, biochemistry, physiology and pharmacology. Several milestones can be cited in the trajectory of this growth, which include continuing development of a plethora of 99 mTc radiopharmaceuticals, automated synthesis of 18 F labelled compounds, labelled peptides for accurate mapping of metastasis and the advances in radionuclide therapy. The International Symposium on Trends in Radiopharmaceuticals, ISTR-2005, under the auspices of International Atomic Energy Agency, will provide scientists and professionals working in the field of radiopharmaceuticals and related sciences an opportunity to review the exciting developments in the field. The International Atomic Energy Agency has been organizing such Symposia on Radiopharmaceuticals since 1973 and the last one was held in Lisbon, Portugal, in 1998

  10. International symposium on trends in radiopharmaceuticals (ISTR-2005). Book of extended synopses

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2005-07-01

    Radiopharmaceuticals, along with imaging instrumentation, are the pillars that support the edifice of clinical nuclear medicine and the former is the major driver enabling investigations of molecular phenomena for better understanding of human disease and developing effective treatments. The growth of nuclear medicine has been intimately linked to availability of new radioisotopes and the discovery of new radiopharmaceuticals. The field of radiopharmaceuticals has witnessed continuous evolution thanks to the immense contributions of scientists from diverse disciplines such as radiochemistry, inorganic chemistry, organic chemistry, biochemistry, physiology and pharmacology. Several milestones can be cited in the trajectory of this growth, which include continuing development of a plethora of {sup 99}mTc radiopharmaceuticals, automated synthesis of {sup 18}F labelled compounds, labelled peptides for accurate mapping of metastasis and the advances in radionuclide therapy. The International Symposium on Trends in Radiopharmaceuticals, ISTR-2005, under the auspices of International Atomic Energy Agency, will provide scientists and professionals working in the field of radiopharmaceuticals and related sciences an opportunity to review the exciting developments in the field. The International Atomic Energy Agency has been organizing such Symposia on Radiopharmaceuticals since 1973 and the last one was held in Lisbon, Portugal, in 1998.

  11. Breast feeding's interruption following radiopharmaceutical administration to nursing mothers

    International Nuclear Information System (INIS)

    Rojo, A.M.; Gomez Parada, I.M.; Dubner, D.; Gisone, P.; Perez de Serrano, M.

    1995-01-01

    The radiopharmaceutical administration to lactating women for therapeutic or diagnostic purpose can achieve a radiological risk to the breast feeding child due to levels of radioactivity in the breast milk. International recommendations regarding safe assumption of nursing mother after radiopharmaceutical administration were analysed. We examined the formula proposed by Rommey et al. to establish objective guidelines in case of the administration of radiopharmaceutical to nursing mothers. The ICRP 54 metabolic model for iodine was modified in order to calculate the suppression breast feeding's period according to the radioactivity measured in the breast milk. (author). 6 refs., 1 fig., 1 tab

  12. Sixth international radiopharmaceutical dosimetry symposium: Proceedings. Volume 2

    Energy Technology Data Exchange (ETDEWEB)

    S.-Stelson, A.T. [ed.] [comp.; Stabin, M.G.; Sparks, R.B. [eds.; Smith, F.B. [comp.

    1999-01-01

    This conference was held May 7--10 in Gatlinburg, Tennessee. The purpose of this conference was to provide a multidisciplinary forum for exchange of state-of-the-art information on radiopharmaceutical dosimetry. Attention is focused on the following: quantitative analysis and treatment planning; cellular and small-scale dosimetry; dosimetric models; radiopharmaceutical kinetics and dosimetry; and animal models, extrapolation, and uncertainty.

  13. Use of radiopharmaceuticals for treating bone metastases

    International Nuclear Information System (INIS)

    Alberti Ramírez, Alejandro; Morín Zorrilla, José; Cruz Arencibia, Jorge

    2016-01-01

    Cancer prevalence is estimated at around 2% of the population and on average between 64-80% of patients with solid tumors develop bone metastases, being breast tumors, lung and prostate those who do more frequency. In this paper an estimate of the prevalence of bone pain from metastases, with reference to the data reported in the literature is presented. the different treatment techniques are summarized for pain management with special emphasis on Radionuclidic therapy, analyzing the different factors to consider for the selection of suitable radiopharmaceutical. cost data and cost-benefit of some radiopharmaceuticals for the purpose to take into account during their selection are provided. It is concluded that although the treatment of metastatic bone disease requires multidisciplinary therapies, Radionuclidic therapy is not sufficiently used, particularly by inadequate perception of risks and costs of radiopharmaceuticals, despite the undeniable support of its efficacy and tolerability. (author)

  14. Quality assurance of radiopharmaceuticals - specifications and test procedures

    International Nuclear Information System (INIS)

    Baldas, J.; Bonnyman, J.; Colmanet, S.F.; Ivanov, Z.; Lauder, R.A.

    1990-10-01

    The authors report on a Radiopharmaceutical Quality Assurance Test Programme carried out by the Australian Radiation Laboratory in which radiopharmaceuticals used in nuclear medicine in Australia are tested for compliance with specifications. Where the radiopharmaceutical is the subject of a monograph in the British Pharmacopoeia or the European Pharmacopoeia, then the specifications given in the Pharmacopoeia are adopted. In other cases the specifications given have been adopted by this Laboratory and have no legal status. In some cases test procedures described have been taken from various Pharmacopoeias or methods published in the literature. In other cases test methods described have been developed at this Laboratory. It should be noted that, unless stated otherwise, specifications listed apply at all times up until product expire

  15. Experimental nuclear medicine radiopharmaceutical development

    International Nuclear Information System (INIS)

    Harper, P.; Lathrop, K.

    1980-01-01

    This report summarizes progress that has been made on the preparation and biological accumulation of various radiopharmaceuticals including C-hexamethonium, C-cholic acid, Mn-51 and labeled amino acids

  16. Quality assessment of radiopharmaceuticals in nuclear medicine services at Northeast states, Brazil

    International Nuclear Information System (INIS)

    Andrade, Wellington Gomes de

    2012-01-01

    The radiopharmaceuticals are used in the field nuclear medicine services (NMS) as tracer in the diagnoses and treatment of many diseases. Radiopharmaceuticals used in nuclear medicine and usually have a minimum of pharmacological effect. The procedures for labelling Radiopharmaceuticals should be observed in order to minimize risks to patients, employees and individuals from the public, and to be administered in humans, must be sterile and free of pyrogens and possess elements all measures of quality controls required a conventional drug. The 'Agencia Nacional de Vigilancia Sanitaria (ANVISA)' in its 'Resolucao de Diretoria Colegiada' (RDC) No. 38 of June 4 th 2008, decided that the NMS must perform quality control in the generators eluate and radiopharmaceuticals according to recommendations of manufacturers and scientific evidence accepted by ANVISA. Thus, this study proposes to evaluate the quality of the generator 99M o- 99m Tc eluate and radiopharmaceuticals labeled with 99m Tc used in most NMS of some states in the Northeast, in relation to radionuclide, chemical, radiochemical purity and pH and promote the inclusion of procedure for quality control of radiopharmaceuticals in routine NMS. The results show that 90% radionuclidic purity, 98.2% purity chemical and radiochemical purity of 46% and 100% of the eluates are in agreement with international pharmacopoeias; already radiopharmaceuticals showed 82.6% purity and all radiochemical pH values are also in accordance with international pharmacopoeias. Even with so many positive results, staff the majority of MNS was not able to perform the quality control of the eluates and radiopharmaceuticals. Showing the importance of implementing of quality control programs of the eluates and radiopharmaceuticals in nuclear medicine. (author)

  17. Radiation decomposition of technetium-99m radiopharmaceuticals

    International Nuclear Information System (INIS)

    Billinghurst, M.W.; Rempel, S.; Westendorf, B.A.

    1979-01-01

    Technetium-99m radiopharmaceuticals are shown to be subject to autoradiation-induced decomposition, which results in increasing abundance of pertechnetate in the preparation. This autodecomposition is catalyzed by the presence of oxygen, although the removal of oxygen does not prevent its occurrence. The initial appearance of pertechnetate in the radiopharmaceutical is shown to be a function of the amount of radioactivity, the quantity of stannous ion used, and the ratio of /sup 99m/Tc to total technetium in the preparation

  18. Present status and prospect of copper radiopharmaceuticals

    International Nuclear Information System (INIS)

    Chen Huawei; Li Hongfeng; Liu Boli

    1996-01-01

    In the past decade most of the efforts of copper radiopharmaceuticals research has been focused on bis(thiosemicarbazonato) copper complexes for use in myocardial and brain imaging agents. In the present work, the analogs of bis(thiosemicarbazone) is studied in labeling antibodies and tumors. The retention mechanism of Cu-PTSM is investigated. Other kinds of ligands, BAT (N 2 S 2 ) for example, can be used to prepare neutral copper complexes in order to obtain brain radiopharmaceuticals in future. (60 refs.)

  19. Influence of Storage Temperature on Radiochemical Purity of 99mTc-Radiopharmaceuticals.

    Science.gov (United States)

    Uccelli, Licia; Boschi, Alessandra; Martini, Petra; Cittanti, Corrado; Bertelli, Stefania; Bortolotti, Doretta; Govoni, Elena; Lodi, Luca; Romani, Simona; Zaccaria, Samanta; Zappaterra, Elisa; Farina, Donatella; Rizzo, Carlotta; Giganti, Melchiore; Bartolomei, Mirco

    2018-03-15

    The influence of effective room temperature on the radiochemical purity of 99m Tc-radiopharmaceuticals was reported. This study was born from the observation that in the isolators used for the preparation of the 99m Tc-radiopharmaceuticals the temperatures can be higher than those reported in the commercial illustrative leaflets of the kits. This is due, in particular, to the small size of the work area, the presence of instruments for heating, the continuous activation of air filtration, in addition to the fact that the environment of the isolator used for the 99m Tc-radiopharmaceuticals preparation and storage is completely isolated and not conditioned. A total of 244 99m Tc-radiopharmaceutical preparations (seven different types) have been tested and the radiochemical purity was checked at the end of preparation and until the expiry time. Moreover, we found that the mean temperature into the isolator was significantly higher than 25 °C, the temperature, in general, required for the preparation and storage of 99m Tc-radiopharmaceuticals. Results confirmed the radiochemical stability of radiopharmaceutical products. However, as required in the field of quality assurance, the impact that different conditions than those required by the manufacturer on the radiopharmaceuticals quality have to be verified before human administration.

  20. Radiopharmaceuticals for cerebral studies; Radiofarmacos para Estudios Cerebrales

    Energy Technology Data Exchange (ETDEWEB)

    Leon Cabana, Alba [Universidad de la Republica, Facultad de Quimica (Uruguay)

    1994-12-31

    For obtain good brain scintillation images in nuclear medicine must be used several radiopharmaceuticals. Cerebral studies give a tumors visual image as well as brain anomalities detection and are helpful in the diagnostic diseases . Are described in this work: a cerebrum radiopharmaceuticals classification,labelled compounds proceeding and Tc 99m good properties in for your fast caption, post administration and blood purification for renal way.

  1. Guidelines on current good radiopharmacy practice (cGRPP) in the preparation of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Dumas, Cecile

    2010-07-01

    Preparation of radiopharmaceuticals for injection involves adherence to regulations on radiation protection as well as to appropriate rules of working under aseptic conditions, which are covered by these guidelines on Good Radiopharmacy Practice (GRPP). The handling of radiopharmaceuticals is potentially hazardous. The level of risk depends in particular upon the types of radiation emitted and the half-lives of the radioactive isotopes. Particular attention must be paid to the prevention of cross-contamination, and to waste disposal. A continuous assessment of the effectiveness of the Quality Assurance system is essential to prove that the procedures applied in the Radiopharmacy Department lead to the expected quality. Clinical trials with new radiopharmaceuticals should follow these regulations on cGRPP as well as the Guideline on Good Clinical Practice. As there is a considerable difference in complexity in preparing 'classical' radiopharmaceuticals in 'kit' procedures and producing radiopharmaceuticals by distinct chemical procedures (Positron Emission Tomography (PET) Radiopharmaceuticals, in house prepared radiopharmaceuticals including in house prepared kits) these guidelines have been divided in two parts (A and B) respecting these differences

  2. Radiopharmaceutical potential of I-131 labelled diazepam

    International Nuclear Information System (INIS)

    Yurt, F.; Unek, P.; Asikoglu, M.; Baggi, S.; Erener, G.; Ozkilic, H.; Uluc, F.; Tuglular, I.

    1998-01-01

    In this study, diazepam is a derivative of the 1.4 benzodiazepine family that the most widely used drug as anticonvulsant agent has been labeled with I-131, as a new radiopharmaceutical and its radiopharmaceutical potential has been determined. Labeling of diazepam has been performed by iodogen method and optimum labeling conditions have been determined. Optimum reaction conditions are 1 mg for iodogen amount; 1-5 mg for diazepam amount, 15-20 minutes for reaction time and room temperature for reaction temperature. Specific activity of labeled compound was 0,15 Ci/mmol level. N-octanol/water ratio was found 1.9 for 131 IDZ ( 131 I labeled diazepam). In vivo experiments have been carried out to determine radiopharmaceutical potentials of labeled compound. Biodistribution studies on rats showed that 131 IDZ have accumulated in kidneys, liver, lungs and brain tissues. Scintigraphic results taken with gamma camera on rabbits agree with biodistribution results of rats. (author)

  3. Molecular target in oncology. Opportunity for radiopharmaceuticals development

    International Nuclear Information System (INIS)

    Navarro Marques, Fabio Luiz

    2016-01-01

    Cancer is a cellular multifactorial disease, regulated by changes in phenotype characteristics, such as adhesion, invasion, migration, and tumorigenesis; genotypic status of commonly altered genes (KRAS and p53); microenvironmental conditions, such pH, oxygen and nutrient supply. All these features provide opportunities for radiopharmaceuticals development, both for diagnostic and therapy. For both applications, radiopharmaceuticals molecules can be divided in small synthetic molecules, small peptides (natural or modified), large molecules such as antibody or nanoparticles. The characteristics of those molecules and use will guide the choice of the radionuclide to be used for labeling it. In the presentation, data from literature and research ongoing in the Faculty of Medicine of the University of São Paulo/Brazil will be used for demonstrate the potential for radiopharmaceuticals development. (author)

  4. Radiopharmaceuticals drug interactions: a critical review

    Directory of Open Access Journals (Sweden)

    Ralph Santos-Oliveira

    2008-12-01

    Full Text Available Radiopharmaceuticals play a critical role in modern medicine primarily for diagnostic purposes, but also for monitoring disease progression and response to treatment. As the use of image has been increased, so has the use of prescription medications. These trends increase the risk of interactions between medications and radiopharmaceuticals. These interactions which have an impact on image by competing with the radiopharmaceutical for binding sites for example can lead to false negative results. Drugs that accelerate the metabolism of the radiopharmaceutical can have a positive impact (i.e. speeding its clearance or, if repeating image is needed, a negative impact. In some cases, for example in cardiac image among patients taking doxirubacin, these interactions may have a therapeutic benefit. The incidence of drug-radiopharmaceuticals adverse reactions is unknown, since they may not be reported or even recognized. Here,we compiled the medical literature, using the criteria of a systematic review established by the Cochrane Collaboration, on pharmaceutical-drug interactions to provide a summary of documented interactions by organ system and radiopharmaceuticals. The purpose is to provide a reference on drug interactions that could inform the nuclear medicine staff in their daily routine. Efforts to increase adverse event reporting, and ideally consolidate reports worldwide, can provide a critically needed resource for prevention of drug-radiopharmaceuticals interactions.Os radiofármacos desempenham função crítica na medicina moderna, primariamente para fins diagnósticos, mas também no monitoramento da progressão de doenças assim como na avaliação de respostas ao tratamento. O uso da tecnologia por imagem tem crescido e conseqüentemente as prescrições de medicamentos (radiofármacos em especial com esse propósito. Este fato, aumenta o risco de interações entre medicamentos e radiofármacos. Interações que podem ter um impacto na

  5. Introduction to the use of FRAM on the effectiveness assessment of a radiopharmaceutical dispatches process

    Energy Technology Data Exchange (ETDEWEB)

    Pereira, Ana G.A.A., E-mail: agaap@ien.gov.br [Instituto de Engenharia Nuclear (IEN/CNEN-RJ), Rio de Janeiro, RJ (Brazil)

    2013-07-01

    This article aims to make an introduction to the use of Functional Resonance Analysis Method (FRAM) on the effectiveness assessment of a specific radiopharmaceutical dispatching process. The main purpose was to provide a didactic view of the method application to further in-depth analysis. The investigation also provided a relevant body of knowledge of radiopharmaceuticals dispatches processes. This work uses the term 'effectiveness assessment' instead of 'risk assessment' due to the broader meaning the former provide. The radiopharmaceutical dispatching process is the final task of a dynamic system designed to attend several medical facilities. It is comprised by functions involving mostly human activities, such as checking and packaging the product and measuring the radiopharmaceutical nuclear activity. Although the dispatch process has well-known steps for its completion, the human factor is the fundamental mechanism of work and control, being susceptible of irregular and instable performance. As a socio-technical system, the risk assessment provided by FRAM may be of importance for safety and quality improvements, even more if considered the nuclear nature of the product, which makes risk assessment critical and mandatory. A system is safe if it is resistant and resilient to perturbations. Identification and assessment of possible risks is, therefore, an essential prerequisite for system safety. Although this seems obvious, most risk assessments are conducted under relative ignorance of the full behavior of the system. Such condition has lead to an approach to assess the risks of intractable systems (i.e., systems that are incompletely described or under specified), namely Resilience Engineering. Into this area, the Functional Resonance Analysis Method has been developed in order to provide concepts, terminology and a set of methods capable of dealing with such systems. The study was conducted following the Functional Resonance Analysis

  6. Introduction to the use of FRAM on the effectiveness assessment of a radiopharmaceutical dispatches process

    International Nuclear Information System (INIS)

    Pereira, Ana G.A.A.

    2013-01-01

    This article aims to make an introduction to the use of Functional Resonance Analysis Method (FRAM) on the effectiveness assessment of a specific radiopharmaceutical dispatching process. The main purpose was to provide a didactic view of the method application to further in-depth analysis. The investigation also provided a relevant body of knowledge of radiopharmaceuticals dispatches processes. This work uses the term 'effectiveness assessment' instead of 'risk assessment' due to the broader meaning the former provide. The radiopharmaceutical dispatching process is the final task of a dynamic system designed to attend several medical facilities. It is comprised by functions involving mostly human activities, such as checking and packaging the product and measuring the radiopharmaceutical nuclear activity. Although the dispatch process has well-known steps for its completion, the human factor is the fundamental mechanism of work and control, being susceptible of irregular and instable performance. As a socio-technical system, the risk assessment provided by FRAM may be of importance for safety and quality improvements, even more if considered the nuclear nature of the product, which makes risk assessment critical and mandatory. A system is safe if it is resistant and resilient to perturbations. Identification and assessment of possible risks is, therefore, an essential prerequisite for system safety. Although this seems obvious, most risk assessments are conducted under relative ignorance of the full behavior of the system. Such condition has lead to an approach to assess the risks of intractable systems (i.e., systems that are incompletely described or under specified), namely Resilience Engineering. Into this area, the Functional Resonance Analysis Method has been developed in order to provide concepts, terminology and a set of methods capable of dealing with such systems. The study was conducted following the Functional Resonance Analysis Method. At first, the

  7. Radiation dose estimates for radiopharmaceuticals

    International Nuclear Information System (INIS)

    Stabin, M.G.; Stubbs, J.B.; Toohey, R.E.

    1996-04-01

    Tables of radiation dose estimates based on the Cristy-Eckerman adult male phantom are provided for a number of radiopharmaceuticals commonly used in nuclear medicine. Radiation dose estimates are listed for all major source organs, and several other organs of interest. The dose estimates were calculated using the MIRD Technique as implemented in the MIRDOSE3 computer code, developed by the Oak Ridge Institute for Science and Education, Radiation Internal Dose Information Center. In this code, residence times for source organs are used with decay data from the MIRD Radionuclide Data and Decay Schemes to produce estimates of radiation dose to organs of standardized phantoms representing individuals of different ages. The adult male phantom of the Cristy-Eckerman phantom series is different from the MIRD 5, or Reference Man phantom in several aspects, the most important of which is the difference in the masses and absorbed fractions for the active (red) marrow. The absorbed fractions for flow energy photons striking the marrow are also different. Other minor differences exist, but are not likely to significantly affect dose estimates calculated with the two phantoms. Assumptions which support each of the dose estimates appears at the bottom of the table of estimates for a given radiopharmaceutical. In most cases, the model kinetics or organ residence times are explicitly given. The results presented here can easily be extended to include other radiopharmaceuticals or phantoms

  8. Factors and pharmaceuticals that affect the radiopharmaceuticals bio distributions

    International Nuclear Information System (INIS)

    Gonzalez, B.M.

    1994-01-01

    The pattern of biodistribution of radiopharmaceuticals may be affected by various agents and therapeutical procedures, chemotherapy agents, thyroid hormones, metals, radiotherapy, surgery, anesthetic agents, dialysis other radiopharmaceutical interactions. Recommendations for the detection of altered biodistribution in patients by causes not directly related with the pathology itself was given. pathology itself was given

  9. Annual report 1993 by the Rossendorf Society of Nuclear Engineering and Analysis

    International Nuclear Information System (INIS)

    Haefele, W.

    1994-03-01

    The second annual report contains, apart from the business report and the organigram, priorities and results achieved in the special fields of nuclear installations (decommissioning and disposal), nuclear waste management (radioactive wastes), nuclear analyses and rehabilitation, radiopharmaceuticals, and safety and radiation protection. (HP) [de

  10. Regulatory requirements for radiopharmaceutical radiochemistry and radiation dosimetry

    International Nuclear Information System (INIS)

    Bonnyman, J.

    1985-01-01

    The Australian Department of Health is responsible for ensuring that radiopharmaceuticals are safe and effective and that their use does not result in unnecessary radiation exposure. Section B1 requirements of New Drug Form 4 (NDF4) fall into the following sections - manufacture, product specifications, quality assurance testing, stability studies and expiry dating. It covers ready to inject pharmaceuticals, radioactive formulations used to prepare a radiopharmaceutical, generators and cold kits

  11. Guidance for nuclear medicine staff on radiopharmaceuticals drug interaction

    International Nuclear Information System (INIS)

    Santos-Oliveira, Ralph

    2009-01-01

    Numerous drug interactions related to radiopharmaceuticals take place every day in hospitals many of which are not reported or detected. Information concerning this kind of reaction is not abundant, and nuclear medicine staff are usually overwhelmed by this information. To better understand this type of reaction, and to help nuclear medicine staff deal with it, a review of the literature was conducted. The results show that almost all of radiopharmaceuticals marketed around the world present drug interactions with a large variety of compounds. This suggests that a logical framework to make decisions based on reviews incorporating adverse reactions must be created. The review also showed that researchers undertaking a review of literature, or even a systematic review that incorporates drug interactions, must understand the rationale for the suggested methods and be able to implement them in their review. Additionally, a global effort should be made to report as many cases of drug interaction with radiopharmaceuticals as possible. With this, a complete picture of drug interactions with radiopharmaceuticals can be drawn. (author)

  12. Radiopharmaceuticals for renal studies

    International Nuclear Information System (INIS)

    Verdera, Silvia

    1994-01-01

    Between the diagnostic techniques using radiopharmaceuticals in nuclear medicine it find renal studies.A brief description about renal glomerular filtration(GFR) and reliability renal plasma flux (ERPF),renal blood flux measurement agents (RBF),renal scintillation agents and radiation dose estimates by organ physiology was given in this study.tabs

  13. Good radiopharmaceuticals practices

    International Nuclear Information System (INIS)

    Verdera E, Silvia

    1994-01-01

    A careful security must be used in the nuclear medicine laboratory concerning to the proceedings, preparation and dispensation of radiopharmaceuticals. Each control laboratory must look after the radiation protection patients,workers and people in general. Between another routinary activities in the present work it find : equipment prearrangement,installations,handling and support of electronic instruments,proceedings,methodology, results and interpretation of analysis , as well as registry maintenance

  14. Radiopharmaceutical therapy in Dominican Republic. Present and future

    International Nuclear Information System (INIS)

    Johny Osvaldo de los Santos

    2005-01-01

    Full text: In this paper we present experience in Dominican Republic on Radiopharmaceutical Therapy. In our country, there are 8 Center with Nuclear Medicine Department. Only, 7 centers are working with Radiopharmaceutical Therapy. Radioiodine treatment with I-131 in Thyroid diseases(Thyroid Cancer and Hyperthyroidism). This is only Nuclear Medicine therapy available in Dominican Republic. The objectives of this paper are to analyze and assess the difficulties and facilities for the development of Radiopharmaceutical Therapy in Dominican Republic. We made surveys with the help of Nuclear Medicine Physicians of different Nuclear Medicine departments. 8 Nuclear Physicians accepted the interview. Two of these Nuclear Medicine Centers are Department of a Cancer Center and they have many patients for therapies. In the majority opinion of Physicians, Cost of Radiopharmaceuticals is principal problem to use Therapy in Dominican Republic. In addition the following problems were identified: Lack of awareness about new therapy in Nuclear Medicine among Physicians of other specialties, lack of adequate training in the current trends of radionuclide therapy and finally lack of basic infrastructure, equipment and finances to buy radiopharmaceuticals and introduce radionuclide therapy. For this reason, Nuclear Medicine Centers prefer to work with only I-131 Therapy and they do not have new programs to start other therapies. In the near future, our department of Nuclear Medicine will work with I-131, pain palliation, treatment of metastatic disease and Treatment of benign diseases. We have interest in offering other therapies in the department and we hope that other departments with more resources, have the same interest, to enhance practice of radionuclide therapy in our country. (author)

  15. Development of radiopharmaceutical for radiosinovectomy

    International Nuclear Information System (INIS)

    Couto, Renata Martinussi

    2009-01-01

    Radiopharmaceuticals prepared with different radionuclides have been used in diagnostic and therapeutic procedures in Nuclear Medicine. The interest in radionuclidic therapy has been increased in last years, with the introduction of new radiopharmaceuticals applied in the destruction of specific cells or to prevent its undesired proliferation. Radiosinovectomy (RSV) is a therapeutic modality that uses radiopharmaceuticals administered in the intra-articular cavity and represents an alternative to the treatment of different arthropaties and, in particular, the arthropaties derived from rheumatoid arthritis and haemophilic. The objective of the present work was to study the labeling of compounds with 90 Y and 177 Lu in order to improve the production conditions and quality control procedures, study the stability of the labeled compounds and preliminary biodistribution studies of the radiopharmaceuticals with potential for RSV applications. The study of the production of 90 Y citrate colloid ( 90 Y-Cit) was based in a labeling procedure using 90 Y Cl 3 solution (37 - 54 MBq) that was previously dried, followed by the addition of yttrium nitrate and sodium citrate in p H 7 at 37 deg C for 30 minutes. The production of hydroxyapatite (HA) labeled with 90 Y was based in a labeling procedure using mono hydrated citric acid, yttrium nitrate and 90 Y Cl 3 solution (37 - 370 MBq). The reaction mixture was incubated for 30 minutes at room temperature and the HA was introduced in aqueous medium and the reaction proceed for 30 minutes under strong stirring. 177 Lu-HA was produced using 177 Lu Cl 3 solution (296 MBq), in presence of lutetium oxide in NaCl medium, p H 7, under continuous stirring for 30 minutes at room temperature. Several reaction parameters were studied for the three radiopharmaceuticals. Labeling yield was determined after particles were centrifuged and washed with NaCl 0,9%. Radiochemical purity was determined by ascending chromatography using different

  16. Short-lived radiopharmaceutical development at E.R. Squibb and Sons, Inc

    International Nuclear Information System (INIS)

    Loberg, M.D.

    1985-01-01

    This paper describes the present status and future plans of E.R. Squibb and Sons, Inc. as they relate to the development of short-lived radiopharmaceuticals. The advantages of short-lived radiopharmaceuticals are summarized as are the problems inherent in their manufacture, quality control, and distribution. The nuclear generator is advocated as the best means of distributing short-lived radiopharmaceuticals. The E.R. Squibb and Sons work with the 82 Sr → 82 Rb generator is summarized

  17. Radiopharmaceuticals for oncology: status and newer trends- an overview

    International Nuclear Information System (INIS)

    Ramamoorthy, N.; Prabhakar, G.

    1997-01-01

    Radiopharmaceuticals have provided a powerful means in the diagnosis and follow up of cancer patients. Radiopharmaceuticals for the treatment of metastatic thyroid cancer and palliation of metastatic bone pain are in extensive use. Newer agents are on the anvil for more efficacious diagnosis and therapy. This article gives an overview of the status and trends in this context. (author)

  18. Production, control and utilization of radioisotopes including radiopharmaceuticals

    International Nuclear Information System (INIS)

    Muenze, R.

    1985-05-01

    From April 29th to May 5th, 1984 27 participants from 21 developing countries stayed within an IAEA Study Tour ('Production, Control and Utilization of Radioisotopes including Radiopharmaceuticals') in the GDR. In the CINR, Rossendorf the reactor, the cyclotron, the technological centre as well as the animal test laboratory were visited. The participants were made familiar by 10 papers with the development, production and control of radiopharmaceuticals in the CINR, Rossendorf. (author)

  19. Traceability in the pharmaceutical industry: application to radiopharmaceutical production

    International Nuclear Information System (INIS)

    Zanette, Camila; Melero, Laura T.U.H.; Araujo, Elaine B. de; Mengatti, Jair; Silva, Katia S. de S.

    2011-01-01

    The development of tools to promote the traceability of the drugs in the pharmaceutical industry during all the production chain is a necessary requisite. The traceability system is applied to enable the identification of the origin, destination and exact location of the drug. Traceability optimizes the process chain, reduces errors, is a requirement for quality process, promotes safety for the user and assists in pharmacovigilance. The health regulatory agency in Brazil (ANVISA) will implement a tracking system for medicaments with RDC no. 59 of 2009, to control distribution since the producer until the patients in order to prevent the traffic and adulteration of drugs. Thus, this study discusses the importance and impact of the new traceability system proposed by ANVISA in the production and distribution of radiopharmaceuticals from the Nuclear and Energy Research Institute (IPEN-CNEN). The radiopharmaceuticals have a difference track when compared with another drug classes. In this context, this RDC would increase the price of the medicines by up to 10%, since it provides deployment of a single stamp supplied by the Mint. Considering that radiopharmaceuticals are not sold to the final consumer (patients), but only for accredited medical clinics and nuclear medicine physicians, and the transport of radiopharmaceuticals is performed by specialized companies licensed by CNEN (National Nuclear Energy Commission), the use of the stamp to ensure authenticity and prevent falsification should not be appropriated and represents and additional cost for the radiopharmaceuticals. (author)

  20. Stannous ion quantitation in sup(99m)Tc-radiopharmaceutical kits

    International Nuclear Information System (INIS)

    Chervu, L.R.; Vallabhajosyula, B.; Mani, J.; Chun, S.B.; Blaufox, M.D.

    1982-01-01

    A simple and inexpensive method for the estimation of stannous ion, Sn(II), in radiopharmaceutical kits is described. The method used is a potentiometric titration of Sn(II) in 1 N HCl medium, using potassium iodate as the oxidizing agent in an atmosphere of nitrogen. The apparatus includes a pH meter, a platinum electrode, and a simple titration cell. Several commonly used radiopharmaceutical kits were analyzed for their Sn(II) content using this method. These studies indicate that the procedure can be used, as a routine quantitative test for the Sn(II) content of various sup(99m)Tc-labeled radiopharmaceuticals. (orig.)

  1. Process for preparing radiopharmaceuticals

    International Nuclear Information System (INIS)

    Barak, M.; Winchell, H.S.

    1977-01-01

    A process for the preparation of technetium-99m labeled pharmaceuticals is disclosed. The process comprises initially isolating technetium-99m pertechnetate by adsorption upon an adsorbent packing in a chromatographic column. The technetium-99m is then eluted from the packing with a biological compound to form a radiopharmaceutical

  2. Technical Direction and Laboratories Fiscal Year 1999 Annual Report

    International Nuclear Information System (INIS)

    CRAWFORD, B.A.

    2000-01-01

    This annual report summarize achievements and list reports issued by members of TDandL, NHC group during Fiscal Year (FY) 1999, (October 1, 1998 through September 30, 1999). This report, issued by this organization, describes work in support of the Hanford Site and other U S . Department of Energy, Richland Operations Office (DOE-RL) programs. It includes information on the organization make-up, interfaces, and mission of the group. The TDandL is a group of highly qualified personnel with diverse disciplines (primarily chemistry specialties) that provide process, analytical, and in-situ chemistry services to engineering customers. This year of operation and interfaces with other contract organizations consumed considerable administrative efforts. Attention was directed to the technical challenges presented by the changing roles, responsibilities, and priorities of Hanford programs

  3. The ARPANSA quality assurance program for radiopharmaceuticals

    International Nuclear Information System (INIS)

    Baldas, J.; Ivanov, Z.

    2003-01-01

    Full text: The Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) conducts a radiopharmaceutical quality assurance test program in which radiopharmaceuticals used in nuclear medicine in Australia are tested for compliance with specifications. Where the radiopharmaceutical is the subject of a monograph in the British Pharmacopoeia or the European Pharmacopoeia, then the specifications given in these Pharmacopoeias are adopted. Where a monograph is only available in the US Pharmacopoeia, then this specification is generally adopted. In other cases the specifications quoted have been adopted by this Agency. Animal biodistribution testing was discontinued in 1997 due to resource limitation. Samples for testing were obtained through commercial channels. All technetium-99m cold kits were reconstituted according to the directions in the package insert using Sodium Pertechnetate [ 99m Tc] injection. The results of testing conducted by the ARPANSA during 1984-1999 are summarised. A significant cause of failure to meet full specifications has been due to non-compliance of the vial/package labels. Copyright (2003) The Australian and New Zealand Society of Nuclear Medicine Inc

  4. Western Research Institute: Annual technical progress report, October 1987--September 1988

    Energy Technology Data Exchange (ETDEWEB)

    1988-12-01

    This report describes the technical progress made by the Western Research Institute of the University of Wyoming Research Institute of the University of Wyoming Research Corporation on work performed for the period October 1, 1987 through September 30, 1988. This research involves five resource areas: oil shale, tar sand, underground coal gasification, advanced process technology, and advanced fuels research. Under the terms of the cooperative agreement, an annual project plan has been approved by DOE. The work reported herein reflects the implementation of the research in the plan and follows the structure used therein. 49 refs., 32 figs., 87 tabs.

  5. Radionuclide production and radiopharmaceutical chemistry with BNL cyclotrons

    International Nuclear Information System (INIS)

    Lambrecht, R.M.; Wolf, A.P.

    1985-01-01

    The Brookhaven National Laboratory (BNL) radiopharmaceutical chemistry program focuses on production and utilization of radionuclides having a half-life of > 2 hr. However, a major portion of the BNL program is devoted to short-lived radionuclides, such as 11 C and 18 F. Activities encompassed in the program are classified into seven areas: cyclotron parameters, radiochemistry, design and rapid synthesis of radiopharmaceuticals and labeled compounds, radiotracer evaluation in animals, studies in humans, technology transfer, and several other areas

  6. Intelligent portal monitor for fast suppression of false positives due to radiopharmaceuticals

    International Nuclear Information System (INIS)

    Johnson, M.W.; Butterfield, K.B.

    1985-01-01

    Monitoring the movement of radioactive material through secure or sensitive areas may be complicated by the existence of unanticipated sources of radiation carried by individuals passing through the area. Typical of such sources are radiopharmaceuticals prescribed for a medical procedure. We report here on an apparatus designed to quickly discriminate between in-vivo radiopharmaceuticals and other nuclear materials, based on a pattern-recognition algorithm and a microcomputer. Principles of operation are discussed, and the data base for the pattern-recognition algorithm is displayed. Operating experience with the apparatus in a trial location is also discussed. Our apparatus correctly identifies in-vivo radiopharmaceuticals in over 80% of all trials; challenges with radioisotopes other than radiopharmaceuticals have led the apparatus, without exception, to reject the challenge isotope as incompatible with medical practice. The apparatus thus rapidly discriminates between individuals bearing radiopharmaceuticals and those bearing illicit sources, such as special nuclear materials. Examples of applications are presented. 7 refs., 4 figs., 1 tab

  7. 11. annual report of the technical advisory committee on the nuclear fuel waste management program

    International Nuclear Information System (INIS)

    1990-10-01

    The Eleventh Annual Report of the Technical Advisory Committee (TAC) assesses the scientific and technical progress made within the Canadian Nuclear Fuel Waste Management Program (NFWMP) during the period July 1989 to June 1990. The Committee notes that the general concept of a multibarrier system involving geologic media and engineered systems is based on known technologies and current scientific knowledge, and has gained strong international scientific and engineering support as currently the most feasible and practical. TAC continues to endorse the full investigation of the concept of nuclear waste disposal deep in plutonic formations, such as those in the Canadian Shield

  8. Towards a harmonized radiopharmaceutical regulatory framework in Europe

    International Nuclear Information System (INIS)

    Decristoforo, A.; Penuelas, I.

    2009-01-01

    Despite European unification regarding a common legal framework for many aspects of pharmaceutical production including industrial manufacture of pharmaceuticals, the practice of pharmacy in general, and of radiopharmacy in particular, differs substantially and are mainly regulated at the national level. Herein the authors discuss major European documents relevant for radiopharmacy practice in Europe and recent developments on the national level especially regarding the small-scale preparation of radiopharmaceuticals (R P). Issues related to marketing authorization (and exemptions from it), standards of preparation, quality requirements, regulations of clinical trials and education will be outlined. Standards for the industrial preparation of pharmaceuticals are defined in Good Manufacturing Practice (GMP), not taking into account specific requirements for the small scale, extemporaneous preparation of R P. The European Association of Nuclear Medicine EANM has published several documents based on GMP and called Good Radiopharmaceutical Practice (cGRPP) to specifically address this in an attempt to harmonize R P preparation across Europe. Clinical trials have been hampered by the introduction of directive 2001/20/E C again aimed at the marketing track of industrial production and currently a number of activities are ongoing to counterbalance this problem in radiopharmaceutical research. Additionally, the role of the European Pharmacopoeia in regulating quality requirements and the need for specific education and training in the small scale radiopharmaceutical preparation are also discussed.

  9. Radiation hygiene problems of radiopharmaceutical preparation at nuclear medicine units

    International Nuclear Information System (INIS)

    Pekarek, J.; Kukacka, R.

    1977-01-01

    The problems of magistral radiopharmaceuticals preparation are indicated and the layout of a unit for the magistral preparation of radiopharmaceuticals is described. The results are briefly reported of a study of radiation load of laboratory personnel preparing radiopharmaceuticals as against doctors actually applying them. It was found that the exposure of hands to ionizing radiation represents the highest hazard for the laboratory personnel. The most important radiation protection principles are pointed out, such as the use of protective clothing, regular preventive medical examinations, appropriately shielded radionuclides and radionuclide generators to be supplied by manufacturers, and a more frequent rotation of personnel working with active and nonactive preparations. (L.O.)

  10. The radiopharmaceuticals labelled with technetium-99m and the radiopharmacy

    International Nuclear Information System (INIS)

    Bodenant, V.

    1998-01-01

    In less than fifty years, the place of nuclear medicine is become primordial. Among all the radiopharmaceuticals used in nuclear medicine, the technetium-99m is the most used because of its physico-chemical properties and its great availability with the molybdenum-99m - technetium-99m generator. Since 1992, the radiopharmaceuticals, the packages, the generators are included in the pharmaceutic monopole. They are now under the reliability of the radio-pharmacist. This thesis has for object to introduce these different radiopharmaceuticals labelled with technetium-99m and to show the primordial place of the radio-pharmacist in a service of nuclear medicine. (N.C.)

  11. In vitro test for pyrogenes in radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Jovanovic, V; Zmbova, B; Bzenic, J [Institut za Nuklearne Nauke Boris Kidric, Belgrade (Yugoslavia); Berkes, J [Institut za Biohemije, Belgrade (Yugoslavia)

    1978-05-01

    Procedure and results of determination of pyrogenic substances in radiopharmaceutical preparations by an in vitro method based on the reaction between bacterial endotoxine and Limulus Amebocyte Lysate are presented. The advantage of this method as compared to the test in experimental animals performed so far has also been analyzed and proved by the fact that it enables avoidance of introduction of radioactive materials in experimental animals and of radiation effects on the results obtained in efficiency studies. The in vitro method is a quick one and requires only small quantities of the radiopharmaceutical preparation to be examined.

  12. Development of new radiopharmaceuticals

    International Nuclear Information System (INIS)

    1989-12-01

    The possibilities to design and prepare better and more organ-specific radiopharmaceuticals for diagnostic nuclear medicine has increased dramatically in the recent past with a deeper understanding of the relationships between chemical structure and biological activity. Whereas most of the research is performed in well-funded laboratories of industrialized countries, there are several developing countries with adequate resources and expertise as to undertake fruitful research in the field of radiopharmacy. With the aim of promoting advanced research in radiopharmacy by developing new radiodiagnostics agents, in particular, hepatobiliary imaging agents labelled with 99m Tc, and to facilitate exchange of information, the IAEA has established in 1983 the present Research Co-ordination Programme (CRP) with a duration of five years. The report includes detailed results obtained by all participants as well as novel preparation procedures for some of the newest and more promising radiopharmaceuticals developed under the auspices of the CRP. The extensive bibliographic reference listing is considered another important information of particular value for scientists in developing countries who do not always have access to updated scientific information sources. Refs, figs and tabs

  13. Molecularly targeted therapeutic radiopharmaceuticals

    International Nuclear Information System (INIS)

    Saw, M.M.

    2007-01-01

    Full text: It is generally agreed that current focus of nuclear medicine development should be on molecular imaging and therapy. Though, the widespread use of the terminology 'molecular imaging' is quite recent, nuclear medicine has used molecular imaging techniques for more than 20 years ago. A variety of radiopharmaceuticals have been introduced for the internal therapy of malignant and inflammatory lesions in nuclear medicine. In the field of bio/medical imaging, nuclear medicine is one of the disciplines which has the privilege of organized and well developed chemistry/ pharmacy section; radio-chemistry/radiopharmacy. Fundamental principles have been developed more than 40 years ago and advanced research is going well into postgenomic era. The genomic revolution and dramatically increased insight in the molecular mechanisms underlying pathology have led to paradigm shift in drug development. Likewise does in the nuclear medicine. Here, the author will present current clinical and pre-clinical therapeutic radiopharmaceuticals based on molecular targets such as membrane-bound receptors, enzymes, nucleic acids, sodium iodide symporter, etc, in correlation with fundamentals of radiopharmacy. (author)

  14. Knowledge-based automated radiopharmaceutical manufacturing for Positron Emission Tomography

    International Nuclear Information System (INIS)

    Alexoff, D.L.

    1991-01-01

    This article describes the application of basic knowledge engineering principles to the design of automated synthesis equipment for radiopharmaceuticals used in Positron Emission Tomography (PET). Before discussing knowledge programming, an overview of the development of automated radiopharmaceutical synthesis systems for PET will be presented. Since knowledge systems will rely on information obtained from machine transducers, a discussion of the uses of sensory feedback in today's automated systems follows. Next, the operation of these automated systems is contrasted to radiotracer production carried out by chemists, and the rationale for and basic concepts of knowledge-based programming are explained. Finally, a prototype knowledge-based system supporting automated radiopharmaceutical manufacturing of 18FDG at Brookhaven National Laboratory (BNL) is described using 1stClass, a commercially available PC-based expert system shell

  15. 188Re(V) Nitrido Radiopharmaceuticals for Radionuclide Therapy.

    Science.gov (United States)

    Boschi, Alessandra; Martini, Petra; Uccelli, Licia

    2017-01-19

    The favorable nuclear properties of rhenium-188 for therapeutic application are described, together with new methods for the preparation of high yield and stable 188 Re radiopharmaceuticals characterized by the presence of the nitride rhenium core in their final chemical structure. 188 Re is readily available from an 188 W/ 188 Re generator system and a parallelism between the general synthetic procedures applied for the preparation of nitride technetium-99m and rhenium-188 theranostics radiopharmaceuticals is reported. Although some differences between the chemical characteristics of the two metallic nitrido fragments are highlighted, it is apparent that the same general procedures developed for the labelling of biologically active molecules with technetium-99m can be applied to rhenium-188 with minor modification. The availability of these chemical strategies, that allow the obtainment, in very high yield and in physiological condition, of 188 Re radiopharmaceuticals, gives a new attractive prospective to employ this radionuclide for therapeutic applications.

  16. 188Re(V) Nitrido Radiopharmaceuticals for Radionuclide Therapy

    Science.gov (United States)

    Boschi, Alessandra; Martini, Petra; Uccelli, Licia

    2017-01-01

    The favorable nuclear properties of rhenium-188 for therapeutic application are described, together with new methods for the preparation of high yield and stable 188Re radiopharmaceuticals characterized by the presence of the nitride rhenium core in their final chemical structure. 188Re is readily available from an 188W/188Re generator system and a parallelism between the general synthetic procedures applied for the preparation of nitride technetium-99m and rhenium-188 theranostics radiopharmaceuticals is reported. Although some differences between the chemical characteristics of the two metallic nitrido fragments are highlighted, it is apparent that the same general procedures developed for the labelling of biologically active molecules with technetium-99m can be applied to rhenium-188 with minor modification. The availability of these chemical strategies, that allow the obtainment, in very high yield and in physiological condition, of 188Re radiopharmaceuticals, gives a new attractive prospective to employ this radionuclide for therapeutic applications. PMID:28106830

  17. Radiopharmaceutical chemistry for positron emission tomography

    NARCIS (Netherlands)

    Elsinga, PH

    Radiopharmaceutical chemistry includes the selection, preparation, and preclinical evaluation of radiolabeled compounds. This paper describes selection criteria for candidates for positron emission tomography (PET) investigations. Practical aspects of nucleophilic and electrophilic

  18. Design of radiopharmaceuticals for monitoring gene transfer therapy

    International Nuclear Information System (INIS)

    Lambrecht, R.M.; Staehler, P.; Kley, J.; Spiegel, M.; Gross, C.; Graepler, F.T.C.; Gregor, M.; Lauer, U.; Oberdorfer, F.

    1998-01-01

    The development of radiopharmaceuticals for monitoring gene transfer therapy with emission tomography is expected to lead to improved management of cancer by the year 2010. There are now only a few examples and approaches to the design of radiopharmaceuticals for gene transfer therapy. This paper introduces a novel concept for the monitoring of gene therapy. We present the optimisation of the labelling of recombinant human β-NGF ligands for in vitro studies prior to using 123 I for SPET and 124 I for PET studies. (author)

  19. Peptide radiopharmaceuticals in nuclear medicine

    International Nuclear Information System (INIS)

    Blok, D.; Vermeij, P.; Feitsma, R.I.J.; Pauwels, E.J.K.

    1999-01-01

    This article reviews the labelling of peptides that are recognised to be of interest for nuclear medicine or are the subject of ongoing nuclear medicine research. Applications and approaches to the labelling of peptide radiopharmaceuticals are discussed, and drawbacks in their development considered. (orig.)

  20. An intelligent portal monitor for fast suppression of false positives due to radiopharmaceuticals

    International Nuclear Information System (INIS)

    Johnson, M.W.; Butterfield, K.B.

    1985-01-01

    Monitoring the movement of radioactive material through secure or sensitive areas may be complicated by the existence of unanticipated sources of radiation carried by individuals passing through the area. Typical of such sources are radiopharmaceuticals prescribed for a medical procedure. The authors report here on an apparatus designed to quickly discriminate between in-vivo radiopharmaceuticals and other nuclear materials, based on a pattern-recognition algorithm and microcomputer. Principles of operation are discussed, and the data base for the pattern-recognition algorithms is displayed. Operating experience with the apparatus in a trial location is also discussed. The apparatus correctly identifies in-vivo radiopharmaceuticals in over 80% of all trials; challenges with radioisotopes other than radiopharmaceuticals have led the apparatus, without exception, to reject the challenge isotope as incompatible with medical practice. The apparatus thus rapidly discriminates between individuals bearing radiopharmaceuticals and those bearing illicit sources, such as special nuclear materials

  1. Radiopharmaceuticals good practices handbook: ARCAL XV radiopharmaceuticals control and production; Manual de buenas practicas radiofarmaceuticas: ARCAL XV produccion y control de radiofarmacos

    Energy Technology Data Exchange (ETDEWEB)

    Verdera Presto, Silvia [comp.; Universidad de la Republica, Facultad de ciencias, Centro de Investigaciones Nucleares, Montevideo (Uruguay)

    1999-12-31

    A safety practice of the therapeutics diagnostic proceeding in nuclear medicine require a permanent provide high quality radiopharmaceuticals manufacture. This work treat to give a guide for all radio pharmacies laboratories that produce,control, fraction and or dispense radiopharmaceuticals products, with attention hospitable radiopharmacy laboratory. Three chapters with recommendations in manufacture good practice in Hospital radiopharmacy, industrial centralized, bibliography and three annexe`s about clean area classification,standards work in laminar flux bell, and guarantee and cleaning areas

  2. Leading safety performance indicators for resilience assessment of radiopharmaceuticals production process

    International Nuclear Information System (INIS)

    Grecco, Claudio H.S.; Santos, Isaac J.A.L.; Carvalho, Paulo V.R.

    2011-01-01

    Radiopharmaceuticals are radiation-emitting substances used in medicine for radiotherapy and imaging diagnosis. A Research Institute, located in Rio de Janeiro, produces three radiopharmaceuticals: the sodium iodate is used in the diagnosis of thyroid dysfunctions, the meta-iodo-benzyl guanidine is used in the diagnosis of cardiac diseases, and the fluorodeoxyglucose is used in diagnosis in cardiology, oncology, neurology and neuro psychiatry. This paper presents a leading safety performance indicators framework to assess the resilience of radiopharmaceuticals production processes. The organizations that use resilience indicators will be able to pro actively evaluate and manage safety. (author)

  3. Leading safety performance indicators for resilience assessment of radiopharmaceuticals production process

    Energy Technology Data Exchange (ETDEWEB)

    Grecco, Claudio H.S.; Santos, Isaac J.A.L.; Carvalho, Paulo V.R., E-mail: grecco@ien.gov.b, E-mail: luquetti@ien.gov.b, E-mail: paulov@ien.gov.b [Instituto de Engenharia Nuclear (IEN/CNEN-RJ), Rio de Janeiro, RJ (Brazil). Div. de Instrumentacao e Confiabilidade Humana; Vidal, Mario C.R., E-mail: mvidal@ergonomia.ufrj.b [Coordenacao dos Programas de Pos-Graduacao de Engenharia (PEP/COPPE/UFRJ), Rio de Janeiro, RJ (Brazil). Programa de Engenharia de Producao. Grupo de Ergonomia e Novas Tecnologias (GENTE)

    2011-07-01

    Radiopharmaceuticals are radiation-emitting substances used in medicine for radiotherapy and imaging diagnosis. A Research Institute, located in Rio de Janeiro, produces three radiopharmaceuticals: the sodium iodate is used in the diagnosis of thyroid dysfunctions, the meta-iodo-benzyl guanidine is used in the diagnosis of cardiac diseases, and the fluorodeoxyglucose is used in diagnosis in cardiology, oncology, neurology and neuro psychiatry. This paper presents a leading safety performance indicators framework to assess the resilience of radiopharmaceuticals production processes. The organizations that use resilience indicators will be able to pro actively evaluate and manage safety. (author)

  4. Drug interactions with radiopharmaceuticals

    International Nuclear Information System (INIS)

    Hesslewood, S.; Leung, E.

    1994-01-01

    Considerable information on documented drug and radiopharmaceutical interactions has been assembled in a tabular form, classified by the type of nuclear medicine study. The aim is to provide a rapid reference for nuclear medicine staff to look for such interactions. The initiation of drug chart monitoring or drug history taking of nuclear medicine patients and the reporting of such events are encouraged. (orig.)

  5. The transport of radiopharmaceuticals in the United States

    International Nuclear Information System (INIS)

    Ferate, F.D.

    2004-01-01

    Among all the various uses of radioactive materials for peaceful purposes, the creation and use of radiopharmaceuticals to diagnose and treat medical ailments has probably brought the greatest benefit to humanity. The use of radionuclides in medicine has mushroomed over the past 20 years, as has the number of nuclides and procedures which are now routinely used in hospitals and clinics around the globe. Parallel to the growth in the use of radiopharmaceuticals has been the growth in shipments of these nuclides and their compounds to the locations where they are used

  6. New radiopharmaceuticals currently used in clinical nuclear medicine

    International Nuclear Information System (INIS)

    Hladik, W.B. III

    1997-01-01

    During 1996 and 1997, six new radiopharmaceuticals have been approved by the U.S. Food and Drug Administration for use in the diagnosis and/or management of patients with various disease states. Four of these new agents are antibody-based diagnostic radiotracers, and one is a therapeutic agent. One radio-pharmaceutical that has been available for several years has been approved for a new, unique indication. Our discussion focuses on the physicochemical and pharmacokinetic properties of these recently released agents as well as their specific role in the management of patients

  7. The transport of radiopharmaceuticals in the United States

    Energy Technology Data Exchange (ETDEWEB)

    Ferate, F.D. [U. S. Dept. of Transportation, Washington, DC (United States)

    2004-07-01

    Among all the various uses of radioactive materials for peaceful purposes, the creation and use of radiopharmaceuticals to diagnose and treat medical ailments has probably brought the greatest benefit to humanity. The use of radionuclides in medicine has mushroomed over the past 20 years, as has the number of nuclides and procedures which are now routinely used in hospitals and clinics around the globe. Parallel to the growth in the use of radiopharmaceuticals has been the growth in shipments of these nuclides and their compounds to the locations where they are used.

  8. Difficulties and aspects to take into account in the production, use and distribution of new radiopharmaceuticals PET; Difficultes et aspects a prendre en compte dans la production, l'utilisation et la distribution des nouveaux radiopharmaceutiques TEP

    Energy Technology Data Exchange (ETDEWEB)

    Sanchez, R.; Rayo, J.I.; Serrano, J.; Infante, J.; Luz Dominguez, M.; Garcia, L.; Duran, C. [Hospital Infanta Cristina, Servicio de Medicina Nuclear, Badajoz (Spain)

    2008-10-15

    This article seeks to describe the requirements, legal and technical, for the production, distribution and use of new radiopharmaceuticals PET (other than the {sup 18}F.D.G.), describing the legislative framework in which we find ourselves, the characteristics of a production and types of synthesis and existing modules. A list of susceptible radiopharmaceuticals is presented that are being currently used in nuclear medicine by specifying the real possibilities of their production and use and which are the difficulties we face.

  9. Ensuring quality while going local: IAEA helps Cuba produce radiopharmaceuticals

    International Nuclear Information System (INIS)

    Jawerth, Nicole

    2015-01-01

    Cancer and cardiovascular disease are health conditions Cuba will now be able to more readily diagnose and treat thanks to its newly built facility for producing key radiopharmaceuticals. Nuclear medicine requires a constant and reliable supply of these radioactive drugs, prepared according to what the industry calls good manufacturing practices (GMP), and there have so far been limitations in getting them to the island nation. “Through our work with the IAEA, we now have a dedicated GMP compliant facility and the expertise to meet most of our national needs for diagnostic and therapeutic radiopharmaceuticals for helping patients,” said René Leyva Montaña, Director of Production at the Isotope Centre (CENTIS), Cuba’s centre dedicated to radiopharmaceutical production.

  10. Radiopharmaceuticals for diagnosis

    International Nuclear Information System (INIS)

    Kuhl, D.E.

    1990-06-01

    During this grant period 1 January 1988--31 December 1990, we have successfully developed a number of new approaches to fluorine-18 labeled compounds, prepared several new radiotracers for both animal studies and eventual clinical trials, and explored the utility of a high-quality industrial robot in radiopharmaceutical applications. The progress during the last grant period is summarized briefly in the following sections. Publications arising from this research are listed below and can be found in Appendix I. 1 fig

  11. Preparation of radiopharmaceutical formulations; Fremstilling av radioaktive farmasoeytiske blandinger

    Energy Technology Data Exchange (ETDEWEB)

    Simon, J.; Garlich, J.R.; Frank, R.K.; McMillan, K

    1998-03-16

    Radiopharmaceutical formulations for complexes comprising at least one radionuclide complexed with a ligand, or its physiologically-acceptable salts thereof, especially {sup 153}samarium-ethylenediaminetetramethylenephosphonic acid, which optionally contains a divalent metal ion, e.g. calcium, and is frozen, thawed, and then administered by injection. Alternatively, the radiopharmaceutical formulations must contain the divalent metal and are frozen only if the time before administration is sufficiently long to cause concern for radiolysis of the ligand. 2 figs., 9 tabs.

  12. Recent radiopharmaceutical research at the AAEC Research Establishment

    International Nuclear Information System (INIS)

    Wilson, J.G.; Boyd, R.E.

    1985-12-01

    During the past few years a large part of the radiochemical research carried out at Lucas Heights has been devoted to the synthesis of ligands capable of forming chelate complexes with technetium-99m, as part of a search for tumour-localising radiopharmaceuticals. An account is given of the synthesis and biological evaluation of a range of these compounds and of the investigation of certain biochemical and biological properties affecting the clinical application of both ligands and radiopharmaceuticals. In addition to the search for novel Tc-99m radiopharmaceuticals, major research programs on the development of Tc-99m generating systems have been in progress at Lucas Heights for several years. Work on the AAEC's Mark III Tc-99m technetium generator has been brought to a successful conclusion. A new type of Tc-99m generator, which uses an insoluble zirconium molybdate gel and provides high yields of pertechnetate by a simple elution technique, has also been developed. Studies are in progress on the osmium-iridium generator

  13. Annual Report for Los Alamos National Laboratory Technical Area 54, Area G Disposal Facility - Fiscal Year 2016

    Energy Technology Data Exchange (ETDEWEB)

    Birdsell, Kay Hanson [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Stauffer, Philip H. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Atchley, Adam Lee [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Miller, Elizabeth D. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Chu, Shaoping [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); French, Sean B. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-03-24

    As a condition to the disposal authorization statement issued to Los Alamos National Laboratory (LANL or the Laboratory) on March 17, 2010, a comprehensive performance assessment and composite analysis (PA/CA) maintenance program must be implemented for the Technical Area 54, Area G disposal facility. Annual determinations of the adequacy of the PA/CA are to be conducted under the maintenance program to ensure that the conclusions reached by those analyses continue to be valid. This report summarizes the results of the fiscal year (FY) 2016 annual review for Area G.

  14. Establishment of PET/CT positron radiopharmaceutical center:radiation protection%PET/CT正电子药物中心的建设之三——放射防护

    Institute of Scientific and Technical Information of China (English)

    耿建华; 陈英茂; 陈盘祖; 田嘉禾

    2011-01-01

    Objective:To investigate the radiation protection for positron radiopharmaceutical center.Methods:According to the current policy about radiation protection in China and the technical requirement of the positron radiopharmaceutical center,the radiation protection for a hospital to establish a PET/CT positron radiopharmaceutical center was discussed.Results:Radiation protection requirement from radiopharmaceutical production to injection for patients was expatiated.The evaluation of radiation protection for a PET/CT positron radiopharmaceutical center was described.Conclusion:The information and suggestions about radiation protection should be provided for hospitals to establish a PET positron radiopharmaceutical center.%目的:探讨PET/CT正电子药物中心建设中的放射防护。方法:根据我国放射防护相关的现行政策及PET/CT正电子药物中心放射防护的特点,论述在PET/CT正电子药物中心的建设中放射防护相关问题。结果:给出了在医疗机构的PET/CT正电子药物中心正电子药物从生产到投入使用各环节中的防护要求,并且对放射防护的评价进行阐述。结论:为医疗机构建立正电子放射性药物生产中心的放射防护方面的工作提供参考。

  15. Design of GMP compliance radiopharmaceutical production facility in MINT

    International Nuclear Information System (INIS)

    Anwar Abd Rahman; Shaharum Ramli; M Rizal Mamat Ibrahim; Rosli Darmawan; Yusof Azuddin Ali; Jusnan Hashim

    2005-01-01

    In 1985, MINT built the only radiopharmaceutical production facility in Malaysia. The facility was designed based on IAEA (International Atomic Energy Agency) standard guidelines which provide radiation safety to the staff and the surrounding environment from radioactive contamination. Since 1999, BPFK (Biro Pengawalan Farmaseutikal Kebangsaan) has used the guidelines from Pharmaceutical Inspection Convention Scheme (PICS) to meet the requirements of the Good Manufacturing Practice (GMP) for Pharmaceutical Products. In the guidelines, the pharmaceutical production facility shall be designed based on clean room environment. In order to design a radiopharmaceutical production facility, it is important to combine the concept of radiation safety and clean room to ensure that both requirements from GMP and IAEA are met. The design requirement is necessary to set up a complete radiopharmaceutical production facility, which is safe, has high production quality and complies with the Malaysian and International standards. (Author)

  16. SKB Annual Report 1995. Including summaries of Technical Reports issued during 1995

    International Nuclear Information System (INIS)

    1996-05-01

    The annual report covers planning, construction and operation of facilities and systems as well as research, development, demonstration work and information activities. The aim of the program is to start the permanent disposal of spent nuclear fuel around year 2008. Work is undertaken for the development of encapsulation technology on an industrial scale and for design of an encapsulation plant. The siting process for the final repository for spent fuel has started with feasibility studies in a few Swedish municipalities in order to evaluate the potential technical conditions and requirements and the influence on the region. 36 refs, figs

  17. SKB Annual Report 1995. Including summaries of Technical Reports issued during 1995

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-05-01

    The annual report covers planning, construction and operation of facilities and systems as well as research, development, demonstration work and information activities. The aim of the program is to start the permanent disposal of spent nuclear fuel around year 2008. Work is undertaken for the development of encapsulation technology on an industrial scale and for design of an encapsulation plant. The siting process for the final repository for spent fuel has started with feasibility studies in a few Swedish municipalities in order to evaluate the potential technical conditions and requirements and the influence on the region. 36 refs, figs.

  18. Radioisotope requirements and usage in the radiopharmaceutical industry

    International Nuclear Information System (INIS)

    Langton, M.A.

    1995-01-01

    Radioisotopes are used extensively in many different productive and beneficial human endeavors. Amersham International, a U.K.-based company originating in the British Scientific Civil Service during World War II, has been actively involved in many of these activities for more than 50 yr. Today they are one of the world's largest suppliers of radioactive compounds and scaled radiation sources for use in industrial quality and safety assurance, life science research, and medicine. This paper outlines one of these applications: the use of radioisotopes as radiopharmaceuticals. Radiopharmaceuticals are radioactive nuclides and labeled compounds that have been developed for the diagnosis and treatment of (human) disease. They are manufactured via highly controlled processes and have gone through regulatory scrutiny and approval far in excess of other radioisotopes used in other applications. Radiopharmaceuticals can be conveniently split into two categories. One type is simply an active analog that mimics the physiological behavior of its inactive counterpart in the body. The other involves an actual pharmacological compound that exhibits the desired physiological behavior, which is then labeled with a radionuclide suitable for either imaging or the delivery of a therapeutic radiation dose as appropriate but which plays no part in the mechanism of action of the drug. The latter type, which is the more common of the two, can be supplied either as an active compounded product or as a open-quotes cold kit,close quotes which is then labeled with the appropriate radiopharmaceutical-grade radionuclide to yield the final product

  19. Forty-Fifth Annual Meeting of the Technical Working Group on Fast Reactors (TWG-FR). Presentations

    International Nuclear Information System (INIS)

    2012-01-01

    The objectives of the meeting were to: • Exchange information on the national programmes on Fast Reactors (FR) and Accelerator Driven Systems (ADS); • Review the progress since the 44 th TWG-FR Annual Meeting, including the status of the actions; • Consider topical technical meeting arrangements for 2012-2013, as well as review FR-related activities included in the IAEA Programme & Budget (P&B) biennium 2012-2013; • Review the IAEA’s concluded, on-going and planned coordinated research projects in the technical fields relevant to the TWG-FR (FRs and ADS), as well as coordination of the TWG-FR’s activities with other organizations and international initiatives (GIF, INPRO, NEA, ESNII, etc.)

  20. The WFNMB Survey on the Introduction of New Radiopharmaceuticals for Clinical Research: Snapshot of the international perspective

    International Nuclear Information System (INIS)

    Jeong, J.M.; Choe, Y.S.; Knapp, F.F. Jr.

    2007-01-01

    Development of new radiopharmaceuticals and their introduction into clinical trials ensures continuing improvement in the practice of nuclear medicine. Although it is crucial that safety and efficacy are established prior to use in humans, the characteristics of radiopharmaceuticals are quite different from other drugs since these agents are generally administered in trace, sub-pharmacological amounts. Diagnostic and therapeutic radiopharmaceutical agents are used only in restricted and controlled areas and are administered only by trained personnel. In many cases - as often for PET -- such diagnostic agents are often used in the same institution where they are prepared. Thus, regulations for the preparation and use of radiopharmaceuticals should be different from other drugs. To evaluate the current status of radiopharmaceutical regulations, we surveyed radiopharmaceutical experts and nuclear medicine societies on an international basis. A questionnaire was provided which focused on the regulations required for the in-house non-commercial preparation of new radiopharmaceutical for routine clinical use or for use in clinical trials. Responses were received from participants in 36 countries. Although both government and institutional approval are required for introduction of new radiopharmaceuticals in the majority of countries, some countries require only institutional approval. In the case of therapeutic radiopharmaceuticals, as may be expected, only physician responsibility is more often required compared with similar approval for use of diagnostic agent in these settings. The requirement of current Good Manufacturing Practice (cGMP) for PET agents was higher than with the other agents. This preponderance of cGMP requirements may be interpreted as much higher than may be expected, since many PET radiopharmaceuticals are used in-house and are prepared in the hospital by pharmaceutical compounding and not by manufacturing. Compounding is not regulated by c

  1. Innovative radiopharmaceuticals in oncology and neurology

    CERN Document Server

    Barbet, Jacques; Chérel, Michel; Guilloteau, Denis

    2017-01-01

    The aim of this Research Topic was to assemble a series of articles describing basic, preclinical and clinical research studies on radiopharmaceuticals and nuclear medicine. The articles were written by attendees of the third Nuclear Technologies for Health Symposium (NTHS, 10th-11th March 2015, Nantes, Frances) under the auspices of the IRON LabEx (Innovative Radiopharmaceuticals for Oncology and Neurology Laboratory of Excellence). This French network, gathering approximately 160 scientists from 12 academic research teams (Funded by “investissements d’Avenir”), fosters transdisciplinary projects between teams with expertise in chemistry, radiochemistry, radiopharmacy, formulation, biology, nuclear medicine and medical physics. The 12 articles within this resulting eBook present a series of comprehensive reviews and original research papers on multimodality imaging and targeted radionuclide therapy; illustrating the different facets of studies currently conducted in these domains.

  2. Computational chemistry and metal-based radiopharmaceuticals

    International Nuclear Information System (INIS)

    Neves, M.; Fausto, R.

    1998-01-01

    Computer-assisted techniques have found extensive use in the design of organic pharmaceuticals but have not been widely applied on metal complexes, particularly on radiopharmaceuticals. Some examples of computer generated structures of complexes of In, Ga and Tc with N, S, O and P donor ligands are referred. Besides parameters directly related with molecular geometries, molecular properties of the predicted structures, as ionic charges or dipole moments, are considered to be related with biodistribution studies. The structure of a series of oxo neutral Tc-biguanide complexes are predicted by molecular mechanics calculations, and their interactions with water molecules or peptide chains correlated with experimental data of partition coefficients and percentage of human protein binding. The results stress the interest of using molecular modelling to predict molecular properties of metal-based radiopharmaceuticals, which can be successfully correlated with results of in vitro studies. (author)

  3. EEC directives and guidelines applicable to radiopharmaceuticals - 1993

    International Nuclear Information System (INIS)

    Cox, P.H.

    1993-01-01

    The manufacture, scale and supply of radiopharmaceuticals in the EEC is regulated by directives that are incorporated into the national laws of the member states. The situation as of 1 January 1993 was not too optimistic, however, as the processing of licensing applications had been completely misjudged. Not one product had been registered as of 1 January. The costs involved are also high and since the European market for radiopharmaceuticals is relatively small, the market cannot afford this. It would appear that the EEC directives are inadquate and too non-specific, so revision is indicated. (orig.)

  4. The role of high performance liquid chromatography in radiochemical/radiopharmaceutical synthesis and quality assurance

    International Nuclear Information System (INIS)

    Boothe, T.E.; Emran, A.M.

    1990-01-01

    The usefulness of HPLC in all areas of radiopharmaceutics has been demonstrated in numerous laboratories, particularly in the development of in-house radiopharmaceuticals for SPECT and PET. HPLC continues to be a powerful tool in preparation and quality assurance (QA) as illustrated in such areas as chemical and radiochemical identification; product separation and isolation; preparative scale purification; and specific activity determination. A review of established HPLC techniques in radiopharmaceutics will be presented. Examples from the literature as well as newer applications will be used in an attempt to assess and define the present-day role of HPLC in the preparation of radiochemicals and radiopharmaceuticals with emphasis on QA

  5. Use of the microwave oven in the radiopharmaceutical preparations in nuclear medicine

    International Nuclear Information System (INIS)

    Soroa Gfeller, Victoria E.; Cabrejas, Raul C.; Mc Elfresh, H.

    2000-01-01

    Several of the 99mTc radiopharmaceuticals require heating in water bath for 30 minutes before successfully completing the labelling process and thus produce optimal diagnostic images with low background and no free 99mTc. Sulphur colloid 99mTc (99mTc-Sc) enables visualization of liver, spleen, bone marrow reticuloendothelial system, lymphoscintigraphy and sentinel node detection. Sestamibi (99mTc-MIBI) is used for identifying myocardium ischemia and tissue metabolically active. Both compounds were the aim of our work, as the objective was to shorten the preparation time while maintaining experimental animal and clinical biodistribution. 99mTc-Sc assays were the most difficult to perform. The best results were achieved through a combination of water heated boiling bath (5 minutes), microwave oven during 18-20 seconds and cooling the preparation previous to intravenous injection, although still the optimal technical parameters have to be achieved. Sestamibi-Tc99m assays showed repeatable results with high labelling efficiency (90-96%) oven energy 40-50% during 14-17 seconds. We conclude that we successfully have reduced the time of both preparations. Sc-99mTc should still to be perfected, the radiopharmaceutical can be used in lymphoscintigraphy scans but it is not recommended for liver and spleen images results. Sestamibi-Tc99m successfully shorten time consumed in the preparation and it is cost effective, results are repeatable and the compound shows a 6 h stability. (author)

  6. Role of the tunisian central pharmacy in the import of radio-pharmaceutical products

    International Nuclear Information System (INIS)

    Souissi Jaziri, Camelia; Moulahi, L.

    2013-01-01

    In Tunisia the centralized organization of the medicine sector has a strategic and economic importance. It presents particular characteristics concerning the importation and the control of drugs. Tcp has a monopoly on the importation of drugs for the country, which enters in the state policy for the control of drug purchasing costs, their availability in different region of the country and their guarantee and quality. The Tcp has a crucial role in the availability of drugs and in the holding safety stock and strategic reserve of the imported pharmaceutical products, either for the public or private sector. The Tcp has to stock up medicaments, chemical and pharmaceutical products, objects of bandages, instruments, accessory tools and other supplies necessary for the human and veterinary medicine. The Tcp packages any specialized or not medicament and all other products or supplies. The Tcp provides medicaments and products entering within the framework of its task to different health groups and hospitals. The Tcp provides distributors, laboratories and pharmacies over the country. In Tunisia the import of radioisotopes used in the medical domain is attributed to the Tcp. The objective is to centralize purchases and to guarantee: the security, the availability as well as the traceability. The Tcp supply radiopharmaceutical products for diagnostic and therapy purposes according to an authorization delivered annually by the National Center of Radiation Protection (NCRP). An authorization of removal used at the customs allows the clearance of products at the level of the air freights by the transit service of the Tcp. Regarding the evolution of purchases of radio-pharmaceutical products, their importation remained stable during the last three years. Indeed, it is approximately around 1MDT annually (954 121 DT in 2010, 939 956 in 2011 and 1047 967 in 2012). Sources of supply are divided between 4 suppliers: International IBA-CISBIO (49.9 pour cent), COVIDIEN EX (TYCO

  7. ANSTO. Annual Report 1992-1993

    International Nuclear Information System (INIS)

    1993-11-01

    Significant events and achievements highlighted in the Annual Reports include: the Research Reactor Review, increase of external revenues by 12.5%, sales of Australian radioisotopes amounting to $8.5 M, regulatory approval for production of thallium-201 in National Medical Cyclotron, completion of first contracts with Wismut GmbH in Germany, production of a database of content of atmospheric particulate matter in air over NSW, word-wide licence agreement signed for further commercialization of blood clot radiopharmaceuticals, collaborative agreement signed with SURPAC Int. for development of geochemical speciation software, complete design of rings in HIFAR for silicon doping. ills., tabs

  8. Radiopharmaceuticals - pattern and development and utilisation in India

    International Nuclear Information System (INIS)

    Iya, V.K.; Mani, R.S.

    1990-01-01

    The availability of research reactors at an early stage of India's Atomic Energy Programme led to developemental efforts in the field of radiopharmaceuticals. The use of several 125 I-labelled compounds like Rose-Bengal, hippuran, etc. for imaging has been replaced over the years by 99m Tc compounds; the final formulations are prepared at the hospital using generators and cold kits supplied by the Board of Radioisotope Technology. Parallel with the development of short-lived generators in radiopharmaceuticals came advances in imaging and instrumentation techniques, the scanners being replaced by sophisticated gamma cameras, with capabilities for tomography and computerisation. About 40 centres in India have the modern instrumentation and equipment needed for carrying out nuclear medicine procedures. Further growth of nuclear medicine centres in the country has, however, been limited by the need to import such advanced high cost instumentation not currently available from indigeneous sources. Regarding in-vitro radiopharmaceuticals, some RIA and IRMA kits and procedures have been developed. These include assay of T 3 , T 4 and TSH in the thyroid group of hormones. There are over a hundred and fifty medical laboratories carrying out RIA procedures. (author)

  9. Radionuclides, radiotracers and radiopharmaceuticals for in vivo diagnosis

    International Nuclear Information System (INIS)

    Wiebe, L.I.

    1984-01-01

    Radioactive tracers for in vivo clinical diagnosis fall within a narrow, strictly-defined set of specifications in respect of their physical properties, chemical and biochemical characteristics, and medical applications. The type of radioactive decay and physical half-life of the radionuclide are immutable properties which, along with the demands of production and supply, limit the choice of radionuclides used in medicine to only a small fraction of those known to exist. In use, the biochemical and physiological properties of a radiotracer are dictated by the chemical form of the radionuclide. This chemical form may range from elemental, molecular or ionic, to complex compounds formed by coordinate or covalent bonding of the radionuclide to either simple organic or inorganic molecules, or complex macromolecules. Few of the radiotracers which are tested in model systems ever become radiopharmaceuticals in the strictest sense. Radionuclides, radiotracers and radiopharmaceuticals in use are reviewed. Drug legislation and regulations concerning drug manufacture, as well as hospital ethical constraints and legislation concerning unsealed sources of radiation must all be satisfied in order to translate a radiopharmaceutical from the laboratory to clinical use. (author)

  10. Radionuclides, radiotracers and radiopharmaceuticals for in vivo diagnosis

    Science.gov (United States)

    Wiebe, Leonard I.

    Radioactive tracers for in vivo clinical diagnosis fall within a narrow, strictly-defined set of specifications in respect of their physical properties, chemical and biochemical characteristics, and (approved) medical applications. The type of radioactive decay and physical half-life of the radionuclide are immutable properties which, along with the demands of production and supply, limit the choice of radionuclides used in medicine to only a small fraction of those known to exist. In use, the biochemical and physiological properties of a radiotracer are dictated by the chemical form of the radionuclide. This chemical form may range from elemental, molecular or ionic, to complex compounds formed by coordinate or covalent bonding of the radionuclide to either simple organic or inorganic molecules, or complex macromolecules. Few of the radiotracers which are tested in model systems ever become radiopharmaceuticals in the strictest sense. Radionuclides, radiotracers and radiopharmaceuticals in use are reviewed. Drug legislation and regulations concerning drug manufacture, as well as hospital ethical constraints and legislation concerning unsealed sources of radiation must all be satisfied in order to translate a radiopharmaceutical from the laboratory to clinical use.

  11. Detection of endotoxins in radiopharmaceutical preparations. III. Limulus test assessment using radiopharmaceutical preparations; correlation with the rabbit pyrogen test

    Energy Technology Data Exchange (ETDEWEB)

    Cohen, Y; Bahri, F; Bruneau, J; Dubuis, M; Dubuis, N; Merlin, L; Michaud, T; Peysson, S

    1986-01-01

    Experiments using 17 radiopharmaceuticals containing known amounts of added endotoxin show that none of them inhibits the pyrogenic reaction of the rabbit. Gelation of the Limulus amoebocyte lysate (LAL) is inhibited by 4 of them: colloidal erbium 169Er citrate, colloidal rhenium 186Re sulfide, colloidal technetium /sup 99m/Tc (Re) sulfide for liver scintigraphy and the colloidal technetium /sup 99m/Tc (Re) sulfide for lymphography. This inhibition is cancelled, either by dilution or after neutral pH adjustment. Both controls were performed on 313 batches of various radiopharmaceuticals, 95% of results were identical (93% negative, 2% positive). The remaining 5% correspond to positive LAL tests vs negative rabbit tests on the same batches. No negative LAL test vs positive rabbit test was observed.

  12. A short history of radiopharmaceutical research in Australia

    International Nuclear Information System (INIS)

    Baker, R.

    1989-01-01

    A brief summary is given of radiopharmaceuticals research carried out in Australia. Historically, a number of the larger hospital radiopharmacies have been, and still are, involved with 99m Tc-cold kit production. Originally, this scenario evolved because the nuclear medicine community was denied access to state-of-the-art products available overseas. Although the situation has improved in recent times, most such departments continue kit production, having made a large capital investment in sterile facilities, equipment and staff. Australian Nuclear Science and Technology Organization has a leading role in radiopharmaceutical research and some of the topics which have occupied its scientists over the last few years are outlined

  13. Proceedings of the Annual Meeting of the Council for Programs in Technical and Scientific Communication (14th, Orlando, Florida, October 7-9, 1987).

    Science.gov (United States)

    Geonetta, Sam C., Ed.

    Based on the notion of "reaching out," this proceedings presents papers from the annual meeting of the Council for Programs in Technical and Scientific Communication. Papers in the proceedings are: "Southern Tech's Technical Writing Certificate" (William S. Pfeiffer); "Reach Out and Quack Someone" (Daniel R. Jones);…

  14. Recent developments in the field of 123I-radiopharmaceuticals

    International Nuclear Information System (INIS)

    Machulla, H.J.; Knust, E.J.

    1984-01-01

    Due to its advantageous nuclear physical properties iodine-123 is an excellent label for radiopharmaceuticals very well suited for measurements by γ-cameras and single-photon emission tomography. The development of 123 I-radiopharmaceuticals should be based on a clear biochemical concept, reliable labelling procedures and careful pharmacokinetic studies in order to evaluate the physiological behaviour of the radioiodinated compounds being analogues of metabolic substrates. The development of 123 I-labelled fatty acids and biogenic amines clearly proved the successful use of 123 I for labelling compounds applied in medical diagnosis. (orig.) [de

  15. Depyrogenation, sterilization and deproteination of radiopharmaceuticals with an ultrafilter

    Energy Technology Data Exchange (ETDEWEB)

    Suzuki, K; Tamate, K; Nakayama, T [National Inst. of Radiological Sciences, Chiba (Japan)

    1984-01-01

    A newly developed filter holder is described for an ultrafiltration method used in the removal of pyrogen, enzyme and bacteria in the preparation of intravenously injectable radiopharmaceuticals. Penetration ratios of bovine serum albumin, glutamate dehydrogenase and Escherichia coli endotoxin through the PTGC ultrafilter (NMWL = 10,000) were measured; these results are useful for estimating penetration ratios of other macromolecules. Attempts to obtain i.v. injectable /sup 13/NH, L- /sup 13/N-glutamate and 3- /sup 123/I-iodotyrosine radiopharmaceuticals were successful; after ultrafiltration, pyrogen, bacteria or protein were not detected.

  16. Shanghai institute of nuclear research, academia sinica annual report 1991

    International Nuclear Information System (INIS)

    1992-01-01

    The Annual Report is a comprehensive review of achievements made by Shanghai Institute of Nuclear Research (SINR), Academia Sinica in 1991, Which concerns nuclear physics (theories, experimentation, and application), nuclear chemistry (radiochemistry, radiopharmaceuticals, labelled compounds, analytical chemistry), radiation chemistry, accelerator physics and technology, nuclear detectors, computer application and maintenance, laboratory engineering, radiation protection and waste treatment. The maintenance, reconstruction and operation of its major facilities are also described

  17. Calibration and qualification of equipment in the pharmaceutical industry: emphasis on radiopharmaceuticals production

    International Nuclear Information System (INIS)

    Melero, Laura T.U.H.; Silva, Katia S. da S.; Zanette, Camila; Araujo, Elaine B. de; Mengatti, Jair

    2011-01-01

    The calibration and qualification of equipment are listed items in RDC number 17 of 2010 which refers about the Good Manufacturing Practice (GMP) of medicaments and RDC number 63 of 2009 which refers about GMP of Radiopharmaceuticals. Both are essential requirements since they are involved in process control to attend the regulatory criteria and are a key part of the validation process. The aim of this work is presenting the importance of calibration and qualification, and the routine use of equipment and facilities in industrial scale production of radiopharmaceuticals in the IPEN/CNEN. The radiopharmacy of IPEN is a pharmaceutical industry that produces radiopharmaceuticals for diagnosis and therapy. It was the pioneer institute in production of radioisotopes and radiopharmaceuticals in Brazil. Currently, 38 products are distributed to the nuclear medicine centers, including primary radioisotopes, labeled molecules and lyophilized reagents for labeling with technetium-99m. To fulfill the GMP requirements for quality assurance of products, several factors must be considered including infrastructure, equipment and raw materials beyond, obviously, the whole production process should be controlled until the release of the final product. Therefore, the calibration and verification of equipment, instruments and other appliances used in the production and quality control should be performed. A program of calibration, qualification and requalification of equipment used in production and quality control of radiopharmaceuticals is necessary for the validation of production processes and analytical methods, and should be established for quality assurance of produced radiopharmaceuticals. (author)

  18. Calibration and qualification of equipment in the pharmaceutical industry: emphasis on radiopharmaceuticals production

    Energy Technology Data Exchange (ETDEWEB)

    Melero, Laura T.U.H.; Silva, Katia S. da S.; Zanette, Camila; Araujo, Elaine B. de; Mengatti, Jair [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)

    2011-07-01

    The calibration and qualification of equipment are listed items in RDC number 17 of 2010 which refers about the Good Manufacturing Practice (GMP) of medicaments and RDC number 63 of 2009 which refers about GMP of Radiopharmaceuticals. Both are essential requirements since they are involved in process control to attend the regulatory criteria and are a key part of the validation process. The aim of this work is presenting the importance of calibration and qualification, and the routine use of equipment and facilities in industrial scale production of radiopharmaceuticals in the IPEN/CNEN. The radiopharmacy of IPEN is a pharmaceutical industry that produces radiopharmaceuticals for diagnosis and therapy. It was the pioneer institute in production of radioisotopes and radiopharmaceuticals in Brazil. Currently, 38 products are distributed to the nuclear medicine centers, including primary radioisotopes, labeled molecules and lyophilized reagents for labeling with technetium-99m. To fulfill the GMP requirements for quality assurance of products, several factors must be considered including infrastructure, equipment and raw materials beyond, obviously, the whole production process should be controlled until the release of the final product. Therefore, the calibration and verification of equipment, instruments and other appliances used in the production and quality control should be performed. A program of calibration, qualification and requalification of equipment used in production and quality control of radiopharmaceuticals is necessary for the validation of production processes and analytical methods, and should be established for quality assurance of produced radiopharmaceuticals. (author)

  19. Annual Report for Los Alamos National Laboratory Technical Area 54, Area G Disposal Facility – Fiscal Year 2015

    Energy Technology Data Exchange (ETDEWEB)

    French, Sean B. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Stauffer, Philip H. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Birdsell, Kay H. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2016-02-29

    As a condition to the disposal authorization statement issued to Los Alamos National Laboratory (LANL or the Laboratory) on March 17, 2010, a comprehensive performance assessment and composite analysis maintenance program must be implemented for the Technical Area 54, Area G disposal facility. Annual determinations of the adequacy of the performance assessment and composite analysis (PA/CA) are to be conducted under the maintenance program to ensure that the conclusions reached by those analyses continue to be valid. This report summarizes the results of the fiscal year (FY) 2015 annual review for Area G.

  20. Sterile kits for the preparation of radiopharmaceuticals: some basic quality control considerations

    International Nuclear Information System (INIS)

    Briner, W.H.

    1975-01-01

    Quality control concepts involved in the formulation of radiopharmaceutical kits, as well as all other radiopharmaceuticals, are meant to protect both the patients who receive these products and the practitioners of nuclear medicine who use these products in their practice. These concepts include the adequacy of site and facilities in which these products are formulated, the level of training and experience of personnel responsible for the formulation of the products, quality assurance procedures employed to monitor the acceptability of products, and, finally, a professional dedication to excellence in all these matters. The absence of any of these in a nuclear medicine or radiopharmaceutical program will result in almost certain disaster

  1. Radiation absorbed dose from medically administered radiopharmaceuticals

    International Nuclear Information System (INIS)

    Roedler, H.D.; Kaul, A.

    1975-01-01

    The use of radiopharmaceuticals for medical examinations is increasing. Surveys carried out in West Berlin show a 20% average yearly increase in such examinations. This implies an increased genetic and somatic radiation exposure of the population in general. Determination of radiation exposure of the population as well as of individual patients examined requires a knowledge of the radiation dose absorbed by each organ affected by each examination. An extensive survey of the literature revealed that different authors reported widely different dose values for the same defined examination methods and radiopharmaceuticals. The reason for this can be found in the uncertainty of the available biokinetic data for dose calculations and in the application of various mathematical models to describe the kinetics and calculation of organ doses. Therefore, the authors recalculated some of the dose values published for radiopharmaceuticals used in patients by applying biokinetic data obtained from exponential models of usable metabolism data reported in the literature. The calculation of organ dose values was done according to the concept of absorbed fractions in its extended form. For all radiopharmaceuticals used in nuclear medicine the energy dose values for the most important organs (ovaries, testicles, liver, lungs, spleen, kidneys, skeleton, total body or residual body) were recalculated and tabulated for the gonads, skeleton and critical or examined organs respectively. These dose values are compared with those reported in the literature and the reasons for the observed deviations are discussed. On the basis of recalculated dose values for the gonads and bone-marrow as well as on the basis of results of statistical surveys in West Berlin, the genetically significant dose and the somatically (leukemia) significant dose were calculated for 1970 and estimated for 1975. For 1970 the GSD was 0.2 mrad and the LSD was 0.7 mrad. For 1975 the GSD is estimated at < 0.5 mrad and the

  2. Preparation of sup(113m)In-labelled compounds of radiopharmaceutical interest. Part of a coordinated programme on radiopharmaceuticals

    International Nuclear Information System (INIS)

    Servian, J.; Robles, A.

    1975-06-01

    Techniques for the preparation and control of already known and new sup(113m)In-radiopharmaceuticals were investigated. New rapid procedures for the control and preparation of a number of radiopharmaceuticals were developed and standardized. After biological distribution studies and clinical tests, new techniques for the preparation of the following indium-113 radiopharmaceuticals were adopted: a) Indium - labelled colloids of: S, Al(OH) 3 , Fe(OH) 3 and AlPO 4 for liver and spleen scintigraphy. b) Indium labelled chelates using the ligands EDTA, DTPA, TTHA (Triethylene-tetramine-hexaacetic acid) and DHPTA (Diamino-hydroxy-propane-tetraacetic acid) for brain scintigraphy. c) Indium labelled Fe(OH) 3 macroaggregates and microspheres for lung scintigraphy. d) Several complexes of sup(113m)In with different ligands (fluoride, tartrate, pyrophosphate, tripolyphosphate, trimetaphosphate, EHDP (or ethane-1-hydroxy-1, 1-diphosphonate), ethylendiamine-pyrophosphate were synthesized and its potential use as bone-scanning agents were evaluated. It was found that the complexes with tartrate, tripolyphosphate and EHDP show appreciable skeletal uptake (bone/muscle ratio are 9.0, 5.5, and 4.7 respectively), although they are inferior to the sup(99m)Tc bone-scanning agents. e) A new simple technique is proposed for the preparation of highly concentrated sup(113m)In solutions. The technique is based on the precipitation of In(OH) 3 , millipore filtration and redissolution in a small volume of 0.05 N HCl

  3. Dosimetric aspects of the treatment of metastatic bone pain with radiopharmaceuticals

    International Nuclear Information System (INIS)

    Garcia, T.; Marti, J. F.; Olivas, C.; Vercher, J. L.; Repetto, R.; Bello, P.

    2014-01-01

    Within the context of treatment of metastatic bone pain with bone seeking radiopharmaceuticals, this paper expounds the results of an analysis of available molecules (both approved for clinical use or still under study) intended to obtain a detailed comparison of their dosimetric characteristics. These can be used to supplement the list of already know differences between them, such as efficacy, appearance and length of the palliative effect, eventual tumoricidal effect, myelotoxicity, sale price and availability. Seven radiopharmaceuticals have been analysed, five of them are based on beta emission radionuclides: 3 2P, 1 53Sm, 1 86Re and 1 88Re and the other two ones are based on high Linear energy Transference emission radionuclides: 1 17mSn and 2 23Ra a series of estimates of the main dosimetric parameters for each radiopharmaceutical analysed have been obtained. The values obtained might be worth being incorporated to the risk/benefit analysis that precedes every choice of the specific radiopharmaceutical to be used with an individual patient. In this way, we hope these results will be of some help for those Nuclear Medicine specialists interested in the treatment of oncological bone pathologies. (Author)

  4. The anesthetics influence (ethilic-eter and urethane) on renal radiopharmaceuticals

    International Nuclear Information System (INIS)

    Muramoto, E.; Achando, S.S.; Araujo, E.B. de; Hamada, H.S.; Silva Valente Goncalves, R. da; Pereira, N.P.S. de; Silva, C.P.G. da.

    1990-01-01

    A comparative study was done using anesthetics like ether ethilic and urethane, in rats (Wistar). A significative variation was observed in the results obtained when renal radiopharmaceuticals were investigated. Using urethane, the renal uptake increase progressivelly due to the inhibition of the renal filtration and it starts to recuperate when the anesthetic effect was eliminated. Using ether ethilic the radiopharmaceuticals are quickly eliminated from the kidneys (tubular or glomerular filtration), showing that the renal function was protected. (author) [pt

  5. Safety and efficacy of radiopharmaceuticals 1987

    International Nuclear Information System (INIS)

    Kristensen, K.; Norbygaard, E.

    1987-01-01

    In this text aspects of the development of new radiopharmaceuticals are reviewed with particular reference to products of biological origin such as monoclonal antibodies and human cells. Also included in this survey are the legal aspects of the introduction of new pharmaceuticals and good radiopharmacy practice

  6. In search of scar seeking radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Salehi, N.; Lawlor, J.M.; Lichtenstein, M.; Allaway, M.; Barencevic, A. [Royal Melbourne Hospital, Melbourne, VIC (Australia). Department of Nuclear Medicine]|[University of Melbourne, VIC (Australia)

    1998-03-01

    Full text: Sensitive detection of acute peri-osseous scar tissue should be valuable for detection of partial ligamentous, tears and other common rheumatological conditions including back pain and ligamentous scars. Our aim was to investigate acute scar uptake of {sup 99m}Tc(V)-DMSA (dimercapto-succinic-acid), {sup 99m}Tc-DMAD (di- methyl-aminodiphosphonate) compared to {sup 99m}Tc-MDP (methylen-diphosphonate), the standard bone-scanning radiopharmaceutical. New Zealand white rabbits were anaesthetised and had 5-7cm of their mid-line abdominal wall surgically incised. At 24, 48, 72, 96 and 240 hours post surgery, 74 MBq (2 mCi) of the above radiopharmaceuticals were injected intravenously and scintigraphy performed 2.5 hours later. Relative count rate in scar is tabulated. In conclusion, the increased activity in the acute surgical site and lesser bone uptake confirmed that Tc (V)-DMSA and Tc-DMAD are superior to Tc- MDP for detection of new scar tissue in the region of bone. 1 tab.

  7. Analytical techniques for the determination of radiochemical purity of radiopharmaceuticals prepared from kits. Part II

    International Nuclear Information System (INIS)

    MacLean, J.R.; Rockwell, L.J.; Welsh, W.J.

    The evaluation of efficacy of commercially available kits used for the preparation of radiopharmaceuticals is one aspect of the Radiation Protection Bureau's radiopharmaceutical quality control program. This report describes some of the analytical methodology employed in the program. Many of the tests can be performed rapidly and with a minimum of special equipment, thus enabling the confirmation of radiopharmaceutical purity prior to patient administration

  8. Fabrication of sterile experimental radiopharmaceuticals: technical and regulatory requirements; Fabrication des medicaments experimentaux radiopharmaceutiques steriles: exigences reglementaires et techniques

    Energy Technology Data Exchange (ETDEWEB)

    Briand, S

    2008-03-15

    The radiopharmaceuticals devoted to the biomedical research were the object of the directive 2001/20/C.E. transposition that defined again the conditions of implementation of biomedical research using drugs at human use, whom authorization is delivered by A.f.s.s.a.p.s.. In an other hand the law 2006-686 of the 13. june 2006 ( called law T.S.N.) has modified the regulatory dispositions relative to the radiation protection norms. These new dispositions allow to the health facilities to realize their research projects without difficulties for experimental drugs supply. (N.C.)

  9. Radiopharmaceutical quality control-Pragmatic approach

    International Nuclear Information System (INIS)

    Barbier, Y.

    1994-01-01

    The quality control must be considered in a practical manner. The radiopharmaceuticals are drugs. They must satisfy the quality assurance control. These products are then conform to Pharmacopeia. But sometimes the user must control some data especially radiochemical purity and pH value. On all the administered solutions four controls are compulsory: radionuclide identity, administered radioactivity, organoleptic character and pH

  10. Development, preparation and control of sup(99m)Tc or sup(113m)In labelled stannous hydroxide radiopharmaceuticals. Part of a coordinated programme on radiopharmaceuticals

    International Nuclear Information System (INIS)

    Alvarez Cervera, J.

    1975-01-01

    The preparation of different sup(99m)Tc and sup(113m)In radiopharmaceuticals using stannous chloride was investigated. Chemical and radiochemical procedures for the quality control of these preparations were studied. Toxicity and biological controls of the preparation were carried out. Procedures for the preparation and control of the following radiopharmaceuticals have been standardized by the authors; albumin macroaggregates labelled with sup(99m)Tc, sup(113m)In and other isotopes for lung scanning; albumin microspheres labelled with sup(99m)Tc for lung scanning; sup(99m)Tc or sup(113m)In-labelled stannous hydroxide colloid for liver scanning; sup(99m)Tc-stannous phytate for liver scanning; sup(99m)Tc-Sn-dextrose, a new radiopharmaceutical which has been proposed by the authors and is now used in Mexico for renal and cerebral scanning and sup(99m)Tc-Sn pyrophosphate and diphosphonate for bone scanning

  11. Environmental Science and Research Foundation. Annual technical report, April 11, 1994--December 31, 1994

    International Nuclear Information System (INIS)

    Reynolds, T.D.; Morris, R.C.; Markham, O.D.

    1995-06-01

    This Annual Technical Report describes work conducted for the Department of Energy, Idaho Operations Office, by the Environmental Science and Research Foundation (Foundation) for work under contract DE-AC07-94ID13268. The Foundation began, on April 11, 1994, to conduct environmental surveillance near to and distant from the Idaho National Engineering Laboratory, provide environmental public relations and education related to INEL natural resource issues, and conduct ecological and radioecological research benefiting major DOE-ID programs including Waste Management, Environmental Restoration, Spent Nuclear Fuels, and Infrastructure

  12. Environmental Science and Research Foundation. Annual technical report, April 11, 1994--December 31, 1994

    Energy Technology Data Exchange (ETDEWEB)

    Reynolds, T.D.; Morris, R.C.; Markham, O.D. [eds.

    1995-06-01

    This Annual Technical Report describes work conducted for the Department of Energy, Idaho Operations Office, by the Environmental Science and Research Foundation (Foundation) for work under contract DE-AC07-94ID13268. The Foundation began, on April 11, 1994, to conduct environmental surveillance near to and distant from the Idaho National Engineering Laboratory, provide environmental public relations and education related to INEL natural resource issues, and conduct ecological and radioecological research benefiting major DOE-ID programs including Waste Management, Environmental Restoration, Spent Nuclear Fuels, and Infrastructure.

  13. Limulus test for pyrogens and radiometric sterility tests on radiopharmaceuticals. Part of a coordinated programme

    International Nuclear Information System (INIS)

    Gopal, N.G.S.

    1976-10-01

    Sterility testing of radiopharmaceuticals prepared at BARC were carried out using the radiometric technique (Radiometric detection of the metabolic product 14 Co 2 ). Batches of different radiopharmaceuticals were tested for pyrogen using the limulus lysate method and the results were compared with the rabbit method. The results of sterility test on 202 batches of 19 different radiopharmaceuticals show that the radiometric method can be used for sterility testing of radiopharmaceuticals labelled with 35 S, 51 Cr, 57 Co, 59 Fe, 82 Br, 86 Rb, sup(99m)Tc, sup(113m)In, 125 I and 169 Yb. The radiometric test proves to be more rapid than the conventional one for the sterility testing of such radiopharmaceuticals. Detection time is between 6-21 hours. In the case of 131 I-labelled radiopharmaceuticals and in the case of chlormerodrin-Hg-203, it was found an interference due to volatile species (sup(131m)Xe in the case of 131 I and some volatile mercury form in the case of chlormerodrin). In these cases it would be possible to carry out the radiometric sterility test after separation of the microorganisms from the radioactive material (by filtration). The limulus lysate method can be employed for control of various pyrogen-prone raw materials and radiopharmaceuticals. Such method is the only method at present available for detecting the low level pyrogen contamination in intrathecal injections. The limulus test is more rapid than the rabbit test

  14. Experience in the quality control of commercial and self-labelled radiopharmaceuticals

    International Nuclear Information System (INIS)

    Strehlau, E.; Weiland, J.

    1980-01-01

    Different methods of quality control of radiopharmaceuticals checked in the laboratory practice are summarized. Starting from the general organization of quality control in the clinical radiochemical laboratory methods of analysis and working regulations are discussed. The quality tests of sup(99m)Tc-generator eluate, that is the testing for radioactive contaminants and for soluble aluminium as well as the testing of sup(99m)Tc-labelled kits and of different other frequently used radiopharmaceuticals are described in detail. Special conditions of examination and results of chromatography and medium-voltage electrophoresis are also given. Furthermore the routine determination of the output in the labelling of denaturated erythrocytes with sup(99m)Tc is discussed. The clinical practice in the case of preparation deficiencies and of possible incidents following the application of radiopharmaceuticals is outlined. (author)

  15. Modern trends in radiopharmaceuticals for diagnosis and therapy. Proceedings of a symposium

    International Nuclear Information System (INIS)

    1998-08-01

    The IAEA held an International Symposium on Modern Trends in Radiopharmaceuticals for Diagnosis and Therapy in Lisbon, Portugal, from 30 March to 3 April 1998. Two earlier symposia were organized on similar topics in Copenhagen, Denmark in 1973 and in Tokyo, Japan, in 1984. The proceedings of these symposia have been published and widely used as reference sources. To facilitate faster publication and more widespread availability, the IAEA has decided to publish the proceedings of this symposium as a cost-free TECDOC. The symposium was organized into 14 sessions consisting of five on 99m Tc radiopharmaceuticals, two each on therapeutic radiopharmaceuticals and radiohalogens/other isotopes and one each on bioevaluation, radiometric assay, medical isotope production, good radiopharmacy practice and technology transfer. In the proceedings the papers from multiple sessions on the same topic have been grouped together for the convenience of the reader. The papers presented in the symposium reflect current and future developments in diagnostic and therapeutic agents. The largest number of papers presented dealt with 99m Tc, highlighting its continuing importance to nuclear medicine and the role of imaging as an important tool. The emerging interest in therapeutic radiopharmaceuticals based on beta emitting short lived isotopes such as 186 Re and 153 Sm was evident from the papers presented in two sessions devoted to this topic. Also of steady interest was the development of agents labelled with other established isotopes, radioiodine in particular and also 111 In and 67 Ga. Regulation, training and good manufacturing practices are important for ensuring safety in regular use of radiopharmaceuticals and were discussed in a separate session. The production of radiopharmaceuticals has become a regular activity in many developing countries, often facilities were presented at the symposium

  16. Modern trends in radiopharmaceuticals for diagnosis and therapy. Proceedings of a symposium

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-08-01

    The IAEA held an International Symposium on Modern Trends in Radiopharmaceuticals for Diagnosis and Therapy in Lisbon, Portugal, from 30 March to 3 April 1998. Two earlier symposia were organized on similar topics in Copenhagen, Denmark in 1973 and in Tokyo, Japan, in 1984. The proceedings of these symposia have been published and widely used as reference sources. To facilitate faster publication and more widespread availability, the IAEA has decided to publish the proceedings of this symposium as a cost-free TECDOC. The symposium was organized into 14 sessions consisting of five on {sup 99m}Tc radiopharmaceuticals, two each on therapeutic radiopharmaceuticals and radiohalogens/other isotopes and one each on bioevaluation, radiometric assay, medical isotope production, good radiopharmacy practice and technology transfer. In the proceedings the papers from multiple sessions on the same topic have been grouped together for the convenience of the reader. The papers presented in the symposium reflect current and future developments in diagnostic and therapeutic agents. The largest number of papers presented dealt with {sup 99m}Tc, highlighting its continuing importance to nuclear medicine and the role of imaging as an important tool. The emerging interest in therapeutic radiopharmaceuticals based on beta emitting short lived isotopes such as {sup 186}Re and {sup 153}Sm was evident from the papers presented in two sessions devoted to this topic. Also of steady interest was the development of agents labelled with other established isotopes, radioiodine in particular and also {sup 111}In and {sup 67}Ga. Regulation, training and good manufacturing practices are important for ensuring safety in regular use of radiopharmaceuticals and were discussed in a separate session. The production of radiopharmaceuticals has become a regular activity in many developing countries, often facilities were presented at the symposium Refs, figs, tabs

  17. Implementation of the Good Practices of Manufacture of PET Radiopharmaceuticals in INOR

    International Nuclear Information System (INIS)

    Sinconegui Gómez, Belkys; Quesada Cepero, Waldo; González González, Joaquín J.; Calderón Marín, Carlos F.; Varela Corona, Consuelo; Figueroa, Roberto

    2016-01-01

    The growing advance of new technologies in Nuclear Medicine such as positron emission tomography (PET) allows visualizing biological processes in vivo and provides more sensitive results in the diagnosis of oncological processes in asymptomatic stages of the disease and contribute significantly to improve cancer management. It is significant to note that these technologies include radiopharmaceuticals marked with 90 Y and 177 Lu for the therapy of patients already diagnosed by the PET technique that contribute to a significant improvement in the quality of life of patients with cancer. Our country, taking into account the importance of this technology for Health, has developed in INOR a project for the obtaining, dispensing and quality control of PET radiopharmaceuticals marked with 68 Ga for diagnosis and its therapeutic analogues marked with 177 Lu and 90Y in Conditions of Good Manufacturing Practices (GMP). The objective of the present work is to present our experiences in the implementation of the Good Practices of Manufacture of PET Radiopharmaceuticals according to regulation 16-2012 GUIDELINES ON GOOD PRACTICES OF MANUFACTURE OF PHARMACEUTICAL PRODUCTS, issued by the State Control Center for Medicines, Equipment and Devices Doctors (CECMED), a Cuban regulatory body. The implementation of the regulation considers from the preparation of personnel involved in the activity, moving through the facilities and equipment to the validation and quality control. A system for the quality assurance of the production of PET radiopharmaceuticals was implemented in accordance with Annex 5 of Regulation 16-2012 of the CECMED. This is the first experience in Cuba of the implementation of Good Manufacturing Practices of PET Radiopharmaceuticals in Hospital Radiopharmacy. The acquired experiences will be extended to the practices for the preparation of radiopharmaceuticals for the conventional Nuclear Medicine in the INOR.

  18. Impact of risk considerations on dosimetry of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Eckerman, K.F.

    1981-01-01

    Estimates of the absorbed dose from clinical procedures involving the administration of radiopharmaceuticals are used primarily to determine the presumed risk of various procedures so that, in-so-far as possible, the selection of a given procedure can be based on a comparison of risk. Although this has been the basic objective, risk evaluation has generally been separated from the dosimetry considerations. In the recent revision of its radiation protection guidance, the International Commission on Radiological Protection (ICRP) has embodied risk considerations in its recommendations and risk concepts have become an integral part of the dosimetric framework. The impact of these considerations on the dosimetric assessments of radiopharmaceuticals and the resulting need for additional information is discussed

  19. Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

    Energy Technology Data Exchange (ETDEWEB)

    Gamboa, Maryelle Moreira Lima; Roesch, Heveline Rayane Moura; Lemos, Vanessa Pinheiro Amaral, E-mail: maryellelg@hotmail.com [PPG BioSaude, Universidade Luterana do Brasil, Canoas, RS (Brazil); Rocha, Bruna Oliveira [Faculty of Biology, Universidade Luterana do Brasil, Canoas, RS (Brazil); Santos-Oliveira, Ralph [Institute of Radiopharmacy Research, Universidade Estadual da Zona Oeste, Rio de Janeiro, RJ (Brazil)

    2014-04-15

    Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ) or positrons emitter (β+), linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. >From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64). In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs. (author)

  20. Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

    International Nuclear Information System (INIS)

    Gamboa, Maryelle Moreira Lima; Roesch, Heveline Rayane Moura; Lemos, Vanessa Pinheiro Amaral; Rocha, Bruna Oliveira; Santos-Oliveira, Ralph

    2014-01-01

    Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ) or positrons emitter (β+), linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. >From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64). In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs. (author)

  1. Acquisition of biokinetic data for internal dose calculations for some novel radiopharmaceuticals

    International Nuclear Information System (INIS)

    Smith, T.; Zanelli, G.D.; Crawley, C.W.

    1986-01-01

    Estimation of radiation dose commitment, expresses as an effective dose equivalent, is a prior requisite to the application for a license to administer radiopharmaceuticals and, therefore, in the case of novel radiopharmaceuticals is leading to an increasing awareness of the need for dosimetry-orientated studies. In this laboratory potential new radiopharmaceuticals are investigated initially by animal studies to assess the possible distribution in man, and subsequently in controlled volunteer studies designed to obtain the maximum possible amount of biokinetic data to allow accurate estimation of radiation dose. A variety of techniques are used for this purpose, including profile counting, partial and whole-body scanning by LFOV gamma camera and whole-body counting, in addition to the analysis of radioactivity in blood and excreta. The use of these techniques is illustrated for the acquisition of biokinetic data and subsequent dosimetry of three novel radiopharmaceuticals: 77 Br-p-bromospiperone (quantification of dopamine receptors in the brain). 99 Tc/sup m/-porphyrins and 99 Tc/sup m/ DEPE (a possible novel blood pool marker for MUGA studies). 14 references, 14 figures, 2 tables

  2. Computational system for activity calculation of radiopharmaceuticals

    African Journals Online (AJOL)

    STORAGESEVER

    2008-12-29

    Dec 29, 2008 ... 2National Nuclear Energy Commission, Brazil. Accepted 24 October ... radiopharmaceuticals in use around the world with ... ment with a very important aspects: no profits ends. The tool ... The software interface is showed in ...

  3. Which radiopharmaceuticals for to-morrow. Heart and brain investigations

    International Nuclear Information System (INIS)

    Maziere, B.

    1994-01-01

    This paper is a critical review of the various radiopharmaceuticals which have been or are presently designed for functional imaging of brain or heart using positron (PET) or single photon emission tomography. Currently used radiopharmaceuticals have been classified into two broad categories: 'passive' radiotracers intended to visualize the perfusion of the organ and 'active' or 'specific' radiotracers used to investigate metabolism or neurotransmission processes. Moreover, the potential interest of radioactive peptides or oligonucleotides which would be biologically stable in vivo and which could target proteins involved in inter or intra-cellular communications will be reviewed. (authors). 47 refs

  4. Analytical techniques for the determination of radiochemical purity of radiopharmaceuticals prepared from kits

    International Nuclear Information System (INIS)

    McLean, J.R.; Rockwell, L.J.; Welsh, W.J.

    1977-01-01

    The evaluation of efficacy of commercially available kits used for the preparation of radiopharmaceuticals is one aspect of the Radiation Protection Bureau's radiopharmaceutical quality control program. This report describes some of the analytical methodology employed in the program. The techniques may be of interest to hospital radiopharmacy personnel as many of the tests can be performed rapidly and with a minimum of special equipment, thus enabling the confirmation of radiopharmaceutical purity prior to patient administration. Manufacturers of kits may also be interested in learning of the analytical methods used in the assessment of their products. (auth)

  5. Radiopharmaceuticals production activities in Egypt

    International Nuclear Information System (INIS)

    Raieh, M.

    1998-01-01

    Applications of radiopharmaceuticals and labelled compounds in the field of nuclear medicine in Egypt have increased so rapidly in the last few years. At present, a large number of hospitals are utilizing these radioisotopic techniques for both diagnosis and treatment. The following production activities are taking place in the Egyptian Radioisotope Production laboratories. By utilizing the research reactor a large number of radioisotopes which find wide applications in nuclear medicine were produced, such as iodine-131, phosphorus-32, sodium-24, potassium-42 and molybdenum-99 / technetium-99m generators. Gallium-67, indium-111 and iodine-123 will be produced locally after installation of the cyclotron at the end of 1998. A large number of Tc-99m based kits for diagnostic medical applications have been produced. Also, many radiopharmaceuticals labelled with iodine-131 were produced. The radioisotope production laboratory is able to supply many hospitals with the radioimmunoassay kits of the thyroid related hormones (T4, T3 and TSH). Research and development activities are taking place in the field of monoclonal antibodies and tumor markers with special consideration of AFP, CEA, PSA and βhCG. (author)

  6. Progress on the application of ligand receptor binding assays in radiopharmaceuticals

    International Nuclear Information System (INIS)

    Zhou Xue; Qian Jinping; Kong Aiying; Zhu Lin

    2010-01-01

    Receptor binding assay is an important drug screening method, which can quickly and inexpensively study the interactions between the targeted receptor and the potential ligands in vitro and provide the information of the relative binding affinity of ligand-receptor. The imaging of many radiopharmaceuticals is based on highly selective radioligand-receptor binding. The technique plays an important role in the design and screening of receptor-targeting radiopharmaceuticals. (authors)

  7. Radiopharmaceutical projects of CNESTEN (Centre National de l'Energie, des Sciences et des Techniques Nucleaires)

    International Nuclear Information System (INIS)

    2000-01-01

    In nuclear medicine, the prescriptions of isotopic investigations are increasing because they can provide early information about morphological anomalies and permit,so to avoid long and onerous treatments. Until now, Morocco imports the radiopharmaceuticals in spite of the difficulties related to administrative procedures. To facilitate these procedures CNESTEN has launched a project which involves the following activities: - Import and distribution of needed radiopharmaceuticals; - development and production of new radiopharmaceutical kits in cooperation with scientific partners. Priority is given to the most prescribed radiopharmaceuticals. Many kits have been produced with manufacturing protocol modifications aiming to improve and optimize the production processes. The quality of the obtained products is tested and their biodistribution kinetics are studied. (F.M.)

  8. Environmental Science and Research Foundation annual technical report: Calendar year 1996

    International Nuclear Information System (INIS)

    Morris, R.C.; Blew, R.D.

    1997-01-01

    This Annual Technical Report describes work conducted for the Department of Energy, Idaho Operations Office (DOE-ID), by the Environmental Science and Research Foundation (Foundation). The Foundation's mission to DOE-ID provides support in several key areas. The authors conduct an environmental monitoring and surveillance program over an area covering much of the upper Snake River Plain, and provide environmental education and support services related to Idaho National Engineering and Environmental Laboratory (INEEL) natural resource issues. Also, the Foundation, with its University Affiliates, conducts ecological and radioecological research in the Idaho National Environmental Research Park. This research benefits major DOE-ID programs including Waste Management, Environmental Restoration, Spent Nuclear Fuels, and Land Management Issues. The major accomplishments of the Foundation and its University Affiliates during the calendar year 1996 are discussed

  9. Environmental Science and Research Foundation annual technical report: Calendar year 1996

    Energy Technology Data Exchange (ETDEWEB)

    Morris, R.C.; Blew, R.D. [eds.

    1997-07-01

    This Annual Technical Report describes work conducted for the Department of Energy, Idaho Operations Office (DOE-ID), by the Environmental Science and Research Foundation (Foundation). The Foundation`s mission to DOE-ID provides support in several key areas. The authors conduct an environmental monitoring and surveillance program over an area covering much of the upper Snake River Plain, and provide environmental education and support services related to Idaho National Engineering and Environmental Laboratory (INEEL) natural resource issues. Also, the Foundation, with its University Affiliates, conducts ecological and radioecological research in the Idaho National Environmental Research Park. This research benefits major DOE-ID programs including Waste Management, Environmental Restoration, Spent Nuclear Fuels, and Land Management Issues. The major accomplishments of the Foundation and its University Affiliates during the calendar year 1996 are discussed.

  10. Radiolabeling of human platelets using four radiopharmaceuticals with Tc-99m

    International Nuclear Information System (INIS)

    Portillo L, M.C.; Godoy, C.

    1991-01-01

    The present investigation work has been done in an evaluation of four different radiopharmaceuticals with Tin II (Glucoheptonate, Pyrophosphate, Citrate and DTPA), with the purpose of determining which one of the four would be obtained a higher rate of radiolabeling of platelets with Tc-99m. In order to evaluate the four radiopharmaceuticals it was procede to the separation and labeling of the human platelets. It was worked with samples of blood from five pacients, and the platelets from each one of them were labeled with the radiopharmaceuticals-Tc-99m. Then was observed a significant difference among the four radiopharmaceuticals studied, with a reliable level of 0.05 being the Glucoheptonate-Tc-99m the best to label platelets, obtaining with the same 50.23% of labeling efficiency, while for DTPA, Pyrophosphate and Citrate, It was obtained 33.42%, 29.82% and |2.62% respectively. Also, it was studied the biodistribution of the labeled platelets, using Glucoheptonate-Tc-99m as a radiopharamceutical. The biodistribution was studied in white mice at different times and it was founded that the place of biodistribution of the labeled platelets is given in greater percentage in the liver, spleen, lungs and kydneis. (Author)

  11. Legislative situation of EEC member states and european provisions concerning preparation and use of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Lalanne, P.

    1977-01-01

    Radiopharmaceuticals are excluded from the directives on pharmaceutical products and considerable gaps exist in the legislation of many countries. The pharmacopoeia provides standards and methods for the quality control of the final product. According to the same principles, it is proposed that special provisions, taking into consideration the very special nature of radiopharmaceuticals, might be introduced in the european economic community legislation, to secure that all radiopharmaceuticals used are safe and of an uniform quality

  12. Indirect iodometric procedure for quantitation of Sn(II) in radiopharmaceutical kits

    International Nuclear Information System (INIS)

    Muddukrishna, S.N.; Chen, A.; Sykes, T.R.; Noujaim, A.A.; Alberta Univ., Edmonton, AB

    1994-01-01

    A method of quantitating stannous ion [Sn(II)] suitable for radiopharmaceutical kits, based on indirect iodometric titration, is described. The method is based on the oxidation of Sn(II) using a known excess of iodine and the excess unreacted iodine determined using thiosulphate by potentiometric titration. The titration cell is a beaker and the titrations are done conveniently under air using an autotitrator in approx. 4 min. The method is accurate and is linear in the range of approx. 10 μg to approx. 6 mg of Sn(II). Several radiopharmaceutical kits were analysed for their Sn(II) content using the method including those containing antibodies or other proteins. The studies indicate that the procedure is rapid, simple and accurate for routine quantitative estimation of Sn(II) in radiopharmaceutical preparations during development, manufacture and storage. (Author)

  13. Radiopharmaceuticals for diagnosis and treatment of arthritis

    International Nuclear Information System (INIS)

    Hosain, F.; Haddon, M.J.; Hosain, H.; Drost, J.K.; Spencer, R.P.

    1990-01-01

    A brief review is given of radiopharmaceuticals for the diagnosis and treatment of arthritis. Topics covered include the pathophysiology of arthritis and the basis for the use of radiotracers, diagnostic procedures and radiotracer applications and therapeutic approaches and radionuclide applications. (UK)

  14. Radiopharmaceutical chelates and method of external imaging

    International Nuclear Information System (INIS)

    Loberg, M.D.; Callery, P.S.; Cooper, M.

    1977-01-01

    A chelate of technetium-99m, cobalt-57, gallium-67, gallium-68, indium-111 or indium-113m and a substituted iminodiacetic acid or an 8-hydroxyquinoline useful as a radiopharmaceutical external imaging agent. The invention also includes preparative methods therefor

  15. Approaches to the design of clean air handling facilities for radiopharmaceuticals

    International Nuclear Information System (INIS)

    2000-01-01

    Manufacturing, handling and administering processes of radiopharmaceuticals have to meet the requirements of both the fields viz. ''radio'' activity and ''pharma'' activity. Both these fields often dictate conflicting requirements. A step by step analysis of these conflicts can lead to practices reasonably acceptable to both the fields. The design approaches include engineering concepts of radiation protection, concepts and practices for pharmaceuticals, biologically unsafe products/processes and manufacturing, handling and administering processes of radiopharmaceuticals

  16. Routine clinical use of radiopharmaceuticals in Latin American developing countries

    International Nuclear Information System (INIS)

    Mitta, A.E.

    1985-01-01

    The paper describes the routine clinical use of radiopharmaceuticals in the developing countries of Latin America made possible by: (1) the International Atomic Energy Agency (IAEA), which sent experts and equipment to many countries and made a substantial bibliographic contribution on the subject; (2) the Latin American Association of Societies of Nuclear Biology and Medicine (ALASBIMN), which fostered the exchange of data on techniques of radiopharmaceutical preparation and quality control by providing materials for tests, etc., and by publishing quality control manuals in some countries, finally in 1982 producing the Manual of Radiopharmaceutical Quality Control, in collaboration with the Inter-American Nuclear Energy Commission (CIEN) and published by the Organization of American States (OAS); (3) the countries themselves under agreements between their atomic energy commissions; (4) radiopharmacy courses organized by universities, either alone or in collaboration with the IAEA, WHO, etc.; (5) professional workers who established radiopharmaceutical services at private centres. Finally, the societies of nuclear medicine and biology in each country, the World Federation of Nuclear Medicine and Biology, the ALASBIMN, the IAEA, etc. organized symposia and meetings which afforded opportunities to professionals of these countries to receive and exchange information, since in Latin America, given its language and human characteristics, the problems are similar. The countries referred to are Argentina, Brazil, Mexico, Uruguay, Bolivia, Paraguay, Chile, Peru, Ecuador, Colombia, Venezuela, Costa Rica, Guatemala, Puerto Rico, El Salvador and Panama; little is known about Honduras, Nicaragua, the Dominican Republic and Cuba. (author)

  17. Synthesis and formulation of 99m Tc-ECD radiopharmaceutical

    International Nuclear Information System (INIS)

    Ocampo G, B.E.

    1998-01-01

    Nuclear medicine is a medical specialty which uses radioactive compounds (radionuclides) for diagnostic and therapeutic purposes. 99m Tc is the more common radionuclide used in many studies in nuclear medicine because its advantages: it has a photopeak of 140 KeV and a half-life of 6 hours; it can be eluted from a Molybdenum 99 generator, so radiopharmaceuticals can be prepared on site. Ethyl cysteine dimer (ECD) labelled with reduced Technetium 99m has been purposed recently as a promising radiopharmaceutical for brain perfusion imaging 99m Tc-ECD is a lipophilic neutral complex which cross the brain blood barrier and show high brain uptake. The objective of this work was synthesize and to design a freeze dried formulation for the instant preparation of 99m Tc-ECD complex useful for brain perfusion imaging. We obtained a freeze dried stable formulation for the preparation of 99m Tc-ECD kit with a radiochemical purity higher than 90 %, which fulfills with the quality control of radiopharmaceuticals. Furthermore, we developed analytic techniques for the determination of the different chemical compounds into the lyophilized kit. (Author)

  18. Stannous ion determination in99mTc - radiopharmaceutical kits

    International Nuclear Information System (INIS)

    Almeida, M.A.T.M. de; Silva, C.P.G. da.

    1989-10-01

    Two simple and selective methods for determination of stannous ion in radiopharmaceutical kits are proposed. One of this permits the estimation of stannic ion. The first method used is a potentiometric tiration of Sn +2 in HCl medium using KIO 3 solution under nitrogen gas and a redox platinum electrode. The second method consist of a compleximetric tiration of tin (Sn +2 and Sn +4 ) using EDTA standart solution at pH 5.5-5.6 without use of nitrogen gas. The employed procedures indicates that both the methods can be used for routine quantitative determination of tin in most labeled radiopharmaceuticals. (author) [pt

  19. Radioisotope and radiopharmaceutical generators

    International Nuclear Information System (INIS)

    Barak, M.; Winchell, H.W.

    1975-01-01

    A chromatographic column for generating technetium-99m isotopes and technetium-99m labeled pharmaceuticals in a simple two-step process is described. Technetium-99m pertechnetate in a first step is isolated by adsorption upon an adsorbent packing. Then the technetium-99m in a second step is eluted from the packing, either with an immediately labeled biological compound to form a radiopharmaceutical, or by a controlled volume of eluant to produce a 99m-technetium-bearing eluate of a desired specific concentration. (Official Gazette)

  20. Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

    Directory of Open Access Journals (Sweden)

    Maryelle Moreira Lima Gamboa

    2014-04-01

    Full Text Available Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ or positrons emitter (β+, linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64. In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs.

  1. Radiopharmaceuticals to 99mTc

    International Nuclear Information System (INIS)

    Leon Cabana, Alba

    1994-01-01

    Studies about 99m Tc had demonstrated that have favorable properties for support diagnostic proceedings in nuclear medicine. This physical and chemical properties used for obtain another radiopharmaceuticals have been employed through re actives kits labelled with Tc 99m . A brief description was given about 99m utilities in diagnostic techniques such as endothelium reticular system,renal and hepatic studies,bone scintillators,cardiac diagnostic and cerebral perfusion

  2. Current status of production and research of radioisotopes and radiopharmaceuticals in Indonesia

    International Nuclear Information System (INIS)

    Soenarjo, Sunarhadijoso; Tamat, Swasono R.

    2000-01-01

    The use of radioactive preparation in Indonesia has sharply increased during the past years, indicated by increase of the number of companies utilizing radioisotopes during 1985 to 1999. It has been clearly stressed in the BATAN's Strategic Plan for 1994-2014 that the production of radioisotopes and radiopharmaceuticals is one of five main industrial fields within the platform of the Indonesian nuclear industry. Research programs supporting the production of radioisotopes and radiopharmaceuticals as well as development of production technology are undertaken by the Research Center for Nuclear Techniques (RCNT) in Bandung and by the Radioisotope Production Center (RPC) in Serpong, involving cooperation with other research center within BATAN, universities and hospitals as well as overseas nuclear research institution. The presented paper describes production and research status of radioisotopes and radiopharmaceuticals in Indonesia after the establishment of P.T. Batan Teknologi in 1996, a government company assigned for activities related to the commercial application of nuclear technology. The reviewed status is divided into two short periods, i.e. before and after the Chairman Decree No. 73/KA/IV/1999 declaring new BATAN organizational structure. Subsequent to the Decree, all commercial requests for radioisotopes and radiopharmaceuticals are fulfilled by P.T. Batan Teknologi, while demands on novel radioactive preparations or new processing technology, as well as research and development activities should be fulfilled by the Center for the Development of Radioisotopes and Radiopharmaceuticals (CDRR) through non-commercial arrangement. The near-future strategic research programs to response to dynamic public demand are also discussed. The status of research cooperation with JAERI (Japan) is also reported. (author)

  3. Production of PET radiopharmaceutical 18F-FDG using synthesizer automatic module

    International Nuclear Information System (INIS)

    Purwoko; Chairuman; Adang Hardi Gunawan; Yayan Tahyan; Eny Lestari; Sri Aguswarini Lestiyowati; Karyadi; Sri Bagiawati

    2010-01-01

    Radiopharmaceutical 2-( 18 F)Fluoro-2-Deoxy-D-Glucose or 18 F(FDG) is an important PET (Positron Emission Tomography) radiopharmaceutical for tumour imaging. In the PET technique glucose metabolism in tumour tissues can be determined quantitatively and used for diagnosis staging and monitoring of treatment tumour or cancer disease in medical oncology. The production of 2-( 18 F)Fluoro-2-Deoxy-D-Glucose 18 F-FDG using compact automated system module TRACERlab MX has been carried out. The modular setup of the apparatus permits reliable for routine synthesis of radiopharmaceuticals 18 F-FDG based on kriptofix mediated nucleophilic fluorination to mannose triflate precursor. Radiochemical yield of 18 F-FDG was 53.895 % (decay time uncorrected) in 40 minutes. The product showed that the colorless and clear solution at pH:6, sterile and pirogen free, kriptofix impurities was low and radiochemical purity was 99.595%. (author)

  4. Environmental Science and Research Foundation, Inc. annual technical report: Calendar year 1997

    Energy Technology Data Exchange (ETDEWEB)

    Reynolds, R.D.; Warren, R.W. [eds.

    1998-05-01

    This Annual Technical Report describes work conducted for the Department of Energy, Idaho Operations Office (DOE-ID), by the Environmental Science and Research Foundation (Foundation). The Foundation`s mission to DOE-ID provides support in several key areas. The Foundation conducts an environmental monitoring and surveillance program over an area covering much of the upper Snake River Plain, and provides environmental education and support services related to Idaho National Engineering and Environmental Laboratory (INEEL) natural resource issues. Also, the Foundation, with its University Affiliates, conducts ecological and radioecological research on the Idaho National Environmental Research Park. This research benefits major DOE-ID programs including Waste Management, Environmental Restoration, Spent Nuclear Fuels, and Land Management Issues. Summaries are included of the individual research projects.

  5. Environmental Science and Research Foundation, Inc. annual technical report: Calendar year 1997

    International Nuclear Information System (INIS)

    Reynolds, R.D.; Warren, R.W.

    1998-05-01

    This Annual Technical Report describes work conducted for the Department of Energy, Idaho Operations Office (DOE-ID), by the Environmental Science and Research Foundation (Foundation). The Foundation's mission to DOE-ID provides support in several key areas. The Foundation conducts an environmental monitoring and surveillance program over an area covering much of the upper Snake River Plain, and provides environmental education and support services related to Idaho National Engineering and Environmental Laboratory (INEEL) natural resource issues. Also, the Foundation, with its University Affiliates, conducts ecological and radioecological research on the Idaho National Environmental Research Park. This research benefits major DOE-ID programs including Waste Management, Environmental Restoration, Spent Nuclear Fuels, and Land Management Issues. Summaries are included of the individual research projects

  6. Radiopharmacy and radiopharmaceuticals in Brazil: sanitarians aspects related to a project of an industry of PET radiopharmaceuticals

    International Nuclear Information System (INIS)

    Santos-Oliveira, Ralph; Benevides, Clayton Augusto; Hwang, Suy Ferreira; Salvi, Roberto Paulo Camara; Freitas, Ione Maria Acioly Teixeira Ricarte de

    2008-01-01

    The increasing use of radiopharmaceuticals for PET (Positron Emission Tomography) has come to the attention of nuclear medicine staff and regulatory bodies. The aim of this study is to provide a national reference in radiopharmacy that could help all nuclear medicine staff and specially the Brazilian's regulatory bodies focused on the industrial project. (author)

  7. Fourth international radiopharmaceutical dosimetry symposium

    International Nuclear Information System (INIS)

    Schlafke-Stelson, A.T.; Watson, E.E.

    1986-04-01

    The focus of the Fourth International Radiopharmaceutical Dosimetry Symposium was to explore the impact of current developments in nuclear medicine on absorbed dose calculations. This book contains the proceedings of the meeting including the edited discussion that followed the presentations. Topics that were addressed included the dosimetry associated with radiolabeled monoclonal antibodies and blood elements, ultrashort-lived radionuclides, and positron emitters. Some specific areas of discussion were variations in absorbed dose as a result of alterations in the kinetics, the influence of radioactive contaminants on dose, dose in children and in the fetus, available instrumentation and techniques for collecting the kinetic data needed for dose calculation, dosimetry requirements for the review and approval of new radiopharmaceuticals, and a comparison of the effect on the thyroid of internal versus external irradiation. New models for the urinary blader, skeleton including the active marrow, and the blood were presented. Several papers dealt with the validity of traditional ''average-organ'' dose estimates to express the dose from particulate radiation that has a short range in tissue. These problems are particularly important in the use of monoclonal antibodies and agents used to measure intracellular functions. These proceedings have been published to provide a resource volume for anyone interested in the calculation of absorbed radiation dose

  8. The development of new radiopharmaceuticals

    International Nuclear Information System (INIS)

    Britton, K.E.

    1990-01-01

    The development of new radiopharmaceuticals is the basis of the continuing growth of nuclear medicine. Chemical interactions of electron clouds in their three-dimensional conformations bring together, in the process of molecular recognition, the reaction of antibody and antigen, receptor and ligand, enzyme and substrate, hormone and response site. This convergence enables the computer design of molecules such as ligands to fit computer-displayed conformational models showing active centres, positive and negative charges and other interactions. Indeed, given a particular molecule, a complementary binding structure can be devised. The hybridoma approach to monoclonal antibody production is being superceded by the bacterial bioengineer. The gene for the hypervariable region from the spleen cells of immunized mouse can be coupled with the myeloma gene. The polymerase chain reaction can duplicate the DNA a million times over in 20 min and the result transfected into a bacterial plasmid to produce the antibody. These scientific problems are soluble in principle and are being solved. However, so much damage to this developing biological field is being done by regulatory authorities that one must ask who should or can regulate the regulators. The problems have to be overcome in order to provide the new radiopharmaceuticals that are the food and wine of nuclear medicine. (orig.)

  9. Radiopharmaceuticals used in nuclear cardiology

    International Nuclear Information System (INIS)

    Costa, H.

    1985-01-01

    During the last years, since short physical mean life radionuclides have started to be used, radionuclide scanning has been experienced with remarkable culmination. There are detector devices, which jointly with computation equipments, allow to obtain multiple images per second as properly rapid gammagraphic series, in order to obtain whole hemodynamic data or to generate functional images no representing an anatomical structure but reporting about cardiac dynamics at regional level. In these techniques, employed in Nuclear Cardiology, the following radionuclides and radiopharmaceuticals are used: radiolabeled albumin 99m Tc red blood cells, 113m In-transferrin, very short physical mean life radionuclides, such as 195m Au, 178 Ta, 191 Ir. In addition, 113 Xe for coronary flow measurements; radiolabeled microspheres and macroparticles for angiogammagraphy; 129 Cs, 43 K, 81 Rb, 82 Rb and 201 Ti, the most largerly used, for myocardial gammagraphy. It is pointed out that fatty acids are the newest, basically if are radioiodate, and some 99m Tc labeled long chain hydrocarbons. It is expressed that 99m Tc-Sn-pyrophosphate has been used for myocardial infarction. Working on the development of new radiopharmaceuticals, basically fatty acids and 99m Tc chelating agents, for the improvement of these techniques is carried out. (author)

  10. A Study on the Quality Control of 18F-FDG Radiopharmaceutical

    International Nuclear Information System (INIS)

    Kim, Ssang Tae; Yong, Chul Soon; Han, Eun Ok

    2010-01-01

    The types of test items which were recorded in this test report of quality control domestic 18 F-FDG radiopharmaceutical which consisted of 13 different types: appearance, half-life, radioactive heterokaryosis, radiochemical Confirmation (measure of Rf value), radiochemical Purity, Ethanol, Acetonitrile, Kryptofix, Aluminium, pH, Endotoxin, aseptic test, and radioactivity·ml-1. The record was fully recorded in 'appearance', 'radioactive heterokaryosis', 'pH', 'Endotoxin', and 'aseptic test'. In 'half-life', 'radiochemical Confirmation (measure of Rf value), 'radiochemical Purity', 'Ethanol', 'Acetonitrile', 'Kryptofix', 'Aluminium', 'radioactivity·ml-1', there were differences in records of each manufacturing business on radioactive medicine and medical supplies. The result of the test showed all 13 items of quality control test were 100% suitable on the basis of recorded data. There were more radiopharmaceutical made in the laboratory than in hospitals and businesses and in for result of suitability test, the laboratory showed higher suitability than did the hospitals or businesses. Domestically, there are differences of the test report items in the safety of radiopharmaceutical of each facility, and since it is not standardized, supplements are needed. To submit standardized test reports of quality guarantee in radiopharmaceutical, GMP of U.S. and CE Mark of Europe should be referred as well as receiving advice from professionals to standardize as suitable domestic standard

  11. Uncertainty sources in radiopharmaceuticals clinical studies; Fontes de incertezas em estudos clinicos com radiofarmacos

    Energy Technology Data Exchange (ETDEWEB)

    Degenhardt, Aemilie Louize; Oliveira, Silvia Maria Velasques de, E-mail: silvia@cnen.gov.br, E-mail: amilie@bolsista.ird.gov.br [Instituto de Radioprotecao e Dosimetria, (IRD/CNEN-RJ), Rio de Janeiro, RJ (Brazil)

    2014-07-01

    The radiopharmaceuticals should be approved for consumption by evaluating their quality, safety and efficacy. Clinical studies are designed to verify the pharmacodynamics, pharmacological and clinical effects in humans and are required for assuring safety and efficacy. The Bayesian analysis has been used for clinical studies effectiveness evaluation. This work aims to identify uncertainties associated with the process of production of the radionuclide and radiopharmaceutical labelling as well as the radiopharmaceutical administration and scintigraphy images acquisition and processing. For the development of clinical studies in the country, the metrological chain shall assure the traceability of the surveys performed in all phases. (author)

  12. Procedures of quality control of radiopharmaceutical activity counters

    International Nuclear Information System (INIS)

    Oliveira, A.E. de; Iwahara, A.; Gaast, H.A. van der; Buckman, S.M.

    1999-01-01

    The Radionuclides Metrology Supervision-Ionizing Radiation Metrology National Laboratory maintain and distributes the brazilian standards for radioactivity measurements. The Brazilian Institute for Metrology, Regulation and Industrial Quality (INMETRO), which is the brazilian authority for standards verification, is coordinating the enhancement of the standards distribution. Concerning to the nuclear medicine related radioisotopes, this network will provide for calibration of brazilian hospitals and clinics instruments, assuring great accuracy of the radiopharmaceuticals activities. This work gives details of the calibration quality control procedures recommended by the Radionuclides Metrology Supervisory (Brazilian National Nuclear Energy Commission) and the Radioactive Standards Division of the Australian Nuclear Technology and Science Organization (ANSTO). This information can be used as a guide for the brazilian nuclear medicine services guaranty on the accuracy and precision of the radiopharmaceuticals activity measurements measurements

  13. Developments in radioisotope production and labelling of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Lambrecht, R.M.

    1998-01-01

    Recent developments in both reactor and accelerator production of radioisotopes finding applications in nuclear medicine and in biomedical research are summarised. The priorities for the production of 48 different cyclotron radioisotopes; and for 42 reactor produced radioisotopes finding biomedical applications are identified. Each includes 5 generator systems. The rapid expansion of cyclotron based radioisotope production and automated synthesis of short-lived radiopharmaceuticals with the position-emitting radionuclides continues to gain momentum. Recent feasibility studies of the cyclotron production of 186 Re, 99m Tc and of 99 Mo are cited as examples of motivation to develop accelerator alternatives to use of nuclear reactors for medical radioisotope production. Examples of SPET and PET radiopharmaceuticals labelled with 131 I, 123 I, 124 I, 18 F, and with therapeutic radionuclides are highlighted. (author)

  14. Urinary excretion and external radiation dose from patients administered with radiopharmaceuticals

    International Nuclear Information System (INIS)

    Konishi, E.; Abe, K.; Kusama, T.

    1994-01-01

    Patients who have received radiopharmaceuticals become a source of exposure to those near them, such as nursing staff or visiting relatives. In order to provide quantitative information to propose protective measures for carers attending patients administered diagnostic amounts of 99 Tc, 67 Ga or 201 Tl (the most frequently used radiopharmaceuticals) the dose rate at various distances from 84 patients was measured using an ionising chamber, and the radioactivity of these compounds in urine collected from some patients was also measured. (author)

  15. Improving radiopharmaceutical supply chain safety by implementing bar code technology.

    Science.gov (United States)

    Matanza, David; Hallouard, François; Rioufol, Catherine; Fessi, Hatem; Fraysse, Marc

    2014-11-01

    The aim of this study was to describe and evaluate an approach for improving radiopharmaceutical supply chain safety by implementing bar code technology. We first evaluated the current situation of our radiopharmaceutical supply chain and, by means of the ALARM protocol, analysed two dispensing errors that occurred in our department. Thereafter, we implemented a bar code system to secure selected key stages of the radiopharmaceutical supply chain. Finally, we evaluated the cost of this implementation, from overtime, to overheads, to additional radiation exposure to workers. An analysis of the events that occurred revealed a lack of identification of prepared or dispensed drugs. Moreover, the evaluation of the current radiopharmaceutical supply chain showed that the dispensation and injection steps needed to be further secured. The bar code system was used to reinforce product identification at three selected key stages: at usable stock entry; at preparation-dispensation; and during administration, allowing to check conformity between the labelling of the delivered product (identity and activity) and the prescription. The extra time needed for all these steps had no impact on the number and successful conduct of examinations. The investment cost was reduced (2600 euros for new material and 30 euros a year for additional supplies) because of pre-existing computing equipment. With regard to the radiation exposure to workers there was an insignificant overexposure for hands with this new organization because of the labelling and scanning processes of radiolabelled preparation vials. Implementation of bar code technology is now an essential part of a global securing approach towards optimum patient management.

  16. Radiopharmaceuticals and hospital radiopharmacy practices: course manual for accreditation/certification of hospital radiopharmacists

    International Nuclear Information System (INIS)

    Ramamoorthy, N.; Shivarudrappa, V.; Bhelose, Amita A.

    2000-02-01

    This manual on hospital radiopharmaceuticals and hospital radiopharmacy practices contains information and recommendations that could be of use to hospital radiopharmacists while the main focus of the book is to impart adequate exposure to basics of radiopharmaceuticals and purity and safety aspects of formulations to be made in hospital radiopharmacy. Papers relevant to INIS are indexed separately

  17. Analytical methods for determination of radiochemical and radionuclidic purity of radiopharmaceuticals containing sup(99m)Tc and sup(113m)In. Part of a coordinated programme on radiopharmaceuticals

    International Nuclear Information System (INIS)

    Galatzeanu, I.

    1974-01-01

    The obtained results on radiochemical and radionuclidic purities determination of sup(99m)Tc and sup(113m)In-radiopharmaceuticals proved to be a good tool for small hospital units and laboratories in satisfying their duty to improve the quality control. The complicated behaviour of technetium in aqueous solutions during the preparation of radiopharmaceuticals, needs further research work to elucidate the mechanisms of interaction of reduced species with media and their disproportionation

  18. Adverse reactions to radiopharmaceuticals and their reporting

    International Nuclear Information System (INIS)

    Keeling, D.

    1988-01-01

    Adverse reactions to radiopharmaceuticals are uncommon and the great majority that do occur are relatively trivial and require little or no treatment. Reporting schemes for such reactions are in operation in a number of countries but they vary in their effectiveness and the best collect only a minority of cases; only 10-15% of total reactions in the United Kingdom, for instance. Radiopharmaceutical reaction reports in the UK for the period 1982-1987 are summarised in a table and then discussed. Reliable incidence figures for such reactions are difficult to obtain. The UK figure is estimated here to be near 1 per 2000. The great majority of reactions reported are of an idiopathic hypersensitivity nature and are related to the chemical form of the material; radiation has very rarely caused recognisable problems since the discontinuance of colloid gold for lymphatic clearance studies. The value of such reaction reports is their role as a forewarning to doctors

  19. Development of an injectable formulation for the preparation of radiopharmaceutical {sup 68}Ga-DOTA-Sar gastrin; Desarrollo de una formulacion inyectable para la preparacion del radiofarmaco {sup 68}Ga-DOTA-Sargastrina

    Energy Technology Data Exchange (ETDEWEB)

    Castillo P, M.

    2015-07-01

    The CCK2 receptor (cholecystokinin) is located in areas of the central and peripheral nervous system and is over expressed in several types of human cancer, as medullar thyroid, lung and ovarian carcinomas. One of the endogenous ligands for the CCK2 receptor is the gastrin, so that radiolabeled peptides analogues to gastrin as Sar gastrin (Gln-Gly-Pro-Trp-Leu-Glu-Glu-Glu-Glu-Glu-Ala-Tyr-Gly-Trp-Nle-Asp-Phe-NH{sub 2}) have been proposed as potential diagnostic radiopharmaceuticals for obtaining tumors images with CCK2 receptors over expressed. The {sup 68}Ga is an ideal candidate for the peptides radiolabelled and has favorable characteristics to be used for diagnostic purposes by imaging with Positron emission tomography (PET). This work aimed to verify the technical documentation of the production process of radiopharmaceutical {sup 68}Ga-DOTA-Sar gastrin for its sanitary registration before the Comision Federal contra Riesgos Sanitarios (COFEPRIS) in Mexico. For optimization of the production process was assessed a factorial design of two variables with mixed levels (27 combinations), where the dependent variable was the radiochemical purity. The analytical method used for evaluating the content of Sar gastrin peptide in the injectable formulation was also validated by High-performance liquid chromatography. Subsequently the validation of the production process was carried out by manufacturing of lots in single-dose of the optimized injectable formulation of the radiopharmaceutical {sup 68}Ga-DOTA-Sar gastrin and the stability study was conducted at different times to determine the useful life time. The following was established as the optimal pharmaceutical formulation: 185 MBq of {sup 68}Ga, 50 μg de DOTA-Sar gastrin, 14 mg of sodium acetate and 0.5 m L of buffer acetates, 1.0 M, ph 4.22 in 2.5 m L of the vehicle. The analytical method used to determine the radiochemical purity of the formulation satisfied the requirements for the intended analytical

  20. Implementation of a metrology programme to provide traceability for radionuclides activity measurements in the CNEN Radiopharmaceuticals Producers Centers

    Energy Technology Data Exchange (ETDEWEB)

    Andrade, Erica A.L. de; Braghirolli, Ana M.S.; Tauhata, Luiz; Gomes, Regio S.; Silva, Carlos J., E-mail: erica@ien.gov.br [Instituto de Engenharia Nuclear (IEN/CNEN-RJ), Rio de Janeiro, RJ (Brazil); Delgado, Jose U.; Oliveira, Antonio E.; Iwahara, Akira, E-mail: ealima@ird.gov.br [Instituto de Radioprotecao e Dosimetria (IRD/CNEN-RJ), Rio de Janeiro, RJ (Brazil)

    2013-07-01

    The commercialization and use of radiopharmaceuticals in Brazil are regulated by Agencia Nacional de Vigilancia Sanitaria (ANVISA) which require Good Manufacturing Practices (GMP) certification for Radiopharmaceuticals Producer Centers. Quality Assurance Program should implement the GMP standards to ensure radiopharmaceuticals have requirements quality to proving its efficiency. Several aspects should be controlled within the Quality Assurance Programs, and one of them is the traceability of the Radionuclides Activity Measurement in radiopharmaceuticals doses. The quality assurance of activity measurements is fundamental to maintain both the efficiency of the nuclear medicine procedures and patient and exposed occupationally individuals safety. The radiation doses received by patients, during the nuclear medicine procedures, is estimated according to administered radiopharmaceuticals quantity. Therefore it is very important either the activity measurements performed in radiopharmaceuticals producer centers (RPC) as the measurements performed in nuclear medicine services are traceable to national standards. This paper aims to present an implementation program to provide traceability to radionuclides activity measurements performed in the dose calibrators(well type ionization chambers) used in Radiopharmaceuticals Producer Center placed in different states in Brazil. The proposed program is based on the principles of GM Pand ISO 17025 standards. According to dose calibrator performance, the RPC will be able to provide consistent, safe and effective radioactivity measurement to the nuclear medicine services. (author)

  1. Current status of production and research of radioisotopes and radiopharmaceuticals in Indonesia

    Energy Technology Data Exchange (ETDEWEB)

    Soenarjo, Sunarhadijoso; Tamat, Swasono R. [Center for Development of Radioisotopes and Radiopharmaceuticals, National Nuclear Energy Agency (BATAN), Kawasan Puspiptek, Serpong, Tangerang (Indonesia)

    2000-10-01

    The use of radioactive preparation in Indonesia has sharply increased during the past years, indicated by increase of the number of companies utilizing radioisotopes during 1985 to 1999. It has been clearly stressed in the BATAN's Strategic Plan for 1994-2014 that the production of radioisotopes and radiopharmaceuticals is one of five main industrial fields within the platform of the Indonesian nuclear industry. Research programs supporting the production of radioisotopes and radiopharmaceuticals as well as development of production technology are undertaken by the Research Center for Nuclear Techniques (RCNT) in Bandung and by the Radioisotope Production Center (RPC) in Serpong, involving cooperation with other research center within BATAN, universities and hospitals as well as overseas nuclear research institution. The presented paper describes production and research status of radioisotopes and radiopharmaceuticals in Indonesia after the establishment of P.T. Batan Teknologi in 1996, a government company assigned for activities related to the commercial application of nuclear technology. The reviewed status is divided into two short periods, i.e. before and after the Chairman Decree No. 73/KA/IV/1999 declaring new BATAN organizational structure. Subsequent to the Decree, all commercial requests for radioisotopes and radiopharmaceuticals are fulfilled by P.T. Batan Teknologi, while demands on novel radioactive preparations or new processing technology, as well as research and development activities should be fulfilled by the Center for the Development of Radioisotopes and Radiopharmaceuticals (CDRR) through non-commercial arrangement. The near-future strategic research programs to response to dynamic public demand are also discussed. The status of research cooperation with JAERI (Japan) is also reported. (author)

  2. Analytical techniques for the determination of radiochemical purity of radiopharmaceuticals prepared from kits. Pt. III

    International Nuclear Information System (INIS)

    McLean, J.R.; Rockwell, L.J.; Welsh, W.J.

    1982-01-01

    The evaluation of efficacy of commercially available kits used for the preparation of radiopharmaceuticals is one aspect of the Radiation Protection Bureau's radiopharmaceutical quality control program. This report describes some of the analytical methodology employed in the program. The techniques may be of interest to hospital radiopharmacy personnel since many of the tests can be performed rapidly and with a minimum of special equipment, thus enabling the confirmation of radiopharmaceutical purity prior to patient administration. Manufacturers of kits may also be interested in learning of the analytical methods used in the assessment of their products

  3. Radiopharmaceuticals for palliative therapy pain; Radiofarmacos para terapia paliativa del dolor

    Energy Technology Data Exchange (ETDEWEB)

    Gaudiano, Javier [Universidad de la Republica, Montevideo (Uruguay). Centro de Medicina Nuclear

    1994-12-31

    Dissemination to bone of various neoplasms is cause of pain with poor response by major analgesics.Indications. Radiopharmaceuticals,description of main characteristics of various {beta} emitter radionuclides.Choose of patients for worm indication of pain palliative therapy with {beta} emitter radiopharmaceuticals is adequate must be careful . Contraindications are recognized.Pre and post treatment controls as clinical examination and complete serology are described.It is essential to subscribe protocols,keep patient well informed,included the physician in charge of the patient as part of the team.Bibliography.

  4. Comparison of two methods of radiopharmaceuticals production and evaluation of their quality

    International Nuclear Information System (INIS)

    Portillo L, M.C.; Rodriguez J, S.

    1987-05-01

    Two methods for the following five radiopharmaceuticals production were compared: sulfur colloid, diethylenetriamine pentaacetic calcium salt, phyrophosphate sodium, albumin aggregated, glucoheptonate calcium salt. Radiochemical purity was determined by electrophoresis, thin-layer chromatography and bio-distribution test in mice and rats. It was concluded that chromatographic method shows better efficiency and that bio-distribution test should be done only when testing new radiopharmaceuticals because the good correlation of this test with thin-layer chromatography. (author)

  5. Cerenkov Luminescence Tomography for In Vivo Radiopharmaceutical Imaging

    Directory of Open Access Journals (Sweden)

    Jianghong Zhong

    2011-01-01

    Full Text Available Cerenkov luminescence imaging (CLI is a cost-effective molecular imaging tool for biomedical applications of radiotracers. The introduction of Cerenkov luminescence tomography (CLT relative to planar CLI can be compared to the development of X-ray CT based on radiography. With CLT, quantitative and localized analysis of a radiopharmaceutical distribution becomes feasible. In this contribution, a feasibility study of in vivo radiopharmaceutical imaging in heterogeneous medium is presented. Coupled with a multimodal in vivo imaging system, this CLT reconstruction method allows precise anatomical registration of the positron probe in heterogeneous tissues and facilitates the more widespread application of radiotracers. Source distribution inside the small animal is obtained from CLT reconstruction. The experimental results demonstrated that CLT can be employed as an available in vivo tomographic imaging of charged particle emitters in a heterogeneous medium.

  6. Radiopharmaceuticals using radioactive compounds in pharmaceutics and medicine

    International Nuclear Information System (INIS)

    Theobald, A.

    1989-01-01

    This review of the latest techniques and developments indicates the importance of radiopharmaceutical techniques in the development of drug compounds. It presents practical demonstrations, offers practical exercises, as well as the underlying theoretical considerations: it will supplement existing (mostly American) texts in this subject, since most industrial pharmaceutical companies have a keen interest in the area and most pharmaceutical courses include the subject at degree level. The authors emphasize the pharmaceutical applications throughout. They review targeting aspects, including cell and protein labelling: and discuss radiotracers in testing dosage forms and formulation studies. Safety and legislation are considered, with reviews of the handling techniques, radiation monitoring, radiochromatography and the use of computer techniques. The latter part of the work discusses standards for radiopharmaceuticals, sterility and pyrogen testing, as well as both radiochromatographic and electrophoretic methods and their importance to quality control. (author)

  7. Engineering Technical Support Center Annual Report Fiscal ...

    Science.gov (United States)

    The United States Environmental Protection Agency (EPA or Agency) Office of Research and Development (ORD) created the Engineering Technical Support Center (ETSC) in 1987, one of several technical support centers created as part of the Technical Support Project (TSP). ETSC provides engineering expertise to Agency program and regional offices and remediation teams working at contaminated sites across the country. The ETSC is operated within ORD’s Land Remediation and Pollution Control Division (LRPCD) of the National Risk Management Research Laboratory (NRMRL) in Cincinnati, Ohio. The ETSC’s mission is to provide site-specific scientific and engineering technical support to Remedial Project Managers, On-Scene Coordinators, and other remediation personnel at contaminated sites. This allows local, regional, or national authorities to work more quickly, efficiently, and cost effectively, while also increasing the technical experience of the remediation team. Since its inception, the ETSC has supported countless projects across all EPA Regions in almost all states and territories. This report highlights significant projects the ETSC supported in fiscal year 2015 (FY15). These projects addressed an array of environmental scenarios, such as remote mining contamination, expansive landfill waste, cumulative impacts from multiple contamination sources, and persistent threats from abandoned industrial sites. Constructing and testing new and innovative treatment technol

  8. Preparações radiofarmacêuticas e suas aplicações Radiopharmaceuticals and applications

    Directory of Open Access Journals (Sweden)

    Rita Oliveira

    2006-06-01

    ármacos em uso clínico corresponde a agentes de perfusão. Atualmente, o esforço de investigação na área da química radiofarmacêutica centra-se no desenvolvimento de radiofármacos específicos que possam fornecer informação, ao nível molecular, relativa às alterações bioquímicas associadas às diferentes patologias.Radiopharmaceuticals are substances without pharmacological activity that are used in Nuclear Medicine for diagnosis and therapy for several diseases. Diagnosis radiopharmaceuticals generally emit gamma radiation or positrons (beta+, because their decay originates penetrating electromagnetic radiation that can cross the tissues and be externally detected. Therapeutic radiopharmaceuticals must include in their composition ionized particles emission nucleus (a, b- or Auger electrons, since their action is based in selective tissue destruction. There are two main methods for image acquisition: SPECT (Single Photon Emission Computerized Tomography that uses g emission radionuclides (99mTc, 123I, 67Ga, 201Tl and PET (Positron Emission Tomography that uses positron emission radionuclides like 11C, 13N, 15O, 18F. Radiopharmaceuticals can be classified into perfusion radiopharmaceuticals (first generation or specific radiopharmaceuticals (second generation. Perfusion radiopharmaceuticals are transported in the blood e reach the target organ in the direct proportion of the blood stream. Specific radiopharmaceuticals contain a biologically active molecule that binds to cellular receptors that must remain biospecific after binding to the radiopharmaceutical. For this type of radiopharmaceuticals, tissue or organ uptake is determined by the biomolecule capacity of recognizing receptors in those biological structures. Radiopharmaceuticals are produced ready to use, in cold kits or in autologal preparations. According to the preparation type there is a different quality control procedure. Most of the radiopharmaceuticals used nowadays are of the perfusion type

  9. Legal aspects of the production and application of radiopharmaceuticals in Germany; Arzeinmittelrechtliche Aspekte der Herstellung und Anwendung von Radiopharmaka

    Energy Technology Data Exchange (ETDEWEB)

    Kuwert, T.; Prante, O. [Universitaetsklinikum, Erlangen (Germany). Nuklearmedizinische Klinik; Meyer, G. [Medizinische Hochschule Hannover (Germany). Klinik fuer Nuklearmedizin

    2009-06-15

    This article deals with the regulation of the production and use of radiopharmaceuticals in Germany. As in other countries, radiopharmaceuticals may be used when licensed by the German equivalent of the Federal Drug Agency or in clinical trials. Furthermore, non-licensed radiopharmaceuticals can be administered to patients for diagnosis when they are produced in the same institution and not more than 20 doses per week and radiopharmaceutical are given. A prerequisite for these three ways of use is the production of the radiopharmaceutical in question according to the guidelines of the good manufacturing practice (GMP) which creates considerable problems for the usually small PET centers installed in the German university hospitals. German law offers a further possibility to apply non-licensed radiopharmaceuticals for clinical purposes: their administration to patients is not forbidden when performed by a physician who produces the substance himself or is at least responsible for its synthesis. This regulation has, however, been met with criticism by government agencies. (orig.)

  10. Radiopharmaceuticals in breast milk

    International Nuclear Information System (INIS)

    Mountford, P.J.; Coakley, A.J.

    1986-01-01

    As assessment has been made of the radiological hazards to an infant following the administration of a radiopharmaceutical to a breast feeding mother. Feeding should be discontinued after administration of most I-131 and I-125 compounds, Ga-67 citrate or Se-78 methionine, and for iodinated compounds where it was possible to resume feeding, a thyroid-blocking agent should be administered. For Tc-99m compounds, pertechnetate had the greatest excretion in milk and interruptions of 12hr and 4hr were considered appropriate for pertechnetate and MAA respectively. Other Tc-99m compounds, Cr-51 EDTA and In-111 leucocytes did not justify an interruption just on the grounds of their associated excretion in milk. The ingestion hazard could be minimized by reducing the administered activity, and in some cases, by the substitution of a radiopharmaceutical with lower breast milk excretion. For Tc-99m lung and brain scans, the absorbed dose due to radiation emitted by the mother (i.e. when cuddling) was less than the ingested dose, but for a Tc-99m bone scan the emitted dose was greater. In all three cases, the emitted dose did not exceed 0 x 5 mGy for the infant in close contact to the mother for one-third of the time. For In-111 leucocytes, the emitted dose was about 2mGy, and it was concluded that close contact should be restricted to feeding times during the first 3 days after injection. 36 references, 2 figures, 5 tables

  11. Radiopharmaceuticals labelled with positron-emitting radioisotopes

    International Nuclear Information System (INIS)

    Comar, D.; Berridge, M.; Maziere, B.; Crouzel, C.

    1982-01-01

    This chapter reviews the preparation of radioisotopes for biochemical and physiological studies and the principal methods for their incorporation into radiopharmaceuticals, while pointing out the problems encountered with their use and considering their medical interest in the following areas: distribution and flow of fluids, metabolic and pharmacokinetic studies. Inorganic and organic radiopharmaceuticals presently in use and most probable to be used in the future are reviewed. It is anticipated that three types of products labelled with 15 O, 13 N, 11 C and 18 F will be developed in the future. The first type includes products which trace general phenomena such as fluid movement or metabolism of sugars, fats and proteins. The compromise between physiological accuracy and imaging technology is discussed in relation to the use of 11 C and 18 F. The second type of product is one to measure more specific parameters such as those of molecular transport kinetics, membrane permeability, cellular pH and receptor-ligand interactions, again with particular reference to 11 C and 18 F. The third type of product discussed is that intended for pharmacology studies, particular reference being made to 68 Ga, 82 Rb. Extensive bibliography. (U.K.)

  12. Automated Synthesis of 68Ga-DOTA-TOC: Methodological Aspects and Suitable Technical Solutions for a Cationic Purification System.

    Science.gov (United States)

    Uccelli, Licia; Boschi, Alessandra; Cittanti, Corrado; Martini, Petra; Lodi, Luca; Zappaterra, Elisa; Romani, Simona; Zaccaria, Samanta; Cecconi, Davide; Rambaldi, Ilaria; Santi, Ivan; Panareo, Stefano; Giganti, Melchiore; Bartolomei, Mirco

    2018-05-08

    The PET Gallium-68 isotope has the advantage of being produced from a generator, so it is also available in nuclear medicine departments without a cyclotron. The preparation of Ga-68 DOTA-labelled compounds is actually performed by remotely controlled automated systems developed in order to assure production efficiency, reproducibility of the results, guarantee fast reaction time, to facilitate the synthesis and minimize the radiation exposure. Many automatic synthesis systems are available on the radiopharmaceutical market, and each of these requires the realization of some technical adaptations for routine use. We reported the Ga-68 DOTATOC production by automated cassette-based theranostic synthesizer system used in combination with a disposable GMP grade cassette system for cationic purification. The synthesizer is integrated with the 68Ge/68Ga generator systems and it allows to perform elution, eluate purification and radiolabeling in about 38 minutes. We have performed between January 2016 and January 2017 over 100 [68Ga]Ga-DOTA-TOC preparation and of these only three have failed. The average synthesis yield of radiopharmaceutical production was 54.4 ± 2.3 % and the average radiochemical purity was 96.94 ± 0.74 %. The methodology and the technical solutions adopted have allowed to obtain a high quality radiopharmaceutical product as required by the European Pharmacopoeia. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  13. Preparation and quality control of technetium-99m radiopharmaceuticals

    International Nuclear Information System (INIS)

    Samuels, D.L.

    1978-11-01

    Appropriate procedures for the production and quality control of technetium-99m based radiopharmaceuticals in hospital radiopharmacy consistent with the recently published Australian Code of Good Manufacturing Practice are discussed

  14. Export of radiopharmaceuticals and establishment of export base of cyclotron

    International Nuclear Information System (INIS)

    Jung, Kyungil; Kim, Youngsik

    2006-01-01

    Sam young Unit ech has seized an opportunity to advance into the radiopharmaceuticals market through successful transfer of radiopharmaceuticals manufacturing technology and medical cyclotron, an original technology in nuclear medicine that is the core of less developed areas in nuclear-related fields. The company has continued to push for research development and establishment of market base through industry-academia-research center cooperation with an aim to complement relatively less developed domestic technology and market than in advanced countries, and is making efforts to establish export base in the overseas market based on stabilized supply in the domestic market. As for radiopharmaceuticals, the company is exporting Tc-99m generator to Vietnam, Thailand and the Philippines and preparing itself to export manufacture facilities for Tc-99m generator to Syria and Kazakhstan. In addition, it plans to export 13Mev Cyclotron that has been commercialized after being developed in the domestic market to the U. S. The company plans to grow up to play a pivotal role in the domestic RT area by conducting proactive business activities with an aim to revitalize the domestic market and further domestic original technologies and products in the global market

  15. Preparation of Radiopharmaceuticals Labeled with Metal Radionuclides

    Energy Technology Data Exchange (ETDEWEB)

    Welch, M.J.

    2012-02-16

    The overall goal of this project was to develop methods for the production of metal-based radionuclides, to develop metal-based radiopharmaceuticals and in a limited number of cases, to translate these agents to the clinical situation. Initial work concentrated on the application of the radionuclides of Cu, Cu-60, Cu-61 and Cu-64, as well as application of Ga-68 radiopharmaceuticals. Initially Cu-64 was produced at the Missouri University Research Reactor and experiments carried out at Washington University. A limited number of studies were carried out utilizing Cu-62, a generator produced radionuclide produced by Mallinckrodt Inc. (now Covidien). In these studies, copper-62-labeled pyruvaldehyde Bis(N{sup 4}-methylthiosemicarbazonato)-copper(II) was studied as an agent for cerebral myocardial perfusion. A remote system for the production of this radiopharmaceutical was developed and a limited number of patient studies carried out with this agent. Various other copper radiopharmaceuticals were investigated, these included copper labeled blood imaging agents as well as Cu-64 labeled antibodies. Cu-64 labeled antibodies targeting colon cancer were translated to the human situation. Cu-64 was also used to label peptides (Cu-64 octriatide) and this is one of the first applications of a peptide radiolabeled with a positron emitting metal radionuclide. Investigations were then pursued on the preparation of the copper radionuclides on a small biomedical cyclotron. A system for the production of high specific activity Cu-64 was developed and initially the Cu-64 was utilized to study the hypoxic imaging agent Cu-64 ATSM. Utilizing the same target system, other positron emitting metal radionuclides were produced, these were Y-86 and Ga-66. Radiopharmaceuticals were labeled utilizing both of these radionuclides. Many studies were carried out in animal models on the uptake of Cu-ATSM in hypoxic tissue. The hypothesis is that Cu-ATSM retention in vivo is dependent upon the

  16. Harvard-MIT research program in short-lived radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Adelstein, S.J.

    1991-01-01

    This report presents research on radiopharmaceuticals. The following topics are discussed: antibody labeling with positron-emitting radionuclides; antibody modification for radioimmune imaging; labeling antibodies; evaluation of technetium acetlyacetonates as potential cerebral blood flow agents; and studies in technetium chemistry. (CBS)

  17. Effects of radiation exposure from radiopharmaceuticals used in diagnostic studies

    International Nuclear Information System (INIS)

    Witcofski, R.L.

    1981-01-01

    In the United States about 90 percent of man-made radiation exposure to the general population is from the use of radiation in diagnostic medicine. Although the doses of radiation from these procedures to individuals are generally quite small, large numbers of people are exposed. Estimates of the radiation doses associated with such use in the healing arts are approximately 15 million person-rem to the general population from diagnostic x ray and 3.3 million person-rem from the diagnostic use of radiopharmaceuticals. The purpose of this paper is to present what is known about the possible effects of radiation from diagnostic radiopharmaceuticals

  18. Study of surface potential contamination in radioisotope and radiopharmaceutical production facilities and alternative solutions

    International Nuclear Information System (INIS)

    Suhaedi Muhammad; Rimin Sumantri; Farida Tusafariah; Djarwanti Rahayu Pipin Soedjarwo

    2013-01-01

    Radioisotope and radiopharmaceutical production facilities that exist in their operations around the world in the form of radiological impacts of radiation exposure, contamination of surface and air contamination. Given the number of existing open source in radioisotope and radiopharmaceutical production facility, then the possibility of surface contamination in the work area is quite high. For that to protect the safety and health of both workers, the public and the environment, then the licensee must conduct an inventory of some of the potential that could result in contamination of surfaces in radioisotope and radiopharmaceutical production facilities. Several potential to cause surface contamination in radioisotope and radiopharmaceutical production facilities consist of loss of resources, the VAC system disorders, impaired production facilities, limited resources and lack of work discipline and radioactive waste handling activities. From the study of some potential, there are several alternative solutions that can be implemented by the licensee to address the contamination of the surface so as not to cause adverse radiological impacts for both radiation workers, the public or the environment. (author)

  19. Career Technical Education Pathways Initiative Annual Report

    Science.gov (United States)

    California Community Colleges, Chancellor's Office, 2014

    2014-01-01

    California's education system--the largest in the United States--is an essential resource for ensuring strong economic growth in the state. The Career Technical Education Pathways Initiative (the Initiative) became law in 2005 with Senate Bills 70 and 1133 and provided more than $380 million over eight years to improve career technical education…

  20. Radiopharmaceuticals in Radiosynoviorthesis

    International Nuclear Information System (INIS)

    Cruz Arencibia, Jorge; Morin Zorrilla, Jose; Garcia Rodriguez, Enrique; Sagarra Veranes, Marta

    2010-01-01

    The Radiosynoviorthesis is a procedure of Metabolic Radiotherapy, consisting in the intraarticular injection of a radiopharmaceutical with a beta emitting radionuclide for the treatment of chronic synovitis, frequently present in rheumatoid arthritis, haemophilia and other systemic diseases. As this is a safe, effective and a relatively low-cost procedure, It is ordinarily used in Europe, USA and in some Latin American countries . The existing commercial products are based on 90 Y, 169 Er, 186 Re and 32 P, although research is carried out on the use of 188 Re, 166 Ho, among others radionuclides. In Cuba a suspension of Chromium Phosphate (III) labeled with 32 P, is on trial. The above-mentioned suspension has enough characteristics to become an efficient and safe product in practice. (Author)

  1. Determination of Sn in 99mTc Radiopharmaceutical Kits by Polarographic Methods

    International Nuclear Information System (INIS)

    Castro, M.; Cruz, J.; Sanchez, M.

    2009-01-01

    Kits of 99 m Tc radiopharmaceuticals are used in nuclear medicine for diagnosis of different diseases. Sn (II) is one of the essential components in their formulations, which is used for reduction 99 m Tc-pertechnetate in cold kits for on-site preparation 99 m Tc-pertechnetate radiopharmaceuticals. Usually, these cold kits contain different additives (complexing agents, antioxidants, buffers, etc.) and the amount of Sn (II) varies from kit to kit. The determination of Sn in these products is essential in assessing their quality. We report here the development of a new polarographic method for the determination of Sn (II) and total Sn in representative radiopharmaceuticals kits (for the content of Sn and chemical composition) produced at the Center of Isotopes of Cuba (CENTIS). These methods were validated by analysis of variance and recovery techniques. From the results of the validation, the characteristic functions of uncertainties and fits are considered for the established methods, which give the necessary evidences to demonstrate the usefulness of these methods according to the current trends in Analytical Chemistry. This work provides practical results of great importance for CENTIS. After the speciation of Sn in the MAG3 radiopharmaceuticals kit is inferred that the production process is affected by uncontrolled factors that influence in the product stability, which demonstrates the necessity for analytical tools for the characterization of products and processes. (Author) 57 refs.

  2. The liability of the radiopharmacist and the nuclear physician in the use of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Coustou, F.

    1986-01-01

    A brief article examines the traditional aspects of the physician's and pharmacist's liability in general followed by a discussion on the liability of the nuclear physician and the radiopharmacist in the use of radiopharmaceuticals. It is concluded that the liabilities involved in the use of radiopharmaceuticals go well beyond the scope of traditional medicine and pharmacy. (UK)

  3. The regional service for the preparation and distribution of radiopharmaceuticals in the west of Scotland

    International Nuclear Information System (INIS)

    Horton, P.W.

    1977-01-01

    The centralised preparation of radiopharmaceuticals was begun in 1965 for reasons of radiological safety and cost effectiveness. It enabled the provision of a single specially designed facility to process large quantities of radioactivity safely and avoided the distributed handling of radioactivity. Effective supervision of the safe usage and disposal of radionuclides in hospitals throughout the region became practicable. It also enabled the bulk purchase of radiopharmaceuticals with lower unit costs and their efficient utilisation due to the large number of users. Since 1965, great changes have taken place in the nature of the common radiopharmaceuticals. Most now have short physical half-lives and must be prepared close to their place of use. This has meant improving the pharmaceutical standards of the facilities and working methods. However, the reasons stated above for a centralised service are still applicable and have been reinforced by others arising from the need for good pharmaceutical manufacturing practice in current radiopharmaceutical production

  4. Analysis of residual solvents in PET radiopharmaceuticals by GC

    International Nuclear Information System (INIS)

    Li Yungang; Zhang Xiaojun; Liu Jian; Tian Jiahe; Zhang Jinming

    2013-01-01

    The residual solvents in PET radiopharmaceuticals were analyzed by GC, which were acetonitrile, ethanol, N, N-dimethylethanolamine (DMEA), dimethylsulfoxide (DMSO). The standard curves were established with the AT-624 capillary column at GC, and the sensitivity of acetonitrile and ethanol were 0.004-0.320 g/L and 0.010-0.120 g/L respectively. The residual solvents of acetonitrile, ethanol, DMEA and DMSO in PET radio- pharmaceuticals were analyzed by GC. The linearity were 0.9994, 0.9999, 0.9997, 0.999 6 respectively. The residual of acetonitrile were (0.0313±0.0433), (0.0829±0.0668), (0.0156±0.0059), (0.0254±0.0266) g/L in 18 F-FDG, 18 F-FLT, 11 C-CFT, 11 C-PIB respectively. The residual of ethanol was (0.0505±0.00528) g/L in 18 F-FDG. The residual of DMSO were (0.0331±0.0180) g/L, (0.0238±0.0100) g/L in 18 F-W372 and 11 C-DTBZ respectively. The residual of DMEA was (0.0348±0.0022) g/L in 11 C-Choline. The survived of organic solvent in PET radiopharmaceuticals can be analyzed with GC directly. The results showed that the QC should be done in PET radiopharmaceuticals purity with semi-HPLC to avoid the high residual. (authors)

  5. Bone-seeking radiopharmaceuticals in skeletal malignancy: evolution, not revolution

    International Nuclear Information System (INIS)

    MacFarlane, D.

    2003-01-01

    Many advanced malignancies are complicated by skeletal metastases, with attendant pain and disability. External beam radiotherapy is still the most effective treatment for isolated lesions. Bone-seeking radiopharmaceuticals were perceived as a means of delivering radiation to multiple lesions simultaneously. A wide variety of radioisotopes have been used in this endeavor, with myelosuppression being the most significant potential adverse effect. Benefits of treatment are modest, including a transient improvement in pain control and perhaps prolongation of the treatment-free period. This is best demonstrated in prostate cancer with lower responses by skeletal metastases from breast and lung cancers. However, the treatment is yet to produce any improvement in patient survival. Experimental approaches to improve treatment efficacy include combination with cytotoxic therapy, and administration earlier in the course of the disease. Bone seeking radiopharmaceuticals have been used in treatment of advanced osteosarcoma in humans and canines and achieved effective palliation. The myelosuppressive effects of these agents have been exploited in patients with multiple myeloma to assist in attaining myeloablation prior to stem cell transplantation. Development of more potent non-radiolabelled bisphosphonates and recognition of their antitumour effect against several tumours has sparked a recrudescence of interest in their use for bone metastases. Set against these developments, the role of bone-seeking radiopharmaceuticals in skeletal metastases may need to be redefined

  6. Pain palliative Radiopharmaceuticals; Radiofarmacos paliativos del dolor

    Energy Technology Data Exchange (ETDEWEB)

    Gonzalez, B M [Instituto Nacional de Pediatria (Mexico)

    1994-12-31

    A pain relieving agents based on {beta} emitters mainly and in some cases a complex preparation are being given for bone metastasis in relation with breast,prostate and lung carcinoma with good performance in clinical practice.Several radionuclides and radiopharmaceuticals are mentioned giving strength to those newly proposed, 153Sm and 186Re.Bibliography.

  7. Harvard-MIT research program in short-lived radiopharmaceuticals. Progress report, March 1, 1983-February 29, 1984

    International Nuclear Information System (INIS)

    Adelstein, S.J.; Brownell, G.L.

    1984-02-01

    This report describes research efforts towards the achievement of a clearer understanding of the solution chemistry of technetium in order to facilitate the design of future clinical agents labeled with Tc-99m, the development of new receptor binding radiopharmaceuticals for the in vivo assessment of insulin receptors and for imaging the adrenal medulla and the brain, the examination of the utility of monoclonal antibodies and liposomes in the design of radiopharmaceuticals for diagnosis and therapy, and the synthesis of short-lived positron-emitting radiopharmaceuticals for transverse imaging of regional physiological processes

  8. [Fortieth Annual] Meeting of the Technical Working Group on Fast Reactors (TWG-FR). Working Material

    International Nuclear Information System (INIS)

    2008-01-01

    The objectives of the meeting were to: - Exchange information on the national programmes on Fast Reactors (FR) and Accelerator Driven Systems (ADS); - Review the progress since the 39th TWG-FR Annual Meeting, including the status of the actions; - Consider meeting arrangements for 2007, 2008 and 2009; - Review the Agency’s ongoing information exchange and co-ordinated research activities in the technical fields relevant to the TWG-FR (FRs and ADS), as well as coordination of the TWG-FR’s activities with other organizations; - Discuss future joint activities in view of the Agency’s Programme and Budget Cycle 2008–2009 (and beyond)

  9. Aptamer-based radiopharmaceuticals for diagnostic imaging and targeted radiotherapy of epithelial tumors

    International Nuclear Information System (INIS)

    Missailidis, Sotiris; Perkins, Alan; Santos-Filho, Sebastiao David; Fonseca, Adenilson de Souza da; Bernardo-Filho, Mario

    2008-01-01

    In the continuous search for earlier diagnosis and improved therapeutic modalities against cancer, based on our constantly increasing knowledge of cancer biology, aptamers hold the promise to expand on current antibody success, but overcoming some of the problems faced with antibodies as therapeutic or delivery agents in cancer. However, as the first aptamer reached the market as an inhibitor against angiogenesis for the treatment of macular degeneration, aptamers have found only limited applications or interest in oncology, and even less as radiopharmaceuticals for diagnostic imaging and targeted radiotherapy of tumours. Yet, the chemistry for the labelling of aptamers and the options to alter their pharmacokinetic properties, to make them suitable for use as radiopharmaceuticals is now available and recent advances in their development can demonstrate that these molecules would make them ideal delivery vehicles for the development of targeted radiopharmaceuticals that could deliver their radiation load with accuracy to the tumour site, offering improved therapeutic properties and reduced side effects. (author)

  10. Aptamer-based radiopharmaceuticals for diagnostic imaging and targeted radiotherapy of epithelial tumors

    Energy Technology Data Exchange (ETDEWEB)

    Missailidis, Sotiris [The Open University, Milton Keynes (United Kingdom). Dept. of Chemistry and Analytical Sciences]. E-mail: s.missailidis@open.ac.uk; Perkins, Alan [University of Nottingham (United Kingdom). Dept. of Medical Physics; Santos-Filho, Sebastiao David; Fonseca, Adenilson de Souza da; Bernardo-Filho, Mario [Universidade do Estado do Rio de Janeiro (UERJ), RJ (Brazil). Inst. de Biologia Roberto Alcantara Gomes. Dept. de Biofisica e Biometria

    2008-12-15

    In the continuous search for earlier diagnosis and improved therapeutic modalities against cancer, based on our constantly increasing knowledge of cancer biology, aptamers hold the promise to expand on current antibody success, but overcoming some of the problems faced with antibodies as therapeutic or delivery agents in cancer. However, as the first aptamer reached the market as an inhibitor against angiogenesis for the treatment of macular degeneration, aptamers have found only limited applications or interest in oncology, and even less as radiopharmaceuticals for diagnostic imaging and targeted radiotherapy of tumours. Yet, the chemistry for the labelling of aptamers and the options to alter their pharmacokinetic properties, to make them suitable for use as radiopharmaceuticals is now available and recent advances in their development can demonstrate that these molecules would make them ideal delivery vehicles for the development of targeted radiopharmaceuticals that could deliver their radiation load with accuracy to the tumour site, offering improved therapeutic properties and reduced side effects. (author)

  11. Missouri local technical assistance program at Missouri University of Science and Technology (formerly University of Missouri--Rolla) : annual progress report January-December 2007.

    Science.gov (United States)

    2009-02-01

    This annual report is a summary of the activities during 2007 for the Missouri Local Technical Assistance Program (Missouri LTAP), which is located at Missouri University of Science and Technology. The report highlights Missouri LTAPs performance ...

  12. Abbreviated New Drug Applications (ANDAS): Future trend in radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kishore, R.

    1990-01-01

    The Drug Price Competition and Patent Term Restoration Act (commonly called Waxman Hatch Amendment) of 1984, to the Federal Food, Drug, and Cosmetic Act provided for abbreviated new drug applications (ANDAs) if the conditions specified in the Code of Federal Regulations (CFR) Title 21, subsection 312.55 are met. Under this subsection, reports of nonclinical laboratory studies and clinical investigations can be omitted. New drugs approved under these regulations are so called generic drugs as opposed to listed or pioneer (innovator) drugs. As the patents on more and more radiopharmaceuticals reach their expiration, the radiopharmaceutical industry is likely to produce more of these generic versions of innovator drugs. The ANDAs are required to contain information specified under subsections 314.50(a), (b), (d)(1) and (3), (e), and (g)

  13. Survey of radiopharmaceuticals used for in vivo studies in medical practice in New Zealand

    International Nuclear Information System (INIS)

    McEwan, A.C.; Smyth, V.G.

    1984-01-01

    To obtain up-to-date information on numbers and types of radiopharmaceutical procedures, a survey was undertaken in the last quarter of 1983. In conjunction with this survey dosimetry data for the range of radiopharmaceutical procedures has been reviewed and extended where necessary so that effective dose equivalents could be estimated and mean genetically significant and malignancy significant doses for the population derived

  14. State of the art and perspectives in radiopharmaceutical field since ACOMEN 8. International Conference (Bordeaux May 11-13, 2005)

    International Nuclear Information System (INIS)

    Vuillez, J.P.; Desruet, M.D.; Desruet, M.D.; Mundler, O.; Karcher, G.

    2009-01-01

    Since previous ACOMEN conference in 2005 on radiopharmaceuticals, many improvements have been encountered: active research has allowed the development of numerous new tracers of interest, with a large part dedicated for PET; clinical applications of radiopharmaceuticals have resulted in patients care improvement, both for management and survival; therapeutic applications are now fully recognized, as internal targeted radiotherapy could be considered as efficient in several cancer diseases; and regulation, despite remaining difficulties, will certainly become more favourable for radiopharmaceuticals. Thus we could make sure that radiopharmaceuticals use will be even more established in the next years. (authors)

  15. Meeting of the Technical Working Group on Fast Reactors (TWG-FR) (39th annual meeting). Working material

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2007-07-01

    The 39th Annual Meeting of the Technical Working Group on Fast Reactors (TWG FR) was held from 15-19 May 2006 in Beijing, China, at the invitation of the China Institute of Atomic Energy (CIAEA). The meeting was attended by TWG-FR Members and Advisers from the following Member States (MS): Belgium (observer), Brazil, China, France, Germany, India, Italy, Japan, the Republic of Kazakhstan, the Republic of Korea, the Russian Federation, Sweden (observer), the United Kingdom, and the United States. Belarus, Switzerland, the European Commission, and OECD/NEA were unable to participate. Moreover, Prof. Carlo Rubbia, CERN director general emeritus, participated, upon IAEA invitation, in the meeting as distinguished scientist and IAEA expert. Mr. S.C. Chetal, from India (Indira Gandhi Centre for Atomic Research, IGCAR), was appointed chairman. The objectives of the meeting were to: - Exchange information on the national programmes on Fast Reactors (FR) and Accelerator Driven Systems (ADS); - Review the progress since the 38th TWG-FR Annual Meeting, including the status of the actions; - Consider meeting arrangements for 2006 and 2007; - Reviewed the Agency's ongoing information exchange and co-ordinated research activities in the technical fields relevant to the TWG-FR (FRs and ADS), as well as co-ordination of the TWG-FR's activities with other organizations; - Discuss future joint activities in view of the Agency's Programme and Budget Cycle 2008-2009 (and beyond)

  16. Quality evaluation of radiopharmaceuticals in nuclear medicine services in the states of Alagoas and Sergipe - Brazil

    International Nuclear Information System (INIS)

    Santos, Poliane Angelo de Lucena; Andrade, Wellington Gomes de; Lima, Fernando Roberto de Andrade; Lima, Fabiana Farias de

    2011-01-01

    Radiopharmaceuticals are compounds associated with a radionuclide. They can be considered as vectors that have some specificity for an organ or a physiological or pathophysiological function. Assessing the radiopharmaceutical's quality is essential to obtain adequate images, avoiding repetition of examinations and unnecessary absorbed dose to the patient. Resolution no. 8 (RCD 38) of 06/04/2008 by Agencia Nacional de Vigilancia Sanitaria (ANVISA) states the obligation of performing a minimum of tests in the routines of nuclear medicine services (NMS). The aim of this work was to evaluate the radiochemical purity and pH of radiopharmaceuticals used in NMS in states of Alagoas and Sergipe - Brazil. Radiochemical purity was determined by thin layer chromatography where a paper Whatman and TLC were used as steady state and the solvents were used related to the appropriate radiopharmaceutical, both as recommended by the manufacturer's directions. The chromatographic strips were placed in closed containers to avoid contact with the walls. After, the strips were cut in 1cm pieces and the activity was determined in each NMS's activity calibrators. The radiopharmaceuticals pH was evaluated by using universal pH paper (Merck) and the obtained color was compared with its range of colors. It was observed that 33.34% and 2.3% of the tested radiopharmaceuticals showed PRQ (radiochemical purity) and pH values, respectively, are outside of the limits described by the manufacturers. The results show that the radiochemical purity assessment in the NMS's routine can indicate problems with a radioisotope tagging, allowing their exclusion before administration. (author)

  17. Production of radiopharmaceuticals by cyclotrons

    International Nuclear Information System (INIS)

    Schmitz, F.; Van Naemen, J.; Monclus, M.; Van Gansbeke, B.; Kadiata, M.; Ekelmans, D.; Moray, M.; Penninckx, R.; Goldman, S.

    2004-01-01

    Companies specialized in the development and installation of accelerator-based systems dedicated to the medical applications brought on the market cyclotrons well fitted to the requests of the industrial community or universities and so covering every segment of the market. These machines are fully automatic, and need reduced maintenance; they are highly specialized for defined tasks. They can produce high beam intensity and realize dual beam irradiation. Also the prices are reducing considerably. The targets and the automatic system follow the same trend. Unfortunately, the flexibility of these devices for new area of research and development has been dramatically reduced. The growing number of PET cameras has increased the popularity of PET tracers used for nuclear imaging. Consequently, there is a growing demand for these radiopharmaceuticals compounds labeled with short-lived radioisotopes for clinical applications. From a research and development tool in the eighties, PET has now grown up to a clinical tool. Moreover, depending of the social welfare, reimbursement of some PET examinations is granted, which accelerates the trend for an extended use of PET tracers. Regulatory affairs try to establish and standardize the control on these radiopharmaceutical compounds produced in a growing number of local radio pharmacies owning a baby cyclotron. On the other hand, the attention of equipment suppliers was brought in the setting up of a total quality control follow up. These efforts were successively achieved by getting for instance the ISO 9001 certificate

  18. Drug interaction with radiopharmaceuticals: effect on the labeling of red blood cells with technetium-99m and on the bioavailability of radiopharmaceuticals

    Directory of Open Access Journals (Sweden)

    Maria Luisa Gomes

    2002-09-01

    Full Text Available The evidence that natural and synthetic drugs can affect radiolabeling or bioavailability of radiopharmaceuticals in setting of nuclear medicine clinic is already known. However, this drug interaction with radiopharmaceuticals (DIR is not completely understood. Several authors have described the effect of drugs on the labeling of blood elements with technetium-99m (99mTc and on the biodistribution of radiopharmaceuticals. When the DIR is known, if desirable or undesirable, the natural consequence is a correct diagnosis. However, when it is unknown, it is undesirable and the consequences are the possibility of misdiagnosis and/or the repetition of the examination with an increase of radiation dose to the patient. The possible explanation to the appearance of DIR are (a radiopharmaceutical modification, (b alteration of the labeling efficiency of the radiopharmaceutical, (c modification of the target, (d modification of no target and/or the (e alteration of the binding of the radiopharmaceutical on the blood proteins. The effect of drugs on the labeling of blood elements with 99mTc might be explained by (i a direct inhibition (chelating action of the stannous and pertechnetate ions, (ii damage induced in the plasma membrane, (iii competition of the cited ions for the same binding sites, (iv possible generation of reactive oxygen species that could oxidize the stannous ion and/or (v direct oxidation of the stannous ion. In conclusion, the development of biological models to study the DIR is highly relevant.A evidência de que drogas naturais ou sintéticas podem afetar a radiomarcação ou a biodisponibilidade de radiofármacos nos procedimentos de medicina nuclear já é bem conhecida. Entretanto, essa interação de droga com radiofármacos (IDR não está completamente compreendida. Vários autores têm descrito o efeito de drogas na marcação de elementos sanguíneos com tecnécio-99m (99mTce na biodistribuição de radiofármacos. Quando a

  19. A Study on the Quality Control of {sup 18}F-FDG Radiopharmaceutical

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Ssang Tae [CareCamp Inc., Seoul (Korea, Republic of); Yong, Chul Soon [Yeungnam University, Gyeongsan (Korea, Republic of); Han, Eun Ok [Daegu Health College, Daegu (Korea, Republic of)

    2010-12-15

    The types of test items which were recorded in this test report of quality control domestic {sup 18}F-FDG radiopharmaceutical which consisted of 13 different types: appearance, half-life, radioactive heterokaryosis, radiochemical Confirmation (measure of Rf value), radiochemical Purity, Ethanol, Acetonitrile, Kryptofix, Aluminium, pH, Endotoxin, aseptic test, and radioactivity·ml-1. The record was fully recorded in 'appearance', 'radioactive heterokaryosis', 'pH', 'Endotoxin', and 'aseptic test'. In 'half-life', 'radiochemical Confirmation (measure of Rf value), 'radiochemical Purity', 'Ethanol', 'Acetonitrile', 'Kryptofix', 'Aluminium', 'radioactivity·ml-1', there were differences in records of each manufacturing business on radioactive medicine and medical supplies. The result of the test showed all 13 items of quality control test were 100% suitable on the basis of recorded data. There were more radiopharmaceutical made in the laboratory than in hospitals and businesses and in for result of suitability test, the laboratory showed higher suitability than did the hospitals or businesses. Domestically, there are differences of the test report items in the safety of radiopharmaceutical of each facility, and since it is not standardized, supplements are needed. To submit standardized test reports of quality guarantee in radiopharmaceutical, GMP of U.S. and CE Mark of Europe should be referred as well as receiving advice from professionals to standardize as suitable domestic standard.

  20. Preparation and in vitro evaluation of 177Lu-iPSMA-RGD as a new heterobivalent radiopharmaceutical

    International Nuclear Information System (INIS)

    Escudero-Castellanos, Alondra; Universidad Autonoma del Estado de Mexico, Toluca, Estado de Mexico; Ocampo-Garcia, B.E.; Ferro-Flores, Guillermina; Santos-Cuevas, C.L.; Isaac-Olive, Keila; Olmos-Ortiz, Andrea; Garcia-Quiroz, Janice; Garcia-Becerra, Rocio; Diaz, Lorenza

    2017-01-01

    This study aimed to synthesize a new 177 Lu-iPSMA-RGD heterobivalent radiopharmaceutical, as well as to assess the in vitro radiopharmaceutical potential to target cancer cells overexpressing PSMA and α(v) β(3) integrins. The radiotracer prepared with a radiochemical purity of 98.8 ± 1.0% showed stability in human serum, specific recognition with suitable affinity to PSMA and α(v)β(3) integrins, and capability to inhibit cancer cell proliferation and VEGF signaling (antiangiogenic effect). Results warrant further preclinical studies to establish the 177 Lu-iPSMA-RGD potential as a dual therapeutic radiopharmaceutical. (author)

  1. Determination of radiochemistry purity and pH of radiopharmaceutical in Northeast nuclear medicine services

    International Nuclear Information System (INIS)

    Andrade, Wellington; Santos, Poliane; Lima, Fernando de Andrade; Lima, Fabiana Farias de

    2013-01-01

    The radiopharmaceutical is a chemical compound associated with a radionuclide, which is selected so that meets the need cf diagnosis and capable of producing quality images. Drugs labeled with 99m Tc radionuclide kits consist of lyophilized, and be handled by the nuclear medicine services (NMS) must pass tests as the resolution of ANVISA (RDC 38) published in 2008. Among these tests are those of radiochemical purity and pH determination. This study evaluated the radiochemical purity of radiopharmaceuticals and pH SMN manipulated in the Northeast. The radiochemical purity (RCP) was determined by thin layer chromatography, which were used Whatman ® and silica gel, with dimensions of 1 x 10 cm, as stationary phase, and solvents indicated in the inserts of manufacturers. The chromatographic strips were placed in sealed containers so as not to touch the walls thereof. After the chromatographic run, the tape was cut every centimeter and the activities determined in doses of each calibrator NMS. The pH of the radiopharmaceutical was assessed through the use of universal pH paper (Merck®) and obtained staining compared with its color scale. The results showed (hat 82.6% and 100% of the radiopharmaceuticals of the samples were within the limits recommended by international pharmacopoeias for radiochemical purity and pl-l, respectively. There is then the need to include in routine tests indicated SMN by ANVISA. Well, they can detect possible problems in the marking of radiopharmaceuticals administered to the patient and avoid inappropriate material. (author)

  2. The quality of 99mTc-radiopharmaceuticals - a basic requirement in the diagnostic nuclear medicine

    International Nuclear Information System (INIS)

    Ivanova, S.; Popsavova, H.; Kostadinova, I.

    2011-01-01

    Development and application of new high quality radiopharmaceuticals (RP) are of a great significance for the development in nuclear medicine. The high quality of the radiopharmaceuticals has a major influence on the accuracy of nuclear medical examinations. Therefore, a good knowledge and application if various control methods, is essential. Radiochemical impurities affect the quality of RP most significantly and they can appear at every stage of the preparation. The aim of this review is to present the literature information concerning the quality of the most commonly used radiopharmaceuticals, labeled with 99m Tc, and all requirements for them, i.e. radiochemical, radionuclide and chemical purity. This is well-known fact that metastable isotope of Technetium is golden standard for diagnostics in nuclear medicine. Research shows that about 80% of approx. 25 million nuclear medical studies a year are performed with this radionuclide. According to the European Pharmacopoeia and to the leaflets provided with the kits, radiochemical purity must exceed 95%. The main radiochemical impurities in 99m Tc-radiopharmaceuticals are free pertechnetate ( 99m TcO 4 - ), whose presence causes accumulation of RP in the thyroid gland, stomach, gastrointestinal tract, or the salivary glands, leading to a wrong diagnosis, and reduced hydrolyzed technetium, which causes visualization of the reticulo-endothelial system. This paper contains information about the authors' experience with analyses of the radiochemical purity of the two most commonly used radiopharmaceuticals in Bulgaria - for bone and renal scintigraphy (MDA and DTPA). An Instant Thin-Layer Chromatography (ITLC) is used for this purpose. It is concluded that the high quality of the applied 99m Tc-radiopharmaceuticals can be guaranteed only with both selection of renowned manufactures, recognized by EU, and a routine daily control of the labeling and generator eluate, meeting all requirements of the manufacturer and

  3. Proceedings of 26. annual academic conference of China Chemical Society--modern nuclear chemistry and radiochemistry

    International Nuclear Information System (INIS)

    2008-08-01

    26. annual academic conference of China Chemical Society was held in Tianjing, 13-16 July, 2008. This proceedings is about modern nuclear chemistry and radiochemistry, the contents include: new elements and new nuclides; advanced nuclear chemistry; radiochemistry and national security; new radiopharmaceutical chemistry; modern radiological analytical chemistry and large scientific facilities; radiological environmental chemistry and nuclear radioactive waste; actinide chemistry and transactinide chemistry; radiochemistry and cross discipline, etc.

  4. Radiopharmaceuticals. 40 years is nothing

    International Nuclear Information System (INIS)

    Hager, Alfredo A.

    2006-01-01

    The nuclear medicine is today a medical speciality recognized and practised in the whole world. The birth was in the middle of the 20th century in the use of molecules or drugs marked with a radionuclide (radiopharmaceutical), for the diagnostic studies in vivo or in vitro, to obtain a therapeutic effect. Early in the decade of 70, its development and evolution was accentuated thanks to electronics, the contribution of new instruments for detection of diagnosis by images (gamma camera) and to the emergence of new radionuclide (in particular, 99m Tc). (author) [es

  5. Parameter estimation and compartmental modelling for individualization of therapeutic dosage of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Giussani, A.; Cantone, C.

    2001-01-01

    A successful application of radiopharmaceuticals for therapy requires a patient-specific optimization of the administration activity. The intention of this contribution is to show how this is possible with a relatively limited effort, by combining an optimized experimental schedule for the collection of the anatomic and physiological data of interest and a rigorous mathematical analysis. The benefits of such an optimization will concern not only the success of the therapy, but also the radiological protection of the patients and could even be translated in a more cost-effective usage of the radiopharmaceutical available. (author)

  6. Metabolic radiopharmaceutical therapy in nuclear medicine; Terapia metabolica mediante radiofarmacos en medicina nuclear

    Energy Technology Data Exchange (ETDEWEB)

    Reguera, L.; Lozano, M. L.; Alonso, J. C.

    2016-08-01

    In 1986 the National Board of Medical Specialties defined the specialty of nuclear medicine as a medical specialty that uses radioisotopes for prevention, diagnosis, therapy and medical research. Nowadays, treatment with radiopharmaceuticals has reached a major importance within of nuclear medicine. The ability to treat tumors with radiopharmaceutical, Radiation selective therapy has become a first line alternative. In this paper, the current situation of the different therapies that are sued in nuclear medicine, is reviewed. (Author)

  7. Influence of sweeteners in the biodistribution of radiopharmaceutical ...

    African Journals Online (AJOL)

    Influence of sweeteners in the biodistribution of radiopharmaceutical and laboratory tests in rats. Michelly Pires Queiroz, Vanessa Santos de Arruda Barbosa, Cecília Maria de Carvalho Xavier Holanda, Janette Monroy Osório, Tarciso Bruno Montenegro Sampaio, Christina da Silva Camillo, Aldo Cunha Medeiros, Marília ...

  8. Incorporation of radiohalogens via versatile organometallic reactions: applications in radiopharmaceutical chemistry

    Energy Technology Data Exchange (ETDEWEB)

    Srivastava, P.C.; Goodman, M.M.; Knapp, F.F. Jr.

    1985-01-01

    Factors that must be considered for the design of radiohalogenated radio-pharmaceuticals include the stability and availability of the substrate, the physical half-life of the radiohalogen and the in vivo stability of the radiolabel. Vinyl and phenyl radiohalogen bonds show more in vivo stability than the alkyl radiohalogen bonds. Consequently, a variety of methods suitable for the synthesis of tissue specific radiopharmaceuticals bearing a vinyl or phenyl radiohalogen have been developed involving the synthesis and halogenation of metallovinyl and phenyl intermediates. The halogens and metallation reactions include iodine and bromine and alanation, boronation, mercuration, stannylation, and thallation, respectively. 19 refs., 1 fig., 1 tab.

  9. Regulatory and technical reports (abstract index journal): Annual compilation for 1994. Volume 19, Number 4

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-03-01

    This compilation consists of bibliographic data and abstracts for the formal regulatory and technical reports issued by the US Nuclear Regulatory Commission (NRC) Staff and its contractors. It is NRC`s intention to publish this compilation quarterly and to cumulate it annually. The main citations and abstracts in this compilation are listed in NUREG number order. These precede the following indexes: secondary report number index, personal author index, subject index, NRC originating organization index (staff reports), NRC originating organization index (international agreements), NRC contract sponsor index (contractor reports), contractor index, international organization index, and licensed facility index. A detailed explanation of the entries precedes each index.

  10. Engineering Technical Support Center Annual Report Fiscal Year 2015

    Science.gov (United States)

    The United States Environmental Protection Agency (EPA or Agency) Office of Research and Development (ORD) created the Engineering Technical Support Center (ETSC) in 1987, one of several technical support centers created as part of the Technical Support Project (TSP). ETSC provid...

  11. Radiological investigation in the outside area of expedition's room during radiopharmaceuticals' expedition

    International Nuclear Information System (INIS)

    Reina, Luiz C.; Monteiro, Ilka H.T.S.; Silva, Joao Carlos P. da; Teixeira, Danilo L.; Pedro, C.R.; Santos, J. Regis dos

    2013-01-01

    Radiopharmaceuticals produced in IEN - Instituto de Engenharia Nuclear of the Brazilian Nuclear Energy Commission, are issued by the radiation protection team, which is responsible for preparing and issuing the packaged documentation required for movement in modal transportation. The documents are: Invoice , Shipper's Declaration of Radioactive Material , Shipper's Declaration of Dangerous Goods - (form IATA ) , Emergency Sheet, sketch of packed. All this documentation is inserted in an envelope of emergency. The Department of Radiological Protection is responsible for issuing such documents except the invoice that is issued by the Commercial Sector (Setcom). A employee of this sector is responsible for delivering it to the shipment sector. The preparation of packaged and documentation is performed in a room located in the building of Radiopharmaceutical Division. The vehicles which are used in the transport are parked outside this building, where are monitored after commissioning of packaged. The present study aims to evaluate potential and occupational radiation risks of people in transit or remain in the area where radioactive material circulates due to the shipment of radiopharmaceuticals for the classification of the area during the operation of dispatch

  12. 2003 Chemical Engineering Division annual technical report

    International Nuclear Information System (INIS)

    Lewis, D.; Graziano, D.; Miller, J. F.; Vandegrift, G.

    2004-01-01

    national importance. Included among them are: Advanced lithium-ion and lithium-polymer batteries for transportation and other applications, Fuel cells, including the use of an oxidative reformer with gasoline as the fuel supply, Production and storage technologies critical to the hydrogen economy, Stable nuclear waste forms suitable for storage in a geological repository, Threat attribution and training relative to radioactive dispersal devices (''dirty bombs''), and Aqueous and pyrochemical processes for the disposition of spent nuclear fuel. Other important programs are focused in superconductivity, catalysis, nanotechnology, and nuclear materials. During fiscal year 2003, CMT had an annual operating budget of approximately $36 million. Of that, more than 90% was from DOE and the remainder from other government agencies and private industry. Displayed below is an overview organization chart of the Division. A complete organization chart appears at the end of this report. In this annual report we present an overview of the technical programs together with representative highlights. The report is not intended to be comprehensive or encyclopedic, but to serve as an indication of the condition and status of the Division

  13. Deficiencies in product labelling instructions and quality control directions for 99mTc radiopharmaceuticals.

    Science.gov (United States)

    Buroni, Federica E; Lodola, Lorenzo; Persico, Marco G; Aprile, Carlo

    2014-02-01

    The aim of the study was to identify deficiencies in product labelling instructions for reconstitution and in the quality control directions detailed in the technical leaflets (TLs) or summary product characteristic (SPC) sheets of commonly used technetium labelling cold kits. The reconstitution and quality control directions in 25 TLs/SPCs were evaluated to identify deficiencies, incompleteness, restrictions, errors, impracticability, and vagueness. In addition, their congruence with the statements given in the relative European Pharmacopoeia (Ph. Eur. VII ed.) monography and diagnostic reference levels of Directive 97/43/EURATOM was evaluated. Deficiencies in information were scored and classified into five categories: 1, absent or incomplete; 2, restrictive; 3, inconsistent or wrong; 4, impractical; and 5, vague. In the 25 documents analyzed a total of 141 deficiencies were found (corresponding to 40.2% of the total scores assigned), and more frequently they pertained to quality control procedures (70.9%), followed by those related to quantitative composition (14.9%), preparation (8.5%), and particle size (5.7%). Nearly 80% of these deficiencies were classified as type 1 - that is, absent or incomplete information. The indications in TLs and SPCs should provide useful information for maintaining the quality and purity of the radiopharmaceutical preparation and ensure the safety level and effectiveness required by law. However, the instructions are often suboptimal or even erroneous, and consequently there are countless failures or difficulties, which represent an impediment to good laboratory practice. We believe that a 'smart' review of radiopharmaceutical documentation would be beneficial in order to align these indications to the real needs of the operators involved in routine in-house nuclear medicine practice.

  14. 188Re radiopharmaceuticals for radiosynovectomy: evaluation and comparison of tin colloid, hydroxyapatite and tin-ferric hydroxide macroaggregates

    International Nuclear Information System (INIS)

    Savio, Eduardo; Ures, María Cristina; Zeledón, Patricia; Trindade, Victoria; Paolino, Andrea; Mockford, Virginia; Malanga, Antonio; Fernández, Marcelo; Gaudiano, Javier

    2004-01-01

    Radiosynovectomy is a therapy used to relieve pain and inflammation from rheumatoid arthritis and related diseases. In this study three 188 Re particulate compounds were characterized according to their physico-chemical properties and their biological behavior in rabbits. The results were compared in order to establish which was the radiopharmaceutical that better fits the requirements of this kind of radiotherapy. Three radiopharmaceutical formulations, tin colloid, hydroxyapatite particles (HA) and ferric hydroxide macroaggregates coated with tin colloid (FHMA), were physically characterized (number, volume and surface of the particles). For this purpose laser diffraction methodology was used. To evaluate cavity leakage of activity the following studies in New Zealand rabbits were performed: scintigraphic images for 48 hr after intraarticular injection of each radiopharmaceutical, biodistribution at 48 hr and urine samples collection during the first 24 hr post-radiopharmaceutical administration. Labeling procedures for 188 Re-HA and 188 Re-Sn-FHMA were labour intensive while 188 Re-Sn was easily prepared. Furthermore, 188 Re-Sn colloid offered the greatest surface area in the 2–10 microm range and was obtained with a radiochemical purity over 95%, while percentage of bound activity for 188 Re-HA and 188 Re-Sn-FHMA were 55% and 92% respectively. Stability was verified for the three radiopharmaceuticals for 24 hr. Scintigraphic studies and biodistribution in rabbits after intraarticular administration of the radiopharmaceuticals showed relevant activity only in the knee, this being over 90% of the residual activity in the whole body at 48 hr in every case. Renal elimination of 188 Re-Sn colloid and 188 Re-Sn-FHMA was detected by activity measurements in urine samples, during the first 12 hr post-radiopharmaceutical injection. The percentage of activity retained in the knee was 69.1% for 188 Re-Sn colloid, 55.1% for 188 Re-Sn-FHMA and 33.6% for 188 Re-HA. The 188

  15. Advances in nuclear medicine and in radiopharmaceuticals, International meeting in Cabo Frio. Program and abstracts

    International Nuclear Information System (INIS)

    2002-01-01

    The meeting of Advances in Nuclear Medicine and in Radiopharmaceuticals, held in Cabo Frio, Rio de Janeiro State, Brazil, in September 26-28, 2002, has provided an excellent opportunity for the presentation and the discussion of the latest achievements and new trends of nuclear medicine techniques and radiopharmaceuticals for the clinical evaluation of inflammation, infection, oncology and therapy of diseases with radionuclides

  16. Harvard-MIT research program in short-lived radiopharmaceuticals. Final report

    International Nuclear Information System (INIS)

    Adelstein, S.J.

    1995-02-01

    The Harvard-MIT Research Program in Short-lived Radiopharmaceuticals was established in 1977 to foster interaction among groups working in radiopharmaceutical chemistry at Harvard Medical School, the Massachusetts Institute of Technology, and the Massachusetts General Hospital. To this was added a group at The Childrens Hospital. From these collaborations and building upon the special strengths of the participating individuals, laboratories and institutions, it was hoped that original approaches would be found for the design of new, clinically useful, radiolabeled compounds. The original thrust of this proposal included: (a) examination of the coordination chemistry of technetium as a basis for rational radiopharmaceutical design, (b) development of an ultrashort-lived radionuclide generator for the diagnosis of congenital heart disease in newborns, (c) synthesis of receptor-site-directed halopharmaceuticals, (d) improved facile labeling of complex molecules with positron-emitting radionuclides. The authors' 1986 proposal was oriented toward organs and disease, emphasizing radiolabeled agents that delineate specific functions and the distribution of receptors in brain, heart, and tumors. In 1989, they further refined their purposes and focused on two major aims: (a) synthesis and utilization of neutral technetium and rhenium complexes of high specific activity, and (b) development of new approaches to the radiolabeling of proteins, peptides, immunoglobulins, and their fragments. In 1992, the authors amended this proposal to concentrate their efforts on biologically active peptides and proteins for targeted radiodiagnosis and therapy

  17. Harvard-MIT research program in short-lived radiopharmaceuticals. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Adelstein, S.J. [Massachusetts Inst. of Tech., Cambridge, MA (United States). Office of Sponsored Programs

    1995-02-01

    The Harvard-MIT Research Program in Short-lived Radiopharmaceuticals was established in 1977 to foster interaction among groups working in radiopharmaceutical chemistry at Harvard Medical School, the Massachusetts Institute of Technology, and the Massachusetts General Hospital. To this was added a group at The Childrens Hospital. From these collaborations and building upon the special strengths of the participating individuals, laboratories and institutions, it was hoped that original approaches would be found for the design of new, clinically useful, radiolabeled compounds. The original thrust of this proposal included: (a) examination of the coordination chemistry of technetium as a basis for rational radiopharmaceutical design, (b) development of an ultrashort-lived radionuclide generator for the diagnosis of congenital heart disease in newborns, (c) synthesis of receptor-site-directed halopharmaceuticals, (d) improved facile labeling of complex molecules with positron-emitting radionuclides. The authors` 1986 proposal was oriented toward organs and disease, emphasizing radiolabeled agents that delineate specific functions and the distribution of receptors in brain, heart, and tumors. In 1989, they further refined their purposes and focused on two major aims: (a) synthesis and utilization of neutral technetium and rhenium complexes of high specific activity, and (b) development of new approaches to the radiolabeling of proteins, peptides, immunoglobulins, and their fragments. In 1992, the authors amended this proposal to concentrate their efforts on biologically active peptides and proteins for targeted radiodiagnosis and therapy.

  18. Radiation risk in pediatric patients: the need for criteria using radiopharmaceuticals activities

    International Nuclear Information System (INIS)

    Simas, Felipe; Instituto de Radioprotecao e Dosimetria; Velasques, Silvia M.

    2009-01-01

    The administration of radionuclides to children for diagnostic procedures should be carried out only if there is a strong clinical indication. The amount of activity administered may be reduced according to body weight, body surface area or other appropriate criteria. In Brazil, activities used for pediatric patients were evaluated (2003-2005) in sixteen selected public and private institutions in Northeast, Southeast and South geographical regions. The present work presents radiopharmaceuticals activities used in Brazil compared with international surveys performed in USA in 2005 and in the European Union in 2007. The activities per patient weight and minimum and maximum activities used per Brazilian installations were compared with those used in USA installations. Per patients, it was calculated the ideal minimum administered activity for each type of radiopharmaceutical by body weight according the Pediatric Dosage Card (PDC) criteria. It was not possible to compare activities for all radiopharmaceuticals used in Brazil because some are not more used outside, e.g. 131 I-NaI, which is replaced by 123 I-NaI for thyroid imaging. The discrepancy between activities used in Brazil compared with those used in USA and Europe may be attributed to the heterogeneity of Brazilian imaging equipment and lack for specific children protocols. The disadvantages for using fractions of adult activities are: necessity of minimum statistical counting for assurance of image quality and dependence upon equipment calibration. It was concluded that is necessary to establish standard criteria for radiopharmaceuticals activities applied to pediatric patients in Brazil and the risks due to additional activities should be estimated individually. (author)

  19. Guidance for nuclear medicine staff on radiopharmaceuticals drug interaction

    Directory of Open Access Journals (Sweden)

    Ralph Santos-Oliveira

    2009-12-01

    Full Text Available Numerous drug interactions related to radiopharmaceuticals take place every day in hospitals many of which are not reported or detected. Information concerning this kind of reaction is not abundant, and nuclear medicine staff are usually overwhelmed by this information. To better understand this type of reaction, and to help nuclear medicine staff deal with it, a review of the literature was conducted. The results show that almost all of radiopharmaceuticals marketed around the world present drug interactions with a large variety of compounds. This suggests that a logical framework to make decisions based on reviews incorporating adverse reactions must be created. The review also showed that researchers undertaking a review of literature, or even a systematic review that incorporates drug interactions, must understand the rationale for the suggested methods and be able to implement them in their review. Additionally, a global effort should be made to report as many cases of drug interaction with radiopharmaceuticals as possible. With this, a complete picture of drug interactions with radiopharmaceuticals can be drawn.Diversos casos de interações medicamentosas com radiofármacos ocorrem diariamente na rotina hospitalar, contudo muitos deles não são notificados ou mesmo percebidos. Informações a respeito desse tipo de reação não é abundante e os profissionais da medicina nuclear muitas vezes estão assoberbados por essas informações. De modo a entender esse tipo de reação e auxiliar a medicina nuclear a lidar com essa situação uma revisão da literatura foi realizada. Os resultados mostraram que a totalidade dos radiofármacos comercializados no mundo apresentam interação medicamentosa com uma enorme variedade de outros medicamentos. Dessa forma sugere-se que revisões sobre radiofármacos inclua um capítulo sobre efeitos adversos. Além disso, um esforço mundial para notificar efeitos adversos deve ser realizado, pois somente

  20. A rapid and efficient preparation of [{sup 123}I]radiopharmaceuticals using a small HPLC Rocket[reg] column

    Energy Technology Data Exchange (ETDEWEB)

    Katsifis, Andrew [Radiopharmaceuticals Division R and D, Australian Nuclear Science and Technology, Organisation, Menai, NSW 2234, Sydney (Australia)]. E-mail: akx@ansto.gov.au; Papazian, Vahan [Radiopharmaceuticals Division R and D, Australian Nuclear Science and Technology, Organisation, Menai, NSW 2234, Sydney (Australia); Jackson, Timothy [Radiopharmaceuticals Division R and D, Australian Nuclear Science and Technology, Organisation, Menai, NSW 2234, Sydney (Australia); Loc' h, Christian [Radiopharmaceuticals Division R and D, Australian Nuclear Science and Technology, Organisation, Menai, NSW 2234, Sydney (Australia)

    2006-01-01

    A simplified method for the rapid and efficient preparation of [{sup 123}I]radiopharmaceuticals is described. Three radiopharmaceuticals, [{sup 123}I]{beta}-CIT, [{sup 123}I]MIBG and [{sup 123}I]clioquinol, were synthesised and purified as model compounds. The radiotracers were labelled with iodine-123 using electrophilic oxidative conditions and purified by a compact semi-preparative reverse phase column (C-18, 3 {mu}m, 7x53 mm, Alltima Rocket[reg, Alltech] using aqueous-ethanol as HPLC solvents that were directly used for radiopharmaceutical formulation. The radiochemical purity of the radioiodinated tracers as assessed by analytical HPLC was higher than 99% with specific activity higher than 3 GBq/nmol. The total preparation time of a radiotracer ranged from 40 to 60 min and, starting from 3.7 GBq of iodine-123, more than 2.5 GBq of formulated radiopharmaceuticals were available for clinical investigations.

  1. Infection imaging with radiopharmaceuticals in the 21st century

    Energy Technology Data Exchange (ETDEWEB)

    Das, Satya S.; Wareham, David W. [St. Bartholomew' s Hospital, London (United Kingdom). Dept. of Medical Microbiology; Britton, Keith E. [St. Bartholomew' s Hospital, London (United Kingdom). Dept. of Nuclear Medicine; Hall, Anne V. [Harefield Hospital, Middlesex (United Kingdom). Microbiology Dept.

    2002-09-01

    Infection continues to be a major cause of morbidity and mortality worldwide. Nuclear medicine has an important role in aiding the diagnosis of particularly deep-seated infections such as abscesses, osteomyelitis, septic arthritis, endocarditis, and infections of prosthetic devices. Established techniques such as radiolabelled leucocytes are sensitive and specific for inflammation but do not distinguish between infective and non-infective inflammation. The challenge for Nuclear Medicine in infection imaging in the 21st century is to build on the recent trend towards the development of more infection specific radiopharmaceuticals, such as radiolabelled anti-infectives (e.g. 99 m Tc ciprofloxacin). In addition to aiding early diagnosis of infection, through serial imaging these agents might prove very useful in monitoring the response to and determining the optimum duration of anti-infective therapy. This article reviews the current approach to infection imaging with radiopharmaceuticals nd the future direction it might take. (author)

  2. Infection imaging with radiopharmaceuticals in the 21st century

    International Nuclear Information System (INIS)

    Das, Satya S.; Wareham, David W.; Britton, Keith E.; Hall, Anne V.

    2002-01-01

    Infection continues to be a major cause of morbidity and mortality worldwide. Nuclear medicine has an important role in aiding the diagnosis of particularly deep-seated infections such as abscesses, osteomyelitis, septic arthritis, endocarditis, and infections of prosthetic devices. Established techniques such as radiolabelled leucocytes are sensitive and specific for inflammation but do not distinguish between infective and non-infective inflammation. The challenge for Nuclear Medicine in infection imaging in the 21st century is to build on the recent trend towards the development of more infection specific radiopharmaceuticals, such as radiolabelled anti-infectives (e.g. 99 m Tc ciprofloxacin). In addition to aiding early diagnosis of infection, through serial imaging these agents might prove very useful in monitoring the response to and determining the optimum duration of anti-infective therapy. This article reviews the current approach to infection imaging with radiopharmaceuticals nd the future direction it might take. (author)

  3. Public exposure due to the transport of radiopharmaceuticals; Exposicao do publico devido ao transporte de radiofarmacos

    Energy Technology Data Exchange (ETDEWEB)

    Rodrigues, Demerval L.; Carneiro, Janete C.G.G.; Sanches, Matias P.; Sordi, Gian Maria A.A., E-mail: dlrodri@ipen.b, E-mail: janetegc@ipen.b, E-mail: msanches@ipen.b, E-mail: gsordi@ipen.b [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)

    2011-10-26

    This paper estimate the radiological impact resulting from radiopharmaceuticals transport from the IPEN to some destinations defined a priori. So, doses were estimated in the public individuals, which are in the streets and vehicles that transit near the public transport, alongside the itinerary went through by packages, during the realization of radiopharmaceuticals transport

  4. Technical meeting (TM) to 'Review of national programmes on fast reactors and accelerator driven systems (ADS)'. Technical Working Group on Fast Reactors (TWG-FR) (37th annual meeting). Working material

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2004-07-01

    The objectives of the 37th Annual Meeting of the Technical Working Group on Fast Reactors, were to: 1) exchange information on the national programmes on Fast Reactors (FR) and Accelerator Driven Systems (ADS); 2) review the progress since the 36th TWG-FR Annual Meeting, including the status of the actions; 3) consider meeting arrangements for 2004 and 2005; 4) review the Agency's co-ordinated research activities in the field of FRs and ADS, as well as co-ordination of the TWG-FR's activities with other organizations. The participants made presentations on the status of the respective national programmes on FR and ADS development. A summary of the highlights for the period since the 36th TWG-FR Annual Meeting is included in this proceedings. Annex IV contains the Review of National Programs on Fast Reactors and Accelerator Driven Systems (ADS), and the TWG-FR Activity Report for the Period May 2003-April 2004.

  5. Radioprotection and management of radioactive residues study in the radiopharmaceuticals laboratories

    International Nuclear Information System (INIS)

    Zidan, Priscila M.; Silva, Maria Isabel B. da

    2002-01-01

    The 123 I, used in the thyroid cancer diagnoses, is being used at several clinics of nuclear medicine, instead of 131 I. This last one, for presenting half-life 15 times bigger than the first one, causes larger doses to the patient and slower exams. Another subject is the management of the residues generated by radiopharmaceutical laboratories, which requests lager physical space, in the case of 131 I. In the present work, six radiopharmaceutical laboratories of the state of Rio de Janeiro were visited. All of them use the 131 I produced by the Nuclear Engineering Institute. In these visits radioprotection procedures and the management of residues of those laboratories were evaluated, as well as the available infrastructure

  6. Quality assurance of radiopharmaceuticals-specifications and test procedures

    International Nuclear Information System (INIS)

    Baldas, J.; Bonnyman, J.; Pojer, P.M.

    1981-08-01

    This report is a compilation of test methods used and specifications adopted for the Radiopharmaceutical Quality Assurance Test Programme conducted by the Australian Radiation Laboratory. In some cases test procedures described have been taken from various Pharmacopoeias or methods published in the literature. In other cases test methods have been developed at the ARL

  7. Frequency of adverse reactions to radiopharmaceuticals in Europe

    Energy Technology Data Exchange (ETDEWEB)

    Hesslewood, S.R.; Keeling, D.H. [Radiopharmacy Department, City Hospital NHS Trust, Dudley Road, Birmingham B18 7QH (United Kingdom)

    1997-09-01

    A prospective survey was performed in 17 nuclear medicine departments during 1996 in an attempt to provide reliable data on the prevalence of adverse reactions to radiopharmaceuticals. All adverse events following radiopharmaceutical administration were recorded, irrespective of the severity or likelihood of causality, and subsequently analysed using an algorithm developed by Silberstein et al., designed to establish a cause-effect relationship. A prevalence of 11 events per 10{sup 5}administrations was obtained (95% confidence limits 3.3-19.2). No serious of life-threatening events were reported. This rate is slightly higher than that obtained in a larger scale study in the United States (2.3 events per 10 {sup 5}administrations, 95% confidence limits 1.2-3.4). The difference may be due to the decision to include or exclude vasovagal events from the analysis, the way in which the algorithm was used and the comparative size and time scale of the two studies. The prevalence of adverse reactions is approximately 1000-fold than less that occurring with iodinated contrast media and drugs. (orig.). With 2 tabs.

  8. Joint CDRH (Center for Devices and Radiological Health) and state quality-assurance surveys in nuclear medicine: Phase 2 - radiopharmaceuticals

    International Nuclear Information System (INIS)

    Hamilton, D.R.; Evans, C.D.

    1986-08-01

    The report discusses survey results on aspects of the quality assurance of radio-pharmaceuticals from 180 nuclear-medicine facilities in the United States. Data were collected from facilities in 8 states. Demographic information about nuclear-medicine operations and quality-assurance programs was gathered by state radiation-control-program personnel. The data collected from the survey show an incomplete acceptance of quality-assurance practices for radiopharmaceuticals. Most of the facilities in the survey indicated that, because an inferior radiopharmaceutical was prepared so infrequently, they did not believe it was cost-effective to perform extensive quality-assurance testing. The Center for Devices and Radiological Health hopes that the information from the survey will stimulate nuclear-medicine professionals and their organizations to encourage appropriate testing of all radiopharmaceuticals

  9. Development of radiopharmaceutical for radiosinovectomy; Desenvolvimento de radiofarmaco para radiosinovectomia

    Energy Technology Data Exchange (ETDEWEB)

    Couto, Renata Martinussi

    2009-07-01

    Radiopharmaceuticals prepared with different radionuclides have been used in diagnostic and therapeutic procedures in Nuclear Medicine. The interest in radionuclidic therapy has been increased in last years, with the introduction of new radiopharmaceuticals applied in the destruction of specific cells or to prevent its undesired proliferation. Radiosinovectomy (RSV) is a therapeutic modality that uses radiopharmaceuticals administered in the intra-articular cavity and represents an alternative to the treatment of different arthropaties and, in particular, the arthropaties derived from rheumatoid arthritis and haemophilic. The objective of the present work was to study the labeling of compounds with {sup 90}Y and {sup 177}Lu in order to improve the production conditions and quality control procedures, study the stability of the labeled compounds and preliminary biodistribution studies of the radiopharmaceuticals with potential for RSV applications. The study of the production of {sup 90}Y citrate colloid ({sup 90}Y-Cit) was based in a labeling procedure using {sup 90}Y Cl{sub 3} solution (37 - 54 MBq) that was previously dried, followed by the addition of yttrium nitrate and sodium citrate in p H 7 at 37 deg C for 30 minutes. The production of hydroxyapatite (HA) labeled with {sup 90}Y was based in a labeling procedure using mono hydrated citric acid, yttrium nitrate and {sup 90}Y Cl{sub 3} solution (37 - 370 MBq). The reaction mixture was incubated for 30 minutes at room temperature and the HA was introduced in aqueous medium and the reaction proceed for 30 minutes under strong stirring. {sup 177}Lu-HA was produced using {sup 177}Lu Cl{sub 3} solution (296 MBq), in presence of lutetium oxide in NaCl medium, p H 7, under continuous stirring for 30 minutes at room temperature. Several reaction parameters were studied for the three radiopharmaceuticals. Labeling yield was determined after particles were centrifuged and washed with NaCl 0,9%. Radiochemical purity was

  10. 7 CFR 3430.55 - Technical reporting.

    Science.gov (United States)

    2010-01-01

    ... required to submit other technical reports or submit the CRIS reports more frequently than annually... 7 Agriculture 15 2010-01-01 2010-01-01 false Technical reporting. 3430.55 Section 3430.55... ASSISTANCE PROGRAMS-GENERAL AWARD ADMINISTRATIVE PROVISIONS Post-Award and Closeout § 3430.55 Technical...

  11. Clinical trials using a radiopharmaceutical investigational drug: What legal environment and what authorizations required?

    International Nuclear Information System (INIS)

    El-Deeb, G.; Nguon, B.; Tibi, A.; Rizzo-Padoin, N.

    2009-01-01

    Recent revision of the legal environment for clinical research in France provided an opportunity to review what a hospital needs to carry out clinical trials using a radiopharmaceutical investigational drug. Legal measures concerning radiopharmaceutical investigational drugs are indeed more complex than those of classical clinical trials because of the additional legal provisions governing the use of ionizing radiation. Thus, requirements by the concerned staff (sponsor, pharmacist, person in charge of the nuclear activity) are described here. (authors) [fr

  12. Chemical and biological nonproliferation program. FY99 annual report; ANNUAL

    International Nuclear Information System (INIS)

    NONE

    2000-01-01

    This document is the first of what will become an annual report documenting the progress made by the Chemical and Biological Nonproliferation Program (CBNP). It is intended to be a summary of the program's activities that will be of interest to both policy and technical audiences. This report and the annual CBNP Summer Review Meeting are important vehicles for communication with the broader chemical and biological defense and nonproliferation communities. The Chemical and Biological Nonproliferation Program Strategic Plan is also available and provides additional detail on the program's context and goals. The body of the report consists of an overview of the program's philosophy, goals and recent progress in the major program areas. In addition, an appendix is provided with more detailed project summaries that will be of interest to the technical community

  13. Internal dosimetry of technetium-99m-labelled radiopharmaceuticals used in clinical nuclear medicine

    Energy Technology Data Exchange (ETDEWEB)

    Roedler, H D [Freie Univ. Berlin (Germany, F.R.). Klinikum Steglitz

    1977-01-01

    For radiopharmaceuticals labelled with /sup 99m/Tc, which is the most common short-lived radionuclide used in nuclear medicine, the possible dose reduction in comparison to other radionuclides for equal administered activities is deduced from the formalism of absorbed dose calculation and compared to the actually achieved decrease of absorbed dose for the most important radiopharmaceuticals. Absorbed doses per ..mu..Ci of administered activity are tabulated for the gonads, red bone marrow, and critical organs of the adult human, the newborn, and the child of 1, 5, 10, and 15 years.

  14. A 3D high-resolution gamma camera for radiopharmaceutical studies with small animals

    CERN Document Server

    Loudos, G K; Giokaris, N D; Styliaris, E; Archimandritis, S C; Varvarigou, A D; Papanicolas, C N; Majewski, S; Weisenberger, D; Pani, R; Scopinaro, F; Uzunoglu, N K; Maintas, D; Stefanis, K

    2003-01-01

    The results of studies conducted with a small field of view tomographic gamma camera based on a Position Sensitive Photomultiplier Tube are reported. The system has been used for the evaluation of radiopharmaceuticals in small animals. Phantom studies have shown a spatial resolution of 2 mm in planar and 2-3 mm in tomographic imaging. Imaging studies in mice have been carried out both in 2D and 3D. Conventional radiopharmaceuticals have been used and the results have been compared with images from a clinically used system.

  15. A Survey on the Usage and Demand of Medical Radioisotope and Radiopharmaceuticals in Malaysia

    International Nuclear Information System (INIS)

    Muhammad Fakhrurazi Ahmad Fadzil; Siti Selina Abdul Hamid; Siti Najila Mohd Janib; Azahari Kasbollah; Syed Asraf Fahlawi Wafa

    2015-01-01

    Medical radioisotope is a small quantity of radioactive substance used in safe, cost effective, for the purpose of diagnostic and therapy of various diseases. In Malaysia, the emerging of new nuclear medicine centers or institutions in both government and private sectors rose abruptly for the past few years. Currently, there are no data available on the usage and demand of medical radioisotope or radiopharmaceuticals. Understanding the usage trending and demand of radiopharmaceuticals and medical radioisotope is essential when related to technology changes in order to meet the market size of these radiopharmaceuticals. Survey result found out that the highest demand and the highest usage among all radioisotopes are Technetium-99m and Radioiodine isotopes such as the Iodine-1331, Iodine131 MIBG, Iodine-123 and Iodine-123 MIBG. Currently, most of the medical isotopes and radiopharmaceuticals are currently imported. Technetium-99m is the backbone of nuclear medicine whereby more than 80 % of Nuclear Medicine services utilize this radioisotope. Technetium-99m supply chain is unstable globally and in coming future, two main reactors (Canada and Holland) that produces 60 % of world Molybdenum-99 will shut down the operation and supply of Molybdenum-99 will be disrupted. As for radioiodine services, currently, Iodine-123 can't be obtained in Malaysia and neighboring countries due to its short half-life, Iodine-123 is useful in diagnostic of thyroid related diseases. As for PET services, the highest demands are F-18 FDG and Gallium-68 Generator for the moment. However the survey data still did not include most of the PET centers in the Klang Valley, northern area (Penang) and the new upcoming PET center in Southern Region (Malacca and Johor). It is important for Malaysia to self-produced medical radioisotope and radiopharmaceuticals to meet the market and local demand of these medical isotopes. (author)

  16. SU-E-I-82: PET Radiopharmaceuticals for Prostate Cancer Imaging: A Review

    International Nuclear Information System (INIS)

    Fernandes, F; Silva, D da; Rodrigues, L

    2015-01-01

    Purpose: The aim of this work was to review new and clinical practice PET radiopharmaceuticals for prostate cancer imaging. Methods: PET radiopharmaceuticals were reviewed on the main databases. Availability, dosimetry, accuracy and limitations were considered. Results: The following radioisotopes with respective physical half-life and mean positron energy were found: 18 F (109,7 min, 249,8 keV), 89 Zr (78,4 hs, 395,5 keV), 11 C (20,4 min, 385,7 keV) and 68 Ga (67,8 min, 836 keV). 68 Ga was the only one not produced by cyclotron. Radiopharmaceuticals uptake by glucose metabolism ( 18 F-FDG), lipogenesis ( 11 C-Choline and 11 C-Acetate), amino acid transport (Anti- 18 F-FACBC), bone matrix ( 18 F-NaF), prostatespecific membrane antigen ( 68 Ga-PSMA and 89 Zr-J591), CXCR receptors ( 89 Ga-Pentixafor), adrenal receptors ( 18 F-FDHT) and gastrin release peptide receptor (bombesin analogue). Most of radiopharmaceuticals are urinary excretion, so bladder is the critical organ. 11C-choline (pancreas), Anti- 18 FFACBC (liver) and 18 F-FBDC (stomach wall) are the exception. Higher effective dose was seen 18 F-NaF (27 μSv/MBq) while the lowest was 11 CAcetate (3,5 μSv/MBq). Conclusion: Even though 18 F-FDG has a large availability its high urinary excretion and poor uptake to slow growing disease offers weak results for prostate cancer. Better accuracy is obtained when 18 F-NaF is used for bone metastatic investigation although physicians tend to choose bone scintigraphy probably due to its cost and practice. Many guidelines in oncology consider 11 C or 18 F labeled with Choline the gold standard for biochemical relapse after radical treatment. Local, lymph node and distant metastatic relapse can be evaluated at same time with this radiopharmaceutical. There is no consensus over bigger urinary excretion for 18 F labeling. Anti- 18 F-FACBC, 68 Ga-PSMA and 68 Ga-Pentixafor are demonstrating good results but more researches are needed. While PSMA imaging seems to be

  17. Radiopharmaceuticals in positron emission tomography: Radioisotope productions and radiolabelling procedures at the Austin and Repatriation Medical Centre

    International Nuclear Information System (INIS)

    Tochon-Danguy, H.J.; Sachinidis, J.I.; Chan, J.G.; Cook, M.

    1997-01-01

    Positron Emission Tomography (PET) is a technique that utilizes positron-emitting radiopharmaceuticals to map the physiology, biochemistry and pharmacology of the human body. Positron-emitting radioisotopes produced in a medical cyclotron are incorporated into compounds that are biologically active in the body. A scanner measures radioactivity emitted from a patient's body and provides cross-sectional images of the distribution of these radiolabelled compounds in the body. It is the purpose of this paper to review the variety of PET radiopharmaceuticals currently produced at the Austin and Repatriation Medical Centre in Melbourne. Radioisotope production, radiolabelling of molecules and quality control of radiopharmaceuticals will be discussed. A few examples of their clinical applications will be shown as well. During the last five years we achieved a reliable routine production of various radiopharmaceuticals labelled with the four most important positron-emitters: oxygen-15 (t, 1/2 =2min), nitrogen-13 (t 1/2 = 10 min), carbon-11 (t 1/2 =20 min) and fluorine-18 (t 1/2 = 110 min). These radiopharmaceuticals include [ 15 O]oxygen, [ 15 O]carbon monoxide, [ 15 O]carbon dioxide, [ 15 O]water, [ 13 N]ammonia, [ 11 C]flumazenil, [ 11 C]SCH23390, [ 18 F]fluoromisonidazole and [ 18 F]fluoro-deoxy-glucose ([ 18 F]FDG). In addition, since the half life of [ 18 F] is almost two hours, regional distribution can be done, and the Austin and Repatriation Medical Centre is currently supplying [ 18 F]FDG in routine to other hospitals. Future new radiopharmaceuticals development include a [ 18 F]thymidine analog to measure cell proliferation and a [ 11 C]pyrroloisoquinoline to visualize serotonergic neuron abnormalities. (authors)

  18. Organic radiopharmaceuticals: recent advances

    International Nuclear Information System (INIS)

    Wolf, A.P.; Fowler, J.S.

    1979-01-01

    Organic radiopharmaceuticals are considered in light of accelerator and nuclide production requirements, special problems relating to the carrier-free state, including terminology, of the special technology required to prepare and manipulate these compounds and new trends in compound design and synthesis. The emphasis is on medical cyclotrons and the positron-emitting radionuclides, carbon-11, nitrogen-13, oxygen-15, and fluorine-18. New routes to synthetic precursors and organic compounds of high specific activity labeled with carbon-11, fluorine-18, and iodine-123 including monosaccharides, aromatic amines, neuroleptics, fatty acids, steroids, and other classes of compounds are discussed. Some compounds are considered in terms of the development and evaluation of structure-activity relationships and including some newer concepts such as metabolic trapping. 67 references

  19. The excretion of radiopharmaceuticals in human breast milk: additional data and dosimetry

    International Nuclear Information System (INIS)

    Rubow, S.; Klopper, J.; Wasserman, H.; Baard, B.; Niekerk, M. van

    1994-01-01

    The amount of radioactivity excreted in breast milk following administration of 11 different radiopharmaceuticals, has been measured. This report summarises the data collected from 60 patients. An effective decay constant for the series of samples from each patient was calculated. In order to formulate reliable guidelines, we calculated the total activity theoretically excreted in milk until complete decay of the radionuclide. Of the various 99m Tc compounds, pertechnetate clearly reaches the highest concentrations in breast milk. The wide variability of data from different patients who received the same radiopharmaceutical despite identical methods of sample collection and data processing confirms the impression gained from literature that transfer of radionuclides into milk varies greatly between individuals. We believe that for radiation protection purposes, a ''worst case'' approach is the most appropriate. With new data available and the revision of ICRP recommendations, the guidelines applicable when radiopharmaceuticals are administered to breast-feeding mothers are reviewed. The effective dose resulting from close contact between patient and infant was included in these calculations. Breast feeding need not be interrupted after administration of 99m Tc-DISIDA, -sulphur colloid, -gluconate and -methoxyisobutylisonitrile (MIBI). However, after administration of 99m Tc-MIBI, close contact should be restricted. 99m Tc-pyrophosphate and -microspheres require interruption periods of several hours. High activities of 99m Tc-pertechnetate may require interruption longer than 2 days. For pertechnetate and 99m Tc-labelled red blood cells, interruption of breast feeding with measurement of activity in expressed milk samples is recommended. Breast feeding is contra-indicated after administration of 67 Ga and 131 I. General guidelines regarding breast feeding after administration of radiopharmaceuticals are summarised. (orig./MG)

  20. Preparation of carbon 11-labelled radiopharmaceuticals by the use of HPLC method

    International Nuclear Information System (INIS)

    Berget, G.; Maziere, M.; Godot, J.M.; Sastre, J.; Prenant, C.; Comar, D.

    1982-06-01

    Various medical examinations and metabolic studies are carried out with carbon 11-labelled radiopharmaceuticals. This radioelement offers a number of advantages: it can be introduced into an organic molecule without changing its properties; the radiation dose delivered to the patient is low (T = 20 mn); since the specific activity obtained is high (0.5 to 2 Ci/μ mole) the injected masses are very small; finally, tomographic images of the distribution of the product in the body may be obtained by the use of positron cameras. However in view of the radioactivities handled on a routine basis the preparations must be carried out without manual intervention, in closed shielded hoods. Synthesis methods and special equipment have been developed. In all cases the reaction mixtures are purified by HPLC, a method chosen for its speed, efficiency, ease of automation and adaptation to any product with a suitable choice of column and eluant. The radiopharmaceuticals are obtained in injectable solution (ethanol-physiological serum, buffered physiological serum) or in a mixture of volatile solvents which are evaporated by nitrogen bubbling and finally sterilised by passage over millipore filter. About ten different radiopharmaceuticals are prepared in this way in the laboratory [fr

  1. Comparative study of radiopharmaceuticals as radiodiagnostic agent of cardiac damage in rats

    International Nuclear Information System (INIS)

    Gallego Heise, R.

    1983-01-01

    Six radiopharmaceuticals were screened in a small-animal model as potential infarct-localizing agents. The model used was subcutaneous inyection of isoproterenol (30 mg/kg of body weight) - induced myocardial lesions in rats, similar to an infarct and ischemia in human beings, corroborated by histological findings. The uptake of each radiopharmaceuticals is measured at various times after lesion initiation. The results are expressed as % I.D./g and through the contrast relations between the activity of whole heart of treated rats and the others tissues. The relation damaged heart/normal heart (DH/NH) of the phosphorated radiopharmaceuticals (sup(99m) Tc-PPi, sup(99m) Tc-MDP, sup(113m) In-EDTMP), and 197 Hg-MPG are significatively greater in rats with heart damaged than in the controls animals (undamaged); these were followed by sup(99m) Tc-GH and sup(99m) Tc-DMSA. Sup(99m) Tc-PPi, was the tracer that showed the mot favorable concentration in the lesion and the best target-non target ratios in most of the time intervals. At early time intervals 197 Hg-MPG showed the best DH/NH relation. (Author)

  2. Technical cooperation for the wider uses of Ho-166 therapeutic agents in European countries

    CERN Document Server

    Park, K B; Choi, S M; Han, K H; Hong, Y D; Park, W W; Shin, B C

    2002-01-01

    Czech has put their priority in developing the radiopharmaceuticals based on reactor produced Ho-166 and a related fabrication will be extended to other EU conturies including Germany, France, etc after a development of project. The collaboration will be based on the mutual agreement for developing the between research institutes, industries and academic institutes and further researches should be followed by the issue of developing radiopharmaceuticals using Ho-166. To strengthen the collaboration, detailed discussions for the practical collaboration have been made through the visitation to the research institution of each counter part. For implementing the collaboration between NPI and KAERI, an institutional basis technical cooperation agreement(TCA) will be concluded. Furthermore, agreement for the substantial collaboration on Ho-166 related researches will be made after the conclusion of the TCA. It will accelerate the commercialization of KAERI developed Ho-166 therapeutic agents into other European cou...

  3. Cyclotron targets and production technologies used for radiopharmaceuticals in NPI

    Czech Academy of Sciences Publication Activity Database

    Fišer, Miroslav; Kopička, Karel; Hradilek, Pavel; Hanč, Petr; Lebeda, Ondřej; Panek, T.; Vognar, M.

    2003-01-01

    Roč. 53, č. 2 (2003), s. A737-A743 ISSN 0011-4626 R&D Projects: GA AV ČR KSK4055109 Keywords : cyclotron * radiopharmaceuticals Subject RIV: CH - Nuclear ; Quantum Chemistry Impact factor: 0.263, year: 2003

  4. New technologies for production of radiopharmaceuticals and other medical preparations

    International Nuclear Information System (INIS)

    Bazaniak, Z.; Iller, E.; Mikolajczak, R.

    2004-01-01

    The Radioisotope Centre POLATOM belongs to the group of R and D institutions whose profile of activities comprises, besides applied research work, also manufacturing of a range of products based on implementation of the Centre's own developments. The Centre possesses considerable experience in its area of expertise: forty-six years of manufacturing of various radiation sources and radiopharmaceuticals, performing metrology and analysis of radioactive materials, which makes OBRI a unique R and D unit. The Centre is a chief manufacturer supplier of radiopharmaceuticals for nuclear medicine in Poland, and also an active exporter with a market of several tens countries. The current trends in the Centre activity assume combination of R and D work with practical application of its results for production purposes. The undertaken research topics are studied in co-operation with domestic and foreign scientific institutions. (author)

  5. Sixth international symposium on radiopharmaceutical chemistry: Abstracts: Final report

    International Nuclear Information System (INIS)

    1986-01-01

    The 113 abstracts are arranged under the following section headings: alkyl spiperone derivatives labeled with fluorine, synthesis of compounds labeled with positron emitters, technetium compounds, positron emitters (target design and synthesis), indium and gallium, halogens, labeled proteins and antibodies, radiopharmaceuticals for brain and SPECT, general, and receptor radioligands

  6. Positron emitting nuclides and their synthetic incorporation in radiopharmaceuticals

    International Nuclear Information System (INIS)

    Fowler, J.S.

    1976-01-01

    11 C, 13 N, and 15 O has potential applicability to the study of metabolism in humans. Problems in the synthesis of radiopharmaceuticals labeled with 11 C, 13 N, and 18 F are described: quality control, radiation exposure, carboxylic acids, glucose, amines, amino acids, nitrosources, fluoroethanol. 54 references

  7. VII. Boettstein Colloquium: PET-Radiopharmaceuticals at PSI: achievement and future prospects

    International Nuclear Information System (INIS)

    Schubiger, P.A.; Beer, H.F.; Blaeuenstein, P.; Leenders, K.E.

    1993-01-01

    The three sessions of the 1993 Boettstein colloquium dealt with the following topics: - PET-radiopharmaceuticals, - PET-scanning: significance of tracer uptake, - clinical options using PET. 22 papers were presented. figs., refs

  8. VII. Boettstein Colloquium: PET-Radiopharmaceuticals at PSI: achievement and future prospects

    Energy Technology Data Exchange (ETDEWEB)

    Schubiger, P.A.; Beer, H.F.; Blaeuenstein, P.; Leenders, K.E.

    1993-12-31

    The three sessions of the 1993 Boettstein colloquium dealt with the following topics: - PET-radiopharmaceuticals, - PET-scanning: significance of tracer uptake, - clinical options using PET. 22 papers were presented. figs., refs.

  9. VII. Boettstein Colloquium: PET-Radiopharmaceuticals at PSI: achievement and future prospects

    Energy Technology Data Exchange (ETDEWEB)

    Schubiger, P A; Beer, H F; Blaeuenstein, P; Leenders, K E

    1994-12-31

    The three sessions of the 1993 Boettstein colloquium dealt with the following topics: - PET-radiopharmaceuticals, - PET-scanning: significance of tracer uptake, - clinical options using PET. 22 papers were presented. figs., refs.

  10. Animal models for the evaluation of radiopharmaceuticals to measure brian blood flow and function

    International Nuclear Information System (INIS)

    Welch, M.J.; Marshall, L.G.I.; Mathias, C.J.

    1987-01-01

    Several techniques have been utilized to carry out initial evaluation of radiopharmaceuticals labeled with technetium-99m and other radionuclides. The simplest technique is to measure the amount of radioactivity in the brain in rats or mice following the intravenous administration of these compounds; brain uptake and washout of radiopharmaceuticals can be estimated. More sophisticated techniques involve measuring the uptake and egress of the radiopharmaceutical following carotid artery administration in rats of primates. The Oldendorf technique compares a tracer with a standard compound e.g. tritiated water, to measure the brain uptake index of various compounds determined by decapiation at short times following administration. Another technique in which consecutive administrations of the compound to be studied and oxygen-15-labeled water are injected via the carotid artery of primates; the brain extraction and washout of the unknown tracer can be evaluated. The blood flow can be varied by altering the pCO 2 of the animal. Examples will be given and techniques compared

  11. Radiopharmaceutical chelates and method of external imaging

    International Nuclear Information System (INIS)

    1976-01-01

    The preparation of the following chemicals is described: chelates of technetium-99m, cobalt-57, gallium-67, gallium-68, indium-111 or indium-113m and a substituted iminodiacetic acid or an 8-hydroxyquinoline useful as a radiopharmaceutical external imaging agent. The compounds described are suitable for intravenous injection, have an excellent in vivo stability and are good organ seekers. Tin(II) choride or other tin(II) compounds are used as chelating agents

  12. Radiopharmaceuticals in positron emission tomography: Radioisotope productions and radiolabelling procedures at the Austin and Repatriation Medical Centre

    Energy Technology Data Exchange (ETDEWEB)

    Tochon-Danguy, H.J.; Sachinidis, J.I.; Chan, J.G.; Cook, M. [Austin and Repatriation Medical Centre, Melbourne, VIC (Australia). Centre for Positron Emission Tomography

    1997-10-01

    Positron Emission Tomography (PET) is a technique that utilizes positron-emitting radiopharmaceuticals to map the physiology, biochemistry and pharmacology of the human body. Positron-emitting radioisotopes produced in a medical cyclotron are incorporated into compounds that are biologically active in the body. A scanner measures radioactivity emitted from a patient`s body and provides cross-sectional images of the distribution of these radiolabelled compounds in the body. It is the purpose of this paper to review the variety of PET radiopharmaceuticals currently produced at the Austin and Repatriation Medical Centre in Melbourne. Radioisotope production, radiolabelling of molecules and quality control of radiopharmaceuticals will be discussed. A few examples of their clinical applications will be shown as well. During the last five years we achieved a reliable routine production of various radiopharmaceuticals labelled with the four most important positron-emitters: oxygen-15 (t,{sub 1/2}=2min), nitrogen-13 (t{sub 1/2}= 10 min), carbon-11 (t{sub 1/2}=20 min) and fluorine-18 (t{sub 1/2}= 110 min). These radiopharmaceuticals include [{sup 15}O]oxygen, [{sup 15}O]carbon monoxide, [{sup 15}O]carbon dioxide, [{sup 15}O]water, [{sup 13}N]ammonia, [{sup 11}C]flumazenil, [{sup 11}C]SCH23390, [{sup 18}F]fluoromisonidazole and [{sup 18}F]fluoro-deoxy-glucose ([{sup 18}F]FDG). In addition, since the half life of [{sup 18}F] is almost two hours, regional distribution can be done, and the Austin and Repatriation Medical Centre is currently supplying [{sup 18}F]FDG in routine to other hospitals. Future new radiopharmaceuticals development include a [{sup 18}F]thymidine analog to measure cell proliferation and a [{sup 11}C]pyrroloisoquinoline to visualize serotonergic neuron abnormalities. (authors) 23 refs., 2 tabs.

  13. Evaluation of quality control of radiopharmaceuticals in Nuclear Medicine service; Avaliacao do controle de qualidade de radiofarmacos em servico de medicina nuclear

    Energy Technology Data Exchange (ETDEWEB)

    Tavares, Jamille A. Lopes; Lira, Renata F. de, E-mail: jam_alt@hotmail.com, E-mail: renatafariasdelira@hotmail.com [Universidade Federal de Pernambuco (UFPE), Recife (Brazil); Santos, Marcus Aurelio P. dos, E-mail: masantos@cnen.gov.br [Centro Regional de Ciencias Nucleares do Nordeste (CRCN-NE/CNEN-PE), Recife, PE (Brazil)

    2014-07-01

    Radiopharmaceuticals are a type of pharmaceutical preparation associated with radionuclides with purpose of diagnosis and therapy. Nuclear Medicine Services (NMS) should perform quality control of radiopharmaceuticals according to the recommendations of the manufacturer and scientific evidences accepted by the National Agency Sanitary Surveillance ( Brazilian ANVISA). This study evaluated the quality of the main radiopharmaceuticals in a NMS of the state of Pernambuco in relation to pH and radiochemical purity. The results showed that 96.8% of the radiopharmaceuticals showed radiochemical purity and all pH values were within the range recommended by the American pharmacopoeia. The study found that the quality control when inserted into the NMS, provides important data that allows exclusion of radiopharmaceuticals with low radiochemistry purity, favoring a reliable diagnosis and ensuring good radiation protection practices and biosecurity for patient and occupationally exposed individuals.

  14. Handling of radiopharmaceuticals drugs in hot cell: Implementation and validation of new hygiene procedures

    International Nuclear Information System (INIS)

    Levigoureux, E.; Hoffman, A.; Bolot, C.; Aulagner, G.; Brun, J.

    2012-01-01

    Exigencies associated with radiopharmaceutical drugs require validation of hygiene procedures. Different bio-cleaning processes were applied. For each, samples were collected from work surface, from preparation field and from the cap of multi-doses vial on agar contact. Twenty-two radiopharmaceutical preparations were inoculated in different liquid media. Results show that modification of bio-cleaning process enables a microbiological contamination reduction (p ≡ 0.0196). All preparations passed the sterility tests. Thus these results enabled the validation of new hygiene process in the radiopharmacy unit. (authors) [fr

  15. Minimising activity and dose with enhanced image quality by radiopharmaceutical administrations

    International Nuclear Information System (INIS)

    Hoeschen, C.; Mattsson, S.; Cantone, M. C.; Mikuz, M.; Lacasta, C.; Ebel, G.; Clinthorne, N.; Giussani, A.

    2010-01-01

    Owing to the introduction of new diagnostic procedures, such as computed tomography (CT), positron emission tomography (PET) and single photon emission computed tomography (SPECT), the individual dose caused by medical exposures has grown rapidly in the last years. This is especially a subject to radiation protection for nuclear medical diagnosis, since in this case radiopharmaceuticals are administered to the patient, meaning not only a radiation exposure to the diseased tissue but also to the healthy tissues of large parts of the body. 'Minimizing Activity and Dose with Enhanced Image quality by Radiopharmaceutical Administrations' (MADEIRA) is a project co-funded by the European Commission within the Seventh Euratom Framework Programme that aims to improve three-dimensional (3D) nuclear medical imaging technologies significantly. MADEIRA is aiming to improve the efficacy and safety of 3D PET and SPECT functional imaging by optimising the spatial resolution and the signal-to-noise ratio, improving the knowledge of the temporal variation of the radiopharmaceuticals' uptake in and clearance from tumorous and healthy tissues, and evaluation of the corresponding patient dose. Using an optimised imaging procedure that improves the information gained per unit administered dose, MADEIRA aims especially to reduce the dose to healthy tissues of the patient. In this paper, an overall summary of the current achievements will be presented. (authors)

  16. Meeting of the Technical Working Group on Fast Reactors (TWG-FR) (41st Annual Meeting). Working Material

    International Nuclear Information System (INIS)

    2008-01-01

    The objectives of the meeting were to: - Exchange information on the national programmes on Fast Reactors (FR) and Accelerator Driven Systems (ADS); - Review the progress since the 40th TWG-FR Annual Meeting, including the status of the actions; - Consider meeting arrangements for 2008, 2009, 2010 and beyond; - Review the IAEA’s ongoing information exchange and coordinated research activities in the technical fields relevant to the TWG-FR (FRs and ADS), as well as coordination of the TWG-FR’s activities with other organizations and international initiatives; - Discuss future joint activities in view of IAEA’s Programme and Budget Cycles beyond 2008-2009

  17. Preparation of Radiopharmaceuticals Labeled with Metal Radionuclides. Final Report

    International Nuclear Information System (INIS)

    Welch, M.J.

    2012-01-01

    The overall goal of this project was to develop methods for the production of metal-based radionuclides, to develop metal-based radiopharmaceuticals and in a limited number of cases, to translate these agents to the clinical situation. Initial work concentrated on the application of the radionuclides of Cu, Cu-60, Cu-61 and Cu-64, as well as application of Ga-68 radiopharmaceuticals. Initially Cu-64 was produced at the Missouri University Research Reactor and experiments carried out at Washington University. A limited number of studies were carried out utilizing Cu-62, a generator produced radionuclide produced by Mallinckrodt Inc. (now Covidien). In these studies, copper-62-labeled pyruvaldehyde Bis(N 4 -methylthiosemicarbazonato)-copper(II) was studied as an agent for cerebral myocardial perfusion. A remote system for the production of this radiopharmaceutical was developed and a limited number of patient studies carried out with this agent. Various other copper radiopharmaceuticals were investigated, these included copper labeled blood imaging agents as well as Cu-64 labeled antibodies. Cu-64 labeled antibodies targeting colon cancer were translated to the human situation. Cu-64 was also used to label peptides (Cu-64 octriatide) and this is one of the first applications of a peptide radiolabeled with a positron emitting metal radionuclide. Investigations were then pursued on the preparation of the copper radionuclides on a small biomedical cyclotron. A system for the production of high specific activity Cu-64 was developed and initially the Cu-64 was utilized to study the hypoxic imaging agent Cu-64 ATSM. Utilizing the same target system, other positron emitting metal radionuclides were produced, these were Y-86 and Ga-66. Radiopharmaceuticals were labeled utilizing both of these radionuclides. Many studies were carried out in animal models on the uptake of Cu-ATSM in hypoxic tissue. The hypothesis is that Cu-ATSM retention in vivo is dependent upon the oxygen

  18. Annual environmental monitoring report, January--December 1976

    International Nuclear Information System (INIS)

    1977-05-01

    Environmental monitoring results continue to demonstrate that, except for penetrating radiation, environmental radiological impact due to SLAC operation is not distinguishable from natural environmental sources. During 1976 the maximum neutron dose near the site boundary was 3.4 mrem. This represents about 3.4% of the annual dose from natural sources at this elevation and 0.68% of the technical standard of 500 mrem per person annually. There have been no measurable increases in radioactivity in ground water attributable to SLAC operations. Airborne radioactivity released from SLAC also continues to make only a negligible environmental impact and result in a site boundary annual dose of less than 0.01 mrem, which represents less than 0.01% of the annual dose from the natural radiation environment and about 0.002% of the technical standard

  19. Core Capabilities and Technical Enhancement -- FY-98 Annual Report

    Energy Technology Data Exchange (ETDEWEB)

    Miller, David Lynn

    1999-04-01

    The Core Capability and Technical Enhancement (CC&TE) Program, a part of the Verification, Validation, and Engineering Assessment Program, was implemented to enhance and augment the technical capabilities of the Idaho National Engineering and Environmental Laboratory (INEEL). The purpose for strengthening the technical capabilities of the INEEL is to provide the technical base to serve effectively as the Environmental Management Laboratory for the Office of Environmental Management (EM). An analysis of EM's science and technology needs as well as the technology investments currently being made by EM across the complex was used to formulate a portfolio of research activities designed to address EM's needs without overlapping work being done elsewhere. An additional purpose is to enhance and maintain the technical capabilities and research infrastructure at the INEEL. This is a progress report for fiscal year 1998 for the five CC&TE research investment areas: (a) transport aspects of selective mass transport agents, (b) chemistry of environmental surfaces, (c) materials dynamics, (d) characterization science, and (e) computational simulation of mechanical and chemical systems. In addition to the five purely technical research areas, this report deals with the science and technology foundations element of the CC&TE from the standpoint of program management and complex-wide issues. This report also provides details of ongoing and future work in all six areas.

  20. Core capabilities and technical enhancement, FY-98 annual report

    Energy Technology Data Exchange (ETDEWEB)

    Miller, D.L.

    1999-04-01

    The Core Capability and Technical Enhancement (CCTE) Program, a part of the Verification, Validation, and Engineering Assessment Program, was implemented to enhance and augment the technical capabilities of the Idaho National Engineering and Environmental Laboratory (INEEL). The purpose for strengthening the technical capabilities of the INEEL is to provide the technical base to serve effectively as the Environmental Management Laboratory for the Department of Energy's Office of Environmental Management (EM). An analysis of EM's science and technology needs as well as the technology investments currently being made by EM across the complex was used to formulate a portfolio of research activities designed to address EM's needs without overlapping work being done elsewhere. An additional purpose is to enhance and maintain the technical capabilities and research infrastructure at the INEEL. This is a progress report for fiscal year 1998 for the five CCTE research investment areas: (a) transport aspects of selective mass transport agents, (b) chemistry of environmental surfaces, (c) materials dynamics, (d) characterization science, and (e) computational simulation of mechanical and chemical systems. In addition to the five purely technical research areas, this report deals with the science and technology foundations element of the CCTE from the standpoint of program management and complex-wide issues. This report also provides details of ongoing and future work in all six areas.

  1. DOE SBIR Phase I Grant No. DE-FG02-00ER83067, ''A Flexible and Economical Automated Nucleophilic [18F]Fluorination synthesis System for PET Radiopharmaceuticals.'' Final Technical Report

    International Nuclear Information System (INIS)

    Padgett, Henry C.

    2001-01-01

    Phase I Final Report. A prototype manual remote synthesis system based on the unit operations approach was designed, constructed, and functionally tested. This general-purpose system was validated by its configuration and initial use for the preparation of the PET radiopharmaceutical [F-18]FLT using [F-18]fluoride ion

  2. Role of a radiopharmacist in the development of a tumor-localizing radiopharmaceutical

    International Nuclear Information System (INIS)

    Briner, W.H.

    1974-01-01

    The development of a new radiopharmaceutical involves heavy responsibility relating to the safety of human lives. Although in past years the primary concern manifested by regulatory agencies was directed toward the radiation characteristics of these agents, more recent attention has been directed to the pharmaceutical quality of radioactive drugs. The technology of radiopharmaceutical design and formulation includes both aspects. Thus radiopharmacists have an exceedingly important role to play in this research and development area, for their training and experience in both the physical and biological sciences, their expertise in pharmaceutical formulation and quality control techniques, and their knowledge of laws and regulations that apply to all drugs can be invaluable. (U.S.)

  3. Analysis of the distribution of radiopharmaceuticals for nuclear medicine in Brazil

    International Nuclear Information System (INIS)

    Kuahara, Lilian T.; Correa, Eduardo L.; Potiens, Maria P.A.

    2013-01-01

    The objective of this study was to analyze the distribution of radiopharmaceuticals produced by Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN), as part of a project to develop a methodology for control and calibration of activimeters used by these Nuclear Medicine Services. This survey was conducted using registry data of registered customers and, with bases in such information, we analyzed the number of clinics all over the country. Considering the distribution of radiopharmaceuticals and what the most used in 2011, there was a total of 365 clinics, and this distribution as follows: Southeast with 56%, South 18%, Northeast 15%, North 4%, and Midwest with 7%. Among the various radioisotopes provided 26 were sold and most in demand are the 67 Ga, 131 I and IPEN-tec (technetium generator)

  4. Disposal of wastes from radiopharmaceuticals administered in human body in hospital

    International Nuclear Information System (INIS)

    Kaneko, Masao

    1976-01-01

    Radiopharmaceuticals used in hospitals have remarkably increased in amount. Among radioactive matters discharged from pharmaceuticals administered into human bodies, a small amount of radio-pharmaceuticals remained in disporsable containers and syringes, excreta from patients administered such drugs and their washing, may cause the problems, radioisotopes with short half-life such as sup(99m)Tc tend to be administered increasingly while radioisotopes with long life have been decreasing. Long life radioactive wastes and short life wastes have to be strictly separated. And then long life radioisotopes wastes have to be condensed and stored, less than a tenth of the maximum allowable density after decay to discharge. Radioactive gas as 133 Xe should be diffused by ventilation. This is the time to make the numerical guide concerning the problem. (Kobatake, H.)

  5. Overview of internal dose evaluation in the radiopharmaceutical production plant at IPEN

    International Nuclear Information System (INIS)

    Todo, Alberto S.; Gerulis, Eduardo; Cardoso, Joaquim C.S.; Rodrigues Junior, Orlando

    2015-01-01

    The internal dosimetry program at the Instituto de Pesquisas Energeticas e Nucleares, IPEN, is accomplished in two steps: the activity measurements are performed at the In Vivo Monitoring Laboratory and subsequently the data analysis and the dose evaluation are carried out by the Dose Calculation Group according to the ICRP models. The objective of this study is to take the whole body and thyroid monitoring results recorded from 2005 to 2015 to see whether the internal contamination control procedure for workers were suitable even with the increase in the radiopharmaceutical production. The study were based in a research called “Search of Variables” for the operations carried out in the restricted areas of radiopharmaceutical production plant, taking into account the dose distribution data for all the tasks recorded by the radioprotection service. This methodology aims to identify and determine the principal variables that impact on the worker's dose. The results were presented for the following variables: individual occupationally exposed, operation variable, area/cell, type of task of operation, which depend on the variable dose. In spite of growth rate in the production of radiopharmaceutical, this study has shown that the improvements in the plant have contributed to the dose reduction of the workers. (author)

  6. Effect of experimental conditions on the stability of Tc-99m radiopharmaceuticals

    International Nuclear Information System (INIS)

    Vucina, J.

    2002-01-01

    The stability of three 99m Tc radiopharmaceuticals in dependence on the experimental conditions and on the presence of some chemical stabiliser was tested. Examined were dimercapto succinate (DMS), pyrophosphate (PyP) and 2,3-dicarboxypropane-1,1-diphosphonate (DPD). The reliability and applicability of the preparation of the three radiopharmaceuticals from the inactive (technetium-cold) kit solutions were tested. Each kit was dissolved in saline (0.9% NaCl). The storage conditions of the inactive kit solutions before labelling were determined. The main problem is the stability of the reductant stannous ions which is very difficult to predict. Ascorbic or gentisic acid was added in order to stabilise the labelled radiopharmaceuticals and ensure their good quality. The best results were obtained by keeping the samples at -20 deg C. Although either stabiliser can be used, much lower concentrations of ascorbic acid are sufficient for an effective protection. Its concentrations of 12-60 μg/ml of the kit stabilise DMS and PyP for about 7-8 days. The solution of DPD was stable even without any stabiliser, presumably dut to the chemical nature of this complex. In routine practice, however, the procedure requires caution, and the staff should be very experienced in radiopharmacy procedures

  7. 1980 Annual status report: provision of scientific and technical services

    International Nuclear Information System (INIS)

    1981-01-01

    Two kinds of objectives are pursued at the JRC in direct support of the various General Directorates of the Commission: Technical Evaluations where system analysis techniques are mainly employed and Technical Assistance where laboratory measurement, technical expertises and management of projects are provided

  8. SKB annual report 1993. Including summaries of technical reports issued during 1993

    International Nuclear Information System (INIS)

    1994-05-01

    This is the annual report on the activities of the Swedish Nuclear and Waste Management Co., SKB. It contains in part I an overview of SKB activities in different fields. Part II gives a description of the research and development work on nuclear waste disposal performed during 1993. Lectures and publications during 1993 as well as reports issued in the SKB technical series are listed in part III. Part IV contains the summaries of all technical reports issued during 1993. SKB is the owner of CLAB, the Central Facility for Interim Storage of Spent Nuclear Fuel, located at Oskarshamn. CLAB was taken into operation in July 1985 and to the end of 1993 in total 1 885 tonnes of spent fuel (measured as uranium) have been received. Transportation from the nuclear sites to CLAB is made by a special ship, M/S Sigyn. At Forsmark the final repository for Radioactive Waste - SFR - was taken into operation in April 1988. The repository is situated in crystalline rock under the Baltic Sea. At the end of 1993 a total of 13 000 m 3 of waste have been deposited in SFR. SKB is in charge of a comprehensive research and development programme on geological disposal of nuclear waste. Some of the main areas for SKB research are: Groundwater movements; Bedrock stability; Groundwater chemistry and nuclide migration; Methods and instruments for in situ characterization of crystalline bedrock; Characterization and leaching of spent nuclear fuel; Properties of bentonite for buffer, backfilling and sealing; Radionuclide transport in biosphere and dose evaluations; Development of performance and safety assessment methodology and assessment models; Construction of an underground research laboratory

  9. Results of quality control studies of technetium 99m labelled radiopharmaceuticals prepared from kits (1980-81)

    International Nuclear Information System (INIS)

    1983-01-01

    This report summarized the results of quality control studies of Tc 99m labelled human serum albumin, macroaggregated albumin, bone imaging and reticuloendothelial system imaging radiopharmaceuticals prepared from commercially available kits. It includes all analyses performed from January 1980 to December 1981 by the radiopharmaceutical quality control section of the Radiation Protection Bureau. These results were obtained by the application of various in vitro and animal (mouse) biodistribution studies

  10. SU-E-I-82: PET Radiopharmaceuticals for Prostate Cancer Imaging: A Review

    Energy Technology Data Exchange (ETDEWEB)

    Fernandes, F [Delfin Farmacos e Derivados Ltda, Lauro De Freitas, Bahia (Brazil); Escola Bahiana de Medicina e Saude Publica, Salvador, Bahia (Brazil); Silva, D da [Delfin Farmacos e Derivados Ltda, Lauro De Freitas, Bahia (Brazil); Rodrigues, L [Escola Bahiana de Medicina e Saude Publica, Salvador, Bahia (Brazil)

    2015-06-15

    Purpose: The aim of this work was to review new and clinical practice PET radiopharmaceuticals for prostate cancer imaging. Methods: PET radiopharmaceuticals were reviewed on the main databases. Availability, dosimetry, accuracy and limitations were considered. Results: The following radioisotopes with respective physical half-life and mean positron energy were found: {sup 18}F (109,7 min, 249,8 keV), {sup 89}Zr (78,4 hs, 395,5 keV), {sup 11}C (20,4 min, 385,7 keV) and {sup 68}Ga (67,8 min, 836 keV). {sup 68}Ga was the only one not produced by cyclotron. Radiopharmaceuticals uptake by glucose metabolism ({sup 18}F-FDG), lipogenesis ({sup 11}C-Choline and {sup 11}C-Acetate), amino acid transport (Anti-{sup 18}F-FACBC), bone matrix ({sup 18}F-NaF), prostatespecific membrane antigen ({sup 68}Ga-PSMA and {sup 89}Zr-J591), CXCR receptors ({sup 89}Ga-Pentixafor), adrenal receptors ({sup 18}F-FDHT) and gastrin release peptide receptor (bombesin analogue). Most of radiopharmaceuticals are urinary excretion, so bladder is the critical organ. 11C-choline (pancreas), Anti-{sup 18}FFACBC (liver) and {sup 18}F-FBDC (stomach wall) are the exception. Higher effective dose was seen {sup 18}F-NaF (27 μSv/MBq) while the lowest was {sup 11}CAcetate (3,5 μSv/MBq). Conclusion: Even though {sup 18}F-FDG has a large availability its high urinary excretion and poor uptake to slow growing disease offers weak results for prostate cancer. Better accuracy is obtained when {sup 18}F-NaF is used for bone metastatic investigation although physicians tend to choose bone scintigraphy probably due to its cost and practice. Many guidelines in oncology consider {sup 11}C or {sup 18}F labeled with Choline the gold standard for biochemical relapse after radical treatment. Local, lymph node and distant metastatic relapse can be evaluated at same time with this radiopharmaceutical. There is no consensus over bigger urinary excretion for {sup 18}F labeling. Anti-{sup 18}F-FACBC, {sup 68}Ga-PSMA and {sup

  11. Dispersion for the preparation of an injectable radiopharmaceutical scanning agent

    International Nuclear Information System (INIS)

    Wolfangel, R.G.

    1976-01-01

    The invention deals with the preparation of a dispersion of a tin (II) sulphur colloid in an aqueous solution with additions of a stabilizing agent. Labelled with sup(99m)Tc, the dispersion can be used as an injectable radiopharmaceutical scanning agent. (VJ) [de

  12. A Survey on the Usage and Demand of Medical Radioisotope and Radiopharmaceuticals in Malaysia

    International Nuclear Information System (INIS)

    Muhammad Fakhrurazi Ahmad Fadzil; Siti Selina Abdul Hamid; Siti Najila Mohd Janib; Azahari Kasbollah; Syed Asraf Fahlawi Wafa

    2016-01-01

    Medical radioisotope is a small quantity of radioactive substance used for the purpose of diagnostic and therapy of various diseases. In Malaysia, the emerging of new nuclear medicine centers or institutions in both government and private sectors rose abruptly for the past few years. Currently, there are no data available on the usage and demand of these medical radioisotope or radiopharmaceuticals. The aim of this study is to assess current medical radioisotopes and radiopharmaceuticals usage and also to provide data on current medical radioisotope and radiopharmaceuticals demand for both private and government hospitals or institutions in Malaysia. A survey for a period of 3 months was conducted across Malaysia. The survey was divided into five (5) main parts and it was distributed among health care professionals involved working with medical radioisotope and radiopharmaceuticals in private, government and university based hospitals or institutions and was distributed manually either by hand, mail or e-mail. Data is presented in either pie chart or bar chart. Survey results found out that the highest demand and the highest usage among all radioisotopes are Technetium-99m and radioiodine isotopes such as the iodine-131, iodine-131 MIBG, iodine-123 and iodine-123 MIBG. Technetium-99m is the backbone of nuclear medicine whereby more than 80 % of Nuclear Medicine services utilize this radioisotope. Technetium-99m supply chain is unstable globally and in coming future, two main reactors that produce 60 % of world Molybdenum-99 will shut down and the supply of molybdenum-99 will be disrupted. In radioiodine services, currently, Iodine-123 cannot be obtained in Malaysia and neighboring countries due to its short half-life. Iodine-123 is useful in diagnostic of thyroid related diseases. As for PET services, the highest demands are F-18 FDG and gallium-68 Generator. It is important for Malaysia to self-produced medical radioisotope and radiopharmaceuticals to meet the

  13. Profile of MIBI liquid phase radiopharmaceutical for myocardial imaging

    International Nuclear Information System (INIS)

    I Daruwati; ME Sriyani; NK Oekar; N Zainuddin; KA Hanafiah

    2016-01-01

    The 99m Tc-MIBI radiopharmaceutical has been used in nuclear medicine in Indonesia for myocardial imaging. BATAN researchers have mastered the technology to manufacture MIBI as a lyophilized kit. A reformulation of MIBI radiopharmaceutical has been conducted to improve the stability of the kit especially in the liquid-phase kit. Basically, radiopharmaceuticals in liquid form are not different from the dry kit. However in the manufacturing of liquid-phase kit, lyophilization process was not done. To improve the stability of liquid kit, a reformulation of the components was conducted by using two separate vials (Formulation 2) and the characteristics were compared with the one-vial formulation (Formulation 1). The MIBI Formulation 2 consists of two vials, vial A containing 0.06 mg of SnCl 2 2H 2 O and 2.6 mg Sodium Citrate 2H 2 O and vial B containing 0.5 mg of [Cu(MIBI) 4 ]BF 4 , 1 mg of cysteine hydrochloride, and 20 mg of mannitol. The purposes of this study were to determine the stability of two different formulations of MIBI as a liquid-phase kit, to compare their stability in different storage condition such as in refrigerator and freezer, and to compare the ratio of activities attained between target and nontarget organs after injection to animal model. As a diagnostic agent, MIBI was reconstituted with Technetium-99m as radionuclide tracer to 99m Tc-MIBI labeled compound. The radiochemical purity of 99m Tc-MIBI was determined by chromatography method using alumina thin-layer chromatography paper as the stationary phase and ethanol 95% as the mobile phase. The results showed MIBI Formulation 2 has a higher stability than Formulation 1. Formulation 2 also maintained a 96.68% radiochemical purity under 52-day storage and attained a target-to-nontarget activity ratio of 8.22. (author)

  14. Recent Progress toward Microfluidic Quality Control Testing of Radiopharmaceuticals

    Directory of Open Access Journals (Sweden)

    Noel S. Ha

    2017-11-01

    Full Text Available Radiopharmaceuticals labeled with short-lived positron-emitting or gamma-emitting isotopes are injected into patients just prior to performing positron emission tomography (PET or single photon emission tomography (SPECT scans, respectively. These imaging modalities are widely used in clinical care, as well as in the development and evaluation of new therapies in clinical research. Prior to injection, these radiopharmaceuticals (tracers must undergo quality control (QC testing to ensure product purity, identity, and safety for human use. Quality tests can be broadly categorized as (i pharmaceutical tests, needed to ensure molecular identity, physiological compatibility and that no microbiological, pyrogenic, chemical, or particulate contamination is present in the final preparation; and (ii radioactive tests, needed to ensure proper dosing and that there are no radiochemical and radionuclidic impurities that could interfere with the biodistribution or imaging. Performing the required QC tests is cumbersome and time-consuming, and requires an array of expensive analytical chemistry equipment and significant dedicated lab space. Calibrations, day of use tests, and documentation create an additional burden. Furthermore, in contrast to ordinary pharmaceuticals, each batch of short-lived radiopharmaceuticals must be manufactured and tested within a short period of time to avoid significant losses due to radioactive decay. To meet these challenges, several efforts are underway to develop integrated QC testing instruments that automatically perform and document all of the required tests. More recently, microfluidic quality control systems have been gaining increasing attention due to vastly reduced sample and reagent consumption, shorter analysis times, higher detection sensitivity, increased multiplexing, and reduced instrumentation size. In this review, we describe each of the required QC tests and conventional testing methods, followed by a

  15. Report and recommendations on the requirements for postgraduate training in radiopharmacy and radiopharmaceutical chemistry 1989

    International Nuclear Information System (INIS)

    Cox, P.H.; Coenen, H.H.; Deckart, H.; Feuger, G.F.; Hesslewood, S.R.; Kristensen, K.; Komarek, P.; Meyer, G.J.; Stocklin, G.; Schubinger, P.A.

    1990-01-01

    The basic information concerning the status of postgraduate training in the radiopharmaceutical sciences contained in this report was compiled from the proceedings of a Workshop on Postgraduate Training in Radiopharmacy organised by the Committee on Radiopharameuticals [EANM Task Group] in Rotterdam in April 1989 under the auspices of The Council of Europe. The implications of this information were discussed at a meeting of the Committee in Strasbourg in August 1989 together with representatives from a number of European radiochemistry groups. From these discussions it was concluded that there was a strong case to propose standards for minimal training requirements for radiopharmacy and radiochemistry which would be applicable to all European countries. The Committee also found it desirable that the EANM should use its influence to obtain formal recognition of the professional responsibilities of the radiopharmaceutical chemist with respect to the production and control of short-lived, cyclotron-produced radiopharmaceuticals. This report gives an inventory of the current situation with regard to the training in radiopharmacy and radiopharmaceutical chemistry which is available in Europe and makes proposals for the establishment of a European postgraduate training programme. The programme is based upon a number of theoretical and practical teaching modules which can be adapted to meet the training requirements for pharmacists, chemists, physicians and other graduate professions. (orig.)

  16. Preparation of kits for 99Tcm radiopharmaceuticals

    International Nuclear Information System (INIS)

    1992-05-01

    This publication details preparation under Good Manufacturing Practices (GMP) of thirteen widely used 99 Tc m radiopharmaceuticals and their quality assurance practices. The objective of this document is to present to those who intend to launch a kit preparation programme a set of preparation procedures and other relevant information gathered during kit production over a period of more than a decade, to serve as a good starting point. The manuals and monographs included in the document are based on the experience gained in two major centres. The publication of this material is intended to give a typical example, and not the only possible procedure for preparing the kits. Following the essentials of these kit preparation procedures, it is always possible to make alterations to the composition of the kits. The kits described here concern widely used 99 Tc m radiopharmaceuticals which do not require a Single Photon Emission Computed Tomography (SPECT) camera. These examples of the ''first generation'' of kits are not very intricate to prepare. Although it is advisable to have only one agent for a given intended use, a few agents for each purpose, e.g. EHDP and MDP for bone imagining, have been included in the document so that the reader can have some flexibility in selecting a particular kit. 24 refs, 2 figs

  17. Synthetic techniques of radiopharmaceuticals production labeled with C-11 for PET in cardiology

    Science.gov (United States)

    Dyubkov, V. S.; Ekaeva, I. V.; Katunina, T. A.; Rumyantsev, A. S.; Silchenkov, A. V.; Tuflina, T. V.

    2017-01-01

    Positron emission tomography (PET) and PET-Computerised Tomography (CT) are unique, non-invasive diagnostic techniques, in which the local, temporal and quantitative distributions of radioactive labelled substances are measured to investigate physiological processes. It is well known that PET centre of Bakulev Scientific Centre for Cardiovascular Surgery is the oldest one in Moscow. During more than fifteen years a large number of patients have received PET scans. Due to main stream of Scientific Centre, emphasis is placed on examining the heart functioning. For the diagnosis innervation of the heart muscle a number of radiopharmaceuticals are used, including PET radiopharmaceuticals such as 11C-CGP 12177, 11C-meta-hydroxyephedrine as well as its synthetic analogues labelled with other PET radionuclides (18F, 68Ga). 11C-meta-hydroxyephedrine is one of the most perspective radiopharmaceutical for an investigation of cardiac receptors function due to required materials availability for a radio synthesis in Russia. The main advantage of proposed 11C-meta-hydroxyephedrine synthesis technique is the use of a catalyst which allows one decrease reaction time from 5 minutes to 30 seconds. Obtained results allow one decrease reaction time of methylation and increase radiochemical and technological yields.

  18. Evaluation of Radioisotope Production Process of 153Sm and 153Sm-EDTMP Radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kadarisman; Sri Hastini; Yayan Tahyan; Abidin; Dadang Hafid; Enny Lestari

    2007-01-01

    Experiments on the process of 153 Sm radioisotope and labeling of 153 Sm-EDTMP radiopharmaceuticals were carried out. This experiments included preparation of Sm 2 O 3 target, dissolution of post irradiation, determination of radioactivity concentration of 153 Sm radioisotope, radionuclide purity, EDTMP labeling, determination of radiochemical purity and pH. In these experiments the total radioactivity 153 Sm product is round about 2845.83 mCi to 36963.31 mCi, or with the radioactivity concentration between 474 mCi/ml to 6160.55 mCi/ml in the SmCl 3 solution form, each its volume is 6.0 ml, and the samarium content is 5.76 mg/ml, and the radionuclide purity of 153 Sm is 100 %. All of the 153 Sm- EDTMP radiopharmaceuticals product are fulfilled requirements the radioactivity concentration, Sm content, radiochemical purity and pH. The radioactivity concentration of 153 Sm-EDTMP radiopharmaceuticals is 37.50 mCi/ml (minimum) to 283.50 mCi/ml (highest). The pH 7.5 were 8 products, and the rest are pH 8.5. Radiochemical purity of 153 Sm-EDTMP are round about 90.00 % to 99.44 %. (author)

  19. Annual environmental monitoring report, January--December 1975

    International Nuclear Information System (INIS)

    1976-04-01

    Environmental monitoring results continue to demonstrate that, except for penetrating radiation, environmental radiological impact due to SLAC operation is not distinguishable from natural environmental sources. During 1975 the maximum neutron dose near the site boundary was 15.8 mrem. This represents about 16 percent of the annual dose from natural sources at this elevation and 3.2 percent of the technical standard of 500 mrem per person annually. There have been no measurable increases in radioactivity in ground water attributable to SLAC operations. Airborne radioactivity released from SLAC also continues to make only a negligible environmental impact and results in a site boundary annual dose of less than 2.4 mrem, which represents less than 2.4 percent of the annual dose from the natural radiation environment and about 0.5 percent of the technical standard

  20. The role of high performance liquid chromatography in radiochemical/radiopharmaceutical synthesis and quality assurance

    International Nuclear Information System (INIS)

    Boothe, T.E.; Emran, A.M.

    1991-01-01

    This article discusses some specifications for HPLC methodology and reviews some recent applications of HPLC with emphasis on quality assurance (QA). Developments in the HPLC field will continue to find their way into practical everyday use in the radiopharmaceutical industry. This is illustrated in the area of column technology by the use of chiral columns for the determination of enantiomeric purity of receptor-based radiopharmaceuticals and by the use of internal surface reversed-phase (ISRP) columns for determination of radiolabelled metabolites in whole blood. An increased use of optimization and chemometric methods should provide better resolution in preparative and analytical procedures. Computer techniques applied to data manipulation could aid in the elimination of human bias in determining radiochemical purities and specific activities. If HPLC is to be adopted as a routine tool for the QC of radiopharmaceuticals, particularly those prepared in-house, more effort should be made to guarantee that proper standards are in place to assure compliance, especially as responsibilities are passed from the more highly trained senior level personnel to the technologist/technician level

  1. Air system in the hot cell for injectable radiopharmaceutical production: requirements for personnel and environment safety and protection of the product

    Energy Technology Data Exchange (ETDEWEB)

    Campos, Fabio E.; Araujo, Elaine B., E-mail: fecampos@ipen.b, E-mail: ebaraujo@ipen.b [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)

    2009-07-01

    . Nevertheless, the application of clean room requirements in radioisotope laboratories in general and hot cells is technically not an easy task. The required negative pressure inside the hot cell depends on the operations to be performed inside the cell, on the type of radionuclide and their total activity. Hot cells works in negative pressure that ranges typically from 200 Pa to 500 Pa below room pressure. The new rules for radiopharmaceutical production will be soon published by ANVISA in order to regulate the GMP in this area. This make urgent the development of national models for hot cells that combines GMP and radioprotection concepts and attempt for the radiopharmaceutical process lines as in development at IPEN. (author)

  2. Air system in the hot cell for injectable radiopharmaceutical production: requirements for personnel and environment safety and protection of the product

    International Nuclear Information System (INIS)

    Campos, Fabio E.; Araujo, Elaine B.

    2009-01-01

    . Nevertheless, the application of clean room requirements in radioisotope laboratories in general and hot cells is technically not an easy task. The required negative pressure inside the hot cell depends on the operations to be performed inside the cell, on the type of radionuclide and their total activity. Hot cells works in negative pressure that ranges typically from 200 Pa to 500 Pa below room pressure. The new rules for radiopharmaceutical production will be soon published by ANVISA in order to regulate the GMP in this area. This make urgent the development of national models for hot cells that combines GMP and radioprotection concepts and attempt for the radiopharmaceutical process lines as in development at IPEN. (author)

  3. Influence of radioactive contaminants on absorbed dose estimates for radiopharmaceuticals

    International Nuclear Information System (INIS)

    Watson, E.E.; Stabin, M.G.

    1986-01-01

    Several popular radiopharmaceutical products contain low levels of radioactive contaminants. These contaminants increase the radiation absorbed dose to the patient without any increased benefit and, in some cases, with a decrease in image quality. The importance of a contaminant to the radiation dosimetry picture is a function of 1) the contaminant level, 2) the physical half-life of the contaminant, 3) the organ uptake and the biological half-time of the contaminant in the various body systems, and 4) the decay mode, energy, etc. of the contaminant. The general influence of these parameters is discussed in this paper; families of curves are included that reflect the changing importance of contaminant dosimetry with respect to the primary radionuclide as a function of these variables. Several specific examples are also given of currently used radiopharmaceutical products which can contain radioactive contaminants (I-123, In-111, Tl-201, Ir-191m, Rb-82, Au-195m). 7 references, 8 figures, 4 tables

  4. Ionisation constants of radiopharmaceuticals by HPLC

    Energy Technology Data Exchange (ETDEWEB)

    Stylli, C.G.; Theobald, A.E.

    It has long been recognised that the pKsub(a) of drugs and radiopharmaceuticals is an important determinant of their biological distribution. In this study an HPLC method for pKa measurement has been developed for radiotracers. It has been validated with several amines and used to estimate the pKsub(a) values of some Tc-99m PnAO complexes by observing the change in chromatographic retention with change in mobile phase pH. The pKsub(a) values were estimated from the data by three methods: derivative analysis, quadratic regression, and the Henderson - Hasselbalch equation.

  5. Ionisation constants of radiopharmaceuticals by HPLC

    International Nuclear Information System (INIS)

    Stylli, C.G.; Theobald, A.E.

    1986-01-01

    It has long been recognised that the pKsub(a) of drugs and radiopharmaceuticals is an important determinant of their biological distribution. In this study an HPLC method for pKa measurement has been developed for radiotracers. It has been validated with several amines and used to estimate the pKsub(a) values of some Tc-99m PnAO complexes by observing the change in chromatographic retention with change in mobile phase pH. The pKsub(a) values were estimated from the data by three methods: derivative analysis, quadratic regression, and the Henderson - Hasselbalch equation. (author)

  6. Preliminary study fo the interference of proteic compounds of radiopharmaceuticals in the test of lisadode amebocitos de limulus (LAL)

    International Nuclear Information System (INIS)

    Aldana, Claudia

    1997-01-01

    In this thesis the objective was evaluate the interference of proteic compounds of the radiopharmaceuticals in the test LAL (lisado of amebocitos de limulus) for this, macroagregates of albumina (MAA) was used with metilendifosfonato (MDP) as control that is the radiopharmaceutical more used in the nuclear medicine centers of the country. Initially preliminary test were carried out to assess if some of two radiopharmaceuticals would cause interference with LAL test, after the test was validated and finally routine tests were made. With the preliminary assays was concluded that proteic compounds did not cause interference (albumina with a concentration of 2 md/dl) with the MAA. However with the MDP cause interference with LAL test. The interference was eliminated with a dilution of 1:8 of the sample. Was concluded that the success of LAL test depends on conditions such as temperature, pH, constant incubation (no minimum variations) and that is a good test for quality control of the radiopharmaceuticals

  7. Energy Materials Coordinating Committee (EMaCC) annual technical report, fiscal year 1984 with fiscal year 1985 data

    Energy Technology Data Exchange (ETDEWEB)

    None

    1985-07-01

    The Department of Energy funded about 374 million dollars of materials science and technology activities in both fiscal years 1984 and 1985. These funds and the commensurate program management responsibilities resided in 21 DOE program offices, each of which has its own mission and responsibilities. The Energy Materials Coordinating Committee (EMaCC) provides a formal mechanism to insure coordinated planning and maximum programmatic effectiveness for the Department's 374 million dollar per year materials effort. The EMaCC reports to the Director of the Office of Energy Research who in turn has oversight responsibilities for proper coordination of the technical programs of the Department. In carrying out this responsibility, EMaCC hosts meetings, organizes working groups, and publishes an annual technical report. This report is mandated by the EMaCC Terms of Reference. Its purpose is to disseminate information on the DOE materials programs for more effective coordination. It describes the materials research programs of various offices and divisions within the Department for FY 1984, contains funding information for FYs 1984 and 1985, and summarizes EMaCC activities for FY 1985.

  8. Energy Materials Coordinating Committee (EMaCC) annual technical report, fiscal year 1984 with fiscal year 1985 data

    International Nuclear Information System (INIS)

    1985-07-01

    The Department of Energy funded about 374 million dollars of materials science and technology activities in both fiscal years 1984 and 1985. These funds and the commensurate program management responsibilities resided in 21 DOE program offices, each of which has its own mission and responsibilities. The Energy Materials Coordinating Committee (EMaCC) provides a formal mechanism to insure coordinated planning and maximum programmatic effectiveness for the Department's 374 million dollar per year materials effort. The EMaCC reports to the Director of the Office of Energy Research who in turn has oversight responsibilities for proper coordination of the technical programs of the Department. In carrying out this responsibility, EMaCC hosts meetings, organizes working groups, and publishes an annual technical report. This report is mandated by the EMaCC Terms of Reference. Its purpose is to disseminate information on the DOE materials programs for more effective coordination. It describes the materials research programs of various offices and divisions within the Department for FY 1984, contains funding information for FYs 1984 and 1985, and summarizes EMaCC activities for FY 1985

  9. Chemical Technology Division annual technical report, 1996

    International Nuclear Information System (INIS)

    1997-06-01

    CMT is a diverse technical organization with principal emphases in environmental management and development of advanced energy sources. It conducts R ampersand D in 3 general areas: development of advanced power sources for stationary and transportation applications and for consumer electronics, management of high-level and low-level nuclear wastes and hazardous wastes, and electrometallurgical treatment of spent nuclear fuel. The Division also performs basic research in catalytic chemistry involving molecular energy resources, mechanisms of ion transport in lithium battery electrolytes, materials chemistry of electrified interfaces and molecular sieves, and the theory of materials properties. It also operates the Analytical Chemistry Laboratory, which conducts research in analytical chemistry and provides analytical services for programs at ANL and other organizations. Technical highlights of the Division's activities during 1996 are presented

  10. Chemical Technology Division annual technical report, 1996

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-06-01

    CMT is a diverse technical organization with principal emphases in environmental management and development of advanced energy sources. It conducts R&D in 3 general areas: development of advanced power sources for stationary and transportation applications and for consumer electronics, management of high-level and low-level nuclear wastes and hazardous wastes, and electrometallurgical treatment of spent nuclear fuel. The Division also performs basic research in catalytic chemistry involving molecular energy resources, mechanisms of ion transport in lithium battery electrolytes, materials chemistry of electrified interfaces and molecular sieves, and the theory of materials properties. It also operates the Analytical Chemistry Laboratory, which conducts research in analytical chemistry and provides analytical services for programs at ANL and other organizations. Technical highlights of the Division`s activities during 1996 are presented.

  11. Radiochemical purity and in vitro stability of Tc-99m radiopharmaceuticals

    International Nuclear Information System (INIS)

    Vucina, J.

    2001-01-01

    The increased contents of long lived 99 Tc, oxygen and cupric ions could affect the labeling yield of eight radiopharmaceuticals. Oxygen and in leaser extend copper were found to affect the radiochemical purity of the preparations. In vitro stability of radiopharmaceuticals, examined on 99m Tc(Sn)-pyrosphoshate solutions, was extended when ascorbic acid was added as the chemical stabilizer. The quantity of 5x10 -7 mol/dm 3 of ascorbic acid was found to be sufficient to keep the content of 99m Tc-pertechnetate below 1 % six hours after labeling even in the cases when 99m Tc was present in high radioactive concentrations (740-814 GBq/dm 3 ). The results led to the development of the kits in which ascorbic or gentisic acid are the standards component in the kit composition (author)

  12. Determination of radiochemical yield of 99mTc radiopharmaceutical preparations using gamma counter and linear radiochromatography scanner

    International Nuclear Information System (INIS)

    Martins, Patricia de A.; Moura, Rebeca G.; Shiki, Andressa M.; Fukumori, Neuza T.O.; Matsuda, Margareth M.N.

    2013-01-01

    The radiochemical purity (RCP) evaluation is a prerequisite for radiopharmaceuticals before the administration in patients. RCP is defined as the proportion of the total radioactivity in the product that is present in the specified chemical form. The most widely used techniques for RCP determination in radiopharmaceutical preparations are thin layer chromatography (TLC-Al), instant thin layer chromatography (ITLC-SG) and paper chromatography (PC). These techniques combined with radioactivity detection are one of the most important tools in the RCP of the radiopharmaceutical compounds. Several methods are used for the determination of the spatial distribution of radioactivity on the strips. The aim of this study was to compare two methods for radioactivity measurement in the determination of RCP in 99m Tc radiopharmaceuticals using gamma counter and linear radiochromatography scanner. Lyophilized radiopharmaceuticals were labeled with 99m Tc. The analysis was carried out using TLC-Al and high performance thin layer chromatography (HPTLC-Cellulose) sheets, ITLC-SG and 3MM Whatman PC. The radioactivity distribution was determined by counting each strip during 1 minute in a radiochromatography TLC scanner. For comparison, the strips were cut into small pieces and each one was separately measured in a gamma-counter during 0.20 minutes in 70-210 KeV 99m Tc window. USP 36 and FDA specify that not less than 90% of the total radioactivity must be in the spot corresponding to 99m Tc labeled compound. In conclusion, the procedure for RCP determination of ALBUMINA-TEC, DEX500-TEC, ECD-TEC, MACRO-TEC and MIBI-TEC can be faster using radiochromatography. (author)

  13. 99m Tc-labeled dendrimers as a potential radiopharmaceutical for tumor diagnosis process

    International Nuclear Information System (INIS)

    Tassano Hartwich, M.

    2008-01-01

    The present thesis to access the Bachelor of Biological Sciences studies the following: biology, molecular biology, pathology, radiotherapy, radiopharmaceuticals, research techniques and malignant neoplasms

  14. Quantitative HPLC determination of [99mTc]-pertechnetate in radiopharmaceuticals and biological samples: Pt. 1

    International Nuclear Information System (INIS)

    Tianze Zhou; Hirth, W.W.; Heineman, W.R.; Deutsch, Edward

    1988-01-01

    Techniques have been developed which allow HPLC (high performance liquid chromatography) to be used for the quantitative determination of [ 99m Tc]pertechnetate in radiopharmaceuticals and biological samples. An instrumental technique accounts for 99m Tc species which do not elute from the HPLC column, while a chemical technique obviates interferences caused by Sn(II). These two techniques are incorporated into an anion exchange HPLC procedure which is applied to the determination of [ 99m Tc]pertechnetate in 99m Tc-diphosphonate radiopharmaceuticals and biological samples. (author)

  15. WIPR 2013 - Radiopharmaceuticals: from research to industry - Book of abstracts

    International Nuclear Information System (INIS)

    2015-01-01

    This workshop aims at presenting the latest progress in the field of radioimmunotherapy: radiopharmaceutical production, radiochemistry, radiolabelling, nuclear imaging and clinical applications. The presentations have been divided into 4 sessions: 1) alpha or beta radioimmunotherapy, 2) peptides or antibodies, 3) the benefits from nuclear imaging, and multimodal imaging

  16. Basic evaluation of 67Ga labeled digoxin derivative as a metal-labeled bifunctional radiopharmaceutical

    International Nuclear Information System (INIS)

    Fujibayashi, Yasuhisa; Konishi, Junji; Takemura, Yasutaka; Taniuchi, Hideyuki; Iijima, Naoko; Yokoyama, Akira.

    1993-01-01

    To develop metal-labeled digoxin radiopharmaceuticals with affinity with anti-digoxin antibody as well as Na + , K + -ATPase, a digoxin derivative conjugated with deferoxamine was synthesized. The derivative had a high binding affinity with 67 Ga at deferoxamine introduced to the terminal sugar ring of digoxin. The 67 Ga labeled digoxin derivative showed enough in vitro binding affinity and selectivity to anti-digoxin antibody as well as Na + , K + -ATPase. The 67 Ga labeled digoxin derivative is considered to be a potential metal-labeled bifunctional radiopharmaceutical for digoxin RIA as well as myocardial Na + , K + -ATPase imaging. (author)

  17. Annual technical report of the prototype fast breeder reactor Monju. 2013

    International Nuclear Information System (INIS)

    2014-08-01

    The prototype fast breeder reactor Monju has accumulated technical achievements in order to establish the fast breeder reactor cycle technology in Japan using the operation and maintenance experience, etc. This annual report summarizes the principal achievements and the data related to the plant management in Monju in fiscal 2013. From the aspect of the management and design evaluation, the following items are summarized: 1) Current status of coping with the order from NRA to alter the safety regulations. 2) Implementation status of reformation of Monju. 3) Current status of the additional geological surveys of crush zones at the Monju site. 4) Development of core seismic assessment method for FBR. Then, from the aspect of the operation and maintenance technology, the following items are summarized: 1) Response to the administrative order to the defect of maintenance management (Part 2). 2) Performance confirmation of the failed fuel detection and location system. 3) Deviation from the limiting conditions for operation in the emergency diesel generator periodic test and so on. Furthermore, from the aspect of the plant management, this report summarizes the data related to the main topics, the history of plant condition, the sodium and water purity management, the radioactive waste management, the equipment inspection and so on. (author)

  18. Why are investors not interested in my radiotracer? The industrial and regulatory constraints in the development of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Zimmermann, Richard G.

    2013-01-01

    Four criteria are essential in the acceptance by investors of new radiopharmaceuticals: the existence of a market and a medical need, the quality of the science and technology behind the new molecule, the feasibility and compliance with regulations and the limited competitive landscape. Potential investors need to get more convincing market evidence, largely beyond the nice preclinical data generated to the point of first discussion. A properly protected compound not jeopardized by earlier published results is a must. A guarantee of an easy and secured source of the ligand is obvious. A safe access to the radionuclide in volumes corresponding to the targeted market is rarely taken into account, but of utmost importance. The evaluation of new drugs by investors will include the evaluation of the real market size for the targeted indication and the position of the drug in the healthcare environment at the time to market. This includes the potential competition with other radiopharmaceuticals, but also with conventional drugs or competitive modalities also at time to market. Both criteria are usually not easily accessible to researchers whose acquaintance remains limited to the scientific and technical part. Starting from this set of information, a first business plan can be deduced based on a best estimate for price per dose and a rough evaluation about the chance and level of reimbursement. In the following most of the events are covered that could jeopardize the development of the drug, focusing on the industrial, economic and regulatory aspects, comprehending the detailed analysis of the currently best available radionuclides

  19. Chemical Technology Division annual technical report 1997

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-06-01

    The Chemical Technology (CMT) Division is a diverse technical organization with principal emphases in environmental management and development of advanced energy sources. The Division conducts research and development in three general areas: (1) development of advanced power sources for stationary and transportation applications and for consumer electronics, (2) management of high-level and low-level nuclear wastes and hazardous wastes, and (3) electrometallurgical treatment of spent nuclear fuel. The Division also performs basic research in catalytic chemistry involving molecular energy resources, mechanisms of ion transport in lithium battery electrolytes, and the chemistry of technology-relevant materials and electrified interfaces. In addition, the Division operates the Analytical Chemistry Laboratory, which conducts research in analytical chemistry and provides analytical services for programs at Argonne National Laboratory (ANL) and other organizations. Technical highlights of the Division`s activities during 1997 are presented.

  20. 1998 Chemical Technology Division Annual Technical Report.

    Energy Technology Data Exchange (ETDEWEB)

    Ackerman, J.P.; Einziger, R.E.; Gay, E.C.; Green, D.W.; Miller, J.F.

    1999-08-06

    The Chemical Technology (CMT) Division is a diverse technical organization with principal emphases in environmental management and development of advanced energy sources. The Division conducts research and development in three general areas: (1) development of advanced power sources for stationary and transportation applications and for consumer electronics, (2) management of high-level and low-level nuclear wastes and hazardous wastes, and (3) electrometallurgical treatment of spent nuclear fuel. The Division also performs basic research in catalytic chemistry involving molecular energy resources, mechanisms of ion transport in lithium battery electrolytes, and the chemistry of technology-relevant materials. In addition, the Division operates the Analytical Chemistry Laboratory, which conducts research in analytical chemistry and provides analytical services for programs at Argonne National Laboratory (ANL) and other organizations. Technical highlights of the Division's activities during 1998 are presented.

  1. Chemical Technology Division annual technical report 1997

    International Nuclear Information System (INIS)

    1998-06-01

    The Chemical Technology (CMT) Division is a diverse technical organization with principal emphases in environmental management and development of advanced energy sources. The Division conducts research and development in three general areas: (1) development of advanced power sources for stationary and transportation applications and for consumer electronics, (2) management of high-level and low-level nuclear wastes and hazardous wastes, and (3) electrometallurgical treatment of spent nuclear fuel. The Division also performs basic research in catalytic chemistry involving molecular energy resources, mechanisms of ion transport in lithium battery electrolytes, and the chemistry of technology-relevant materials and electrified interfaces. In addition, the Division operates the Analytical Chemistry Laboratory, which conducts research in analytical chemistry and provides analytical services for programs at Argonne National Laboratory (ANL) and other organizations. Technical highlights of the Division's activities during 1997 are presented

  2. Characterization of contaminated nuclear sites, facilities and materials: radioisotope and radiopharmaceutical manufacturers and suppliers. Final report

    International Nuclear Information System (INIS)

    1983-01-01

    The Environmental Protection Agency (EPA) is developing environmental protection standards for evaluating the risks and characterizing problems associated with disposal of radioactive wastes arising from decontamination and decommissioning DandD operations. Information on operations conducted at sites authorized to possess radioactive materials for the production and/or distribution of radioisotopes and radiopharmaceuticals was compiled and evaluated. This information was used to project the types, nature, and volumes of wastes which are likely to be generated during decontamination and decommissioning at representative facilities and identifying special problems that may occur. Radioisotope and radiopharmaceutical manufacturers have been grouped together because decommissioning operations will be similar. Nuclear pharmacies were also evaluated because of their increasing numbers and their role as middlemen between manufacturers and users of radiopharmaceuticals. The majority of the radioactive waste will arise from the decontamination of the laboratories, rather than the disposal of components

  3. Calculating patient specific doses in X-ray diagnostics and from radiopharmaceuticals

    International Nuclear Information System (INIS)

    Lampinen, J.

    2000-01-01

    The risk associated with exposure to ionising radiation is dependent on the characteristics of the exposed individual. The size and structure of the individual influences the absorbed dose distribution in the organs. Traditional methods used to calculate the patient organ doses are based on standardised calculation phantoms, which neglect the variance of the patient size or even sex. When estimating the radiation dose of an individual patient, patient specific calculation methods must be used. Methods for patient specific dosimetry in the fields of X-ray diagnostics and diagnostic and therapeutic use of radiopharmaceuticals were proposed in this thesis. A computer program, ODS-60, for calculating organ doses from diagnostic X-ray exposures was presented. The calculation is done in a patient specific phantom with depth dose and profile algorithms fitted to Monte Carlo simulation data from a previous study. Improvements to the version reported earlier were introduced, e.g. bone attenuation was implemented. The applicability of the program to determine patient doses from complex X-ray examinations (barium enema examination) was studied. The conversion equations derived for female and male patients as a function of patient weight gave the smallest deviation from the actual patient doses when compared to previous studies. Another computer program, Intdose, was presented for calculation of the dose distribution from radiopharmaceuticals. The calculation is based on convolution of an isotope specific point dose kernel with activity distribution, obtained from single photon emission computed tomography (SPECT) images. Anatomical information is taken from magnetic resonance (MR) or computed tomography (CT) images. According to a phantom study, Intdose agreed within 3 % with measurements. For volunteers administered diagnostic radiopharmaceuticals, the results given by Intdose were found to agree with traditional methods in cases of medium sized patients. For patients

  4. International seminar on therapeutic applications of radiopharmaceuticals. Programme. Book of extended synopses

    International Nuclear Information System (INIS)

    1998-12-01

    The document includes extended synopses of 64 presentations given at the International Seminar on Therapeutic Applications of Radiopharmaceuticals, held in Hyderabad, India, 18-22 January 1999. A separate indexing was prepared for each presentation

  5. Preparation of gallium-68 radiopharmaceuticals for positron tomography. Progress report, November 1, 1980-December 31, 1981

    International Nuclear Information System (INIS)

    Welch, M.J.

    1981-06-01

    Although the germanium-68 → gallium-68 generator is probably the only source of positron-emitting radionuclides that could enable the widespread application of positron tomography, the commercially available 68 Ga/ 68 Ge generator system suffers from several major disadvantages. The most important of these is that the generator is eluted with EDTA, which forms a very strong chelate with gallium. In order to produce radiopharmaceuticals other than 68 Ga-EDTA, it is first necessary to break the stable EDTA complex and remove all traces of EDTA. This procedure adds several steps and a significant amount of time to procedures for preparing 68 Ga-radiopharmaceuticals. Several years ago, we developed a new generator using a solvent extraction system which produces 68 Ga-oxine (8-hydroxyquinoline), a weak chelate. We have also carried out studies to compare generator systems which produce 68 Ga in an ionic form. Using the gallium-68 eluted from these various generator systems, several 68 Ga-labeled radiopharmaceuticals have been synthesized and tested in vitro and in vivo. In addition, attempts have been made to design and synthesize a lipophilic ligand for gallium-68. The stability of radiogallium complexed with a series of potentially lipophilic complexing agents has been studied using chromatographic techniques and in vivo distribution data. The potential of these complexing agents for altering the biodistribution of gallium radiopharmaceuticals has also been investigated

  6. Development of more efficacious Tc-99m organ imaging agents for use in nuclear medicine by characterization of radiopharmaceuticals. Final report, September 1, 1992--June 30, 1998

    International Nuclear Information System (INIS)

    Heineman, W.R.; Seliskar, C.J.

    1998-01-01

    The primary goals of this project were twofold: (1) Development of a microsensor that would demonstrate the capability for in vivo monitoring of a radiopharmaceutical after its injection into a test animal; and (2) Exploration of capillary electrophoresis (CE) as a separation technique for the analysis of radiopharmaceuticals that are mixtures of different compounds. The combination of in vivo sensors for real-time monitoring of specific chemical states of a radiopharmaceutical in individual organs and CE for analysis of radiopharmaceuticals prior to injection would provide valuable information regarding the fate of an imaging agent after administration. Such information should give insight into strategies for the development of more efficacious radiopharmaceuticals

  7. Species dependence of [64Cu]Cu-Bis(thiosemicarbazone) radiopharmaceutical binding to serum albumins

    International Nuclear Information System (INIS)

    Basken, Nathan E.; Mathias, Carla J.; Lipka, Alexander E.; Green, Mark A.

    2008-01-01

    Introduction: Interactions of three copper(II) bis(thiosemicarbazone) positron emission tomography radiopharmaceuticals with human serum albumin, and the serum albumins of four additional mammalian species, were evaluated. Methods: 64 Cu-labeled diacetyl bis(N 4 -methylthiosemicarbazonato)copper(II) (Cu-ATSM), pyruvaldehyde bis(N 4 -methylthiosemicarbazonato)copper(II) (Cu-PTSM) and ethylglyoxal bis(thiosemicarbazonato)copper(II) (Cu-ETS) were synthesized and their binding to human, canine, rat, baboon and porcine serum albumins quantified by ultrafiltration. Protein binding was also measured for each tracer in human, porcine, rat and mouse serum. Results: The interaction of these neutral, lipophilic copper chelates with serum albumin is highly compound- and species-dependent. Cu-PTSM and Cu-ATSM exhibit particularly high affinity for human serum albumin (HSA), while the albumin binding of Cu-ETS is relatively insensitive to species. At HSA concentrations of 40 mg/ml, '% free' (non-albumin-bound) levels of radiopharmaceutical were 4.0±0.1%, 5.3±0.2% and 38.6±0.8% for Cu-PTSM, Cu-ATSM and Cu-ETS, respectively. Conclusions: Species-dependent variations in radiopharmaceutical binding to serum albumin may need to be considered when using animal models to predict the distribution and kinetics of these compounds in humans

  8. Radiological impact from the transport of radiopharmaceuticals of the IPEN/CNEN-SP

    International Nuclear Information System (INIS)

    Rodrigues, Demerval Leonidas

    2009-01-01

    When a package is shipped, people who work, live or travel in the route used for transportation of radioactive materials are irradiated, as well as those who are inside vehicles that travel in the same or opposite directions. Therefore, the proposed work has as main objective to estimate the radiological impact of the transportation of radiopharmaceuticals of IPEN/CNEN-SP to some predefined destinations. The doses in individuals who are in the public streets and in vehicles that travel close to the means of transportation, along the route traveled by packages, during the transport of radiopharmaceuticals were estimated. The doses were also estimated for drivers, from both the operation of driving the vehicle, and the loading and unloading of packages, because these tasks are performed by the drivers. (author)

  9. Efficiancy of hydrogen peroxide for cleaning production areas and equipments in the radiopharmaceutical production

    Energy Technology Data Exchange (ETDEWEB)

    Baptista, Tatyana S.; Batista, Vanessa; Gomes, Antonio; Matsuda, Margareth; Fukumori, Neuza; Araujo, Elaine B. de, E-mail: tsbaptista@ipen.br [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)

    2013-07-01

    A great challenge in the radiopharmaceuticals production is to fulfill the Good Manufacturing Practices (GMPs), involving the validation of process and of all supporting activities such as cleaning and sanitization. The increasingly strict requirements for quality assurance system, with several norms and normative resolutions has led to a constant concern with programs and cleaning validation in pharmaceutical production. The main goal of GMP is to reduce risks inherent to pharmaceutical production, that is to reduce product contamination with microorganisms and cross-contamination. The basic requirements to prevent contamination is the development and implementation of efficient cleaning programs. In the case of clean rooms for the production of injectable radiopharmaceuticals, the requirement for cleaning programs is evidently higher due to the characteristics of these areas with hot cells for radioactive materials, where sterile radiopharmaceuticals are manipulated and distributed before administration to patients just after minutes or hours of its preparation. In the Radiopharmacy Department at IPEN it was established a cleaning program for clean rooms and hot cells using a hydrogen peroxide solution (20% proxitane alfa). The objective of this work was to assess effectiveness of this cleaning agent in reducing and/or eliminating microbial load in the clean rooms and equipment to acceptable levels in accordance with the current legislation. The analysis was conducted using results of the environmental monitoring program with and settling contact plates in clean rooms after the cleaning procedures. Furthermore, it was possible to evaluate the action of the sanitizing agent on the microbial population on the surface of equipment and clean rooms. It was also evaluated the best way to accomplish the cleaning program considering the dosimetric factor in each production process, as the main concern of pharmaceutical companies is the microbiological contamination, in

  10. Efficiancy of hydrogen peroxide for cleaning production areas and equipments in the radiopharmaceutical production

    International Nuclear Information System (INIS)

    Baptista, Tatyana S.; Batista, Vanessa; Gomes, Antonio; Matsuda, Margareth; Fukumori, Neuza; Araujo, Elaine B. de

    2013-01-01

    A great challenge in the radiopharmaceuticals production is to fulfill the Good Manufacturing Practices (GMPs), involving the validation of process and of all supporting activities such as cleaning and sanitization. The increasingly strict requirements for quality assurance system, with several norms and normative resolutions has led to a constant concern with programs and cleaning validation in pharmaceutical production. The main goal of GMP is to reduce risks inherent to pharmaceutical production, that is to reduce product contamination with microorganisms and cross-contamination. The basic requirements to prevent contamination is the development and implementation of efficient cleaning programs. In the case of clean rooms for the production of injectable radiopharmaceuticals, the requirement for cleaning programs is evidently higher due to the characteristics of these areas with hot cells for radioactive materials, where sterile radiopharmaceuticals are manipulated and distributed before administration to patients just after minutes or hours of its preparation. In the Radiopharmacy Department at IPEN it was established a cleaning program for clean rooms and hot cells using a hydrogen peroxide solution (20% proxitane alfa). The objective of this work was to assess effectiveness of this cleaning agent in reducing and/or eliminating microbial load in the clean rooms and equipment to acceptable levels in accordance with the current legislation. The analysis was conducted using results of the environmental monitoring program with and settling contact plates in clean rooms after the cleaning procedures. Furthermore, it was possible to evaluate the action of the sanitizing agent on the microbial population on the surface of equipment and clean rooms. It was also evaluated the best way to accomplish the cleaning program considering the dosimetric factor in each production process, as the main concern of pharmaceutical companies is the microbiological contamination, in

  11. Intergrated approach to quality control procedures of radioisotopes and radiopharmaceuticals

    International Nuclear Information System (INIS)

    Rohani Mohamad

    1986-01-01

    Various aspects of the quality control procedures for radioisotopes and radiopharmaceuticals have been discussed. The paper high lighted those procedures that are important in ensuring the efficacy of the product. It also gives a general idea of the various procedures that are actually carried out by the Quality Control Section. (A.J.)

  12. The use of transducers for automated radiopharmaceutical synthesis procedures

    International Nuclear Information System (INIS)

    Ruth, T.J.; Adam, M.J.; Morris, D.; Jivan, S.; Tyldesley, S.

    1991-01-01

    There are essentially two reasons why a synthetic procedure for producing a radiopharmaceutical is automated. The First is to reduce radiation exposure and the second is to increase reliability. Reducing radiation exposure can be accomplished in a number of ways. The most common approaches include the use of: hotcells with manipulators, remotely controlled solenoid valves behind shielding, either a PC or a PLC to control the solenoid valves, or robotics. The question of reliability impacts on each of these methods differently. The use of a hotcell with manipulators requires a highly skilled operator and in general is not suitable for microchemistry and very short half-lives. The remotely controlled system is prone to operator error, for example activating the wrong valving sequence. The computer controlled system is dependent on a feedback system if it is to operate open-quotes intelligentlyclose quotes; and finally the robotic system is dependent on feedbacks, as well as, careful, set-up within the robotic coordinate system. The remainder of this paper will discuss the feedback loops, required for the automated/robotic chemistry associated with the synthesis of positron emitting radiopharmaceuticals

  13. Determination of the influence factors of the radiopharmaceutical vials dimensions used for activimeter calibration at IPEN

    International Nuclear Information System (INIS)

    Martins, E.W.; Potiens, M.P.A.

    2012-01-01

    This paper presents the establishment of a quality control program and correction factors for the geometry of the vials used for distribution of radiopharmaceutical and activimeters calibration. The radiopharmaceutical produced by IPEN 67 Ga, 131 I, 201 Tl and 99m Tc had been tested using two different vials. Results show a maximum variation of 22% for 201 Tl, and the minimum variation was 2.98% for 131 I. The correction factors must be incorporated in the routine calibration of the activimeters. - Highlights: ► Establishement of quality control program for reference activimeters. ► Determination of correction factors for the geometry of vials. ► Radiopharmaceuticals tested for different vials were 67 Ga, 131 I, 201 Tl and 99m Tc. ► The maximum variation was 22% for 201 Tl and the minimum variation was 2.98% for 131 I. ► Correction factors must be incorporated in the calibration of the activimeters.

  14. To the radiotoxicity of {sup 99m}Tc radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Ftacnikova, S [Inst. of Preventive and Clinical Medicine, 83301 Bratislava (Slovakia)

    1996-12-31

    In this paper the radiotoxicity and RBE values of Auger electrons for {sup 99m}Tc radiopharmaceuticals were discussed. Expression for the expected RBE for {sup 99m}Tc compounds is given. For the Auger electrons emitted in the decay of {sup 99m}Tc the RBE(Auger) = 10 and a value of 20 for the radiation weighing factor were recommended. (J.K.) 4 refs.

  15. IKO Annual Report 1976

    International Nuclear Information System (INIS)

    1977-01-01

    The IKO Annual Report of 1976 relates their progress in different projects and project fields. The fields covered include electron scattering, pion and muon physics, theory, radio- and nuclear chemistry, technical department, MEA, nuclear reactions and nuclear spectroscopy

  16. International seminar on therapeutic applications of radiopharmaceuticals. Programme. Book of extended synopses

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-12-01

    The document includes extended synopses of 64 presentations given at the International Seminar on Therapeutic Applications of Radiopharmaceuticals, held in Hyderabad, India, 18-22 January 1999. A separate indexing was prepared for each presentation Refs, figs, tabs

  17. The radiopharmaceuticals labelled with technetium-99m and the radiopharmacy; Les radiopharmaceutiques marques au technetium-99m et la radiopharmacie

    Energy Technology Data Exchange (ETDEWEB)

    Bodenant, V

    1998-10-01

    In less than fifty years, the place of nuclear medicine is become primordial. Among all the radiopharmaceuticals used in nuclear medicine, the technetium-99m is the most used because of its physico-chemical properties and its great availability with the molybdenum-99m - technetium-99m generator. Since 1992, the radiopharmaceuticals, the packages, the generators are included in the pharmaceutic monopole. They are now under the reliability of the radio-pharmacist. This thesis has for object to introduce these different radiopharmaceuticals labelled with technetium-99m and to show the primordial place of the radio-pharmacist in a service of nuclear medicine. (N.C.)

  18. Use of technegas as a radiopharmaceutical for the measurement of gastric emptying

    Energy Technology Data Exchange (ETDEWEB)

    Kwiatek, M.A. [School of Medical Radiation, University of South Australia, Adelaide (Australia); Jones, K.L. [School of Medical Radiation, University of South Australia, Adelaide (Australia)]|[Department of Medicine, Royal Adelaide Hospital, The University of Adelaide, Adelaide (Australia); Burch, W.M. [John Curtin School of Medical Research, Australian National University, Australian Capital Territory (Australia); Horowitz, M. [Department of Medicine, Royal Adelaide Hospital, The University of Adelaide, Adelaide (Australia); Bartholomeusz, F.D.L. [Department of Nuclear Medicine, Royal Adelaide Hospital, Adelaide (Australia)

    1999-08-01

    Many radiopharmaceuticals and test meals that are used to measure gastric emptying are less than optimal. A vegetable-based solid meal, such as rice, labelled with a radiopharmaceutical that also has the capacity to measure gastric emptying of liquids, is likely to be ideal. The role of Technegas as a radioisotopic marker to measure gastric emptying of rice and liquids was evaluated. Technegas-labelled rice was incubated in 0.9% saline, 1 M HCl and simulated gastric fluid (3.2 g/l pepsinogen, pH 2-3) to assess stability of the label. In eight healthy volunteers gastric emptying of two meals - 200 g rice (370 kcal) and 75 g dextrose dissolved in 300 ml water (300 kcal), both labelled with 20 MBq of Technegas - was measured scintigraphically. Over 4 h, the average label stability was 93.7%{+-}0.5% in 0.9% saline, 91.0%{+-}0.4% in 1 M HCl and 93.6%{+-}0.7% in simulated gastric juice. The lag phase was longer for rice than dextrose (25{+-}7 min vs 4{+-}2 min; P<0.05), but there was no difference in the post-lag emptying rate (2.1{+-}0.3 kcal/min vs 1.7{+-}0.2 kcal/min; P=0.2) between the two meals. We conclude that Technegas is a suitable radiopharmaceutical for measurement of gastric emptying of rice and nutrient-containing liquids. (orig.) With 2 figs., 16 refs.

  19. Determination and reliability of dose coefficients for radiopharmaceuticals; Ermittlung der Zuverlaessigkeit von Dosiskoeffizienten fuer Radiopharmaka

    Energy Technology Data Exchange (ETDEWEB)

    Spielmann, V.; Li, W.B.; Zankl, M.; Oeh, U.

    2015-11-15

    The dose coefficients used in nuclear medicine for dose calculations of radiopharmaceuticals are based on recommendations by ICRP (International Commission on radiological protection) and the MIRD (Medical Internal Radiation Dose Committee) using mathematical models for the temporal activity distributions in organs and tissues (biokinetic models) and mathematical models of the human body. These models using an idealized human body do not include uncertainty estimations. The research project is aimed to determine the uncertainties and thus the reliability of the dose coefficients for radiopharmaceuticals and to identify the biokinetic and dosimetric parameters that contribute most of the uncertainties.

  20. What Lies Within: Using Radiopharmaceuticals to Reveal and Target Diseases Hidden Inside the Human Body

    International Nuclear Information System (INIS)

    Jawerth, Nicole

    2014-01-01

    The ability to pinpoint the location and size of a cancerous mass hidden inside of a patient’s body was unthinkable less than 100 years ago. Today, with the help of special scanning machines, doctors are able to use radioactive drugs known as radiopharmaceuticals to get a glimpse inside the human body, and these pharmaceuticals can even be used in treating many health conditions. In nuclear medicine, radiopharmaceuticals play an essential role for minimally invasive diagnostic, treatment and care management procedures for many diseases, especially cancer, as well as for relieving pain associated with certain cancers

  1. Positron emitting radiopharmaceuticals for cancer

    International Nuclear Information System (INIS)

    Krohn, K.A.; Graham, M.M.

    1989-01-01

    Cancer is principally a biochemical disease involving abnormal enzymology, gene expression and/or membrane composition. Cytotoxic chemical treatments, including radiation products, are important in controlling cancer. It therefore follows that imaging of the biochemical differences between tumor and normal tissues should lead to more effective therapy. Metabolic imaging should identify the best new treatment protocol for an individual patient and may identify specific causes of resistance to therapy. Methods have been developed for imaging the metabolism of energy substrates (glucose and O 2 ), and DNA precursors (thymidine) and for specifically identifying hormone-dependent tumors (estrogen or testosterone) and hypoxic tissues (bioreductive alkylators). Together these new radiopharmaceuticals are leading to better cancer therapy, not just improving diagnosis, but more by following the different responses of tumor and surrounding normal tissues to cytotoxic therapy

  2. Annual technical report of the prototype fast breeder reactor Monju. 2012

    International Nuclear Information System (INIS)

    2013-09-01

    The prototype fast breeder reactor Monju has accumulated technical achievements in order to establish the fast breeder reactor cycle technology in Japan using the operation and maintenance experience, etc. This annual report summarizes the primary achievements and the data related to the plant management in Monju during fiscal 2012. From the aspect of the design evaluation, the following items are summarized: 1) Comprehensive safety assessments of Monju taking into account the accident at Fukushima Daiichi Nuclear Power Station of Tokyo Electric Power Company, 2) Evaluation of nuclear characteristics based on the data of core confirmation test, 3) Evaluation of hydrogen flux from steam generator tubes, 4) Construction of the advanced safeguards system, 5) Development of a plant dynamics analytical model for the Monju ex-vessel fuel storage system. Then, from the aspect of the maintenance technology, the following items are summarized: 1) Response to the administrative order to the defect of maintenance management, 2) Recovery of in vessel transfer machine dropping accident, 3) Work management by introduction of packaged isolation, 4) Evaluation of result of vibration control of RID sampling blower for secondary sodium loop. Furthermore, from the aspect of the plant management, this report summarizes the data related to the main topics, the history of plant condition, the sodium and water purity management, the radioactive waste management, the equipment inspection and so on. (author)

  3. Formulation of an inhibitor radiopharmaceutical of prostatic antigen of 177Lu-Glu-Nh-CO-Nh-Lys membrane

    International Nuclear Information System (INIS)

    Ortega S, D.

    2015-01-01

    The prostate specific membrane antigen (PSMA) is a zinc metalloenzyme that is expressed on the cell membrane and highly expressed in prostate cancer. Recently, it has been demonstrated that the peptide sequence Glu-Nh-CO-Nh-Lys inhibit PSMA activity through an electrostatic interaction with the Zn. Several theragnostic radiopharmaceuticals with base in 177 Lu have been developed for radiotherapy of specific molecular targets because gamma and beta emissions of the radionuclide (β = 0.498 MeV and γ= 0.133 MeV). However, there is currently no label a formulation for preparing a radiopharmaceutical of 177 Lu-Glu-Nh-CO-Nh-Lys useful treatment of prostate cancer. The aim of this research was to optimize and document the process of production of the radiopharmaceutical 177 Lu-Glu-Nh-CO-Nh-Lys for sanitary registration application before the Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS). The optimization of the production process was assessed a factorial design of three variables with mixed levels (3 x 3 x 2) where the dependent variable is the radiochemical purity, the analytical method was validated by UV-Vis spectrophotometry. Next, process validation was carried out by labeling 3 lots of the optimized formulation of the radiopharmaceutical (5.55 GBq (2.16 μg) of 177 LuCl 3 , 90 mg peptide PSMA, 50 mg ascorbic acid and 150 μL of acetate buffer 1 M ph 5), long-term stability was performed by high resolution liquid chromatography) to determine its useful shelf life. 3 validation batches were prepared under protocols of Good Manufacturing Practice (GMP) in the Production Plant of Radiopharmaceuticals of the Instituto Nacional de Investigaciones Nucleares (ININ), meet specifications preset by obtaining a sterile and free development of bacterial endotoxin yields of labeled 100% and which retains its quality characteristics radiochemical purity greater than 90% for at least 15 days. (Author)

  4. Quality assessment of radiopharmaceuticals in nuclear medicine services at Northeast states, Brazil; Avaliacao da qualidade de radiofarmacos em servicos de medicina nuclear de estados da regiao nordeste

    Energy Technology Data Exchange (ETDEWEB)

    Andrade, Wellington Gomes de

    2012-07-01

    The radiopharmaceuticals are used in the field nuclear medicine services (NMS) as tracer in the diagnoses and treatment of many diseases. Radiopharmaceuticals used in nuclear medicine and usually have a minimum of pharmacological effect. The procedures for labelling Radiopharmaceuticals should be observed in order to minimize risks to patients, employees and individuals from the public, and to be administered in humans, must be sterile and free of pyrogens and possess elements all measures of quality controls required a conventional drug. The 'Agencia Nacional de Vigilancia Sanitaria (ANVISA)' in its 'Resolucao de Diretoria Colegiada' (RDC) No. 38 of June 4{sup th} 2008, decided that the NMS must perform quality control in the generators eluate and radiopharmaceuticals according to recommendations of manufacturers and scientific evidence accepted by ANVISA. Thus, this study proposes to evaluate the quality of the generator {sup 99M}o-{sup 99m}Tc eluate and radiopharmaceuticals labeled with {sup 99m}Tc used in most NMS of some states in the Northeast, in relation to radionuclide, chemical, radiochemical purity and pH and promote the inclusion of procedure for quality control of radiopharmaceuticals in routine NMS. The results show that 90% radionuclidic purity, 98.2% purity chemical and radiochemical purity of 46% and 100% of the eluates are in agreement with international pharmacopoeias; already radiopharmaceuticals showed 82.6% purity and all radiochemical pH values are also in accordance with international pharmacopoeias. Even with so many positive results, staff the majority of MNS was not able to perform the quality control of the eluates and radiopharmaceuticals. Showing the importance of implementing of quality control programs of the eluates and radiopharmaceuticals in nuclear medicine. (author)

  5. Career and Technical Education. 2016 Annual Report

    Science.gov (United States)

    Utah System of Higher Education, 2016

    2016-01-01

    Career and Technical Education (CTE) is a key ingredient to meet the needs of Utah's economy. Utah System of Higher Education (USHE) institutions offer CTE programs in all regions of the state, working closely with local business and industry leaders to develop and deliver programs specifically tailored to local workforce development needs. This…

  6. Career and Technical Education. 2015 Annual Report

    Science.gov (United States)

    Utah System of Higher Education, 2015

    2015-01-01

    Career and Technical Education (CTE) is a key ingredient to meet the needs of Utah's economy. Utah System of Higher Education (USHE) institutions offer CTE programs in all regions of the state, working closely with local business and industry leaders to develop and deliver programs specifically tailored to local workforce development needs. This…

  7. 68Ga-Based Radiopharmaceuticals: Production and Application Relationship

    Directory of Open Access Journals (Sweden)

    Irina Velikyan

    2015-07-01

    Full Text Available The contribution of 68Ga to the promotion and expansion of clinical research and routine positron emission tomography (PET for earlier better diagnostics and individualized medicine is considerable. The potential applications of 68Ga-comprising imaging agents include targeted, pre-targeted and non-targeted imaging. This review discusses the key aspects of the production of 68Ga and 68Ga-based radiopharmaceuticals in the light of the impact of regulatory requirements and endpoint pre-clinical and clinical applications.

  8. Molecular Engineering of Technetium and Rhenium Based Radiopharmaceuticals

    International Nuclear Information System (INIS)

    Zubieta, J.

    2003-01-01

    The research was based on the observation that despite the extraordinarily rich coordination chemistry of technetium and rhenium and several notable successes in reagent design, the extensive investigations by numerous research groups on a variety of N 2 S 2 and N 3 S donor type ligands and on HYNIC have revealed that the chemistries of these ligands with Tc and Re are rather complex, giving rise to considerable difficulties in the development of reliable procedures for the development of radiopharmaceutical reagents

  9. Harvard-MIT research program in short-lived radiopharmaceuticals. Progress report, March 1, 1985-February 28, 1986

    International Nuclear Information System (INIS)

    1986-03-01

    The Harvard-MIT Research Program in Short-Lived Radiopharmaceuticals was established in 1977 to foster interaction among groups working at Harvard Medical School, the Massachusetts Institute of Technology and the Massachusetts General Hospital in fields related to radiopharmaceutical chemistry. From these collaborations and building upon the special, but different, strengths of the participating individuals, laboratories and institutions, it was hoped that original approaches would be found for the design of new, clinically useful, labeled compounds. We believe that examination of the record demonstrates that this has been a fruitful alliance

  10. Harvard--MIT research program in short-lived radiopharmaceuticals. Progress report, September 1, 1977--April 30, 1978

    International Nuclear Information System (INIS)

    Adelstein, S.J.; Brownell, G.L.

    1978-05-01

    Progress is reported on the following studies: chemistry studies designed to achieve a more complete understanding of the fundamental chemistry of technetium in order to facilitate the design of future radiopharmaceuticals incorporating the radionuclide /sup 99m/Tc; the development of new radiopharmaceuticals intended to improve image quality and lower radiation doses by the use of short-lived radionuclides and disease-specific agents; the development of short-lived positron-emitting radionuclides which offer advantages in transverse section imaging of regional physiological processes; and studies of the toxic effects of particulate radiation

  11. Evaluation of radiochemistry purity and p H of radiopharmaceuticals in nuclear medicine services at Pernambuco, Brazil

    International Nuclear Information System (INIS)

    Andrade, Wellington; Lima, Fabiana Farias de; Santos, Poliane A.L.; Lima, Fernando Roberto de Andrade; Lima, Fabiana Farias de

    2011-01-01

    Radiopharmaceuticals are cellular or molecular structures that have a radionuclide in its composition and they are used for diagnosing or treating diseases. The evaluation of the radiochemical purity of radiopharmaceuticals is essential to produce images with artifacts free, as well as avoid unnecessary absorbed dose to the patient. Since they are administered in humans is important and necessary that they undergo rigorous quality control. Due to this fact, the norm in ANVISA RDC 38/2008 declaring the mandatory completion of a minimum of tests in routine nuclear medicine services before human administration. (author)

  12. Determination of the influence factors of the radiopharmaceutical vials dimensions used for activimeter calibration at IPEN.

    Science.gov (United States)

    Martins, E W; Potiens, M P A

    2012-07-01

    This paper presents the establishment of a quality control program and correction factors for the geometry of the vials used for distribution of radiopharmaceutical and activimeters calibration. The radiopharmaceutical produced by IPEN 67Ga, 131I, 201Tl and 99mTc had been tested using two different vials. Results show a maximum variation of 22% for 201Tl, and the minimum variation was 2.98% for 131I. The correction factors must be incorporated in the routine calibration of the activimeters. Copyright © 2011 Elsevier Ltd. All rights reserved.

  13. Why are investors not interested in my radiotracer? The industrial and regulatory constraints in the development of radiopharmaceuticals.

    Science.gov (United States)

    Zimmermann, Richard G

    2013-02-01

    Four criteria are essential in the acceptance by investors of new radiopharmaceuticals: the existence of a market and a medical need, the quality of the science and technology behind the new molecule, the feasibility and compliance with regulations and the limited competitive landscape. Potential investors need to get more convincing market evidence, largely beyond the nice preclinical data generated to the point of first discussion. A properly protected compound not jeopardized by earlier published results is a must. A guarantee of an easy and secured source of the ligand is obvious. A safe access to the radionuclide in volumes corresponding to the targeted market is rarely taken into account, but of utmost importance. The evaluation of new drugs by investors will include the evaluation of the real market size for the targeted indication and the position of the drug in the healthcare environment at the time to market. This includes the potential competition with other radiopharmaceuticals, but also with conventional drugs or competitive modalities also at time to market. Both criteria are usually not easily accessible to researchers whose acquaintance remains limited to the scientific and technical part. Starting from this set of information, a first business plan can be deduced based on a best estimate for price per dose and a rough evaluation about the chance and level of reimbursement. In the following most of the events are covered that could jeopardize the development of the drug, focusing on the industrial, economic and regulatory aspects, comprehending the detailed analysis of the currently best available radionuclides. Copyright © 2013 Elsevier Inc. All rights reserved.

  14. Survey or quality for radiopharmaceuticals and activimeters available in services of nuclear medicine from Recife, Pernambuco State, Brazil

    International Nuclear Information System (INIS)

    Nogueira, Fernanda Maria Dornellas Camara

    2001-08-01

    The radiopharmaceutical used in Nuclear Medicine must present high chemical and radiochemical purities in order to obtain images with contrast and clearness adequate for the diagnosis. Test should be made by the Nuclear Medicine institutes to evaluate the presence of molybdenum, aluminium and the free Tc O 4 - /TC-HR in the radiopharmaceutical before they use it. On the other hand, the activity to be administered to the patient is determined by the activimeters available in the Nuclear Medicine institutions. So it is necessary to perform tests to verify operating conditions of the activimeter to guarantee that the dose received by patient is the prescribed by the physician. In Brazil, few clinics of Nuclear Medicine are implanting the tests of the radiopharmaceutical and of the activimeters. The objective of this work is to establish the procedures for the radiopharmaceutical tests and to evaluate the quality of the radiopharmaceutical used at the clinics of Recife, as well as the operation conditions of the activemeters in these institutions. The results show that all the activimeters analyzed present a good performance and that the equipment with Geiger-Muller detectors present larger instability than the ones that use ionization chamber. Concerning the Mo/Tc generators, it was observed that only one presented Mo in the generator eluate with concentration over the acceptable limits and that the concentration of Al found in the samples analyzed were below the limits. On the other hand, in 73% of the MIBI analyzed samples were observed problems with its preparation that were caused by the procedures adopted at the clinics, which do not follow the manufacturers recommendations. (author)

  15. Determination of radiochemical yield of {sup 99m}Tc radiopharmaceutical preparations using gamma counter and linear radiochromatography scanner

    Energy Technology Data Exchange (ETDEWEB)

    Martins, Patricia de A.; Moura, Rebeca G.; Shiki, Andressa M.; Fukumori, Neuza T.O.; Matsuda, Margareth M.N., E-mail: patyosborne@yahoo.com [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)

    2013-07-01

    The radiochemical purity (RCP) evaluation is a prerequisite for radiopharmaceuticals before the administration in patients. RCP is defined as the proportion of the total radioactivity in the product that is present in the specified chemical form. The most widely used techniques for RCP determination in radiopharmaceutical preparations are thin layer chromatography (TLC-Al), instant thin layer chromatography (ITLC-SG) and paper chromatography (PC). These techniques combined with radioactivity detection are one of the most important tools in the RCP of the radiopharmaceutical compounds. Several methods are used for the determination of the spatial distribution of radioactivity on the strips. The aim of this study was to compare two methods for radioactivity measurement in the determination of RCP in {sup 99m}Tc radiopharmaceuticals using gamma counter and linear radiochromatography scanner. Lyophilized radiopharmaceuticals were labeled with {sup 99m}Tc. The analysis was carried out using TLC-Al and high performance thin layer chromatography (HPTLC-Cellulose) sheets, ITLC-SG and 3MM Whatman PC. The radioactivity distribution was determined by counting each strip during 1 minute in a radiochromatography TLC scanner. For comparison, the strips were cut into small pieces and each one was separately measured in a gamma-counter during 0.20 minutes in 70-210 KeV {sup 99m}Tc window. USP 36 and FDA specify that not less than 90% of the total radioactivity must be in the spot corresponding to {sup 99m}Tc labeled compound. In conclusion, the procedure for RCP determination of ALBUMINA-TEC, DEX500-TEC, ECD-TEC, MACRO-TEC and MIBI-TEC can be faster using radiochromatography. (author)

  16. Radiopharmaceutical: options to marketing authorization; Le medicament radiopharmaceutique: les alternatives a l'AMM

    Energy Technology Data Exchange (ETDEWEB)

    Guilloteau, D.; Valat, Ch. [Centre Hospitalier Regional Universitaire, Service Medecine Nucleaire In Vitro, INSERM U 619, 37 - Tours (France); Verbruggen, A. [University Hospital Gasthuisberg, Lab. of Radiopharmaceutical Chemistry, Leuven (Belgium)

    2005-04-15

    In France, since the law 92-1279 (December 1992) the tracer used in nuclear medicine are considered as medicines, and all the regulations applicable to general medicines have to be followed for radiopharmaceuticals. The best situation in order to use radiopharmaceutical in nuclear medicine center is to use a tracer with a marketing authorization. However due to the very high cost to obtain this authorization, many tracers validated by scientific community will never been sold by pharmaceutical companies. However in respect with legal rules, it is possible to prepare these tracers in the hospital radiopharmacy, under the responsibility of the radio-pharmacist. We discuss here these different possibilities (magistral preparation...) and the conditions for these preparations. (author)

  17. Facilitation of the Estuary/Ocean Subgroup and the Expert Regional Technical Group, Annual Report for 2015

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, Gary E. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2015-08-01

    This document is the annual report for the period September 1, 2014 through August 31, 2015 for the project—Facilitation of the Estuary/Ocean Subgroup (EOS) and the Expert Regional Technical Group (ERTG). Pacific Northwest National Laboratory (PNNL) conducted the project for the Bonneville Power Administration (BPA). The EOS and ERTG are part of the research, monitoring, and evaluation (RME) and habitat restoration efforts, respectively, developed by the Action Agencies (BPA, U.S. Army Corps of Engineers [Corps or USACE], and U.S. Bureau of Reclamation) in response to obligations arising from the Endangered Species Act as a result of operation of the Federal Columbia River Power System (FCRPS) and implemented under the Columbia Estuary Ecosystem Restoration Program (CEERP). BPA/Corps (2015) explain the CEERP and the role of RME and the ERTG. For the purposes of this report, the lower Columbia River and estuary (LCRE) includes the floodplain from Bonneville Dam down through the lower river and estuary into the river’s plume in the ocean. The main purpose of this project is to facilitate EOS and ERTG meetings and work products. Other purposes are to provide technical support for CEERP adaptive management, CEERP restoration design challenges, and tributary RME. From 2002 through 2008, the EOS worked to design the federal RME program for the estuary/ocean (Johnson et al. 2008). From 2009 to the present day, EOS activities have involved RME implementation; however, EOS activities were minimal during the current reporting period. PNNL provided technical support to CEERP’s adaptive management process by convening 1.2 meetings of the Action Agencies (AAs) and drafting material for the “CEERP 2015 Restoration and Monitoring Plan” (BPA/Corps 2015).

  18. Report of an International Atomic Energy Agency's Advisory Group meeting on ''Quality control of cyclotron-produced radiopharmaceuticals''

    International Nuclear Information System (INIS)

    Vera-Ruiz, H.; Marcus, C.S.; Pike, V.W.

    1990-01-01

    The special requirements for the preparation and quality control of cyclotron-produced tracers have been described with particular reference to the production of short-lived positron-emitting radiopharmaceuticals. The regulatory philosophy and training aspects of implementation are considered followed by various aspects of quality of control including good production practice, chemical purity, radionuclide purity, radiochemical purity, specific activity, shelf-life and sterility and apyrogenicity. Finally some organizational aspects such as legal and regulatory aspects, supply of radiopharmaceuticals and professional liability are considered. (UK)

  19. Radiopharmaceutical prescription in nuclear medicine departments; La prescription medicale des radiopharmaceutiques au sein d'un service de medecine nucleaire

    Energy Technology Data Exchange (ETDEWEB)

    Biechlin-Chassel, M.L. [Radiopharmacie, service de pharmacie, Centre hospitalier de Chambery, 73 - Chambery (France); Lao, S. [Service de medecine nucleaire, CHU-Hopital de l' Archet, 06 - Nice (France); Bolot, C. [Service de pharmacie, hospices civiles de Lyon, groupement hospitalier Est, 69 - Bron (France); Francois-Joubert, A. [Service de medecine nucleaire, centre hospitalier de Chambery, 73 - Chambery (France)

    2010-11-15

    In France, radiopharmaceutical prescription is often discussed depending to which juridical structure the nuclear medicine department is belonging. According to current regulation, this prescription is an obligation in a department linked to hospital with a pharmacy department inside. But situation remains unclear for independent nuclear medicine departments where physicians are not constrained to prescribe radiopharmaceuticals. However, as radiographers and nurses are only authorized to realize theirs acts in front of a medical prescription, one prescription must be realized. Nowadays, computerized prescription tools have been developed but only for radiopharmaceutical drugs and not for medical acts. In the aim to achieve a safer patient care, the prescription regulation may be applied whatever differences between nuclear medicines departments. (authors)

  20. Species dependence of [{sup 64}Cu]Cu-Bis(thiosemicarbazone) radiopharmaceutical binding to serum albumins

    Energy Technology Data Exchange (ETDEWEB)

    Basken, Nathan E. [Division of Nuclear Pharmacy, Department of Industrial and Physical Pharmacy, Purdue University, West Lafayette, IN 47907 (United States)], E-mail: nbasken@purdue.edu; Mathias, Carla J. [Division of Nuclear Pharmacy, Department of Industrial and Physical Pharmacy, Purdue University, West Lafayette, IN 47907 (United States); Lipka, Alexander E. [Department of Statistics, Purdue University, West Lafayette, IN 47907 (United States); Green, Mark A. [Division of Nuclear Pharmacy, Department of Industrial and Physical Pharmacy, Purdue University, West Lafayette, IN 47907 (United States)], E-mail: magreen@purdue.edu

    2008-04-15

    Introduction: Interactions of three copper(II) bis(thiosemicarbazone) positron emission tomography radiopharmaceuticals with human serum albumin, and the serum albumins of four additional mammalian species, were evaluated. Methods: {sup 64}Cu-labeled diacetyl bis(N{sup 4}-methylthiosemicarbazonato)copper(II) (Cu-ATSM), pyruvaldehyde bis(N{sup 4}-methylthiosemicarbazonato)copper(II) (Cu-PTSM) and ethylglyoxal bis(thiosemicarbazonato)copper(II) (Cu-ETS) were synthesized and their binding to human, canine, rat, baboon and porcine serum albumins quantified by ultrafiltration. Protein binding was also measured for each tracer in human, porcine, rat and mouse serum. Results: The interaction of these neutral, lipophilic copper chelates with serum albumin is highly compound- and species-dependent. Cu-PTSM and Cu-ATSM exhibit particularly high affinity for human serum albumin (HSA), while the albumin binding of Cu-ETS is relatively insensitive to species. At HSA concentrations of 40 mg/ml, '% free' (non-albumin-bound) levels of radiopharmaceutical were 4.0{+-}0.1%, 5.3{+-}0.2% and 38.6{+-}0.8% for Cu-PTSM, Cu-ATSM and Cu-ETS, respectively. Conclusions: Species-dependent variations in radiopharmaceutical binding to serum albumin may need to be considered when using animal models to predict the distribution and kinetics of these compounds in humans.