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)

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

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

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)

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)

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)

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)

Knowledge evaluation for knowledge management implementation: A case study of the radiopharmaceutical centre of IPEN

Energy Technology Data Exchange (ETDEWEB)

Ricciardi, R.I. [Instituto de Pesquisas Energeticas e Nucleares, Nuclear and Energy Research Institute, IPEN-Brazil, Cidade Universitaria, Sao Paulo, SP (Brazil)]. E-mail: rita@ipen.br; Barroso, A.C.O. [Instituto de Pesquisas Energeticas e Nucleares, Nuclear and Energy Research Institute, IPEN-Brazil, Cidade Universitaria, Sao Paulo, SP (Brazil)]. E-mail: barroso@ipen.br; Ermine, J.-L. [INT - Institut National des Telecommunications, Evry Cedex (France)]. E-mail: jean-louis.ermine@int-evry.fr

2006-07-01

In recent years, organisations have used multiple methods and approaches to design their strategic and action plans. In this context, resource-based view (RBV) and knowledge-based view (KBV) frameworks have received increased attention as being instrumental to strategy formulation. The synergy of these approaches with knowledge management initiatives is intuitive and their use in a common framework is discussed here to show the importance of methods and instruments to mapping and assessing the knowledge assets of an organisation. The application of such methods to the radiopharmaceutical centre of IPEN is described. (author)

Knowledge evaluation for knowledge management implementation: A case study of the radiopharmaceutical centre of IPEN

International Nuclear Information System (INIS)

Ricciardi, R.I.; Barroso, A.C.O.; Ermine, J.-L.

2006-01-01

In recent years, organisations have used multiple methods and approaches to design their strategic and action plans. In this context, resource-based view (RBV) and knowledge-based view (KBV) frameworks have received increased attention as being instrumental to strategy formulation. The synergy of these approaches with knowledge management initiatives is intuitive and their use in a common framework is discussed here to show the importance of methods and instruments to mapping and assessing the knowledge assets of an organisation. The application of such methods to the radiopharmaceutical centre of IPEN is described. (author)

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)

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)

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)

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.)

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

International Nuclear Information System (INIS)

2000-07-01

Radiopharmaceuticals are compounds containing radioisotopes that are used in nuclear medicine for a variety of diagnostic studies and, to a limited extent, for therapy. Almost 80% of the diagnostic studies are carried out with 99m Tc containing radiopharmaceuticals (half-life, six hours). Recently, another class of radiopharmaceuticals contains the ultra short-lived isotopes 11 C, 13 N and 15 O as well as 18 F, which are mostly produced and immediately used in the hospital cyclotron Positron Emission Tomography (PET) facilities. In therapy, 131 I is widely used for thyroid disorders, 32 P for treatment of abnormal increase in circulating red blood cells, while 153 Sm and 89 Sr are used for palliation of pain in patients suffering from bone metastases. They contain very small amounts of chemical ingredients, normally do not have any pharmacological effects, and are administered in small volumes. Radiopharmaceuticals are produced, used and exported both in developing and developed countries. The scale of production is small compared to conventional pharmaceuticals. Monographs on radiopharmaceuticals can be found in many pharmacopoeias, such as BP, USP, EP and other compendia. This field is also marked by active research and development of new products both for diagnosis and therapy. Traditionally, production and supply of radiopharmaceuticals started as research activities of national nuclear laboratories operating reactors and cyclotrons. Certain products found useful and effective were continued to be provided to the clinics as a service from the nuclear centres. In developed countries demand of radiopharmaceuticals is so considerable that production and sale are increasingly taken over by commercial companies. On the other hand, in many developing countries, demand is still limited, and radiopharmaceutical production and supply still remain more of a service operation at the national nuclear centres. Depending on the radioactivity levels handled, production has to

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

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.

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

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.

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

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)

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)

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

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

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

Production of Radioisotopes and Radiopharmaceuticals at the Dalat Nuclear Research Reactor

International Nuclear Information System (INIS)

Duong Van Dong; Pham Ngoc Dien; Bui Van Cuong; Mai Phuoc Tho; Nguyen Thi Thu; Vo Thi Cam Hoa

2014-01-01

After reconstruction, the Dalat Nuclear Research Reactor (DNRR) was inaugurated on March 20th, 1984 with the nominal power of 500 kW. Since then the production of radioisotopes and labelled compounds for medical use was started. Up to now, DNRR is still the unique one in Vietnam. The reactor has been operated safely and effectively with the total of about 37,800 hrs (approximately 1,300 hours per year). More than 90% of its operation time and over 80% of its irradiation capacity have been exploited for research and production of radioisotopes. This paper gives an outline of the radioisotope production programme using the DNRR. The production laboratory and facilities including the nuclear reactor with its irradiation positions and characteristics, hot cells, production lines and equipment for the production of Kits for labelling with 99m Tc and for quality control, as well as the production rate are mentioned. The methods used for production of 131 I, 99m Tc, 51 Cr, 32 P, etc. and the procedures for preparation of radiopharmaceuticals are described briefly. Status of utilization of domestic radioisotopes and radiopharmaceuticals in Vietnam is also reported. (author)

Good practice in the production of radiopharmaceuticals

International Nuclear Information System (INIS)

Cruz Arencibia, Jorge

2012-01-01

In the paper the evolution of concepts regarding the quality of the pharmaceutical products is analyzed in the framework of the production of radiopharmaceuticals at CENTIS. The world trends range from the quality control of the fi nal product to the comprehensive concept of quality management. It is concluded from the analysis that CENTIS has an appropriate system of Good Manufacturing Practice as a result of 15 years of systematic, growing and qualified attention to the issue, in correspondence with the world tendencies and the continuous support of CECMED, the Cuban regulatory authority. That is certified by the fact that all the production processes of CENTIS have been licensed and all the CENTIS products in the market have been registered. The existing conditions at CENTIS are favorable to establish and certificate a Quality Management System. (author)

One year's experience of the WA medical cyclotron and radiopharmaceutical production facility

International Nuclear Information System (INIS)

DeRoach, J.; Tuchyna, T.; Jones, C.; Price, R.

2004-01-01

Full text: The WA PET Centre Medical Cyclotron, a facility novel in Western Australia, produced its first bolus of FDG for patient injection for PET scanning in August 2003. This paper describes the methodology and practices employed during the past 12 months for ensuring that reliable routine provision of FDG is maintained, in parallel with facilitating the development and production of achievable new radiopharmaceuticals. An FDG production team of six staff and, a maintenance and development team of 4 staff were created from the 3.4 staff specifically recruited for this service and from incumbent staff. Teams were also set up to carry out development projects related to the service. Training procedures were created under the department's ISO9001:2000 accreditation system for the certification of production and maintenance staff. Practices and documentation systems were put in place in anticipation of a pending cGMP audit. Several unplanned major changes to equipment and infrastructure were necessary post commissioning. These changes included purchase of a different FDG synthesis module from that originally supplied, and modifications to engineering services, including changes to air conditioning, changes to supply of vacuum and upgrading of drainage in the laboratory area. A device for the measurement of end of bombardment yield was built, so that the efficiencies of the various synthesis modules could be accurately determined. Strict radiation protection procedures were put in place. All staff were provided with luxels and finger TLDs for monthly reporting of their radiation levels, as well as electronic monitors for real-time monitoring. From August 2003 to June 2004 (11 months) 2229 FDG patient doses were produced and dispensed by this facility. An average of 8.0 patient doses per available working day were dispensed during the 2003 period, rising to 11.1 patient doses per day in 2004. Several 11 NH3 doses were also delivered. The cyclotron was unavailable for

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)

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)

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)

KAERI's challenge to steady production of radioisotopes and radiopharmaceuticals

International Nuclear Information System (INIS)

Park, J.H.; Han, H.S.; Park, K.B.

2000-01-01

The Korea Atomic Energy Research Institute (KAERI) is a national organization in Korea, and has been doing many research and development works in radioisotope production and applications for more than 30 years. Now KAERI regularly produces radioisotopes (I-131, Tc-99m, Ho-166) for medical use and Ir-192 for industrial use. Various I-131 labeled compounds and more than 10 kinds of Tc-99m cold kits are also produced. Our multi-purpose reactor, named HANARO, has been operative since April of 1995. HANAKO is an open tank type reactor with 30 MW thermal capacity. This reactor was designed not only for research on neutron utilization but for production of radioisotopes. KAERI intended to maximize the radioisotope production capability. For this purpose, radioisotope production facilities (RIPF) have been constructed adjacent to the HANARO reactor building. There are four banks of hot cells equipped with manipulators and some of the hot cells were installed according to the KGMP standards and with clean rooms. In reviewing our RI production plan intensively, emphasis was placed on the development of new radiopharmaceuticals, development of new radiation sources for industrial and therapeutic use, and steady production of selected radioisotopes and radiopharmaceuticals. The selected items are Ho-166 based pharmaceuticals, fission Mo-99/Tc-99m generators. solution and capsules of I-131, and Ir-192 and Co-60 for industrial use. The status and future plan of KAERI's research and development program will be introduced, and will highlight programs for steady production. (author)

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.)

Production of radionuclides and radiopharmaceuticals at the Argentine Atomic Energy National Commission

International Nuclear Information System (INIS)

Mitta, A.E.A.; Bonetto, Oscar; Kurcbart, Horacio; Mancini, Alberto; Marquez, R.O.; Palcos, M.C.; Quihillalt, E.L.; Salas, G.N.B. de; Suner, A.A.; Troparevsky, M.L.P. de.

1978-03-01

The production of radionuclides and radiopharmaceuticals at the CNEA is described, as well as the preparation of reagent's sets, and informations is given on the preparation of Tc-99m and In-113m generators. Some figures of the production of 1974-1976 are given. (author) [es

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)

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.)

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

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.

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

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.)

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

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

Radiopharmaceutical management in Brazil: the case of fluorodeoxyglucose production

International Nuclear Information System (INIS)

Pereira, Vitor da Silva

2016-01-01

Nowadays, the combination of fluorodeoxyglucose tracer (FDG) and PET/CT equipment is the best technological condition for medical diagnosis, allowing the generation of images that associate anatomy and metabolic functions of tissues or organs. Constitutional Amendment (CA) No 49 of 2006, relaxed the state monopoly on the production of radioactive substances, allowing private investment in radioisotope area with half-life of less than or equal to two hours, as a way to increase the supply of these materials to national health sector. In order to reflect on the Brazilian production of radiopharmaceuticals, especially FDG was performed a theoretical study with a qualitative approach, substantiated by documentary research and data collection through a questionnaire sent to the producing private companies of this radiopharmaceutical. Initially, it sought to identify in the federal level the legal and regulatory parameters for the activity; then the existing competitive environment was observed, and, finally, were prospected the business perspectives on the behavior of domestic demand of this product. The results showed the growth of production and its largest geographical distribution in the country, beyond what would be possible only considering public investment; but short of expectations surrounding the enactment of Constitutional Amendment. Private entrepreneurs believe in market growth; since, most of the population has no access to the benefits that the medical imaging diagnostic with the use of FDG may allow. It was also noted that there is a need to improve the regulatory framework in relation to licensing procedures; as well as implementation of common marketing parameters. (author)

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.)

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.)

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)

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

Manufacturing and test of a low cost polypropylene bag to reduce the radioactive gas released by a radiopharmaceutical production facility

Energy Technology Data Exchange (ETDEWEB)

Tavares, Jose Carlos Freitas; Lacerda, Marco Aurelio de Sousa, E-mail: jcft@cdtn.b, E-mail: masl@cdtn.b [Centro de Desenvolvimento da Tecnologia Nuclear (SEPRA/ CDTN/CNEN-MG) Belo Horizonte, MG (Brazil). Servico de Protecao Radiologica; Nascimento, Leonardo Tafas Constantino do; Silva, Juliana Batista da, E-mail: ltcn@cdtn.b, E-mail: silvajb@cdtn.b [Centro de Desenvolvimento da Tecnologia Nuclear (SECPRA/ CDTN/CNEN-MG) Belo Horizonte, MG (Brazil). Secao de Producao de Radiofarmacos

2011-07-01

The main objective of this work was to evaluate the efficiency of a plastic gas storage bag to reduce the radioactive gas released by the chimney of a radiopharmaceutical production facility during the 2-[{sup 18}F]fluoro-2- deoxy-D-glucose ({sup 18}FDG) synthesis. The studied facility was the Development Centre of Nuclear Technology (CDTN/CNEN) in Belo Horizonte, Brazil. The bag was manufactured utilizing foils of polypropylene of 360 x 550 x 0.16 mm and disposable components of the cassette of the synthesizer. Two synthesis of {sup 18}FDG were done using the same hot cell and synthesizer to evaluate the efficiency of the bag. The manufactured bag was put in the gas exit of the synthesizer and the activity reported by the online radiation monitoring system in the first synthesis. These results were compared to the activity released in a synthesis performed without the bag. We observed when the bag was used the amount released was about 0.2% in 270 minutes. The second synthesis was performed without the bag, about 7,1% of the input activity was released by the exhaust of the facility in the same time interval. The bag presented a very good efficiency in the reducing of the radioactive gas released by the chimney of the radiopharmaceutical production facility. (author)

Manufacturing and test of a low cost polypropylene bag to reduce the radioactive gas released by a radiopharmaceutical production facility

International Nuclear Information System (INIS)

Tavares, Jose Carlos Freitas; Lacerda, Marco Aurelio de Sousa; Nascimento, Leonardo Tafas Constantino do; Silva, Juliana Batista da

2011-01-01

The main objective of this work was to evaluate the efficiency of a plastic gas storage bag to reduce the radioactive gas released by the chimney of a radiopharmaceutical production facility during the 2-[ 18 F]fluoro-2- deoxy-D-glucose ( 18 FDG) synthesis. The studied facility was the Development Centre of Nuclear Technology (CDTN/CNEN) in Belo Horizonte, Brazil. The bag was manufactured utilizing foils of polypropylene of 360 x 550 x 0.16 mm and disposable components of the cassette of the synthesizer. Two synthesis of 18 FDG were done using the same hot cell and synthesizer to evaluate the efficiency of the bag. The manufactured bag was put in the gas exit of the synthesizer and the activity reported by the online radiation monitoring system in the first synthesis. These results were compared to the activity released in a synthesis performed without the bag. We observed when the bag was used the amount released was about 0.2% in 270 minutes. The second synthesis was performed without the bag, about 7,1% of the input activity was released by the exhaust of the facility in the same time interval. The bag presented a very good efficiency in the reducing of the radioactive gas released by the chimney of the radiopharmaceutical production facility. (author)

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.)

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

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

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)

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.)

The added value of Good Manufacturing Practices (GMP) in the production of radiopharmaceuticals

NARCIS (Netherlands)

Gerrits, Edwin; Woerdenbag, Herman; Luurtsema, Geert; de Hooge, Marjolijn; Boersma, Hendrikus

2017-01-01

Manufacturers of medicinal products including radiopharmaceuticals have to follow regulations from their governmental organizations as well as professional societies to ensure built-in quality combined with patient safety issues. This chapter is a concise review of Good Manufacturing Practices (GMP)

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)

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)

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

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

Reliability of eye lens dosimetry in workers of a positron emission tomography radiopharmaceutical production facility

International Nuclear Information System (INIS)

Silva, Teógenes A. da; Guimarães, Margarete C.; Meireles, Leonardo S.; Teles, Luciana L.D.; Lacerda, Marco Aurélio S.

2016-01-01

A new regulatory statement was issued concerning the eye lens radiation protection of persons in planned exposures. A debate was raised on the adequacy of the dosimetric quantity and on its method of measurement. The aim of this work was to establish the individual monitoring procedure with the EYE-D™ holder and a MCP-N LiF:Mg,Cu,P thermoluminescent chip detector for measuring the personal dose equivalent H_p(3) in workers of a Positron Emission Tomography Radiopharmaceutical Production Facility. - Highlights: • New regulatory statement was issued concerning eye lens radiation protection. • The calibration procedure of dosimeters for measuring H_p(3) was studied on a slab and cylindrical phantoms. • H_p(3) measurements in workers in a radiopharmaceutical production facility were done.

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

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)

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)

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

Study of the production of the radiopharmaceutical 18F-FLT in automated system: contribution for process validation

International Nuclear Information System (INIS)

Zanette, Camila

2013-01-01

Radiopharmaceutical 18 F-FLT is a thymidine nucleoside analogue and a promising tumor proliferation marker for PET images. The synthesis of this radiopharmaceutical is not simple, and often has low yields. This radiopharmaceutical has already been studied for some years; however, there is no production, nor are there clinical studies in Brazil. The study of the production process and its compliance with the guidelines of Good Manufacturing Practices (ANVISA) are of extreme importance. This study aimed to investigate the synthesis of this radiopharmaceutical, evaluate methods of quality control that will be used in future production routines, perform cytotoxicity studies, biodistribution studies and PET imaging in animals, thereby contributing to the development and elaboration of the process validation protocol and to the establishment of analytical methods to be used during production routines. Initially, we studied the synthesis and production of 18 F-FLT, with the evaluation of three different temperatures of radiolabeling to check the behavior of the radiochemical yield and stability of the nal product. Studies of analytical methodology comprised the analysis of radionuclide identification, determination of chromatographic profiles, radiochemical purity, residual solvents, and pH. In vitro studies of internalization and cytotoxicity were also carried out. In in vivo studies, we evaluated the pharmacokinetics, biodistribution in healthy animals and in animals with tumor models, in addition to PET/CT images in animals with melanomas. The final product had high radiochemical purity and was stable for up to 10 hours after the synthesis, but got a relatively low radiochemical yield, as described in the literature. The tested analytical methods proved suitable for use in the quality control of 18 F-FLT. In in vitro studies, 18 F-FLT showed a significant percentage of binding to tumor cells, and the nonradiolabeled molecule was not considered toxic for these studied

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

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

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

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

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

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

Radiopharmaceuticals are applied in Nuclear Medicine in diagnostic and therapeutic procedures and must be manufactured in accordance with the basic principles of Good Manufacturing Practices (GMP) for sterile pharmaceutical products. In order to prevent the uncontrolled spread of radioactive contamination, the processing of radioactive materials requires an exhausted and shielded special enclosure called hot cell. The quality of air inside the hot cell must be controlled in order to prevent the contamination of the product with particulate material or microorganisms. On the other hand, the hot cell must prevent external contamination with radioactive material. The aim of this work is to discuss the special requirements for hot cells taking in account the national rules for injectable pharmaceutical products and international standards available. Ventilation of radiopharmaceutical production facilities should meet the requirement to prevent the contamination of products and the exposure of working personnel to radioactivity. Positive pressure areas should be used to process sterile products. In general, any radioactivity should handle within specifically designed areas maintained under negative pressures. The production of sterile radioactive products should therefore be carried out under negative pressure surrounded by a positive pressure zone ensuring that appropriate air quality requirements are met. Some of the recent developments in the use of radioisotopes in medical field have also significantly impacted on the evolution of handling facilities. Application of pharmaceutical GMP requirements for air quality and processing conditions in the handling facilities of radioactive pharmaceuticals has led to significant improvements in the construction of isolator-like hot cells and clean rooms with HEPA filtered ventilation and air conditioning (HVAC) systems. Clean grade A (class 100) air quality hot cells are now available commercially, but in a high cost

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

Radiopharmaceuticals are applied in Nuclear Medicine in diagnostic and therapeutic procedures and must be manufactured in accordance with the basic principles of Good Manufacturing Practices (GMP) for sterile pharmaceutical products. In order to prevent the uncontrolled spread of radioactive contamination, the processing of radioactive materials requires an exhausted and shielded special enclosure called hot cell. The quality of air inside the hot cell must be controlled in order to prevent the contamination of the product with particulate material or microorganisms. On the other hand, the hot cell must prevent external contamination with radioactive material. The aim of this work is to discuss the special requirements for hot cells taking in account the national rules for injectable pharmaceutical products and international standards available. Ventilation of radiopharmaceutical production facilities should meet the requirement to prevent the contamination of products and the exposure of working personnel to radioactivity. Positive pressure areas should be used to process sterile products. In general, any radioactivity should handle within specifically designed areas maintained under negative pressures. The production of sterile radioactive products should therefore be carried out under negative pressure surrounded by a positive pressure zone ensuring that appropriate air quality requirements are met. Some of the recent developments in the use of radioisotopes in medical field have also significantly impacted on the evolution of handling facilities. Application of pharmaceutical GMP requirements for air quality and processing conditions in the handling facilities of radioactive pharmaceuticals has led to significant improvements in the construction of isolator-like hot cells and clean rooms with HEPA filtered ventilation and air conditioning (HVAC) systems. Clean grade A (class 100) air quality hot cells are now available commercially, but in a high cost

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

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

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

Evaluation of a measurement system for Uranium electrodeposition control to radiopharmaceuticals production

Energy Technology Data Exchange (ETDEWEB)

Tufic Madi Filho; Adonis Marcelo Saliba Silva; Jose Patricio Nahuel Cardenas; Maria da Conceicao Costa Pereira; Valdir Maciel Lopes; Alexandre, P. S.; Diogo, F. S.; Rafael, T. P.; Vitor, O. A; Anderson, F. L.; Lucas, R. S.; Brianna, S.; Eduardo, L. C. [Nuclear and Energy Research Institute, IPEN-CNEN/SP, Av. Prof. Lineu Prestes 2242 Cid Univers. CEP: 05508-000- Sao Paulo-SP, (Brazil)

2015-07-01

For 2016, studies by international bodies forecast a crisis in the supply of Molybdenum ({sup 99}Mo), which is the generator of {sup 99m}Tc, widely used for medical diagnoses and treatments. As a result, many countries are making efforts to prevent this crisis. Brazil is developing the Brazilian Multipurpose Reactor (RMB) project, under the responsibility of the National Nuclear Energy Commission (CNEN). The RMB is a nuclear reactor for research and production of radioisotopes used in the production of radiopharmaceuticals and radioactive sources, broadly used in industrial and research areas in Brazil. Electrodeposition of uranium is a common practice to create samples for alpha spectrometry and this methodology may be an alternative way to produce targets of low enriched uranium (LEU) to fabricate radiopharmaceuticals, as {sup 99}Mo, used for cancer diagnosis. To study the electrodeposition, a solution of 10 mM uranyl nitrate, in 2-propanol, containing uranium enriched to 2.4% in {sup 235}U, with pH = 1, was prepared and measurements with an alpha spectrometer were performed. These studies are justified by the need to produce {sup 99}Mo since, despite using molybdenum in bulk, Brazil is totally dependent on its import. In this project, we intend to obtain a process that may be technologically feasible to control the radiation targets for {sup 99}Mo production. (authors)

Evaluation of a measurement system for Uranium electrodeposition control to radiopharmaceuticals production

International Nuclear Information System (INIS)

Tufic Madi Filho; Adonis Marcelo Saliba Silva; Jose Patricio Nahuel Cardenas; Maria da Conceicao Costa Pereira; Valdir Maciel Lopes; Alexandre, P. S.; Diogo, F. S.; Rafael, T. P.; Vitor, O. A; Anderson, F. L.; Lucas, R. S.; Brianna, S.; Eduardo, L. C.

2015-01-01

For 2016, studies by international bodies forecast a crisis in the supply of Molybdenum ( 99 Mo), which is the generator of 99m Tc, widely used for medical diagnoses and treatments. As a result, many countries are making efforts to prevent this crisis. Brazil is developing the Brazilian Multipurpose Reactor (RMB) project, under the responsibility of the National Nuclear Energy Commission (CNEN). The RMB is a nuclear reactor for research and production of radioisotopes used in the production of radiopharmaceuticals and radioactive sources, broadly used in industrial and research areas in Brazil. Electrodeposition of uranium is a common practice to create samples for alpha spectrometry and this methodology may be an alternative way to produce targets of low enriched uranium (LEU) to fabricate radiopharmaceuticals, as 99 Mo, used for cancer diagnosis. To study the electrodeposition, a solution of 10 mM uranyl nitrate, in 2-propanol, containing uranium enriched to 2.4% in 235 U, with pH = 1, was prepared and measurements with an alpha spectrometer were performed. These studies are justified by the need to produce 99 Mo since, despite using molybdenum in bulk, Brazil is totally dependent on its import. In this project, we intend to obtain a process that may be technologically feasible to control the radiation targets for 99 Mo production. (authors)

Study to master "1"8F-FDG radiopharmaceutical production process by Korean Cyclotron KOTRONS 13 MeV at Hanoi Irradiation Center

International Nuclear Information System (INIS)

Nguyen Quang Anh; Tran Manh Thang; Dam Thi Tam; Mai Van Vinh

2016-01-01

A PET Cyclotron center is built in Hanoi Irradiation Center (HIC), VINATOM and expectation put in operation in the middle of 2016. Three main processes in "1"8F-FDG synthesis general process of Samyoung Unitech synthesizer module were studied as: effect of time to water removal process, effect of time to nucleophilic substitution reaction, and effect of temperature and time to hydrolysis process. The optimum parameters are collected and re-installed for "1"8F-FDG synthesizer module to achieve highest yield. The human resource was trained basic to advanced theoretical and practical training programs of 18F-FDG Radiopharmaceutical Production by Vietnamese and Korean senior experts in HICs facility for this project. After training courses, the human resource is able to produce and quality control "1"8F-FDG Radiopharmaceutical in different modules and quality control systems such as GE-MX (GE), Synthera (IBA), and Samyoung Unitech (SYU). "1"8F-FDG Radiopharmaceutical was produced in HIC achieves British Pharmacopeia (BP) standards and tested in animals. Animal PET/CT scanner images show clearly distribution of FDG according to physiological characters. Besides, this project were establishing "1"8F-FDG Radiopharmaceutical Production Process by cyclotron KOTRONS13 and Samyoung Unitech synthesizer module and Quality Assurance, Quality Control Process attain BP standards at Hanoi Irradiation Center; and establishing the training documents for practical production human resource training, "1"8F-FDG radiopharmaceutical Quality Assurance Process, Quality Control Process which attain BP standards. (author)

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

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)

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

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.

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)

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

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

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)

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.

Calibrating the radiation detector of the ventilation of a PET radiopharmaceutical production facility

International Nuclear Information System (INIS)

Lacerda, Marco Aurelio de Sousa; Tavares, Jose Carlos Freitas; Silva, Juliana Batista da

2011-01-01

The aim of this work is to demonstrate a new methodology of estimating the calibration factor of the ventilation duct of a PET radiopharmaceutical facility. The proposed methodology was studied to minimize contamination risks for the workers, as well as the uncertainties attributed to the gas sampling. The studied facility was the Development Centre of Nuclear Technology (CDTN/CNEN) in Belo Horizonte, Brazil. It was performed 3 consecutive irradiations with normal water (H 2 16 O) for production of nitrogen-13 to estimate the calibration factor of the detector located in the chimney of the facility. The readings of the detector were registered by the online radiation monitoring system (MEDISMARTS) during the transfer of the irradiated liquid until the count rate decreased for the background (BG) levels. The remaining activity of the water from the vial was measured and the decay corrected to the beginning of the transfer of the activity. The mean calibration factor estimated was (3.6 +- 0.5) kBq . m -3 . cps -1 . The maximum activities registered in the three irradiations were, respectively, 278 s, 370 s and 366 s after transferring of the activity to the hot cell. The conservative assumptions adopted and the values found for the calibration factor, which were close to the manufacturer published data, permit to estimate, safely, the discharges of radioactive gases in the installation. (author)

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

Yields of nuclear reactions for the production of radiopharmaceuticals 18F, 43K, 67Ga, 111In and 123I with charged particles

International Nuclear Information System (INIS)

Bem, P.; Burjan, V.; Schaferlingova, W.; Vincour, J.; Kopecky, P.

1977-02-01

Experimental results are given of reaction yields in the preparation of radiopharmaceuticals ( 18 F, 43 K, 67 Ga, 111 In, 123 I) using common cyclotron beams, i.e., proton beams, deuteron beams, 3 He and alpha particles in an energy range of up to several MeV/nucleon. A detailed analysis is made of the choice of suitable target materials for the production of the above radiopharmaceuticals with regard to the economical use of the accelerator and of the purity of the radiopharmaceuticals prepared. (I.W.)

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

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

The good laboratory practice and good clinical practice requirements for the production of radiopharmaceuticals in clinical research

NARCIS (Netherlands)

De Vos, FJ; De Decker, M; Dierckx, RA

Radiopharmaceuticals account for more than 95% of the group of sterile pharmaceutical products and should therefore be handled and produced with care. Since the introduction of the European directive, all pharmaceuticals used in clinical studies must be prepared under good manufacturing practice

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

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

On organization of medical radionuclides production in Ukraine

International Nuclear Information System (INIS)

Zelens'kij, V.F.; Pilipenko, M.Yi.; Shulyika, M.G.; Skibyin, V.Yi.; Kostyin, V.Ya.; Vyikman, Ya.E.; Kalmikov, L.Z.; Nesterov, V.G.; Krasnoperova, A.P.

1994-01-01

Annual demand for radiopharmaceuticals in Ukraine is about 50.000 GBq and expenses for their purchase are about 1 - 2 mln US dollars per year. It determines expediency of their production in Ukraine. Taking into consideration the fact that one of the aftereffects of the accident at Chernobyl Atomic Power Station is inevitable increase of the number of oncological diseases (including malignant growths of the thyroid gland) the demand for radionuclides will be increasing steadily. Therefore, it is clear that organization of the centre for radiopharmaceuticals production will not solve the problem of providing radiological departments with them. One of the possible ways to solve the problem is creation of a network of regional centres for radioactive isotopes production. Realisation of the suggested program will allow to solve the problem of providing the medical establishments of Ukraine with medical radionuclides. Performed technical and economical evaluation shows that the expenses will be compensated in 2.9 years

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)

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)

The centralised production and quality control of radiopharmaceuticals

International Nuclear Information System (INIS)

Boyd, R.E.

1980-01-01

The concept of a centralised facility for the production testing and distribution within a metropolitan, regional or national area, although not new, is now gaining widespread acceptance in many countries. The rationalisation of resources and operation on a large scale ensures savings in costs. The aim of the centralised radiopharmacy is the regular and routine provision of high quality radiopharmaceuticals and to do this it must have access to a multidisciplinary group of scientists working with the support of trained technicians. These specialists require working facilities which are quite unique and designed according to complex engineering criteria to ensure the safety both of the environment and the patient. Production processes and equipment must be selected on the basis of reliability, minimal operational skill and the ease of maintenance. The infra structure of the organisation must provide the logistic support to ensure that the products from the centralized radiopharmacy reach the end-users at the times, places and in the amounts requested. This should be achieved with a success rate which engenders confidence. The Australian Atomic Energy Commission has operated a national radiopharmacy for more than a decade, delivering more than 150000 patient doses per year over the vast distances which separate the Australian capital cities. These activities have helped nuclear medicine to flourish in Australia; it is expected that the creation of the radioisotope production facilities at PUSPATI will have the same effect in Malaysia. (author)

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

Development of a pattern hot cell for production of injectable radiopharmaceuticals

International Nuclear Information System (INIS)

Campos, Fabio Eduardo de

2010-01-01

A controlled ambient should be established to the production/processing of materials susceptible to contamination, like injectable pharmaceuticals, in order to agree with normative and regulatory requirements. Considering medical but also toxic, radioactive and dangerous products, the ambient should work in special conditions to assure that the materials, which in same cases can be also volatile, do not escape to the external ambient, working in a selective, secure and controlled way. The conditions recommended by local and international rules in use, report an negative pressured ambient in relation to the adjacent areas. The technology related with the sizing of project to this kind of system is fully described in the literature, taking in account the rules that clearly describe the essential requirements. However, it is necessary to develop a controlled ambient for radiopharmaceutical production, in a way compatible with the concept of clean rooms and with the safety related to the manipulation of open radioactive wastes. In this work, some devices were created, methods and procedures were established making possible the classification of the ambient inside the hot cell, without physical barriers in the area, using ergonomic, flexible and practical conditions of work, that can results in the improvement of the productivity. The project resulted in the creation of a controlled ambient, in agreement with the normative requirements, using a pass through for entrance and exit of the materials, without compromise the internal air condition. The tight of the hot cell was obtained using doors with efficient sealing system and active joints. Tong manipulators were used to produce ergonomic and secure conditions, without compromise the internal conditions related to tight and classification in A and B grade, according to local and international rules. An efficient ventilation/exhaustion system was adopted to produce these results, composed by filters and special devices

Quality Assurance of technitium-labelled radiopharmaceuticals in the Radiation and Isotopes Centre of Khartoum (RICK)

International Nuclear Information System (INIS)

Adlan, A.A.

2005-09-01

This descriptive, exploratory study was conducted in the nuclear medicine department at the Radiation and Isotopes Center of Khartoum (RICK) during 2003-2005 the aim of the study was explore and define the dimensions of a problem which was regarded as urgent by the people working in the field of nuclear medicine in Sudan. The problem concerned the quality of technitium-labelled radiopharmaceuticals which are used in more than 90% of the nuclear medicine imaging studies performed in nuclear medicine. Impure 9 ''9''m Tc-labelled radiopharmaceuticals may create problems, and could lead to false diagnosis. These agents must be tested for determination of the levels of radionuclides, radiochemical and chemicals, before administration to patients. They should also be sterile and pyrogen-free. A number of data collection methods, were used by the researcher for adequate exploration of the dimensions of the problem including interviews, questionnaires and close observations to all activities related to the preparation of radiopharmaceuticals in the hot laboratory. Information concerning all the aspects of quality assurance were collected. These aspects were management and organisation of the work, equipment and tools, knowledge and practical experience of the staff members and methods of preparation and administration of the radioactive agents. Data from different sources were then compared with observation results for more validation and finally lead to the following results: All the quality control tests were not normally performed in the department, therefore the levels of impurities in these agents were not exactly determined, moreover these preparations were subject to contamination with microorganisms, due to low level of cleanliness at the work area. The study detected a number of defaults which were likely to be the causes behind these problems. These were, bad management and organisation, in availability of equipment, tools and materials necessary for testing

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)

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

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)

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)

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

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

Optimization of production and quality control of therapeutic radionuclides and radiopharmaceuticals. Final report of a co-ordinated research project 1994-1998

International Nuclear Information System (INIS)

1999-09-01

The 'renaissance' of the therapeutic applications of radiopharmaceuticals during the last few years was in part due to a greater availability of radionuclides with appropriate nuclear decay properties, as well as to the development of carrier molecules with improved characteristics. Although radionuclides such as 32 P, 89 Sr and 131 I, were used from the early days of nuclear medicine in the late 1930s and early 1940s, the inclusion of other particle emitting radionuclides into the nuclear medicine armamentarium was rather late. Only in the early 1980s did the specialized scientific literature start to show the potential for using other beta emitting nuclear reactor produced radionuclides such as 153 Sm, 166 Ho, 165 Dy and 186-188 Re. Bone seeking agents radiolabelled with the above mentioned beta emitting radionuclides demonstrated clear clinical potential in relieving intense bone pain resulting from metastases of the breast, prostate and lung of cancer patients. Therefore, upon the recommendation of a consultants meeting held in Vienna in 1993, the Co-ordinated Research Project (CRP) on Optimization of the Production and quality control of Radiotherapeutic Radionuclides and Radiopharmaceuticals was established in 1994. The CRP aimed at developing and improving existing laboratory protocols for the production of therapeutic radionuclides using existing nuclear research reactors including the corresponding radiolabelling, quality control procedures; and validation in experimental animals. With the participation of ten scientists from IAEA Member States, several laboratory procedures for preparation and quality control were developed, tested and assessed as potential therapeutic radiopharmaceuticals for bone pain palliation. In particular, the CRP optimised the reactor production of 153 Sm and the preparation of the radiopharmaceutical 153 Sm-EDTMP (ethylene diamine tetramethylene phosphonate), as well as radiolabelling techniques and quality control methods for

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.

Standardization of 123I and 18F for providing traceability of activity meters performed in the Radiopharmaceutical Production Service of the Instituto de Engenharia Nuclear, RJ, Brazil

International Nuclear Information System (INIS)

Andrade, E.A.L.; Delgado, J.U.; Iwahara, A.; Contic, C.C.

2013-01-01

The commercialization and use of radiopharmaceuticals in Brazil are regulated by Sanitary Vigilance National Agency which requiring Good Manufacturing Practices certification for all segments within the Nuclear Medicine. Quality Assurance Programmes should implement the standard requirements to ensure that radiopharmaceuticals have requirements quality to proving its efficiency. Several aspects should be controlled, and one of them is the traceability of the Radionuclides Activity Measurement in radiopharmaceuticals doses. This paper aims to provide traceability to dose calibrators (well type ionization chambers) used for 123 I and 18 F activity measurements in Radiopharmaceuticals Production Service placed in Institute of Nuclear Engineering, Rio de Janeiro, RJ, Brazil. (author)

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)

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)

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.

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.)

Experiences in radioisotope production in the German Democratic Republic with special reference to radiopharmaceuticals

International Nuclear Information System (INIS)

Muenze, R.

1988-01-01

Radioisotope production has been carried out in the German Democratic Republic for 30 years. Based on a 10 MW research reactor, a cyclotron and certain irradiation facilities at units of national nuclear power stations, a widespread assortment of radioisotopes is produced with emphasis to radiopharmaceuticals as the main materials. Domestic production covers the national demand in these products where the production is technologically feasible under our conditions. A complete supply of the users in the country (more than 7000 licences) is accomplished by an intense co-operation with neighbouring countries, including mutual assistance in reactor shut down periods and supply with special radioactive materials and products. International co-operation within the framework of the IAEA takes place, mainly as scientific and technological assistance to many developing countries. (author)

Radiopharmaceutical activities administered for paediatric nuclear medicine procedures in Australia

International Nuclear Information System (INIS)

Towson, J.E.; Smart, R.C.; Rossleigh, M.A.; Children's Hospital, Randwick, NSW

2000-01-01

A survey of radiopharmaceutical activities used at the eight hospital centres specialising in paediatric nuclear medicine in Australia was conducted in 1999-2000 by the Australian and New Zealand Society of Nuclear Medicine and the Australasian Radiation Protection Society. Data on the maximum and minimum administered activities was obtained for 43 paediatric imaging procedures. The maximum values were significantly less than the corresponding Reference Activities for adults determined in a previous study. Activities for individual patients are calculated using surface area scaling at five centres and body weight scaling at three centres. The median values of A max and A min are recommended as Paediatric Reference Activities. The effective dose to patients of various sizes for the Paediatric Reference Activities and both methods of scaling was calculated for each procedure. Copyright (2000) Australasian Radiation Protection Society Inc

Leveraging management information in improving call centre productivity

Directory of Open Access Journals (Sweden)

Manthisana Mosese

2016-04-01

Objectives: This research explored the use of management information and its impact on two fundamental functions namely, improving productivity without compromising the quality of service, in the call centre of a well-known South African fashion retailer, Edcon. Following the implementation of the call centre technology project the research set out to determine how Edcon can transform their call centre to improve productivity and customer service through effective utilisation of their management information. Method: Internal documents and reports were analysed to provide the basis of evaluation between the measures of productivity prior to and post the implementation of a technology project at Edcon’s call centre. Semi-structured in-depth and group interviews were conducted to establish the importance and use of management information in improving productivity and customer service. Results: The results indicated that the availability of management information has indeed contributed to improved efficiency at the Edcon call centre. Although literature claims that there is a correlation between a call centre technology upgrade and improvement in performance, evident in the return on investment being realised within a year or two of implementation, it fell beyond the scope of this study to investigate the return on investment for Edcon’s call centre. Conclusion: Although Edcon has begun realising benefits in improved productivity in their call centre from their available management information, information will continue to play a crucial role in supporting management with informed decisions that will improve the call centre operations. [pdf to follow

Introducing the PET Centre Prague

International Nuclear Information System (INIS)

Belohlavek, O.

2001-01-01

The PET Centre Prague (www.homolka.cz/nm) was established in 1999 as the outcome of a joint project of the public Na Homolce Hospital and the Nuclear Research Institute Rez, plc, the Czech radiopharmaceutical producer. Technical and financial assistance was provided by the International Atomic Energy Agency, which perceived the Centre as its model project that could serve as a guide for the development of PET centres in countries sharing a comparable level of development with the Czech Republic. The article maps the history of the project, its design, workplace lay-out and equipment, radiation protection arrangements and spectrum of the first approx. 3000 investigations. (author)

Advances in the production of isotopes and radiopharmaceuticals at the Atomic Energy Corporation of South Africa

International Nuclear Information System (INIS)

Louw, P.A.; De Villiers, W.Y.Z.; Jarvis, N.V.

1997-01-01

The Atomic Energy Corporation of South Africa Ltd (AEC) owns and operates the 20 MW research reactor, SAFARI-1. Utilisation of the reactor has in recent years changed from research and materials testing to the production of isotopes. The most important breakthrough achieved in recent years is the production of high quality fission 99Mo. This has been produced routinely since April 1993 and supplied to clients across the world. A capability for the reliable production of 1000 Ci of 99Mo per week (calibrated for six days after production) has been proven. The AEC has also established facilities to produce its own 99mTc generators together with a most of radiopharmaceutical kits for diagnostic nuclear medicine purposes. The production of 153 Sm and 131 I (tellurium oxide route) has been operational for many years. Applications include therapeutic radiopharmaceuticals such as 153 Sm-EDTMP for bone cancer pain palliation, 13' I-Lipiodol for liver cancer and 131 I capsules for thyroid treatment. Facilities for the production of other isotopes such as 131 I (from fission), 32 P and 35 S are in various stages of completion. Extensive analytical methods and equipment have been developed and are routinely used to certify the quality of exported isotopes. Irradiation and encapsulation of 192 Ir is also performed routinely at the AEC. Modern facilities allow for the production of isotopes such as 131 Ba and 140 La on an ad hoc basis. Quality assurance procedures based on ISO9000 were developed for all aspects of the production of the various isotopes. Documentation, such as Drug Master Files, required by authorities in various countries has also been submitted and accepted

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.)

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.

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.

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

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

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

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.)

Optimization of the production process of a lyophilized formulation for radiopharmaceutical obtaining 99mTc-EDDA/HYNIC-E-[c(RGDfK)]2

International Nuclear Information System (INIS)

Sanchez R, S.

2013-01-01

In this work was optimized the production process of a lyophilized pharmaceutical formulation for the preparation of radiopharmaceutical 99m Tc-EDDA/HYNIC-E-[c(RGDfK)] 2 , the union specifies to the integrin s α v β 3 was demonstrated to be used in the nuclear medicine cabinets in the obtaining of scan images for the opportune detection of breast cancer. The good lyophilized pharmaceutical formulation for the preparation of radiopharmaceutical 99m Tc-EDDA/HYNIC-E-[c(RGDfK)] 2 was established like: HYNIC-E-[c(RGDfK)] 2 - 25 μg; Stannous chloride (SnCl 2 ) 20 μg; Ethylenediamine diacetic acid (EDDA) 10 mg; N-tris(hydroxymethyl)methyl glycin (Tricine) 20 mg; Mannitol 50 mg. The results of radiochemical purity of the sterile formulation and free of bacterial endotoxins for the three validation lots prepared under protocols of good manufacturing practices were 97.62 ± 1.48%, 96.54 ± 1.89%, and 97.66 ± 0.57%, for what the production procedure complies the predefined specifications. The radiopharmaceutical 99m Tc-EDDA/HYNIC-E-[c(RGDfK)]2 prepared from the lyophilized pharmaceutical formulation showed to be stable during a period 24 hours, for what can be used in the centers of molecular nuclear medicine. Images in vivo were obtained of the integrin s over-expression α v β 3 from the radiopharmaceutical 99m Tc-EDDA/HYNIC-E-[c(RGDfK)]2 obtained of the lyophilized and optimized pharmaceutical formulation. The lyophilized pharmaceutical formulation (HYNIC-RGD-Sn) showed stability during 12 months, due to this factor, is requested before the COFEPRIS the radiopharmaceutical expiration for this same period (accession number 123300401A0155). (Author)

Optimization of production and quality control of therapeutic radionuclides and radiopharmaceuticals. Final report of a co-ordinated research project 1994-1998

Energy Technology Data Exchange (ETDEWEB)

NONE

1999-09-01

The `renaissance` of the therapeutic applications of radiopharmaceuticals during the last few years was in part due to a greater availability of radionuclides with appropriate nuclear decay properties, as well as to the development of carrier molecules with improved characteristics. Although radionuclides such as {sup 32}P, {sup 89}Sr and {sup 131}I, were used from the early days of nuclear medicine in the late 1930s and early 1940s, the inclusion of other particle emitting radionuclides into the nuclear medicine armamentarium was rather late. Only in the early 1980s did the specialized scientific literature start to show the potential for using other beta emitting nuclear reactor produced radionuclides such as {sup 153}Sm, {sup 166} Ho, {sup 165}Dy and {sup 186-188}Re. Bone seeking agents radiolabelled with the above mentioned beta emitting radionuclides demonstrated clear clinical potential in relieving intense bone pain resulting from metastases of the breast, prostate and lung of cancer patients. Therefore, upon the recommendation of a consultants meeting held in Vienna in 1993, the Co-ordinated Research Project (CRP) on Optimization of the Production and quality control of Radiotherapeutic Radionuclides and Radiopharmaceuticals was established in 1994. The CRP aimed at developing and improving existing laboratory protocols for the production of therapeutic radionuclides using existing nuclear research reactors including the corresponding radiolabelling, quality control procedures; and validation in experimental animals. With the participation of ten scientists from IAEA Member States, several laboratory procedures for preparation and quality control were developed, tested and assessed as potential therapeutic radiopharmaceuticals for bone pain palliation. In particular, the CRP optimised the reactor production of {sup 153}Sm and the preparation of the radiopharmaceutical {sup 153}Sm-EDTMP (ethylene diamine tetramethylene phosphonate), as well as radiolabelling

Design and optimization of the production process of radiopharmaceutical 177Lu-DOTA-Nal3-Octreotide for the treatment of gastro-entero-pancreatic tumors

International Nuclear Information System (INIS)

Sanchez G, M. F.

2013-01-01

The radiolabel peptides are molecules of interest in nuclear medicine for their therapeutic and diagnostic application in cancer. Among an impressing group of relevant peptides, those similar of the somatostatin, as the Nal 3 -Octreotide (NOC), have established as potential radiopharmaceuticals when presenting significant affinity for the receptors of this peptide hormone that are over expressed and broadly distributed in tumors of neuroendocrine origin, as the gastro-entero-pancreatic tumors. On the other hand, the Lutetium-177 ( 177 Lu) is an ideal candidate for the peptides radiolabel and has favorable characteristics to be used in radionuclide therapy. The objective of this work was designing, optimizing and to document the production process of the radiopharmaceutical 177 Lu-DOTA-Nal 3 -Octreotide ( 177 Lu-DOTANOC) for the solicitude of its sanitary registration before the Comision Federal contra Riesgos Sanitarios (COFEPRIS). For the optimization of the production process a factorial design of three variables was evaluated with mixed levels (18 combinations), where the dependent variable is the radiochemical purity and the analytic method used to determine this parameter (High Performance Liquid Chromatography) was validated. Later on, by means of the production of 3 lots of the optimized formula of the radiopharmaceutical 177 Lu-DOTANOC the production process was validated and the stability long term study to determine the period of useful life was carried out. The following pharmaceutical formulation was adopted as good: 1.85 GBq (0.5μg) of 177 Lu, 250 μg of DOTANOC and 150 μL of acetates Buffer 1 M ph 5 in 5 m L of the medium. The analytic method used to determine the radiochemical purity of the formulation satisfied the requirements for the wished analytic application. We can conclude that the 3 validation lots prepared under protocols of Good Production Practices, in the Plant of Radiopharmaceuticals Production of the Instituto Nacional de

Reinvestigation of the radiopharmaceutical production of radioiodinated long-chain fatty acids. Vol. 3

Energy Technology Data Exchange (ETDEWEB)

El-Shaboury, G; El-Kolaly, M T; Raieh, M [Labelled Compounds Department, Hot Laboratories Center, Atomic Energy Authority, Cairo (Egypt)

1996-03-01

An improved and simple radiopharmaceutical production technique for radioiodination of {omega} - (Br) or (I) fatty acids ({omega}) - Br or I-(C H{sub 2}){sub n} Co{sub 2} H, where n = 16 to 17 with Na{sup 13I} for myocardial imaging study is described. The technique of production is reported here based on an isotope or non - isotopic exchange reaction between the inactive halogenated fatty acids and lyophilized ethanolic solution of Na{sup 131} I (previously dispensed in 0.02 M NaOH solution) at 80 Degree C within 30 min in absolute ethanol (dehydrated and redistill at 78.5 to 80 degree C over nitrobenzene b.p. 208 to 212 degree C). Although considerable radiochemical yields have been obtained using a wide variety of organic solvents as an isotropic or non-isotropic exchange media such as acetone, methyl ethyl ketone, benzene as well as di-n-propyl ketone; certain problems due to the evaporation of these solvents during the process of purification have been observed. These problems were completely avoided by the initial dissolution of the reactants in dehydrated ethyl alcohol which facilitate direct dispensing of the final radioiodinated acids in diluted human serum albumen without any decomposition. Basically, following the radioiodination process the radioiodinated fatty acids ethanolic solution is passed through out an AgCl-impregnated filter to remove the untreated inorganic radioiodine (2 to 5%). The final pure solution (containing over 99.o% radioiodinated pure fatty acids) is dispensed in human serum albumen (4%), and then sterilized by passing it through 0.22 mum milli pore bacterial filter. The technique is being applied for the radiopharmaceutical production of radioiodinated-phenyl long-chain fatty acids such as iodo phenoxy-, and iodobenzamido-heptadecanoic acids. 3 figs.

Reinvestigation of the radiopharmaceutical production of radioiodinated long-chain fatty acids. Vol. 3

International Nuclear Information System (INIS)

El-Shaboury, G.; El-Kolaly, M.T.; Raieh, M.

1996-01-01

An improved and simple radiopharmaceutical production technique for radioiodination of ω - (Br) or (I) fatty acids (ω) - Br or I-(C H 2 ) n Co 2 H, where n = 16 to 17 with Na 13I for myocardial imaging study is described. The technique of production is reported here based on an isotope or non - isotopic exchange reaction between the inactive halogenated fatty acids and lyophilized ethanolic solution of Na 131 I (previously dispensed in 0.02 M NaOH solution) at 80 Degree C within 30 min in absolute ethanol (dehydrated and redistill at 78.5 to 80 degree C over nitrobenzene b.p. 208 to 212 degree C). Although considerable radiochemical yields have been obtained using a wide variety of organic solvents as an isotropic or non-isotropic exchange media such as acetone, methyl ethyl ketone, benzene as well as di-n-propyl ketone; certain problems due to the evaporation of these solvents during the process of purification have been observed. These problems were completely avoided by the initial dissolution of the reactants in dehydrated ethyl alcohol which facilitate direct dispensing of the final radioiodinated acids in diluted human serum albumen without any decomposition. Basically, following the radioiodination process the radioiodinated fatty acids ethanolic solution is passed through out an AgCl-impregnated filter to remove the untreated inorganic radioiodine (2 to 5%). The final pure solution (containing over 99.o% radioiodinated pure fatty acids) is dispensed in human serum albumen (4%), and then sterilized by passing it through 0.22 mum milli pore bacterial filter. The technique is being applied for the radiopharmaceutical production of radioiodinated-phenyl long-chain fatty acids such as iodo phenoxy-, and iodobenzamido-heptadecanoic acids. 3 figs

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

Modernization of the Radioisotopes Production Laboratory of the La Reina Nuclear Center in Chile: Incorporating advanced concepts of safety and good manufacturing practices

International Nuclear Information System (INIS)

Lagos Espinoza, Silvia

2014-01-01

A radioisotopes and radiopharmaceuticals production laboratory was established in Chile in the 1960s for research activities. From 1967 until January 2012, it was dedicated to the manufacturing of radioisotopes and radiopharmaceuticals for medical diagnosis and treatment purposes. In 2012, modernization of the facility’s design and technology began as part of the IAEA technical cooperation project, Modernizing the Radioisotopes Production Laboratory of La Reina Nuclear Centre by Incorporating Advanced Concepts of Safety and Good Manufacturing Practices, (CHI4022)

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)

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

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.

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.

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

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.)

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)

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

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)

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)

FDA's requirements for radiation dosimetry of radiopharmaceutical drug products

International Nuclear Information System (INIS)

Abel, N.M.

1986-01-01

The primary concern of the Office of Drug Research and Review of the Food and Drug Administration in the field of radiation dosimetry is to ensure that radiopharmaceutical drug products are safe when used as investigational drugs (INDs) and are both safe and effective when a new drug application (NDA) is approved. In order to accomplish this, the sponsor of either an IND or applicant in the case of NDA must provide information that clearly describes the radiation dose that a patient will receive from the administration of the drug. The submitted numerical estimates of the radiation dose should be based on an absorbed fraction method of radiation dose calculation, such as the system set forth by the Medical Internal Radiation Dose (MIRD) Committee of the Society of Nuclear Medicine or the system set forth by the International Commission on Radiological Protection (ICRP). This presentation will describe in detail the data that a sponsor of an IND needs to submit to satisfy the regulatory requirements. Examples will be given of common mistakes and omissions by sponsors in their presentation of data

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

Refurbishing of a Freeze Drying Machine, used in Nuclear Medicine for Radiopharmaceuticals Production

International Nuclear Information System (INIS)

Gaytan-Gallardo, E.; Desales-Galeana, G.

2006-01-01

The refurbishing of a freeze drying machine used in the radiopharmaceuticals production, applied in nuclear medicine in the Radioactive Materials Department of the Nuclear Research National Institute in Mexico (ININ in Spanish), is presented. The freeze drying machine was acquired in the 80's decade and some components started having problems. Then it was necessary to refurbish this equipment by changing old cam-type temperature controllers and outdated recording devices, developing a sophisticated software system that substitutes those devices. The system is composed by a freeze drying machine by Hull, AC output modules for improved temperature control, a commercial data acquisition card, and the software system

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

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)

Radiation protection optimization in practices for radiopharmaceuticals production at IEN

International Nuclear Information System (INIS)

Santos, Osvaldir Paulo dos

2004-06-01

This works has arisen from the need of updating radiological protection procedures, creating new ones and training qualified personnel to perform radiological protection duties in a nuclear facility. The main purpose of the research was to assess and minimize gamma and neutron dose rates emitted during the production and handling of radiopharmaceuticals at IEN/DIRA. A mobile measurements system (SMMG-N) was developed for on-site measurements. This system has proven to be more handy than the equipment formerly used for for this task. It has also proven to reduce the measurements uncertainties and to allow for the standardization of assessment procedures. He dose rates calculated using the data provided by this system have been compared with results obtained otherwise and good agreement was observed between them. This study has confirmed the need to improve the radiation shielding of KIPROS target-chamber and target vault in order to meet the radiological principles of dose rate limitation and optimization. (author)

Radiation protection optimization in practices for radiopharmaceuticals production at IEN

International Nuclear Information System (INIS)

Santos, P. dos; Delgado, Jose U.; Cardoso, Domingos D'Oliveira

2005-01-01

This work has arisen from the need of updating radiological protection procedures, creating new ones and training qualified personal to perform radiological protection duties in a nuclear facility. The main purpose of the research was to assess and minimize gamma and neutron dose rates emitted during the production and handling of radiopharmaceuticals at IEN/DIRA. A mobile measurements system (SMMG-N) was developed for on-site measurements. This system has proven to be handier than the equipment formerly used for this task. It has also proven to define the measurements uncertainties and to allow for the standardization of assessment procedures. Here dose rates calculated using the data provided by this system have been compared with results obtained otherwise and good agreement was observed between them. This study has confirmed the need to improve the radiation shielding of target-chamber and target vault in order to meet the radiological principles of dose rate limitation and optimization. (author)

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

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

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.)

Clean room for the production of cold kits: two year experience with the production of kits for 99mTc radiopharmaceuticals

International Nuclear Information System (INIS)

Muralidharan, Sheela H.; Nair, Preeti; Ghodke, Archana S.; Pillai, Thara; Sheri, Kumar Uma; Vanaja, R.; Mehra, Kiran S.; Sachdev, S.S.; Sivaprasad, N.

2010-01-01

A new clean room has been designed and constructed at Radiopharmaceuticals Programme, BRIT keeping in view the functional aspects for the production of 'cold' kits for the preparation of 99m Tc radiopharmaceuticals for supply to nuclear medicine centers and is in operation, since October, 2008. This clean room is the first clean room in the country designed exclusively for cold kit production. The clean room was validated and trial batches were produced and quality controlled prior to put it in regular production operation. The clean environment is maintained by separate AHU (air handling unit) located out side the clean room. A technical crew maintain the AHU unit and maintain record of parameters such as humidity, air flow, blower speed, chiller temperature etc. During a typical batch production not more than two persons are present in the formulation room. The formulated solution (filtered through 0.22μ membrane filter) is passed though a pass box between the formulation and dispensing area. The no. of people allowed in the dispensing area which is a critical area of class 100 is restricted to not more than four that too no person is allowed to be in between direct flow of HEPA filtered air and the dispensing table. The number of vials to be dispensed is arranged in trays and 1 ml of the formulated sterile solution is dispensed into each vial and the vials are transferred in to the lyophilization chamber. Sterile vials are introduced into class 100 area and the vials are removed after lyophilization though a pass box. After lyophilization vials are sealed with aluminum caps and stored at 2-10 deg C. Since the commissioning of the new clean room, about 120 batches of 10 different kit products were prepared and 1,20,000 kit vials were supplied to various hospitals for nuclear medicine investigation

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.)

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)

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

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

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.

Automation and use of robotic arm for development and routine production of radiopharmaceuticals

International Nuclear Information System (INIS)

Salvadori, P.A.; Di Sacco, S.; Riva, A.; Fusani, L.

1993-01-01

The target of a radiopharmaceutical group is twofold: production of radiotracers for clinical use (routine) and development of new compounds. The level of activity to be handled selects the strategy to be used for radiocompounds handling, ranging from direct manipulation during basic development at microcurie level to sophisticated equipments such as automated black-boxes and robotic arms at curie level. The authors looked for a common solution, to both the management of routine productions and the problems arising during activity scaling up in new tracer development, by choosing a robotic arm integrated by a variety of specialized automatic devices able to perform actions which are difficult (too slow, too precise, too complicated, etc.,) to be made by the robot. The final solution from this approach is a open-quotes synthetic stationclose quotes with flexible architecture which can be used for different applications without harware modification/adaptation

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

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

Radiopharmaceutical activities administered for paediatric nuclear medicine procedures in Australia

International Nuclear Information System (INIS)

Towson, J.E.; Smart, R.C.; Rossleigh, M.A.

2001-01-01

A survey of radiopharmaceutical activities used at the eight hospital centres specialising in paediatric nuclear medicine in Australia was conducted in 1999-2000 by the Australian and New Zealand Society of Nuclear Medicine and the Australasian Radiation Protection Society. Data on the maximum and minimum administered activities (A max and A min ) as obtained for 43 paediatric imaging procedures are presented. The results are also available on the ANZSNM and ARPS websites at: http://www.anzsnm.org.au and http://www.arps.org.au. The A max values were significantly less than the corresponding Reference Activities for adults determined in a previous study. Activities for individual patients are calculated using surface area scaling at five centres and body weight scaling at three centres. The median values of A max and A min are recommended as Paediatric Reference Activities. The effective dose to patients of various sizes for the Paediatric Reference Activities and both methods of scaling was calculated for each procedure. Copyright (2000) The Australian and New Zealand Society of Nuclear Medicine Inc

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)

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.

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

Validation of the cleaning and sanitization method for radiopharmaceutical production facilities

International Nuclear Information System (INIS)

Robles, Anita; Morote, Mario; Moore, Mariel; Castro, Delcy; Paragulla, Wilson; Novoa, Carlos; Otero, Manuel; Miranda, Jesus; Herrera, Jorge; Gonzales, Luis

2014-01-01

A protocol for the cleaning and sanitization method for radiopharmaceutical production facilities has been designed and developed for the inner surface of the hot cells for the production of Sodium Pertechnetate Tc-99m and Sm-153 EDTMP, considering an extreme situation for each hot cell. Cleaning is performed with double-distilled water and sanitation with two disinfectant solutions, 70 % isopropyl alcohol and 3 % hydrogen peroxide in alternate weeks. Microbiological analysis of sanitized surfaces were made after 20 minutes and 48 hours for the hot cell of Tc-99m and 72 hours for the hot cell of EDTMP Sm-153 in 3 consecutive tests by the method of direct contact with plates containing culture medium, made for each sampling point (6 in the first and five in the second). The results showed that the microbial load on surfaces sanitized was below acceptable limits and that the lifetime of cleaning and sanitization is 48 hours for the hot cell of Tc-99m and 72 hours for the one of EDTMP-Sm-153. As a conclusion, the method of cleaning and sanitization is effective to reduce or eliminate microbial contamination therefore, the process is validated. (authors).

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)

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)

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.

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

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.)

Activities of radiopharmaceuticals administered for diagnostic and therapeutic procedures in nuclear medicine in Argentina: results of a national survey

International Nuclear Information System (INIS)

Bomben, Ana M.; Chiliutti, Claudia A.

2004-01-01

Nuclear medicine in Argentine is carried out at 292 centres, distributed all over the country, mainly concentrated in the capital cities of the provinces. With the purpose of knowing the activity levels of radiopharmaceuticals that were administered to patients for diagnostic and therapeutic procedures in nuclear medicine, a national survey was conducted, during 2001 and 2002. This survey was answered voluntarily by 107 centres. Sixty-four percent of the participants centres are equipped with SPECT system while the other centres have a gamma camera or scintiscanner. There were 37 nuclear medicine procedures, chosen among those most frequently performed, were included in the survey. In those diagnostic procedures were included tests for: bone, brain, thyroid, kidney, liver, lung and cardiovascular system; and also activities administered for some therapeutic procedures. The nuclear medicine physicians reported the different radiopharmaceutical activities administered to typical adult patients. In this paper are presented the average radiopharmaceutical activity administered for each of the diagnostic and therapeutic procedures included in the survey and the range and distribution of values. In order to place these data in a frame of reference, these average values were compared to the guidance levels for diagnostic procedures in nuclear medicine mentioned at the Safety Series no. 115. From this comparison it was noticed that the activities administered in the 40% of the diagnostic procedures included in the survey were between ±30% of the reference values. For those nuclear medicine procedures that could not be compared with the above mentioned guidance levels, the comparison was made with values published by UNSCEAR or standards recommended by international bodies. As a result of this study, it is important to point out the need to continue the gathering of data in a wider scale survey to increase the knowledge about national trends. It is also essential to widely

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)

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.

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

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.

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

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

Exposure of employees engaged on the production and quality control of radiopharmaceuticals labelled with Tc-99m and I-131

International Nuclear Information System (INIS)

Trtic, T.; Jovanovic, M.; Vranjes, S.; Vucina, J.; Vuksanovic, Lj.

1995-01-01

In this paper, the analysis is presented, of exposure control of employees in the Laboratory for radioisotopes, of the Vinca Institute of nuclear sciences, engaged in the production and quality control of the Tc-99m generator and radiopharmaceuticals labelled with Tc-99m and I-131. Effective doses equivalent (mSv) was measured by personal thermoluminescent dosimeter in the Laboratory for radiation and environmental protection each month. We calculated effective dose equivalents for each year in the period 1986-1990. Thirty one employees were analysed. They were separated into the groups both on the basis of radioisotope which they worked with and the kind of the professional work. The highest average effective doses equivalent were received in the group producing of Tc-99m generator (4-12.5 mSv) and in the group producing I-131 radiopharmaceuticals (3.55-13.73 mSv). (author)

Product Lifecycle Management Centre of Technology

CSIR Research Space (South Africa)

Barnard, Rentia

2017-10-01

Full Text Available - Rentia Barnard.pdf.txt Content-Type text/plain; charset=UTF-8 1 Interactive activities Contents Product Lifecycle Management Centre of Technology Rentia Barnard National Industrialisation Support Initiative (NISI) 3 Initiative (NISI...

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)

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)

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.

Productions and interests of the radiopharmaceuticals labelled by 11C, 13N, 15O, and 18F

International Nuclear Information System (INIS)

Blanc-Borras, Louisette

1985-01-01

As medical diagnosis methods based on the use of short-life radioelements such as carbon-11, nitrogen-13, oxygen-15 and fluorine-18 have been developed, these four radio-isotopes are notably adapted to external detection by tomography. Besides, due to their short period, their radioactive concentration per mass unity is very high. In the first part of this research thesis, the author presents the characteristics of these four radio-isotopes, describes the operation of cyclotrons and the principles, benefits, drawbacks, and types of positron emission tomography. The second part addresses the production of the radionuclides and precursors, the production of radiopharmaceutical products (haemoglobin, sugars, amino acids, fatty acids, steroid marking, and drug marking). The third part reports some studies illustrating the pharmaceutical interest of these radioelements [fr

Untangling the web of European regulations for the preparation of unlicensed radiopharmaceuticals : a concise overview and practical guidance for a risk-based approach

NARCIS (Netherlands)

Lange, Rogier; ter Heine, Rob; Decristoforo, Clemens; Penuelas, Ivan; Elsinga, Philip H.; van der Westerlaken, Monique M. L.; Hendrikse, N. Harry

Radiopharmaceuticals are highly regulated, because they are controlled both as regular medicinal products and as radioactive substances. This can pose a hurdle for their development and clinical use. Radiopharmaceuticals are fundamentally different from other medicinal products and these regulations

Production of 99Tcm radiopharmaceuticals for brain, heart and kidney imaging. Final report of a co-ordinated research programme 1991-1994

International Nuclear Information System (INIS)

1995-07-01

The report contains highlights of the achievements of the IAEA Co-ordinated Research programme on Evaluation on the Use of Bulk Reagents for the Production of 99 Tc m Radiopharmaceutical and Kits, the participants' summary reports (Argentina, Chile, Greece, India, Indonesia, Japan, Malaysia, Portugal, Russian Federation, Thailand, Uruguay, United States of America), recommended product protocols for five compounds and the participants' recommendations regarding continued support and further directions of co-ordinated research work. Refs, 6 figs, 8 tabs, 6 schemes

Production And Quality Control Of Radiopharmaceutical 18F-FDG

International Nuclear Information System (INIS)

Dinh Thi Bich Lieu; Nguyen Van Si; Vu Van Tien

2011-01-01

18 F-FDG is a radiopharmaceutical for imaging diagnosis with PET/CT in Nuclear Medicine. Criteria of injection pharmaceuticals are the highest standards. So, quality assurance and quality control must be followed very strictly. The selection of the procedure for 18 F-FDG has based on several criteria: high chemical efficiency, short synthesis time, toxic component free and etc. The quality control of 18 F-FDG consist many fields such as: nuclear physic (nuclear purity), radiochemistry (radionuclear purity, radiochemical purity), chemistry (chemical purity), radiation measurement (half life), microbiology (pyrogen, endotoxin), etc. which is following USP, BP or EP. (author)

Comparative study of eye dose and chest dose received during radiopharmaceutical production processes

International Nuclear Information System (INIS)

Chindarkar, A.S.; Chavan, S.V.; Sawant, D.K.; Sahoo, L.; Gopalakrishnan, R.K.; Sneha, C.; Sachdev, S.S.; Dey, A.C.

2018-01-01

Radiopharmaceutical laboratory, BRIT, Vashi produces different radiopharmaceuticals of 131 I, 153 Sm, 99 Mo/ 99m Tc and 177 Lu. Principle gamma energies of these isotopes vary from 103 to 740 KeV and their maximum beta energies vary from 384 to 1214 KeV. In the light of the revised eye lens dose limit recommended in IAEA Basic Safety Standard Interim Edition No. GSR Part 3 (IAEA-2011), the study of radiation dose for eye lens was carried out using CaSO 4 : Dy based Thermo luminescence dosimeter (TLD). This TLD was worn at center of the forehead to measure eye lens dose. This TLD dose was then compared with chest TLD dose to deduce any correlation between these TLD doses. These TLD doses were assessed on quarterly basis. Eight quarter data of these TLD doses were compared

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)

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

Present status of research on Re-186 radiopharmaceuticals at Radioisotope Production Center

Energy Technology Data Exchange (ETDEWEB)

Mutalib, A [Radioisotope Production Center, National Atomic Energy Agency Kawasan PUSPIPTEK, Serpong (Indonesia)

1998-10-01

Rhenium shows a close chemical similarity to technetium and is suitable for radiotherapy because the {beta}-emitting radionuclides {sup 186}Re (t{sub 1/2} 90 h, E{sub {beta}} = 1.1 MeV, E{sub {gamma}} = 137 keV) and {sup 188}Re (t{sub 1/2} = 17 h, E{sub {beta}} = 2.1 MeV). The {gamma}-emission associated with decay of {sup 186}Re is also useful in scintigraphy. The research on {sup 186}Re radiopharmaceuticals at Radioisotope Production Center has been carried out since April 1997. Interest in radioimmunotherapy (RIT) led us to the development of labeling antibodies with rhenium isotopes. Although there are several methods for coupling radiometal to antibody, we prefer an indirect labeling method in which a bifunctional chelating agent is used for coupling of {sup 186}Re to monoclonal antibodies. In this report we outline the study on the preparation of {sup 186}Re DMSA-TFP as precursor for labeling with monoclonal antibody. (author)

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

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

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

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

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.

Isotope products manufacture in Russia and its prospects

International Nuclear Information System (INIS)

Malyshev, S.V.; Okhotina, I.A.; Kalelin, E.A.; Krasnov, N.N.; Kuzin, V.V.; Malykh, J.A.; Makarovsky, S.B.

1997-01-01

At the present stage of the world economy development, stable and radioactive isotopes,preparations and products on their base are widely used in many fields of the national economy, medicine and scientific researches. The Russian Federation is one of the largest worldwide producers of a variety of nuclide products on the base of more than 350 isotopes, as follows: stable isotopes reactor, cyclotron, fission product radioactive isotopes, ion-radiation sources compounds, labelled with stable and radioactive isotopes, radionuclide short-lived isotope generators, radiopharmaceuticals, radionuclide light and heat sources; luminous paints on base of isotopes. The Russian Ministry for Atomic Energy coordinates activity for development and organization of manufacture and isotope products supply in Russia as well as for export. Within many years of isotope industry development, there have appeared some manufacturing centres in Russia, dealing with a variety of isotope products. The report presents the production potentialities of these centres and also an outlook on isotope production development in Russia in the next years

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

Gallium‐68 DOTATATE Production with Automated PET Radiopharmaceutical Synthesis System: A Three Year Experience

Directory of Open Access Journals (Sweden)

Alireza Aslani

2014-10-01

Full Text Available Objective(s: Gallium‐68 (Ga‐68 is an ideal research and hospital‐based PET radioisotope. Currently, the main form of Ga‐68 radiopharmaceutical that is being synthesised in‐house is Ga‐68 conjugated with DOTA based derivatives. The development of automated synthesis systems has increased the reliability, reproducibility and safety of radiopharmaceutical productions. Here we report on our three year, 500 syntheses experience with an automated system for Ga‐68 DOTATATE. Methods: The automated synthesis system we use is divided into three parts of a servomotor modules, b single use sterile synthesis cassettes and, c a computerized system that runs the modules. An audit trail is produced by the system as a requirement for GMP production. The required reagents and chemicals are made in‐. The Germanium breakthrough is determined on a weekly basis. Production yields for each synthesis are calculated to monitor the performance and efficiency of the synthesis. The quality of the final product is assessed after each synthesis by ITLC‐SG and HPLC methods. Results: A total of 500 Ga‐68 DOTATATE syntheses (>800 patient doses were performed between March 2011 and February 2014. The average generator yield was 81.3±0.2% for 2011, 76.7±0.4% for 2012 and 75.0±0.3% for 2013. Ga‐68 DOTATATE yields for 2011, 2012, and 2013 were 81.8±0.4%, 82.2±0.4% and 87.9±0.4%, respectively. These exceed the manufacturer’s expected value of approximately 70%. Germanium breakthrough averaged 8.6×10‐6% of total activity which is well below the recommended level of 0.001%. The average ITLC‐measured radiochemical purity was above 98.5% and the average HPLC‐measured radiochemical purity was above 99.5%. Although there were some system failures during synthesis, there were only eight occasions where the patient scans needed to be rescheduled. Conclusion: In our experience the automated synthesis system performs reliably with a relatively low incident

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

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)

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)

Radiological safety and GMP in the bulk batch manufacturing, formulation and dispensing of radiopharmaceuticals

International Nuclear Information System (INIS)

Thulasidhasan, A.; Tiwary, Bikash; Kumar, Uma Sheri; Kale, Pooja; Tiwary, Richa; Gaurav, Ananad; Shah, B.K.; Topale, P.D.; Prabhakar, G.; Sachdev, S.S.

2010-01-01

Full text: Radiopharmaceutical Program of BRIT is involved in the manufacturing of ready to use radiopharmaceuticals for therapy for the last three decades. Ready to use Radiopharmaceutical products include, 131 I-Sodium iodide solution and capsules for thyroid carcinoma and metastatic lesions, 131 I MIBG injection for diagnosis and therapy of adrenal medullae tumors and their mets, 153 Sm-EDTMP injection and 32 P- Sodium orthophosphate injection for bone pain palliative treatment. BRIT's radiopharmaceutical production facility is a radioisotope laboratory classified as Type-III facility for handling radioisotopes of Group-II, Group-III and Group-IV approved by AERB. This facility meets all the radiological safety requirements as per AERB guidelines. Production of above mentioned radiopharmaceuticals is carried out in Production Plants (PP), β, γ Glove boxes (GB) and Fume hoods (FH). Typical production procedure involves bulk processing, formulation, sterilization and dispensing of doses. Production Plants (PP) are exclusively designed facilities to carry out the production in a radiologically safe manner, at the same time maintaining aseptic conditions required for injectables as per the current GMP. Each production plant has a leak tight Isolator box, made up of high quality SS which has provisions for remote handling devices like, Tongs, dispensing systems, service points for vacuum, gas, compressed air, water and electric power. This Isolator box is shielded from all sides by required amount of lead (2 inch or 4 inch), and has an access port called 'Transport Port Box' with double door transport lock and is equipped with a trolley. Two filter unit systems are fitted at the top of the plant and each unit comprises of activated Charcoal filter and HEPA filter in tandem, this in turn is connected to special exhaust meant for radioactive gases. Similarly, the designs of β, γ Glove boxes (GB) and Fume hoods (FH) also incorporate all radiological safety features

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

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

Radiopharmaceutical management in Brazil: the case of fluorodeoxyglucose production; Gestao de radiofarmacos no Brasil: o caso da producao de fluordesoxiglicose

Energy Technology Data Exchange (ETDEWEB)

Pereira, Vitor da Silva

2016-07-01

Nowadays, the combination of fluorodeoxyglucose tracer (FDG) and PET/CT equipment is the best technological condition for medical diagnosis, allowing the generation of images that associate anatomy and metabolic functions of tissues or organs. Constitutional Amendment (CA) No 49 of 2006, relaxed the state monopoly on the production of radioactive substances, allowing private investment in radioisotope area with half-life of less than or equal to two hours, as a way to increase the supply of these materials to national health sector. In order to reflect on the Brazilian production of radiopharmaceuticals, especially FDG was performed a theoretical study with a qualitative approach, substantiated by documentary research and data collection through a questionnaire sent to the producing private companies of this radiopharmaceutical. Initially, it sought to identify in the federal level the legal and regulatory parameters for the activity; then the existing competitive environment was observed, and, finally, were prospected the business perspectives on the behavior of domestic demand of this product. The results showed the growth of production and its largest geographical distribution in the country, beyond what would be possible only considering public investment; but short of expectations surrounding the enactment of Constitutional Amendment. Private entrepreneurs believe in market growth; since, most of the population has no access to the benefits that the medical imaging diagnostic with the use of FDG may allow. It was also noted that there is a need to improve the regulatory framework in relation to licensing procedures; as well as implementation of common marketing parameters. (author)

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

Inhibition of viability of microorganisms in [18F]-labeled radiopharmaceuticals

International Nuclear Information System (INIS)

Jörg, G.; Fosselmann, M.; Leis, W.; Oberdorfer, F.; Fehsenfeld, Ch.

2017-01-01

Introduction: Good manufacturing practice (GMP)-compliant production of radiopharmaceuticals for parenteral application requires great efforts in maintenance of clean room infrastructure and equipment in order to reliably guarantee the constant hygienic quality of the product (sterility). Terminal sterilization of the product is not always possible due to short half-life or due to thermal instability of the compound. The typical method for sterilization in these cases is sterile filtration prior to dispensing (distribution of product solution from bulk to patient vials). Therefore, aseptic processing techniques have to be in place in order to ensure sterility. Still, there remains some risk of microbial contamination of the product, and hence a risk for the patient to suffer from infection. Due to the short half-life of the labeling radionuclides, this aspect is aggravated by only retrospectively possible testing for sterility. This work investigated the potential of [ 18 F]-radiation to intrinsically inactivate microorganisms (MO) that might have slipped through the aseptic process. Methods: Defined numbers of viable cells of different bacterial strains and molds were incubated with defined amounts of [ 18 F]-activity. After decay of radiation the number of surviving viable cells was determined, D 10 -values were calculated and evaluated. Results: The MOs tested exhibit a broad range of [ 18 F]-radiation susceptibility, D 10 -values range from a sensitive 114 MBq/mL (46 Gy) to a durable 2,048 MBq/mL (790 Gy). Conclusion: The intrinsic [ 18 F]-radiation in radiopharmaceuticals is no safe measure to generally ensure sterility of the product solution in terms of “autosterilization”, because of dependence on various parameters. Advances in knowledge and implications for patient care: This work presents for the first time experimental data on the influence of [ 18 F]-radiation on MOs. The results suggest, that aseptic processing techniques are essential and that

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

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.

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

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)

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)

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

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

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

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

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

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

Automation of cells of radiopharmaceuticals production

International Nuclear Information System (INIS)

Negrini, Aguinaldo Donizete

2010-01-01

The 67 Ga is an important radiopharmaceutical used to identify inflammatory processes in chronic illnesses, diagnosis by image of tumors in soft tissues and the possibility to evaluate the result for therapeutic intervention. In the present work a module of 67 Ga processing was developed with the objective to reduce the interventions in the hot cell, in order to avoid oxidation caused by metallic materials, and consuming in hoses of the peristaltic pumps, that release residues that blocked the valves used in the process. With materials such as: acrylic, PVC, PEEK e teflon and they are used vacuum as method (way) of fluid transferences instead of peristaltic pump in the majority of the procedures, with this improvements the system can make shorter the lengths of transference hoses, increasing the yield in the process with less interventions for maintenance and time exposure of the workers, guaranteeing the quality and reducing the time of the processing. using a mobile system for displacement of the processing module making in the cleanness and maintenance of the cell that works with radioactive material. Reducing the time of exposure dose of the workers in compliance with RDC-17 of ANVISA, which ruling the Good Manufacturing Practice Procedures. (author)

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

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

Annual report 1992 - Austrian Research Centre Seibersdorf

International Nuclear Information System (INIS)

Hillebrand, G.

1994-01-01

This is a non-technical progress report (in English) of the activities of the Research Centre Seibersdorf in the fields of energy and safety, materials research, isotope and radiation techniques, environment protection, health and food and industrial consulting. Within other non nuclear related highlights the newly built radio-pharmaceutical laboratory is described, which will guarantee the reliable supply of products and develop new diagnostic and therapeutic preparations. A newly developed whole-body counter for measuring internal radiation is in use in the Vienna General Hospital to obtain better information of the patient's metabolism and can thus assess the efficiency of pharmaceuticals. The research in the field of toxicology and carcinogenicity was intensified. Geological dating was performed for the 'Continental Deep-Drilling Programme' on behalf of the Max Planck Institute. Environmental data acquisition was mainly conducted in the field of ozone, water quality, air pollution and electro-smog (quittner, rieger)

Annual report 1992 - Austrian Research Centre Seibersdorf

International Nuclear Information System (INIS)

Hillebrand, G.

1994-01-01

This is a non-technical progress report (in German) of the activities of the Research Centre Seibersdorf in the fields of energy and safety, materials research, isotope and radiation techniques, environment protection, health and food and industrial consulting. Within other non nuclear related highlights the newly built radio-pharmaceutical laboratory is described, which will guarantee the reliable supply of products and develop new diagnostic and therapeutic preparations. A newly developed whole-body counter for measuring internal radiation is in use in the Vienna General Hospital to obtain better information of the patient's metabolism and can thus assess the efficiency of pharmaceuticals. The research in the field of toxicology and carcinogenicity was intensified. Geological dating was performed for the 'Continental Deep-Drilling Programme' on behalf of the Max Planck Institute. Environmental data acquisition was mainly conducted in the field of ozone, water quality, air pollution and electro-smog (quittner, rieger)

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

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.)

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

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

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.

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

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.)

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.

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

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)

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.)

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

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

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)

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)

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

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)

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

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

Improving the layout of recycling centres by use of lean production principles.

Science.gov (United States)

Sundin, Erik; Björkman, Mats; Eklund, Mats; Eklund, Jörgen; Engkvist, Inga-Lill

2011-06-01

There has been increased focus on recycling in Sweden during recent years. This focus can be attributed to external environmental factors such as tougher legislation, but also to the potential gains for raw materials suppliers. Recycling centres are important components in the Swedish total recycling system. Recycling centres are manned facilities for waste collection where visitors can bring, sort and discard worn products as well as large-sized, hazardous, and electrical waste. The aim of this paper was to identify and describe the main flows and layout types at Swedish recycling centres. The aim was also to adapt and apply production theory for designing and managing recycling centre operations. More specifically, this means using lean production principles to help develop guidelines for recycling centre design and efficient control. Empirical data for this research was primarily collected through interviews and questionnaires among both visitors and employees at 16 Swedish recycling centres. Furthermore, adapted observation protocols have been used in order to explore visitor activities. There was also close collaboration with a local recycling centre company, which shared their layout experiences with the researchers in this project. The recycling centres studied had a variety of problems such as queues of visitors, overloading of material and improper sorting. The study shows that in order to decrease the problems, the recycling centres should be designed and managed according to lean production principles, i.e. through choosing more suitable layout choices with visible and linear flows, providing better visitor information, and providing suitable technical equipment. Improvements can be achieved through proper planning of the layout and control of the flow of vehicles, with the result of increased efficiency and capacity, shorter visits, and cleaner waste fractions. The benefits of a lean production mindset include increased visitor capacity, waste

A remotely operated, automated system for the infusion of shielded therapeutic radiopharmaceuticals

International Nuclear Information System (INIS)

Macfarlane, D.J.; Bartlett, M.; Bellen, J.; Peters, J.; Domagala, M.; Allison, R.

1999-01-01

Full text: A number of radiopharmaceuticals may soon emerge into mainstream clinical oncology for palliative and therapeutic treatment for a variety of malignancies. These agents are characterized by high linear energy transfer particulate emissions. Dispensing and administration of these therapies on a regular basis pose a substantial radiation burden to staff, from direct g-emissions and from Bremsstrahlung (braking) radiations. In an effort to implement the ALARA principle, a multidisciplinary team was given the brief to design a system which permitted: (1) safe, sterile transfer of a nominated quantity of radiopharmaceutical into a shielded reservoir compatible with the infusion pump; (2) remote variation of volume and administration rate upon command; (3) purging of delivery system following administration of dose; (4) monitoring of and communication with patient during infusion; (5) use of TGA-approved delivery system. The final design centred around an Abbott 'Lifecare 5000' volumetric dual-channel intravenous infusion pump and featured: microprocessor control with mutiline LCD prompting display; remote operation of keypad by pneumatic actuator; CCTV monitoring of patient, pump and physiological data; delivery of therapy dose from a shielded vial; flushing of therapy vial by 'back-priming'; and full array of safety alarms (air in line, occlusion, empty vial, etc). Further developments include audio communication with patient and remote physiological monitoring

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.)

Production of {sup 99}Tc{sup m} radiopharmaceuticals for brain, heart and kidney imaging. Final report of a co-ordinated research programme 1991-1994

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-07-01

The report contains highlights of the achievements of the IAEA Co-ordinated Research programme on Evaluation on the Use of Bulk Reagents for the Production of {sup 99}Tc{sub m} Radiopharmaceutical and Kits, the participants` summary reports (Argentina, Chile, Greece, India, Indonesia, Japan, Malaysia, Portugal, Russian Federation, Thailand, Uruguay, United States of America), recommended product protocols for five compounds and the participants` recommendations regarding continued support and further directions of co-ordinated research work. Refs, 6 figs, 8 tabs, 6 schemes.

Lutetium-177 DOTATATE Production with an Automated Radiopharmaceutical Synthesis System.

Science.gov (United States)

Aslani, Alireza; Snowdon, Graeme M; Bailey, Dale L; Schembri, Geoffrey P; Bailey, Elizabeth A; Pavlakis, Nick; Roach, Paul J

2015-01-01

Peptide Receptor Radionuclide Therapy (PRRT) with yttrium-90 ((90)Y) and lutetium-177 ((177)Lu)-labelled SST analogues are now therapy option for patients who have failed to respond to conventional medical therapy. In-house production with automated PRRT synthesis systems have clear advantages over manual methods resulting in increasing use in hospital-based radiopharmacies. We report on our one year experience with an automated radiopharmaceutical synthesis system. All syntheses were carried out using the Eckert & Ziegler Eurotope's Modular-Lab Pharm Tracer® automated synthesis system. All materials and methods used were followed as instructed by the manufacturer of the system (Eckert & Ziegler Eurotope, Berlin, Germany). Sterile, GMP-certified, no-carrier added (NCA) (177)Lu was used with GMP-certified peptide. An audit trail was also produced and saved by the system. The quality of the final product was assessed after each synthesis by ITLC-SG and HPLC methods. A total of 17 [(177)Lu]-DOTATATE syntheses were performed between August 2013 and December 2014. The amount of radioactive [(177)Lu]-DOTATATE produced by each synthesis varied between 10-40 GBq and was dependant on the number of patients being treated on a given day. Thirteen individuals received a total of 37 individual treatment administrations in this period. There were no issues and failures with the system or the synthesis cassettes. The average radiochemical purity as determined by ITLC was above 99% (99.8 ± 0.05%) and the average radiochemical purity as determined by HPLC technique was above 97% (97.3 ± 1.5%) for this period. The automated synthesis of [(177)Lu]-DOTATATE using Eckert & Ziegler Eurotope's Modular-Lab Pharm Tracer® system is a robust, convenient and high yield approach to the radiolabelling of DOTATATE peptide benefiting from the use of NCA (177)Lu and almost negligible radiation exposure of the operators.

Technetium compounds

International Nuclear Information System (INIS)

Johannsen, B.; Spies, H.

1981-01-01

Radiopharmaceutical, chemical and pharmacological investigations on the development and application of carrier-free sup(99m)Tc radiopharmaceuticals are comprehensively reported. The radiopharmaceutical section deals with the elaboration of labelling methods. The influence of different factors on the kit production and the sup(99m)Tc radiopharmaceutical preparation is discussed. The relationship between the chemical structure and the biodistribution is in the centre of the radiopharmalogical section. (author)

Synthesis, analysis, purification and biodistribution in an animal model of radiopharmaceutical 177Lu3+ -dotatato for diagnostic and therapeutic use in neuroendocrine tumors

International Nuclear Information System (INIS)

Caldeira Filho, Jose de Souza

2009-01-01

The aim of this work was to propose rationalization in the synthesis, analysis and purification of radiopharmaceutical 177 Lu 3+ - DOTATATO for diagnostic and therapeutic use in neuroendocrine tumors, as well as for evaluation g biodistribution of this radiopharmaceutical an animal-mode. The complexation reaction for the synthesis of radiopharmaceutical was carried out in ammonium acetate buffer 0.5 M, p H 7.0, for 30 minutes at 95 deg C. The radiochemical purity was > 95%, according to analysis by chromatography in ITLC-SG, when using the sodium citrate buffer 0,1 M, p H 5.0, as the mobile phase. The molar-limit ratio 177 Lu 3+ :DOTATATO, in ammonium acetate buffer 0.5 M, p H 7.0, for 30 minutes at 95 deg C, was dependent on the specific activity and origin of the radioisotope, this being 1:3.5 (370 MBq : 26μg) for that from the Oak Ridge National Laboratory /USA, and 1:16 (370 MBq: 11.8 μg) for that from Nuclear Analytical and Medical Services/Holland, when considering a decay of five days from the production date of te radioisotopes. This rationalization in the synthesis of radiopharmaceutical 177 Lu 3+ - DOTATATO permits high economy in production costs. Chemical studies on the synthesis of radiopharmaceuticals also placed in evidence the interference of 177 Hf 4+ , the decay product of 177 Lu 3= , as the 177 Lu 3= competitor for DOTATATO. Radiopharmaceutical preparation proved to be stable during 24 hours, at an activity rate of 2775 MBq, with the addition of 0.6 mg/mL of gentisic acid and when kept in dry ice. In biodistribution studies on Swiss and Nuce mice, the specificity of radiopharmaceutical for somatostatin positive-receptor tissues, such as the pancreas, stomach, lungs, adrenal glands, kidneys and the cell tumor AR42J was demonstrated. (author)

Reactor and /or accelerator: general remarks on strategic considerations in sourcing/producing radiopharmaceuticals and radiotracer for the Philippines

International Nuclear Information System (INIS)

Nazarea, A.D.

1996-01-01

The most important sources of radionuclides in the world are particle accelerators and nuclear reactors. Since the late 1940's many radiotracers and radiopharmaceuticals have been innovated and conceived, designed, produced and applied in important industrial and clinical/ biomedical settings. For example in the health area, reactor-produced radionuclides have become indispensable for diagnostic imaging involving, in its most recent and advanced development, radioimmunoscintigraphy, which exploits the exquisite ligand-specificity of monoclonal antibodies, reagents which in turn are the products of advances in biotechnology. Thus far, one of the most indispensable radiopharmaceuticals has been 99m Tc, which is usually obtained as a daughter decay product of 99 Mo. In January 1991, some questions about the stability of the worldwide commercial supply of 99 Mo became highlighted when the major commercial world producer of 99 Mo, Nordion International, shut down its facilities temporarily in Canada due to contamination in its main reactor building (see for instance relevant newsbrief in J. Nuclear Medicine (1991): 'Industry agrees to join DOE study of domestic moly-99 production'). With the above background, my remarks will attempt to open discussions on strategic considerations relevant to questions of 'self reliance' in radiotracers/radiopharmaceutical production in the Philippines. For instance, the relevant question of sourcing local radionuclide needs from a fully functioning multipurpose cyclotron facility within the country that will then supply the needs of the local industrial, biomedical (including research) and health sectors; and possibly, eventually acquiring the capability to export to nearby countries longer-lived radiotracers and radiopharmaceuticals

In-house cyclotron production of high-purity Tc-99m and Tc-99m radiopharmaceuticals.

Science.gov (United States)

Martini, Petra; Boschi, Alessandra; Cicoria, Gianfranco; Zagni, Federico; Corazza, Andrea; Uccelli, Licia; Pasquali, Micòl; Pupillo, Gaia; Marengo, Mario; Loriggiola, Massimo; Skliarova, Hanna; Mou, Liliana; Cisternino, Sara; Carturan, Sara; Melendez-Alafort, Laura; Uzunov, Nikolay M; Bello, Michele; Alvarez, Carlos Rossi; Esposito, Juan; Duatti, Adriano

2018-05-30

In the last years, the technology for producing the important medical radionuclide technetium-99m by cyclotrons has become sufficiently mature to justify its introduction as an alternative source of the starting precursor [ 99m Tc][TcO 4 ] - ubiquitously employed for the production of 99m Tc-radiopharmaceuticals in hospitals. These technologies make use almost exclusively of the nuclear reaction 100 Mo(p,2n) 99m Tc that allows direct production of Tc-99m. In this study, it is conjectured that this alternative production route will not replace the current supply chain based on the distribution of 99 Mo/ 99m Tc generators, but could become a convenient emergency source of Tc-99m only for in-house hospitals equipped with a conventional, low-energy, medical cyclotron. On this ground, an outline of the essential steps that should be implemented for setting up a hospital radiopharmacy aimed at the occasional production of Tc-99m by a small cyclotron is discussed. These include (1) target production, (2) irradiation conditions, (3) separation/purification procedures, (4) terminal sterilization, (5) quality control, and (6) Mo-100 recovery. To address these issues, a comprehensive technology for cyclotron-production of Tc-99m, developed at the Legnaro National Laboratories of the Italian National Institute of Nuclear Physics (LNL-INFN), will be used as a reference example. Copyright © 2018 Elsevier Ltd. All rights reserved.

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)

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.

Report on the 1. research coordination meeting on 'Development of therapeutic radiopharmaceuticals based on 177Lu for radionuclide therapy'

International Nuclear Information System (INIS)

2006-01-01

Radionuclide therapy (RNT) employing radiopharmaceuticals labelled with emitting radionuclides is fast emerging as an important part of nuclear medicine. Radionuclide therapy is effectively utilized for bone pain palliation, thus providing significant improvement in quality of life of patients suffering from pain resulting from bone metastasis. Targeting primary diseases by using specific carrier molecules labelled with radionuclides is also widely investigated and efficacious products have been emerging for the treatment of Lymphoma and Neuroendocrine tumours. In order to ensure the wider use of radiopharmaceuticals, it is essential to carefully consider the choice of radionuclides that together with the carrier molecules will give suitable pharmacokinetic properties and therapeutic efficacy. The criteria for the selection of a radionuclide for radiotherapy are suitable decay characteristics and amenable chemistry. However, the practical considerations in selecting a radionuclide for targeted therapy are availability in high radionuclidic purity as well as high specific activity and low production cost and comfortable delivery logistics. 177 Lu is one of the isotopes emerging as a clear choice for therapy. Worldwide, the isotope is under investigation for approximately 30 different clinical applications, including treatment of colon cancer, metastatic bone cancer, non-Hodgkin's lymphoma, and lung cancer. 177 Lu decays with a half-life of 6.71 d by emission of particles with E max of 497 keV (78.6%), 384 keV (9.1%) and 176 keV (12.2%). It also emits photons of 113 keV (6.4%) and 208 keV (11%), that are ideally suited for imaging the in-vivo localization and dosimetric calculations applying a gamma camera. The physical half-life of 177 Lu is comparable to that of 131 I, the most widely used therapeutic radionuclide. The long halflife of 177 Lu provides logistic advantage for production, QA/QC of the products as well as feasibility to supply the products to places

HPLC-MS technique for radiopharmaceuticals analysis and quality control

International Nuclear Information System (INIS)

Macasek, F.; Buriova, E.; Bruder, P.; Vera-Ruiz, H.

2003-01-01

Potentialities of liquid chromatography with mass spectrometric detector (MSD) were investigated with the objective of quality control of radiopharmaceuticals; 2-deoxy-2-[ 18 F]fluoro-D-glucose (FDG) being an example. Screening of suitable MSD analytical lines is presented. Mass-spectrometric monitoring of acetonitrile-aqueous ammonium formate eluant by negatively charged FDG.HCO 2 - ions enables isotope analysis (specific activity) of the radiopharmaceutical at m/z 227 and 226. Kryptofix 222 provides an intense MSD signal of the positive ion associated with NH 4 + at m/z 394. Expired FDG injection samples contain decomposition products from which at least one labelled by 18 F and characterised by signal of negative ions at m/z 207 does not correspond to FDG fragments but to C5 decomposition products. A glucose chromatographic peak, characterised by m/z 225 negative ion is accompanied by a tail of a component giving a signal of m/z 227, which can belong to [ 18 O]glucose; isobaric sorbitol signals were excluded but FDG-glucose association occurs in the co-elution of separation of model mixtures. The latter can actually lead to a convoluted chromatographic peak, but the absence of 18 F makes this inconsistent. Quantification and validation of the FDG component analysis is under way. (author)

Study of the production of the radiopharmaceutical {sup 18}F-FLT in automated system: contribution for process validation; Estudo da producao do radiofarmaco FLT-{sup 18}F em sistema automatizado: contribuicao para a validacao do processo

Energy Technology Data Exchange (ETDEWEB)

Zanette, Camila

2013-07-01

Radiopharmaceutical {sup 18}F-FLT is a thymidine nucleoside analogue and a promising tumor proliferation marker for PET images. The synthesis of this radiopharmaceutical is not simple, and often has low yields. This radiopharmaceutical has already been studied for some years; however, there is no production, nor are there clinical studies in Brazil. The study of the production process and its compliance with the guidelines of Good Manufacturing Practices (ANVISA) are of extreme importance. This study aimed to investigate the synthesis of this radiopharmaceutical, evaluate methods of quality control that will be used in future production routines, perform cytotoxicity studies, biodistribution studies and PET imaging in animals, thereby contributing to the development and elaboration of the process validation protocol and to the establishment of analytical methods to be used during production routines. Initially, we studied the synthesis and production of {sup 18}F-FLT, with the evaluation of three different temperatures of radiolabeling to check the behavior of the radiochemical yield and stability of the nal product. Studies of analytical methodology comprised the analysis of radionuclide identification, determination of chromatographic profiles, radiochemical purity, residual solvents, and pH. In vitro studies of internalization and cytotoxicity were also carried out. In in vivo studies, we evaluated the pharmacokinetics, biodistribution in healthy animals and in animals with tumor models, in addition to PET/CT images in animals with melanomas. The final product had high radiochemical purity and was stable for up to 10 hours after the synthesis, but got a relatively low radiochemical yield, as described in the literature. The tested analytical methods proved suitable for use in the quality control of {sup 18}F-FLT. In in vitro studies, {sup 18}F-FLT showed a significant percentage of binding to tumor cells, and the nonradiolabeled molecule was not considered toxic

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

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.

Product configuration of infra structure systems for data centres

DEFF Research Database (Denmark)

Hvam, Lars; Christensen, Tim Teglgaard; Jensen, Søren Brogaard

2007-01-01

centres, and components and systems for these systems. At the heart of its mass customisation strategy are a module-based product range and the use of product configuration systems for sales and order processing. In addition, the company has implemented a manufacturing concept, which involves the mass...

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

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

Fluorine-18 radiopharmaceuticals beyond [F-18]FDG for use in oncology and neurosciences

NARCIS (Netherlands)

Coenen, H. H.; Elsinga, P. H.; Iwata, R.; Kilbourn, M. R.; Pillai, M. R. A.; Rajan, M. G. R.; Wagner, H. N.; Zaknun, J. J.

2010-01-01

Positron emission tomography (PET) is a rapidly expanding clinical modality worldwide thanks to the availability of compact medical cyclotrons and automated chemistry for the production of radiopharmaceuticals. There is an armamentarium of fluorine-18 (F-18) tracers that can be used for PET studies

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

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)

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

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

The preparation of organic radiopharmaceuticals and labelled compounds using short-lived cyclotron-produced radionuclides

International Nuclear Information System (INIS)

Uhlenhut, G.J.; Koch, H.

1982-01-01

Accelerator-produced nuclides and radiopharmaceutical production are discussed with examples of pertinent methods of isotope production, methods of incorporation into organic molecules, and the general problems attandant on the production and use of these materials in this new and interdisciplinary effort. The literature is surveyed with stress being given to the use of 11 C, 13 N and 15 O. 205 references are included. (author)

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

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

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.

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

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.

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)

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

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)

Internal dose evaluation of workers involved in radioisotopes and radiopharmaceuticals handling for medical use

International Nuclear Information System (INIS)

Cesar, R.B.P.; Mesquita, C.H. de

1987-01-01

The internal dose levels of IPEN workers, involved in the production of radioisotopes and radiopharmaceuticals for medical use are surveyed. In this production, the workers were splited in six group: research and development, routine production, quality control, packaging, radiological protection and maintenance. The internal dose was evaluated according to the models described by ICRP-30, from the results obtained in the whole body counters monitoring. (C.G.C.) [pt

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

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.)

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

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.

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

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)

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)

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

A Peltier thermal cycling unit for radiopharmaceutical synthesis

International Nuclear Information System (INIS)

McKinney, C.J.; Nader, M.W.

2001-01-01

We have investigated the use of Peltier devices to rapidly cycle the temperature of reaction vessels in a radiopharmaceutical synthesis system. Peltier devices have the advantage that they can be actively cooled as well as heated, allowing precise and rapid control of vessel temperatures. Reaction vessel temperatures of between -6 deg. C and 110 deg. C have been obtained with commercially available devices with reasonable cycle times. Two devices have been used as the basis for a general purpose, two-pot synthesis system for production of [ 11 C] compounds such as raclopride

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

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

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

A perspective on plant origin radiolabeled compounds, their biological affinities and interaction between plant extracts with radiopharmaceuticals

International Nuclear Information System (INIS)

Zumrut Biber Muftuler, F.; Ayfer Yurt Kilcar; Perihan Unak

2015-01-01

Plant origin products having anticancer properties come into prominence due to widespread of cancer. There is significant increase on the usage of plant origin products and their purification to investigate the potential use at the treatment and diagnosis. Plant origin radiolabeled compounds have been attracting more scientific attention since the achievement of earlier researches. Furthermore, plant extracts are consumed quite a lot with unknown side effects of their contents. Researchers focus on investigation of their interactions with radiopharmaceuticals. Current review is carried out to evaluate the contribution of plant extracts for the development of new plant origin radiolabeled ( 125 / 131 I, 99m Tc) compounds for imaging and/or therapy and to investigate the interaction of plant extracts with radiopharmaceuticals. (author)

PET Radiopharmaceuticals in Brazil and Belarus: Economic Comparison Using the Case of 18FDG.

Science.gov (United States)

Brinkevich, Sviatoslav; Pires, Leonardo Paredes; Portilho, Filipe Leal; Santos-Oliveira, Ralph

2018-01-01

The production of radiopharmaceuticals, especially the PET ones, is a complex combination of economic and social factors. Despite the social aspects, that are essential, the economic issue must be considered and play an important parameter for the implementation and maintenance of producer centers around the world, with especial regards for countries which face economic crisis and/or belongs to aegis of under development countries. In order to evaluate this scenario with carried out this study, comparing a well-established producer center in Brazil and a new on in Belarus. The results showed that the producer center in Brazil face serious economic problems and all the production logistic must be re-done. On the other hand the new producer center in Belarus started following a new model of production and although it has not been profitable, the perspectives seem to be better than the Brazilian producer center. The Brazilian model for PET radiopharmaceutical productions should be revised in order to avoid waste and create a new perspective for the research area. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

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)

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

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

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)

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

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)

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.)

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

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.)

Activity-based costing evaluation of [18F]-fludeoxyglucose production.

Science.gov (United States)

Krug, Bruno; Van Zanten, Annie; Pirson, Anne-Sophie; Crott, Ralph; Vander Borght, Thierry

2008-01-01

As healthcare expenses are escalating in many countries, the sector faces a new challenge of becoming more cost efficient. There is an urgent need for more accurate data on the costs of healthcare procedures. The cost of Positron Emission Tomography (PET) with [(18)F]-fludeoxyglucose ((18)F-FDG) studies is mainly influenced by the price of the radiopharmaceutical, which may vary throughout Europe from 300 to 500 Euro per patient dose (370 MBq). The aim of the current study is to conduct an activity-based costing (ABC) estimation of (18)F-FDG production in Europe to better identify the different cost components and to analyse their relative contribution to the total cost. Financial data were collected on capital expense and global operating costs through interviews with industry experts, PET centre managers, evaluation of prior studies, and review of expenses incurred at the University Medical Centre in Groningen (The Netherlands). After mapping the activities, we divided the cost in five categories: wage, equipment, consumables, overhead and space costs. A sensitivity analysis was performed for key cost components, including the compliance with regulatory requirements. The critical factor for profitability was throughput. Including the European regulation procedure, the cost for 370 MBq (18)F-FDG patient dose, 3 h EOS without delivery cost, ranges between 155 and 177 Euro/dose for two production runs and between 210 and 237 Euro/dose for one production run. These costs are predominantly determined by personnel and equipment costs, although the cost for quality assurance increases steadily. The ABC analysis provides significant insight into the production cost components of (18)F-FDG through different operating configurations. Reductions in equipment prices, increased availability of radiopharmaceuticals, growth in demand, and improvements in reimbursement will all contribute to the financial viability of this imaging technique.

Activity-based costing evaluation of [18F]-fludeoxyglucose production

International Nuclear Information System (INIS)

Krug, Bruno; Pirson, Anne-Sophie; Borght, Thierry vander; Zanten, Annie van; Crott, Ralph

2008-01-01

As healthcare expenses are escalating in many countries, the sector faces a new challenge of becoming more cost efficient. There is an urgent need for more accurate data on the costs of healthcare procedures. The cost of Positron Emission Tomography (PET) with [ 18 F]-fludeoxyglucose ( 18 F-FDG) studies is mainly influenced by the price of the radiopharmaceutical, which may vary throughout Europe from 300 to 500 Euro per patient dose (370 MBq). The aim of the current study is to conduct an activity-based costing (ABC) estimation of 18 F-FDG production in Europe to better identify the different cost components and to analyse their relative contribution to the total cost. Financial data were collected on capital expense and global operating costs through interviews with industry experts, PET centre managers, evaluation of prior studies, and review of expenses incurred at the University Medical Centre in Groningen (The Netherlands). After mapping the activities, we divided the cost in five categories: wage, equipment, consumables, overhead and space costs. A sensitivity analysis was performed for key cost components, including the compliance with regulatory requirements. The critical factor for profitability was throughput. Including the European regulation procedure, the cost for 370 MBq 18 F-FDG patient dose, 3 h EOS without delivery cost, ranges between 155 and 177 Euro/dose for two production runs and between 210 and 237 Euro/dose for one production run. These costs are predominantly determined by personnel and equipment costs, although the cost for quality assurance increases steadily. The ABC analysis provides significant insight into the production cost components of 18 F-FDG through different operating configurations. Reductions in equipment prices, increased availability of radiopharmaceuticals, growth in demand, and improvements in reimbursement will all contribute to the financial viability of this imaging technique. (orig.)

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

Applying knowledge engineering tools for the personal computer to the operation and maintenance of radiopharmaceutical production systems

International Nuclear Information System (INIS)

Alexoff, D.L.

1990-01-01

A practical consequence of over three decades of Artificial Intelligence (AI) research has been the emergence of Personal Computer-based AI programming tools. A special class of this microcomputer-based software, called expert systems shells, is now applied routinely outside the realm of classical AI to solve many types of problems, particularly in analytical chemistry. These AI tools offer not only some of the advantages inherent to symbolic programming languages, but, as significant, they bring with them advanced program development environments which can facilitate software development and maintenance. Exploitation of this enhanced programming environment was a major motivation for using an AI tool. The goal of this work is to evaluate the use of an example-based expert system shell (1st Class FUSION, 1st Class Expert Systems, Inc.) as a programming tool for developing software useful for automated radiopharmaceutical production

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

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

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

Report on the 1. research coordination meeting on 'Development of therapeutic radiopharmaceuticals based on {sup 177}Lu for radionuclide therapy'

Energy Technology Data Exchange (ETDEWEB)

NONE

2006-07-01

Radionuclide therapy (RNT) employing radiopharmaceuticals labelled with emitting radionuclides is fast emerging as an important part of nuclear medicine. Radionuclide therapy is effectively utilized for bone pain palliation, thus providing significant improvement in quality of life of patients suffering from pain resulting from bone metastasis. Targeting primary diseases by using specific carrier molecules labelled with radionuclides is also widely investigated and efficacious products have been emerging for the treatment of Lymphoma and Neuroendocrine tumours. In order to ensure the wider use of radiopharmaceuticals, it is essential to carefully consider the choice of radionuclides that together with the carrier molecules will give suitable pharmacokinetic properties and therapeutic efficacy. The criteria for the selection of a radionuclide for radiotherapy are suitable decay characteristics and amenable chemistry. However, the practical considerations in selecting a radionuclide for targeted therapy are availability in high radionuclidic purity as well as high specific activity and low production cost and comfortable delivery logistics. {sup 177}Lu is one of the isotopes emerging as a clear choice for therapy. Worldwide, the isotope is under investigation for approximately 30 different clinical applications, including treatment of colon cancer, metastatic bone cancer, non-Hodgkin's lymphoma, and lung cancer. {sup 177}Lu decays with a half-life of 6.71 d by emission of particles with E{sub max} of 497 keV (78.6%), 384 keV (9.1%) and 176 keV (12.2%). It also emits photons of 113 keV (6.4%) and 208 keV (11%), that are ideally suited for imaging the in-vivo localization and dosimetric calculations applying a gamma camera. The physical half-life of {sup 177}Lu is comparable to that of {sup 131}I, the most widely used therapeutic radionuclide. The long halflife of {sup 177}Lu provides logistic advantage for production, QA/QC of the products as well as feasibility to

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.)

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.)

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.

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

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)

Determination of bacterial endotoxin (pyrogen) in radiopharmaceuticals by the gel clot method. Validation

International Nuclear Information System (INIS)

Fukumori, Neuza Taeko Okasaki

2008-01-01

Before the Limulus amebocyte lysate (LAL) test, the only available means of pirogenicity testing for parenteral drugs and medical devices was the United States Pharmacopoeia (USP) rabbit pyrogen test. Especially for radiopharmaceuticals, the LAL assay is the elective way to determine bacterial endotoxin. The aim of this work was to validate the gel clot method for some radiopharmaceuticals without measurable interference. The FDA's LALTest guideline defines interference as a condition that causes a significant difference between the endpoints of a positive water control and positive product control series using a standard endotoxin. Experiments were performed in accordance to the USP bacterial endotoxins test in the 131 I- m-iodobenzylguanidine; the radioisotopes Gallium-67 and Thallium-201; the lyophilized reagents DTPA, Phytate, GHA, HSA and Colloidal Tin. The Maximum Valid Dilution (MVD) was calculated for each product based upon the clinical dose of the material and a twofold serial dilution below the MVD was performed in duplicate to detect interferences. The labeled sensitivity of the used LAL reagent was 0.125 EU mL -1 (Endotoxin Units per milliliter). For validation, a dilution series was performed, a twofold dilution of control standard endotoxin (CSE) from 0.5 to 0.03 EU mL -1 , to confirm the labeled sensitivity of the LAL reagent being tested in sterile and non pyrogenic water, in quadruplicate. The same dilution series was performed with the CSE and the product in the 1:100 dilution factor, in three consecutive batches of each radiopharmaceutical. The products 131 I-m-iodobenzylguanidine, Gallium-67, Thallium-201, DTPA, HSA and Colloidal Tin were found compatible with the LAL test at a 1:100 dilution factor. Phytate and GHA showed some interference in the gel clot test. Other techniques to determine endotoxins as the chromogenic (color development) and the turbidimetric test (turbidity development), were also assessed to get valuable quantitative and

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.

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

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

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)

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)

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

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.)

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

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.)

Radiopharmaceuticals in metastatic bone pain palliation

International Nuclear Information System (INIS)

Garcia, Enrique; Alberti, Alejandro; Cruz Arencibia, Jorge; Morin Zorrilla, Jose

2012-01-01

In the present work the current status of the use of Radiopharmaceuticals in the treatment of the pain provoked by bony metastasis is revised. Particular attention is devoted to the used doses, the effectiveness and security of the existent products in the market and in development. The convenience of the routine use in the case of multiple metastasis is established, since the results are adequate and the risks acceptable. The doses are examined, the adverse effects and the importance of the costs is indicated and related with it the supply of Radionuclides. Reference is made so much to the practice of countries developed as to that of countries of smaller resources. It is pointed out the Cuban experience and the perspectives of the use in our country.(author)

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

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

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.

Cyclotron-produced radioisotopes and their clinical use at the Austin PET Centre

International Nuclear Information System (INIS)

Tochon-Danguy, H.J.

1997-01-01

A Centre for Positron Emission Tomography (PET) has been established within the Department of Nuclear Medicine at the Austin and Repatriation Medical Centre in Melbourne. PET is a non-invasive technique based on the use of biologically relevant compounds labelled with short-lived positron-emitting radionuclides such as carbon-11, nitrogen-13, oxygen-15 and fluorine-18. The basic equipment consists of a medical cyclotron (10 MeV proton and 5 MeV deuteron), six lead-shielded hot cells with associated radiochemistry facilities and a whole body PET scanner. During its first five years of operation, the Melbourne PET Centre, has pursued a strong radiolabelling development program, leading to an ambitious clinical program in neurology, oncology and cardiology. This presentation will describe the basic principles of the PET technique and review the cyclotron-produced radioisotopes and radiopharmaceuticals. Radiolabelling development programs and clinical applications are also addressed

Production and use of {sup 18}F by TRIGA nuclear reactor: a first report

Energy Technology Data Exchange (ETDEWEB)

Burgio, N.; Ciavola, C.; Festinesi, A.; Capannesi, G. [ENEA, Centro Ricerche Casaccia, Rome (Italy). Dipt. Innovazione

1999-02-01

The irradiation and radiochemical facilities at public research centre can contribute to the start up of the regional PET centre. In particular, the TRIGA reactor of Casaccia Research Centre could produce a sufficient amount of {sup 18}F to start up a PET centre and successively integrated the cyclotron production. This report establishes, in the light of the preliminary experimental works, a guideline to the reactor`s production and extraction of {sup 18}F in a convenient form for the synthesis of the most representative PET radiopharmaceutical: {sup 18}F-FDG. [Italiano] Le facilities di irraggiamento e i laboratori Radiochimici dei Centri Statali di Ricerca possono contribuire allo sviluppo di centri regionali PET (Tomografia ed Emissione Positronica). In particolare, il reattore TRIGA del Centro Ricerca Casaccia potrebbe produrre un quantitativo di {sup 18}F sufficiente alle attivita` formative propedeutiche al centro PET che, successivamente sarebbe in grado di avviare una propria produzione da ciclotrone. Questo rapporto stabilisce le linee guida sperimentali per la produzione del {sup 18}F da reattore nucleare e la sua successiva estrazione in una forma conveniente per la sintesi del piu` rappresentativo dei radiofarmaci PET: il {sup 18}F-FDG.

Quantitative studies in radiopharmaceutical science. Progress report, April 1-August 31, 1986

International Nuclear Information System (INIS)

Cooper, M.

1986-09-01

This report covers progress made during the first reporting period since the redirection of the project. In radiochemistry, achievements in fluorine-18 tracer studies including purification and reaction kinetics of 2-fluorodeoxyglucose and production of 6-fluoroDOPA. Radiopharmaceuticals have been prepared and tested for studies on CNS dopaminergic systems. By use of dynamic positron emission tomography the cerebral transport and metabolism of glucose continues to be studied. 6 figs

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

Eichrom's ABEC trademark resins: Alkaline radioactive waste treatment, radiopharmaceutical, and potential hydrometallurgical applications

International Nuclear Information System (INIS)

Bond, A.H.; Gula, M.J.; Chang, F.; Rogers, R.D.

1997-01-01

Eichrom's ABEC trademark resins selectivity extract certain anions from high ionic strength acidic, neutral, or strongly alkaline media, and solute stripping can be accomplished by eluting with water. ABEC resins are stable to pH extreme and radiolysis and operate in high ionic strength and/or alkaline solutions where anion-exchange is often ineffective. Potential applications of the ABEC materials include heavy metal and ReO 4 - separations in hydrometallurgy and purification of perrhenate iodide, and iodate in radiopharmaceutical production. Separation of 99m TcO 4 - from its 99 MoO 4 2- parent and stripping with water or physiological saline solution have been demonstrated for radiopharmaceutical applications. Removal of 99 TcO 4 - and 129 I - from alkaline tank wastes has also been successfully demonstrated. The authors will discuss the scale-up studies, process-scale testing, and market development of this new extraction material

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.

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

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

Full text: The 5th International Radiopharmaceutical Therapy Colloquium was held on 29th October 2002 as a pre-congress meeting of the World Federation of Nuclear Medicine and Biology Congress in Santiago, Chile. Work-in-Progress research papers were presented by leaders in the field of therapeutic nuclear oncology. Speakers gave untitled presentations without abstracts and reported data from studies performed only days or weeks before the meeting. Such cutting edge research presentations stimulated lively discussion which also addressed the problems encountered and ways in which they may be circumvented. Radioimmunotherapy of haematological malignancy was discussed by Greg Wiseman of the Mayo Clinic, and Thomas Behr of the University of Marburg. Radiopeptide therapy of neuroendocrine tumours was presented by Larry Kvols from the University of Florida, and locoregional therapy of glioma was presented by John Buscombe of the Royal Free Hospital, London. All speakers reported encouraging clinical results with objective tumour responses, increased survival and improved quality of life, which encourages wider clinical application of these novel radiopharmaceutical therapies. The Round Table Discussion on clinical applications of Rhenium-188 radiopharmaceuticals was chaired by Russ Knapp from Oak Ridge National Laboratory and Hans Biersack of the University of Bonn. Following an outline of current developments by Russ Knapp preliminary results of clinical trials were presented for discussion. Hans Biersack, Javier Gaudiano from Montevideo and Achim Kropp from Dresden reported effective palliation of painful skeletal metastases with 188Re-HEDP. Ajit Padhy gave an update of the IAEA multicentre trial of intrahepatic arterial 188Re-Lipiodol therapy of hepatocellular carcinoma and Harvey Turner reported preliminary results in hepatoma patients using an alternative kit formulation of 188Re-Lipiodol in Fremantle. Early experience with Rhenium 188 in the prevention of re

Rhenium radioisotopes for therapeutic radiopharmaceutical development

International Nuclear Information System (INIS)

Knapp, F.F. Jr.; Beets, A.L.; Pinkert, J.; Kropp, J.; Lin, W.Y.; Wang, S.Y.

2001-01-01

Rhenium-186 and rhenium-188 represent two important radioisotopes which are of interest for a variety of therapeutic applications in oncology, nuclear medicine and interventional cardiology. Rhenium-186 is directly produced in a nuclear reactor and the 90 hour half-life allows distribution to distant sites. The relatively low specific activity of rhenium-186 produced in most reactors, however, permits use of phosphonates, but limits use for labelled peptides and antibodies. Rhenium-188 has a much shorter 16.9 hour half-life which makes distribution from direct reactor production difficult. However, rhenium-188 can be obtained carrier-free from a tungsten-188/rhenium-188 generator, which has a long useful shelf-life of several months which is cost-effective, especially for developing regions. In this paper we discuss the issues associated with the production of rhenium-186- and rhenium-188 and the development and use of various radiopharmaceuticals and devices labelled with these radioisotopes for bone pain palliation, endoradiotherapy of tumours by selective catheterization and tumour therapy using radiolabelled peptides and antibodies, radionuclide synovectomy and the new field of vascular radiation therapy. (author)

Development of a pattern hot cell for production of injectable radiopharmaceuticals; Desenvolvimento de um modelo de cela para processamento de radiofarmacos injetaveis

Energy Technology Data Exchange (ETDEWEB)

Campos, Fabio Eduardo de

2010-07-01

A controlled ambient should be established to the production/processing of materials susceptible to contamination, like injectable pharmaceuticals, in order to agree with normative and regulatory requirements. Considering medical but also toxic, radioactive and dangerous products, the ambient should work in special conditions to assure that the materials, which in same cases can be also volatile, do not escape to the external ambient, working in a selective, secure and controlled way. The conditions recommended by local and international rules in use, report an negative pressured ambient in relation to the adjacent areas. The technology related with the sizing of project to this kind of system is fully described in the literature, taking in account the rules that clearly describe the essential requirements. However, it is necessary to develop a controlled ambient for radiopharmaceutical production, in a way compatible with the concept of clean rooms and with the safety related to the manipulation of open radioactive wastes. In this work, some devices were created, methods and procedures were established making possible the classification of the ambient inside the hot cell, without physical barriers in the area, using ergonomic, flexible and practical conditions of work, that can results in the improvement of the productivity. The project resulted in the creation of a controlled ambient, in agreement with the normative requirements, using a pass through for entrance and exit of the materials, without compromise the internal air condition. The tight of the hot cell was obtained using doors with efficient sealing system and active joints. Tong manipulators were used to produce ergonomic and secure conditions, without compromise the internal conditions related to tight and classification in A and B grade, according to local and international rules. An efficient ventilation/exhaustion system was adopted to produce these results, composed by filters and special devices

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

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.

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)

Determination of Sn in 99{sup m}Tc Radiopharmaceutical Kits by Polarographic Methods; Determinacion de Estano en Radiofarmacos de 99{sup m}Tc mediante Metodos Polarograficos

Energy Technology Data Exchange (ETDEWEB)

Castro, M; Cruz, J; Sanchez, M

2009-07-01

Kits of 99{sup 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{sup m}Tc-pertechnetate in cold kits for on-site preparation 99{sup 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.

Recommendations from the SoFRa (Societe francaise de radiopharmacie) for transporting radiopharmaceuticals: How to apply the decree on the transport of radioactive goods

International Nuclear Information System (INIS)

Barre, E.; Rizzo-Padoin, N.; Delolmo, S.; Debordeaux, F.; Beco, V. de; El Deeb, G.; Gupta, S.; Nguyen, M.L.; Sigrist, S.

2016-01-01

In France, road transport of dangerous goods is regulated by the May 29, 2009 'TMD decree', which enforces the European Agreement concerning the international carriage of dangerous goods by road, known as the 'ADR Agreement' or 'ADR'. This regulation allows packages containing radioactive material to be transported on the French territory, including packages that contain radiopharmaceutical products intended for medical use (radiopharmaceuticals, generators, precursors). However, this regulation is poorly known by radio-pharmacists and nuclear medicine personnel who have to either send or receive these goods on a daily basis. This article aims to set out a summary of the key provisions that apply to radiopharmacy and to make recommendations regarding the reception and shipment of radiopharmaceutical packages. (authors) [fr

Standardization of {sup 123}I and {sup 18}F for providing traceability of activity meters performed in the Radiopharmaceutical Production Service of the Instituto de Engenharia Nuclear, RJ, Brazil; Padronizacao do Iodo-123 e Fluor-18 para provimento de rastreabilidade das medicoes de atividade realizadas no Servico de Producao de Radiofarmacos do Instituto de Engenharia Nuclear

Energy Technology Data Exchange (ETDEWEB)

Andrade, E.A.L., E-mail: erica@ien.gov.br [Instituto de Engenharia Nuclear (IEN/CNEN-RJ), Rio de Janeiro, RJ (Brazil); Delgado, J.U.; Iwahara, A.; Contic, C.C., E-mail: delgado@ird.gov.br, E-mail: iwahara@ird.gov.br, E-mail: ccconti@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 Sanitary Vigilance National Agency which requiring Good Manufacturing Practices certification for all segments within the Nuclear Medicine. Quality Assurance Programmes should implement the standard requirements to ensure that radiopharmaceuticals have requirements quality to proving its efficiency. Several aspects should be controlled, and one of them is the traceability of the Radionuclides Activity Measurement in radiopharmaceuticals doses. This paper aims to provide traceability to dose calibrators (well type ionization chambers) used for {sup 123}I and {sup 18}F activity measurements in Radiopharmaceuticals Production Service placed in Institute of Nuclear Engineering, Rio de Janeiro, RJ, Brazil. (author)

Cyclotron-produced radioisotopes and their clinical use at the Austin PET Centre

Energy Technology Data Exchange (ETDEWEB)

Tochon-Danguy, H.J. [Centre for PET, Melbourne, VIC (Australia). Austin and Repatriation Medical Centre

1997-12-31

A Centre for Positron Emission Tomography (PET) has been established within the Department of Nuclear Medicine at the Austin and Repatriation Medical Centre in Melbourne. PET is a non-invasive technique based on the use of biologically relevant compounds labelled with short-lived positron-emitting radionuclides such as carbon-11, nitrogen-13, oxygen-15 and fluorine-18. The basic equipment consists of a medical cyclotron (10 MeV proton and 5 MeV deuteron), six lead-shielded hot cells with associated radiochemistry facilities and a whole body PET scanner. During its first five years of operation, the Melbourne PET Centre, has pursued a strong radiolabelling development program, leading to an ambitious clinical program in neurology, oncology and cardiology. This presentation will describe the basic principles of the PET technique and review the cyclotron-produced radioisotopes and radiopharmaceuticals. Radiolabelling development programs and clinical applications are also addressed. 30 refs., 1 tab., 1 fig.

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)

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.

Performance evaluation of activimeter for PET radiopharmaceutical measuring based on 18F

International Nuclear Information System (INIS)

Fragoso, Maria da Conceicao de Farias; Oliveira, Mercia Liane de; Lima, Fernando Roberto de Andrade

2014-01-01

Proficiency test is an essential tool to assess the reliability and accuracy of measurements. In this work, proficiency tests (Z-score, accuracy and relative deviation) were applied to evaluate the performance of the activimeter used at Radiopharmaceuticals Production Division of the Regional Center for Nuclear Sciences of the Northeast (CRCN-NE/CNEN). The results were evaluated in compliance with ISO/IEC Guide 43-1. Additionally, correction factors for different measurement geometries were determined experimentally for those devices. (author)

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

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.

Logistics for evaluation of doses received by IOE due to handling 18FDG-radiopharmaceutical during processing (IEN/CNEN) and in radiodiagnostic (clinical)

Energy Technology Data Exchange (ETDEWEB)

Santos, Osvaldir P. dos; Silva, Joao Carlos P.; Silva, Luiz Carlos Reina P.; Cortines, Geraldo, E-mail: osvaldir@ien.gov.br, E-mail: jcarlos@ien.gov.br, E-mail: reina@ien.gov.br, E-mail: gcortines@ien.gov.br [Instituto de Engenharia Nuclear (IEN/CNEN-RJ), Rio de Janeiro, RJ (Brazil)

2013-07-01

The objective of this study is to propose an improvement in radiological practices involving production, transportation and application of radiopharmaceutical {sup 18}F, by tracking the radiation doses received by occupationally exposed individuals (OEI) that develop production practices, transportation and application of some patients in hospitals and clinics in Rio de Janeiro, the radiopharmaceutical {sup 18}FDG. In light of the results and observations of how these practices are developed, it's necessary to evaluate and suggest a logistics to minimize the doses received by OEI during these practices, seeking improvements in the actions and procedures for radiological protection. In practice the production of the radiopharmaceutical, the study focuses on the time of withdrawal of {sup 18}FDG cell processing, where the technician is exposed to higher dose rates. At this stage, we take to accomplish, yet two other reviews: the first is the placement of electronic dosimeters inside and outside the lead apron, whose objective is to assess the attenuation capacity of the apron. This last procedure refers to the use of a phantom cylindrical containing TLD 700 dosimeter in order to evaluate, using a mathematical model (MCNP), the doses ends (hand) of the technician, the process of removing the radiopharmaceutical of the cell and to compare the dosimetric dose recorded in the ring. Regarding the transport of {sup 18}FDG, we take into account the doses recorded in the cabin of the vehicle and the doses recorded in the dosimeter of the carrier. Finally, the doses received by health professionals who handle {sup 18}FDG are analyzed, since its withdrawal from the packing until administration to the patient. (author)

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

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

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

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)

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

Radiopharmaceutical production at Lucas Heights

International Nuclear Information System (INIS)

Druce, M.

1987-01-01

The difficult problems of operating and maintaining complex equipment, meeting despatch deadlines, ensuring product quality, production scheduling and controlling staff are discussed in relation to Australia's national radioisotope production plant

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.

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

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

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)

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

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

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 ...

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

Good radiopharmacy practice and regulation

International Nuclear Information System (INIS)

Bremer, O.

1998-01-01

Production, control, distribution and clinical application of radiopharmaceuticals have not been subject to the same regulations and legislation developed for conventional pharmaceutical products. Generally the production of radiopharmaceuticals have started up at national nuclear energy research centres, where the products have been regarded more as radioactive tracers than pharmaceutical products. Gradually pharmaceutical philosophy and requirements have been introduced in the field and necessary changes in legislation have been introduced. The registration process to obtain official market authorisation for a radiopharmaceutical have been introduced in most countries. This process of registration is constantly changing with regards to the amount and the type of documentation required by the health authorities. Correspondingly the general requirements for the systems applied in pharmacy for the production, control, quality assurance and medical application have also become an integral part of the field of radiopharmacy. Is the present situation generally satisfactory? The ever increasing demands leads to increasing costs and thereby higher prices on the products for the end users. Do the present requirements generally ensure that the radiopharmaceuticals applied are safe and effective for the patient? (author)

Constancy tests and quality assurance of the activimeters used in a radiopharmaceutical production unit

International Nuclear Information System (INIS)

Gontijo, Rodrigo M.G.; Mamede, Marcelo; Ferreira, Andréa V.; Nascimento, Leonardo T.C.; Costa, Flávia M.; Silva, Juliana B.

2017-01-01

Activimeters (or dose calibrators) are essential instruments to verify activity of radiopharmaceutical after production and also before the dose administration in humans or animals for molecular imaging. The efficiency and safety measurements depend on, beside other factors, constancy tests and quality assurance. Thereby, the aim of this work was to perform constancy tests and quality assurance in the activimeters of the UPPR/CDTN, based on the CNEN-NN 3.05 Brazilian standard and the manufacturer's manual. Physical inspection, auto zero, background check, camera voltage, data check and constancy test were done. In addition, accuracy and precision tests were performed using a set of standard certified radioactive sources ( 57 Co, 133 Ba and 137 Cs), according to the CNEN NN 3.05 Brazilian standard. Linearity test was also performed to evaluate the response of the equipment in over the entire range of activities used in routine. The equipment are periodically submitted to the quality control tests and the results were compared. After performing the proposed tests it is possible to conclude that activimeters are in accordance with the requirements of the CNEN standard and manufacturer's manual. A quality control checklist was prepared to guide users and to record the results of quality assurance testing to monitor the equipment performance. This initiative is part of the quality assurance program implemented at UPPR. (author)

Constancy tests and quality assurance of the activimeters used in a radiopharmaceutical production unit

Energy Technology Data Exchange (ETDEWEB)

Gontijo, Rodrigo M.G.; Mamede, Marcelo [Centro de Desenvolvimento da Tecnologia Nuclear (CDTN/CNEN-MG), Belo Horizonte, MG (Brazil); Ferreira, Andréa V.; Nascimento, Leonardo T.C.; Costa, Flávia M.; Silva, Juliana B., E-mail: rodrigo.gontijo@cdtn.br, E-mail: mamede.mm@gmail.com [Universidade Federal de Minas Gerais (IMA/FM/UFMG), Belo Horizonte, MG (Brazil). Departamento de Anatomia e Imagem

2017-07-01

Activimeters (or dose calibrators) are essential instruments to verify activity of radiopharmaceutical after production and also before the dose administration in humans or animals for molecular imaging. The efficiency and safety measurements depend on, beside other factors, constancy tests and quality assurance. Thereby, the aim of this work was to perform constancy tests and quality assurance in the activimeters of the UPPR/CDTN, based on the CNEN-NN 3.05 Brazilian standard and the manufacturer's manual. Physical inspection, auto zero, background check, camera voltage, data check and constancy test were done. In addition, accuracy and precision tests were performed using a set of standard certified radioactive sources ({sup 57}Co, {sup 133}Ba and {sup 137}Cs), according to the CNEN NN 3.05 Brazilian standard. Linearity test was also performed to evaluate the response of the equipment in over the entire range of activities used in routine. The equipment are periodically submitted to the quality control tests and the results were compared. After performing the proposed tests it is possible to conclude that activimeters are in accordance with the requirements of the CNEN standard and manufacturer's manual. A quality control checklist was prepared to guide users and to record the results of quality assurance testing to monitor the equipment performance. This initiative is part of the quality assurance program implemented at UPPR. (author)

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)

Country report: India. Development of Radiopharmaceuticals Based on 188Re and 90Y for Radionuclide Therapy

International Nuclear Information System (INIS)

Venkatesh, M.; Pandey, U.; Dhami, P.S.; Chakravarty, R.; Kameswaran, M.; Subramanian, S.; Dash, A.; Samuel, G.

2010-01-01

During the past decade, our group has focused attention on the development of therapeutic radiopharmaceuticals incorporating radioisotopes such as 90 Y, 188 Re etc. As the primary source of the radioisotopes 90 Y and 188 Re are the 90 Sr/ 90 Y generators and 188 W/ 188 Re generators respectively, the local availability of these generator systems is very important for the successful development of radiopharmaceuticals incorporating these radioisotopes. In this context, 90 Sr/ 90 Y generators based on Supported Liquid Membrane (SLM) [1-3] and electrochemical techniques [4] could be designed and deployed in our laboratories for the elution of 90 Y to be used for preparation of 90 Y labeled products. This work formed a part of the IAEA co-ordinated CRP on “Development of Generator Technologies for Therapeutic Radionuclides: 90 Y and 188 Re”. In this report, work on the development of 90 Y radiopharmaceuticals for treatment of liver cancer and non-Hodgkin’s lymphoma (NHL) is reported. In addition, comparison of the Extraction Paper Chromatography technique (EPC) developed for determination of 90 Sr contamination in 90 Y samples with the US Pharmacopeia recommended method as well as the validation of the EPC technique is presented

Determination of elemental levels in radiopharmaceuticals by instrumental neutron activation analysis

International Nuclear Information System (INIS)

Capote Rodriguez, Gil; Guevara, Sergio Ribeiro; Arribere, Maria; Hernandez Rivero, Tulio

2001-01-01

Neutron Activation Analysis (NAA) both Instrumental (INAA) and Radiochemical (RNAA) have been extensively applied to the determination of minor and trace elements in samples of quite different origin and composition. Particularly, the analysis of microquantities of toxic elements in biological samples by INAA and RNAA is extensively reported. NAA has been also applied to the determination of minor and trace constituents in biomedical products. The use of the INAA in pharmaceutical samples has not been reported yet. This could be due in some extent because of the specificity of these types of samples, and also because of the need to irradiate the samples in a nuclear reactor. The objective of the present work was to study the feasibility of applying INAA for the quantification of minor and trace constituents in three radiopharmaceuticals. The formulation of these products was elaborated by the Isotope Center and proposed for registration to the corresponding authorities. The active components of three radiopharmaceuticals were analyzed: Hexamethylene propylene Amino oxine (HMPAO), Dimercaptosuccinic Acid (DMSA) and Diethylenetriamine penta-acetic Acid (DTPA). The samples were dried up to constant weight at room temperature. In order to avoid possible interferences from the irradiated polyethylene vials, the samples were pressed into the form of pills using a die of stainless steel. The weights of the samples ranged from 50 mg to 200 mg. Samples in duplicates were irradiated in the 0.5 k W Bariloche RA-6 Research Nuclear Reactor. To induce more (n,gamma) reactions and therefore increase the number of analytes and also to minimize interferences from activation products, the irradiation was carried out using two regimens. For the measurement, irradiated pills were put into clean polyethylene containers. The measurements were carried out with a 67 cm 3 ORTEC HPGe intrinsic-N coaxial detector with a resolution of 2.0 keV FWHM at 1.33 MeV and with an efficiency of 12

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)

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)

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)

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

Fluorine-18 radiopharmaceuticals beyond [18F]FDG for use in oncology and neurosciences

International Nuclear Information System (INIS)

Coenen, H.H.; Elsinga, P.H.; Iwata, R.; Kilbourn, M.R.; Pillai, M.R.A.; Rajan, M.G.R.; Wagner, H.N.; Zaknun, J.J.

2010-01-01

Positron emission tomography (PET) is a rapidly expanding clinical modality worldwide thanks to the availability of compact medical cyclotrons and automated chemistry for the production of radiopharmaceuticals. There is an armamentarium of fluorine-18 ( 18 F) tracers that can be used for PET studies in the fields of oncology and neurosciences. However, most of the 18 F-tracers other than 2-deoxy-2-[18F]fluoro-D-glucose (FDG) are in less than optimum human use and there is considerable scope to bring potentially useful 18 F-tracers to clinical investigation stage. The International Atomic Energy Agency (IAEA) convened a consultants' group meeting to review the current status of 18 F-based radiotracers and to suggest means for accelerating their use for diagnostic applications. The consultants reviewed the developments including the synthetic approaches for the preparation of 18 F-tracers for oncology and neurosciences. A selection of three groups of 18 F-tracers that are useful either in oncology or in neurosciences was done based on well-defined criteria such as application, lack of toxicity, availability of precursors and ease of synthesis. Based on the recommendations of the consultants' group meeting, IAEA started a coordinated research project on 'Development of 18 F radiopharmaceuticals (beyond [ 18 F]FDG) for use in oncology and neurosciences' in which 14 countries are participating in a 3-year collaborative program. The outcomes of the coordinated research project are expected to catalyze the wider application of several more 18 F-radiopharmaceuticals beyond FDG for diagnostic applications in oncology and neurosciences.

Quality control of radioactive products in the hospital

International Nuclear Information System (INIS)

Bizollon, Ch.A.; Galy, G.

1986-01-01

A classification is given of the radiopharmaceuticals used for diagnostic or therapeutic purposes followed by the verification procedures required for each category of radiopharmaceutical to check whether or not a product is usable. (UK)

Automation of (64)Cu production at Turku PET Centre.

Science.gov (United States)

Elomaa, Viki-Veikko; Jurttila, Jori; Rajander, Johan; Solin, Olof

2014-07-01

At Turku PET Centre automation for handling solid targets for the production of (64)Cu has been built. The system consists of a module for moving the target from the irradiation position into a lead transport shield and a robotic-arm assisted setup for moving the target within radiochemistry laboratory. The main motivation for designing automation arises from radiation hygiene. Copyright © 2014 Elsevier Ltd. All rights reserved.

Production of the radiopharmaceuticals labelling albumin nano-colloid with 99mTc for scintiscanning studies of the lymphatic system and bone marrow

International Nuclear Information System (INIS)

Gonzalez Alvarado, Alba Evelia

1997-01-01

The objective of the present work was to carried out the production in Guatemala, of a new radiopharmaceutical in the General Direction of Nuclear Energy for the detection of the cancer, as well as its implementation, the quality control by means of the radiochemical purity, the microbiology control and organoleptic quality , to evaluate the biodistribution in rats and to check its stability. The work was carried out formulating the pharmaco albumin Nano-colloid, then it was labelled with 99m Tc, the radiochemical purity was evaluated, measuring the disintegrations in minutes of the 99m Tc in an scintillation counter type well, being determined the percentage of union from the 99m Tc to the nanocolloid, with a purity bigger than 90%

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)

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

Country report: Brazil. Development of Radiopharmaceuticals Based on {sup 188}Re and {sup 90}Y for Radionuclide Therapy at IPEN-CNEN/SP

Energy Technology Data Exchange (ETDEWEB)

Osso, Jr., J. A.; Barrio, G.; Dias, C. R.B.R.; Brambilla, T. P.; Dantas, D. M.; Suzuki, K. N.; Barboza, M. F.S.; Bortoleti, E.; Fukumori, N. T.; Mengatti, J. [Radiopharmacy Center – Institute of Energetic and Nuclear Research – IPE N-CNEN/SP, São Paulo – Brazil (Brazil)

2010-07-01

The overall objective of this CRP is to develop radiopharmaceuticals for targeted therapy using {sup 188}Re and {sup 90}Y and to study the performance of generators with long lived parent radionuclides as well as to validate the QC control procedures for estimating the purity of generator eluents. The CRP is expected to enhance the capability in production of {sup 90}Y and {sup 188}Re radiopharmaceuticals to meet the increasing demand of therapeutic products for clinical applications, in particular in Brazil. In this period efforts were made towards the assembling of {sup 90}Sr-{sup 90}Y generators, quality control of {sup 90}Y, the labelling of DMSA(V) and anti-CD20 with {sup 188}Re and the labelling of Hydroxiapatite(HA) with {sup 90}Y. (author)

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)

APPLICATION OF LIQUID-CHROMATOGRAPHY COMBINED WITH MASS-SPECTROMETRY (LC-MS) TO ESTABLISH IDENTITY AND PURITY OF PET-RADIOPHARMACEUTICALS

NARCIS (Netherlands)

FRANSSEN, EJF; LUURTSEMA, G; MEDEMA, J; VISSER, GM; JERONISMUSSHALINGH, CM; BRUINS, AP; VAALBURG, W

This article describes the application of liquid chromatography combined with mass-spectrometry (LC-MS) as a new quality control tool for PET-radiopharmaceuticals. The final step in the production of 2-[F-18]fluoro-2-deoxy-D-glucose (F-18-FDG) is a purification by HPLC. This procedure was validated

First Human Use of a Radiopharmaceutical Prepared by Continuous-Flow Microfluidic Radiofluorination: Proof of Concept with the Tau Imaging Agent [18F]T807

Directory of Open Access Journals (Sweden)

Steven H. Liang

2014-10-01

Full Text Available Despite extensive preclinical imaging with radiotracers developed by continuous-flow microfluidics, a positron emission tomographic (PET radiopharmaceutical has not been reported for human imaging studies by this technology. The goal of this study was to validate the synthesis of the tau radiopharmaceutical 7-(6-fluoropyridin-3-yl-5H-pyrido[4,3-b]indole ([18F]T807 and perform first-in-human PET scanning enabled by microfluidic flow chemistry. [18F]T807 was synthesized by our modified one-step method and adapted to suit a commercial microfluidic flow chemistry module. For this proof of concept, the flow system was integrated to a GE Tracerlab FXFN unit for high-performance liquid chromatography purification and formulation. Three consecutive productions of [18F]T807 were conducted to validate this radiopharmaceutical. Uncorrected radiochemical yields of 17 ± 1% of crude [18F]T807 (≈ 500 mCi, radiochemical purity 95% were obtained from the microfluidic device. The crude material was then purified, and > 100 mCi of the final product was obtained in an overall uncorrected radiochemical yield of 5 ± 1% (n = 3, relative to starting [18F]fluoride (end of bombardment, with high radiochemical purity (≥ 99% and high specific activities (6 Ci/μmol in 100 minutes. A clinical research study was carried out with [18F]T807, representing the first reported human imaging study with a radiopharmaceutical prepared by this technology.

Development of a lyophilized formulation for the preparation of radiopharmaceutical 68Ga-DOTA-E-[c(RGDfK)]2 for the diagnosis of breast cancer tumors

International Nuclear Information System (INIS)

Terron A, E. J.

2015-01-01

Radiopharmaceuticals of third generation by its design that includes peptides capable of selectively directing the radiation to a specific molecular target are useful in molecular medicine for obtaining molecular images that allow recording in vivo phenomena temporal-space of molecular or cellular processes, with diagnostic or therapeutic applications. Generally, peptides that recognize cellular receptors that are over-expressed in cancer cells of interest are used; such is the case of RGD (arginine-glycine-aspartic acid) a tri-peptide sequence which recognizes to the membrane receptors α(v)β(3) and α(v)β(5) that are involved in metastasis and angiogenic processes as well as in tumor cells of breast glioma. The high affinity and selectivity of RGD peptide with integrin s α(v)β(3) and α(v)β(5) is the basis for designing radiopharmaceuticals for diagnostic of breast cancer and the metastasis and angiogenic processes. In this paper a useful lyophilized formulation was development for obtaining 68 Ga-DOTA-E-[c(RGDfK)] 2 radiopharmaceutical that for its effectiveness, stability and security can be used in humans. The production process of core-equipment DOTA-E-[c(RGDfK] 2 /Buffer sodium acetate 1.0 M was optimized, and the formulation was transferred to the radiopharmaceuticals production plant of the Instituto Nacional de Investigaciones Nucleares (ININ). The optimized formulation of the core-equipment for the 68 Ga-DOTA-E-[c(RGDfK)] 2 radiopharmaceutical preparation is: DOTA-E-[c(RGDfK)] 2 peptide - 75 μg; Mannitol - 50 mg; Sodium acetate - 14 mg; Sodium acetate buffer 1.0 M ph 4.3 - 0.5 m L. The production process was validated and stability studies were carried out to the validation batches in compliance with the validation master plan of the ININ and in adherence to compliance of the applicable national and international regulations. Also the legal dossier was drawn up in order to make the application of sanitary registration before Comision Federal para

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

Production of radiopharmaceutical 99mTc using wasteless reactor Zr-Mo gel-technology

International Nuclear Information System (INIS)

Savushkin, I.; Gurko, O.; Ravkova, E.

2002-01-01

An original methodology and technological process of the wasteless reactor gel-technology of 99m Tc producing on the basis of centralised Zr-Mo gel-generator have been developed by the Institute of Power Engineering Problems, National Academy of Sciences of Belarus in co-operation with the Research Institute of Oncology and Medical Radiology, Ministry of Health of Belarus. This approach allows 99m Tc to be produced on the basis of MoO 3 with an 99 Mo activity of 3-20 Ci. The technological process of 99m Tc sodium pertechnetate production is remotely controlled and automated. Based on clinical tests performed by the Ministry of Health of Belarus, the clinical application of 99m Tc produced by this technology has been approved. The irradiation conditions of the target, consequence of technological process, technological yield of objective product on the example of operation of one generator, reprocessing and rendering of the wastes are analysed and described. The distinctive features of the technology developed are as follows: (a) Use of native molybdenum as the starting target. (b) Absence of deleterious and toxic impurities from the final product (nitrates, organics, etc.). (c) Application of a modified method of 99m Tc extraction from 99 Mo with the help of the Zr-Mo-gel (that is, application of a true gel, not the powder obtained by gel drying), reducing the number of process stages and simplifying the technology. (d) Easy automation and remote control. (e) Simplicity of design and compactness, opening up wide application fields for the unit. It is suggested that clinical centres should be equipped with centralised high-performance 99m Tc generators. Such centres can supply 99m Tc sodium pertechnetate daily to radioisotope laboratories within the radius of 100 km. Technical and economic calculations show that the centralised gel-generators possess industrial, technical and economic parameters making them superior to small/portable generators based on loading with

State of the art and development of radioactive material processing

International Nuclear Information System (INIS)

Muenze, R.; Hladik, O.

1981-01-01

The radioisotope production at the Rossendorf Nuclear Research Centre is reviewed, considering irradiation facilities (nuclear reactor, cyclotron), processing of activated materials, in particular of nuclear fuel after short-term irradiation and the chemical separation of fission products, and the production of sup(99m)Tc radiopharmaceuticals

Cyclotron Produced Radionuclides: Guidance on Facility Design and Production of [18F]Fluorodeoxyglucose (FDG)

International Nuclear Information System (INIS)

2012-01-01

Positron emission tomography (PET) has advanced rapidly in recent years and is becoming an indispensable imaging modality for the evaluation and staging of cancer patients. A key component of the successful operation of a PET centre is the on-demand availability of radiotracers (radiopharmaceuticals) labelled with suitable positron emitting radioisotopes. Of the hundreds of positron labelled radiotracers, 2-[ 18 F]-fluoro-2-deoxy-D-glucose (FDG) is the most successful and widely used imaging agent in PET today. While FDG is utilized largely in oncology for the management of cancer patients, its applications in neurology and cardiology are also steadily growing. A large number of PET facilities have been established in Member States over the past few years, and more are being planned. The design and operation of a facility for the production of FDG requires attention to detail, in particular the application of good manufacturing practices (GMP) guidelines and quality assurance. The product must conform to the required quality specifications and must be safe for human use. This book is intended to be a resource manual with practical information for planning and operating an FDG production facility, including design and implementation of the laboratories, facility layout, equipment, personnel and FDG quality assessment. GMP and quality management are discussed only briefly, since these topics are covered extensively in the IAEA publication Cyclotron Produced Radionuclides: Guidelines for Setting up a Facility (Technical Reports Series No. 471). It should be noted that manufacturing processes and quality specifications for FDG are not currently globally harmonized, and these do vary to some extent. However, there is no disagreement over the need to ensure that the product is manufactured in a controlled manner, that it conforms to applicable quality specifications and that it is safe for human use. Administrators, managers, radiopharmaceutical scientists, production

Design and optimization of the production process of radiopharmaceutical {sup 177}Lu-DOTA-Nal{sup 3}-Octreotide for the treatment of gastro-entero-pancreatic tumors; Diseno y optimizacion del proceso de produccion del radiofarmaco {sup 177}Lu-DOTA-Nal{sup 3}-Octreotido para el tratamiento de tumores gastroenteropancreaticos

Energy Technology Data Exchange (ETDEWEB)

Sanchez G, M. F.

2013-07-01

The radiolabel peptides are molecules of interest in nuclear medicine for their therapeutic and diagnostic application in cancer. Among an impressing group of relevant peptides, those similar of the somatostatin, as the Nal{sup 3}-Octreotide (NOC), have established as potential radiopharmaceuticals when presenting significant affinity for the receptors of this peptide hormone that are over expressed and broadly distributed in tumors of neuroendocrine origin, as the gastro-entero-pancreatic tumors. On the other hand, the Lutetium-177 ({sup 177}Lu) is an ideal candidate for the peptides radiolabel and has favorable characteristics to be used in radionuclide therapy. The objective of this work was designing, optimizing and to document the production process of the radiopharmaceutical {sup 177}Lu-DOTA-Nal{sup 3}-Octreotide ({sup 177}Lu-DOTANOC) for the solicitude of its sanitary registration before the Comision Federal contra Riesgos Sanitarios (COFEPRIS). For the optimization of the production process a factorial design of three variables was evaluated with mixed levels (18 combinations), where the dependent variable is the radiochemical purity and the analytic method used to determine this parameter (High Performance Liquid Chromatography) was validated. Later on, by means of the production of 3 lots of the optimized formula of the radiopharmaceutical {sup 177}Lu-DOTANOC the production process was validated and the stability long term study to determine the period of useful life was carried out. The following pharmaceutical formulation was adopted as good: 1.85 GBq (0.5μg) of {sup 177}Lu, 250 μg of DOTANOC and 150 μL of acetates Buffer 1 M ph 5 in 5 m L of the medium. The analytic method used to determine the radiochemical purity of the formulation satisfied the requirements for the wished analytic application. We can conclude that the 3 validation lots prepared under protocols of Good Production Practices, in the Plant of Radiopharmaceuticals Production of the

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)

Synthesis of dendrimer-based biotin radiopharmaceuticals to enhance whole-body clearance

International Nuclear Information System (INIS)

Sato, Noriko; Park, Chang W.; Kim, Hyung-Sik; Han, Eui-Sik; Wong, Karen J.; Paik, Ronald S.; Park, Luke S.; Yao Zhengsheng; Carrasquillo, Jorge A.; Paik, Chang H.

2003-01-01

To synthesize a biotin radiopharmaceutical that clears rapidly, dendrimer was used as a carrier and conjugated with succinimidyl 3-[ 125 I]iodobenzoate and tetrafluorophenyl norbiotinamidosuccinate. Then, succinic anhydride was used to reduce its pI. In mice, the non-succinylated product showed high liver (67% ID/g) and kidney (44% ID/g) uptakes and whole-body retention (94% ID) at 20 min that persisted for 12 hr. The corresponding organ uptakes (22% and 11% ID/g) and the whole-body retention (47% ID) were drastically reduced by succinylation (p<0.0001). Lysine co-injection further lowered renal uptake

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

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)

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

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

Radiopharmaceutical development and clinical needs

International Nuclear Information System (INIS)

Vieira, M.R.

1998-01-01

The use of radionuclides for medical applications has continued to grow at a very rapid pace. The use of radiotracers for nuclear medicine imaging and for radiotherapy of cancer as well as certain benign disorders is firmly established as an important clinical modality. Over the past ten years, nuclear medicine has experienced an evolution towards functional studies and novel therapeutic approaches. New radionuclides are required for these applications. In the developmental stages, each new isotope has to go through a phase of careful scrutiny and evaluation, and practical concerns related to the cost of production and availability must be addressed. The development of 18 F-labeled radiopharmaceuticals has opened a completely new area of investigation. Research on bioconjugates (this term includes radiolabeled antibodies, peptides, receptor-specific and other bioactive molecules) has experienced rapid growth because of the promise of a number of these ''bioactive molecules'' to serve as selective carriers of radionuclides for tumor-associated and other specific antigens/receptors ''in vivo''. The new concept of nuclear medicine, particularly when applied to the field of oncology is directed towards the physiological mechanisms and the study of molecular disfunctions. The search for new radiopharmaceuticals thus aims at studying tumors at a tissue and molecular level. Examples of this new approach are scans utilizing the following substances: -guanethidine and noradrenaline analogues such as meta-iodo-benzyl-guanidine labeled with iodine-131 or iodine-123 aimed at targeting neuroendocrine cells and their secretory granules; -various monoclonal antibodies directed at different tumor types, both for diagnostic and therapeutic purposes. Radioimmunotherapy is considered particularly suited for treatment of tumors not easily amenable to surgery and for the treatment of small disseminated lesions; -somatostatin analogs tagged with indium-111 or more recently with Yttrium

Worst-case study for cleaning validation of equipment in the radiopharmaceutical production of lyophilized reagents: Methodology validation of total organic carbon

International Nuclear Information System (INIS)

Porto, Luciana Valeria Ferrari Machado

2015-01-01

Radiopharmaceuticals are defined as pharmaceutical preparations containing a radionuclide in their composition, mostly intravenously administered, and therefore compliance with the principles of Good Manufacturing Practices (GMP) is essential and indispensable. Cleaning validation is a requirement of the current GMP, and consists of documented evidence, which demonstrates that the cleaning procedures are able to remove residues to pre-determined acceptance levels, ensuring that no cross contamination occurs. A simplification of cleaning processes validation is accepted, and consists in choosing a product, called 'worst case', to represent the cleaning processes of all equipment of the same production area. One of the steps of cleaning validation is the establishment and validation of the analytical method to quantify the residue. The aim of this study was to establish the worst case for cleaning validation of equipment in the radiopharmaceutical production of lyophilized reagent (LR) for labeling with 99m Tc, evaluate the use of Total Organic Carbon (TOC) content as indicator of equipment cleaning used in the LR manufacture, validate the method of Non-Purgeable Organic Carbon (NPOC), and perform recovery tests with the product chosen as worst case. Worst case product's choice was based on the calculation of an index called 'Worst Case Index' (WCI), using information about drug solubility, difficulty of cleaning the equipment and occupancy rate of the products in line production. The products indicated 'worst case' was the LR MIBI-TEC. The method validation assays were performed using carbon analyser model TOC-Vwp coupled to an autosampler model ASI-V, both from Shimadzu®, controlled by TOC Control-V software. It was used the direct method for NPOC quantification. The parameters evaluated in the validation method were: system suitability, robustness, linearity, detection limit (DL) and quantification limit (QL), precision

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)

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

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

Recent achievements in Tc-99m radiopharmaceutical direct production by medical cyclotrons.

Science.gov (United States)

Boschi, Alessandra; Martini, Petra; Pasquali, Micol; Uccelli, Licia

2017-09-01

99m Tc is the most commonly used radionuclide in the field of diagnostic imaging, a noninvasive method intended to diagnose a disease, assess the disease state and monitor the effects of treatments. Annually, the use of 99m Tc, covers about 85% of nuclear medicine applications. This isotope releases gamma rays at about the same wavelength as conventional X-ray diagnostic equipment, and owing to its short half-life (t ½  = 6 h) is ideal for diagnostic nuclear imaging. A patient can be injected with a small amount of 99m Tc and within 24 h almost 94% of the injected radionuclide would have decayed and left the body, limiting the patient's radiation exposure. 99m Tc is usually supplied to hospitals through a 99 Mo/ 99m Tc radionuclide generator system where it is produced from the β decay of the parent nuclide 99 Mo (t ½  = 66 h), which is produced in nuclear reactors via neutron fission. Recently, the interruption of the global supply chain of reactor-produced 99 Mo, has forced the scientific community to investigate alternative production routes for 99m Tc. One solution was to consider cyclotron-based methods as potential replacement of reactor-based technology and the nuclear reaction 100 Mo(p,2n) 99m Tc emerged as the most worthwhile approach. This review reports some achievements about 99m Tc produced by medical cyclotrons. In particular, the available technologies for target design, the most efficient extraction and separation procedure developed for the purification of 99m Tc from the irradiated targets, the preparation of high purity 99m Tc radiopharmaceuticals and the first clinical studies carried out with cyclotron produced 99m Tc are described.

Cyclotron Produced Radionuclides: Guidance on Facility Design and Production of [{sup 18}F]Fluorodeoxyglucose (FDG)

Energy Technology Data Exchange (ETDEWEB)

NONE

2012-01-15

Positron emission tomography (PET) has advanced rapidly in recent years and is becoming an indispensable imaging modality for the evaluation and staging of cancer patients. A key component of the successful operation of a PET centre is the on-demand availability of radiotracers (radiopharmaceuticals) labelled with suitable positron emitting radioisotopes. Of the hundreds of positron labelled radiotracers, 2-[{sup 18}F]-fluoro-2-deoxy-D-glucose (FDG) is the most successful and widely used imaging agent in PET today. While FDG is utilized largely in oncology for the management of cancer patients, its applications in neurology and cardiology are also steadily growing. A large number of PET facilities have been established in Member States over the past few years, and more are being planned. The design and operation of a facility for the production of FDG requires attention to detail, in particular the application of good manufacturing practices (GMP) guidelines and quality assurance. The product must conform to the required quality specifications and must be safe for human use. This book is intended to be a resource manual with practical information for planning and operating an FDG production facility, including design and implementation of the laboratories, facility layout, equipment, personnel and FDG quality assessment. GMP and quality management are discussed only briefly, since these topics are covered extensively in the IAEA publication Cyclotron Produced Radionuclides: Guidelines for Setting up a Facility (Technical Reports Series No. 471). It should be noted that manufacturing processes and quality specifications for FDG are not currently globally harmonized, and these do vary to some extent. However, there is no disagreement over the need to ensure that the product is manufactured in a controlled manner, that it conforms to applicable quality specifications and that it is safe for human use. Administrators, managers, radiopharmaceutical scientists

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

Study of the demand for radiopharmaceutical 18F-FDG in the metropolitan regions of Sao Paulo and adjacent areas

International Nuclear Information System (INIS)

Sato, Renato Cesar

2006-01-01

Nuclear Medicine in Brazil and worldwide has developed distinction with diagnosis techniques that allow metabolic research of the disease, changing in a significant fashion the patient's outcome. This innovative technology leads expectations from specific fields up to society itself. This research studied the use of 18 F-FDG radiopharmaceutical in the metropolitan region of Sao Paulo and adjacent areas, as well as the recent trade structure and the difficulties that should be overcome with the increase of the 18 F-FDG demand. This research counted on the analysis of the international radiopharmaceutical trade and the main changes that have been happening in this area in Brazil during the past few years. Interviews were performed with professionals within the area of nuclear medicine and data has been collected through questionnaire sent to the consuming centers of the radiopharmaceutical in the region covered in this research. The interviews expressed the opinions of the interviewees concerning transformations in this field and future tendencies and the information obtained from the survey was the basis of complementation of the use of radiopharmaceutical on equipment such as Single Photon Emission Computed Tomography (SPECT), Positron Emission Tomography (PET) and Positron Emission Tomography I Computer Tomography (PET/CT). The major use of 18 F-FDG has been used for oncology diagnosis with equipment such as PET and PEC/CT. This use shall grow in the next years, maybe expanding to other specialties such as neurology and cardiology. Although nowadays restricted to the cities of Sao Paulo and Rio de Janeiro, there is a possibility of expansion to other diagnosis modalities in other states of the country that are starting to structure the production of the radioisotope. The recent change in the constitution permitting the production and commerce of short half-life radioisotopes also contributes to the increase the interest of private funding of this sector in which

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)

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)

Study of a new radiometric sterility test in radiopharmaceuticals

International Nuclear Information System (INIS)

Sanchez P, A.R.

1976-01-01

A new radiometric method is studied for the determination of sterility. It is based on a culture marked with carbon-14 and the measurement by liquid scintillation of the radioactivity of the gaseous products released after a short period of incubation. The studied samples consisted in nonradioactive solutions and different radiopharmaceuticals, through a regulated current of nitrogen there is a transportation of gaseous and volatile products produced in each flask, which were received in a liquid scintillation vial. The experimental data permit to conclude that through the radiometric method the results can be obtained after 24 hours or less of incubation, instead of a period of several days which was necessary with the traditional process. Due to the sensitivity of the method it is possible to inoculate a minimum volume of sample, this is important in the case of the preparation of little parts for injection as it occurs generally with the pharmaceuticals. (author)

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.

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.

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)

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

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

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)

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

Compartmental analysis to predict biodistribution in radiopharmaceutical design studies

Energy Technology Data Exchange (ETDEWEB)

Lima, Marina F.; Pujatti, Priscilla B.; Araujo, Elaine B.; Mesquita, Carlos H. [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)], e-mail: mflima@ipen.br

2009-07-01

The use of compartmental analysis allows the mathematical separation of tissues and organs to determinate the concentration of activity in each fraction of interest. Although the radiochemical purity must observe Pharmacopoeia specification (values upper 95%), very lower contains of free radionuclides could contribute significantly as dose in the neighborhood organs and make tumor up take studies not viable in case of radiopharmaceutical on the basis of labeled peptides. Animal studies with a product of Lutetium-177 labeled Bombesin derivative ({sup 177}Lu-BBNP) developed in IPEN-CNEN/SP and free Lutetium-177 developed in CNEA/EZEIZA was used to show how subtract free {sup 177}Lu contribution over {sup 177}Lu-BBNP to estimate the radiopharmaceutical potential as diagnosis or therapy agent. The first approach of the studies included the knowledge of chemical kinetics and mimetism of the Lutetium and the possible targets of the diagnosis/therapy to choose the possible models to apply over the sampling standard methods used in experimental works. A model with only one physical compartment (whole body) and one chemical compartment ({sup 177}Lu-BBNP) generated with the compartmental analysis protocol ANACOMP showed high differences between experimental and theoretical values over 2.5 hours, in spite of the concentration of activity had been in a good statistics rang of measurement. The values used in this work were residence time from three different kinds of study with free {sup 177}Lu: whole body, average excretion and maximum excretion as a chemical compartment. Activity concentration values as time function in measurements of total whole body and activity measurement in samples of blood with projection to total circulating blood volume with {sup 177}Lu-BBNP. Considering the two sources of data in the same modeling a better consistence was obtained. The next step was the statistic treatment of biodistribution and dosimetry in mice (Balb C) considering three chemical

On the concepts of carrier and specific activity in nuclear chemistry, radioanalytical chemistry and radiopharmaceutical chemistry

International Nuclear Information System (INIS)

Bonardi, Mauro L.

2011-01-01

At present a IUPAC Project regarding 'Terminology, Quantities and Units concerning Production and Applications of Radionuclides in Radiopharmaceutical and Radioanalytical Chemistry' states that: 'CARRIER is a chemical species - already present in the preparation or intentionally added - which will carry a given radionuclide in its associated species through the radiochemical procedure and/or prevents the radionuclide in its associated species from undergoing non-specific processes due to its low concentration'

Impurity radionuclide analysis for the radiopharmaceutical Na[123I] using gamma spectrometry

International Nuclear Information System (INIS)

Araujo, Miriam Taina Ferreira de; Silva, Ronaldo Lins da; Poledna, Roberto; Delgado, Jose Ubiratan; Andrade, Erica de Araujo Lima de; Oliveira, Antonio Eduardo de; Laranjeiras, Adilson Silva; Braghirolli, Ana Maria Silveira

2014-01-01

During the process of manufacturing a radiopharmaceutical radionuclide impurities nature can be generated. With the need to meet the standards of ANVISA recommends that applications of doses as low as feasible in patients, the concern comes with a 'boost' that can come from these radionuclidic impurities generated in the production process and or manipulation. For Na[¹²³I] provided by IEN is important to quantify its major impurity, ¹²¹Te as well as gaining a better understanding of the parameters related to the decay scheme, since the data in the literature show discrepancies. (author)

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)

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)

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

New legal requirements for submission of product information to poisons centres in EU member states.

Science.gov (United States)

de Groot, Ronald; Brekelmans, Pieter; Desel, Herbert; de Vries, Irma

2018-01-01

In the past eight years, the European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) has been intensively involved in a European Commission led process to develop EU legislation on the information of hazardous products that companies have to notify to EU Poisons Centres (or equivalent "appointed bodies"). As a result of this process, the Commission adopted Regulation (EU) No 2017/542, amending the CLP Regulation by adding an Annex on harmonised product submission requirements. Harmonised mixture information requirements: Detailed and consistent information on the composition of the hazardous product will become available to EU Poisons Centres (PC). The information will be submitted by companies to PCs (or equivalent "appointed bodies") using a web-based software application or in-house software. Two new important features are introduced. Firstly, to be able to rapidly identify the product formula, a Unique Formula Identifier (UFI) on the product label links to the submitted information. Secondly, for better comparability of reports on poisonings between EU member states, a harmonised Product Categorisation System will specify the intended use of a product. Rapid product identification and availability of detailed composition information will lead to timely and adequate medical intervention. This may lead to considerable reduction in healthcare costs. Additionally, for companies trading across the EU, costs of submission of this information will be reduced significantly. Next steps: From 2017, an implementation period has started, consisting of a three-year period for stakeholders to implement the new requirements, followed by a gradual applicability for consumer products (2020), professional products (2021) and industrial use-only products (2024). Technical tools to generate the electronic format and the UFI together with guidance documents are expected to be made available by the end of 2017 by the European Chemicals Agency (ECHA). Guidance on

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.

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

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)

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)

The design, construction, and commissioning of a multi-use cyclotron facility

International Nuclear Information System (INIS)

Ho, S.; Hutcheson, M.; Schick-Martin, D.; Dalzell, M.; Alexander, N.

2015-01-01

The Sylvia Fedoruk Canadian Centre for Nuclear Innovation in Saskatchewan is in the process of commissioning the Saskatchewan Centre for Cyclotron Sciences that is to be used for both academic research and commercial radiopharmaceutical production. The hybrid nature of this facility comes with unique challenges in satisfying both the rigid demands of pharmaceutical production while providing the necessary flexibility for academic research. In order to meet these competing demands, the Fedoruk Centre has assembled a distinct combination of skill sets and areas of expertise to operate a facility with an interdisciplinary focus. (author)

Optimization of the production process of a lyophilized formulation for radiopharmaceutical obtaining {sup 99m}Tc-EDDA/HYNIC-E-[c(RGDfK)]{sub 2}; Optimizacion del proceso de fabricacion de una formulacion liofilizada para la obtencion del radiofarmaco {sup 99m}Tc-EDDA/HYNIC-E-[c(RGDfK)]{sub 2}

Energy Technology Data Exchange (ETDEWEB)

Sanchez R, S.

2013-07-01

In this work was optimized the production process of a lyophilized pharmaceutical formulation for the preparation of radiopharmaceutical {sup 99m}Tc-EDDA/HYNIC-E-[c(RGDfK)]{sub 2}, the union specifies to the integrin s α{sub v}β{sub 3} was demonstrated to be used in the nuclear medicine cabinets in the obtaining of scan images for the opportune detection of breast cancer. The good lyophilized pharmaceutical formulation for the preparation of radiopharmaceutical {sup 99m}Tc-EDDA/HYNIC-E-[c(RGDfK)]{sub 2} was established like: HYNIC-E-[c(RGDfK)]{sub 2} - 25 μg; Stannous chloride (SnCl{sub 2}) 20 μg; Ethylenediamine diacetic acid (EDDA) 10 mg; N-tris(hydroxymethyl)methyl glycin (Tricine) 20 mg; Mannitol 50 mg. The results of radiochemical purity of the sterile formulation and free of bacterial endotoxins for the three validation lots prepared under protocols of good manufacturing practices were 97.62 ± 1.48%, 96.54 ± 1.89%, and 97.66 ± 0.57%, for what the production procedure complies the predefined specifications. The radiopharmaceutical {sup 99m}Tc-EDDA/HYNIC-E-[c(RGDfK)]2 prepared from the lyophilized pharmaceutical formulation showed to be stable during a period 24 hours, for what can be used in the centers of molecular nuclear medicine. Images in vivo were obtained of the integrin s over-expression α{sub v}β{sub 3} from the radiopharmaceutical {sup 99m}Tc-EDDA/HYNIC-E-[c(RGDfK)]2 obtained of the lyophilized and optimized pharmaceutical formulation. The lyophilized pharmaceutical formulation (HYNIC-RGD-Sn) showed stability during 12 months, due to this factor, is requested before the COFEPRIS the radiopharmaceutical expiration for this same period (accession number 123300401A0155). (Author)

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)

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

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)

Human-Centred Design: sustainable ideas and scenarios for the development of projects and products based on knowledge and human abilities

OpenAIRE

Sbordone, Maria Antonietta

2008-01-01

Human-Centred Design is defined as the discipline relating to products and services that, in different ways, takes into account the psycho-physical wellness of human beings, and is formulated according to an approach based on User-Centred Design (UCD). The User-Centred Design approach considers the relationships and the interactions users have with products while using them, and is developed within disciplines not properly belonging to the field of design. At the beginning of last century, wi...

Results of the quality assurance testing program for radiopharmaceuticals 1995

Energy Technology Data Exchange (ETDEWEB)

Baldas, J.; Binnyman, J.; Ivanov, Z.; Lauder, R.

1996-07-01

The results of the quality assurance testing conducted by the Australian Radiation Laboratory is summarised. Overall 111 batches of 27 different types of radiopharmaceuticals were tested on samples obtained through normal commercial channels. Failure to meet full specifications was observed in 10 of the 111 batches. All technetium-99m cold kits were reconstituted according to the directions in the package insert using sodium pertechnetate ( {sup 99m}Tc) injection. Radionuclidic purity has been determined at the calibration time, except for Thallous [{sup 201}Tl] Chloride injection where the highest impurity level up to product expiry is quoted. Non-compliance of the vial label was observed in one of the ten batches failing specification and was the sole cause of product failure for this batch. Vial label non-compliance consisted of, absence of volume in the vial. Six batches failed the biodistribution test but in no case did this involve failure of the distribution for the target organs. tabs.

Results of the quality assurance testing program for radiopharmaceuticals 1995

International Nuclear Information System (INIS)

Baldas, J.; Binnyman, J.; Ivanov, Z.; Lauder, R.

1996-07-01

The results of the quality assurance testing conducted by the Australian Radiation Laboratory is summarised. Overall 111 batches of 27 different types of radiopharmaceuticals were tested on samples obtained through normal commercial channels. Failure to meet full specifications was observed in 10 of the 111 batches. All technetium-99m cold kits were reconstituted according to the directions in the package insert using sodium pertechnetate ( 99m Tc) injection. Radionuclidic purity has been determined at the calibration time, except for Thallous [ 201 Tl] Chloride injection where the highest impurity level up to product expiry is quoted. Non-compliance of the vial label was observed in one of the ten batches failing specification and was the sole cause of product failure for this batch. Vial label non-compliance consisted of, absence of volume in the vial. Six batches failed the biodistribution test but in no case did this involve failure of the distribution for the target organs. tabs

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)

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

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.

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)

Country report: India. Development of Radiopharmaceuticals Based on {sup 188}Re and {sup 90}Y for Radionuclide Therapy

Energy Technology Data Exchange (ETDEWEB)

Venkatesh, M.; Pandey, U.; Dhami, P. S.; Chakravarty, R.; Kameswaran, M.; Subramanian, S.; Dash, A.; Samuel, G. [Bhabha Atomic Research Centre, Trombay, Mumbai 400 085 (India)

2010-07-01

During the past decade, our group has focused attention on the development of therapeutic radiopharmaceuticals incorporating radioisotopes such as {sup 90}Y, {sup 188}Re etc. As the primary source of the radioisotopes {sup 90}Y and {sup 188}Re are the {sup 90}Sr/{sup 90}Y generators and {sup 188}W/{sup 188}Re generators respectively, the local availability of these generator systems is very important for the successful development of radiopharmaceuticals incorporating these radioisotopes. In this context, {sup 90}Sr/{sup 90}Y generators based on Supported Liquid Membrane (SLM) [1-3] and electrochemical techniques [4] could be designed and deployed in our laboratories for the elution of {sup 90}Y to be used for preparation of {sup 90}Y labeled products. This work formed a part of the IAEA co-ordinated CRP on “Development of Generator Technologies for Therapeutic Radionuclides: {sup 90}Y and {sup 188}Re”. In this report, work on the development of {sup 90}Y radiopharmaceuticals for treatment of liver cancer and non-Hodgkin’s lymphoma (NHL) is reported. In addition, comparison of the Extraction Paper Chromatography technique (EPC) developed for determination of {sup 90}Sr contamination in {sup 90}Y samples with the US Pharmacopeia recommended method as well as the validation of the EPC technique is presented.

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)

Development of PET and SPECT radiopharmaceuticals to study multi-drug resistance (MDR)

International Nuclear Information System (INIS)

Katsififs, A.; Dikic, B.; Greguric, I.; Knott, R.; Mattner, F.

2002-01-01

PgP. This generic structure also offers the flexibility to prepare a wide range of molecules that are readily suitable for halogenation with either Iodine-123 or F-18 for radiopharmaceutical development. Finally these phenolic type of molecules based on Quercetin are relatively less toxic than equivalent drugs. In this proposal an extensive research program is required to develop specific drugs for the different efflux pumps present in the body, which represent multi drug resistance. A successful outcome is critically dependent on the initial synthesis of a large number of compounds for screening. The combined effort of the three institutions will boost resources significantly to a critical level required to competitively produce successful outcomes in the project. Optimisation studies on derivatives of these flavonols will be made in parallel with the assistance of in vitro studies by measuring the binding of compounds to the ATP sites of Pgp. An extensive in vitro screening program has been established in Paris, prior to radiolabelling and in vivo evaluation. Structural optimisation and attachment of radionuclides to promising molecular targets will be explored using molecular modelling. Initially computational chemistry using Sybyl will be undertaken to develop a pharmacophore and to assist with the incorporation of the radionuclide in the appropriate position. In vivo evaluation will be undertaken in specific animal models both at the University of Tours in France as well as at the Sydney Cancer Centre in Australia. PET functional imaging studies may be undertaken on successful candidates at the SHFJ in Orsay, France whilst SPECT imaging will be undertaken in both Tours and in Sydney. In addition to intellectual property and potential commercial product(s), specific PET or SPECT radiopharmaceuticals can provide valuable information on the assessment of MDR in cancer patients through functional, non-invasive, imaging and therefore make significant contributions to

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

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

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)

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)

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 ...

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.

Design, synthesis, and evaluation of new organomedicinal radiopharmaceuticals. Progress report, March 1, 1981-February 28, 1982

International Nuclear Information System (INIS)

Hanson, R.N.

1982-01-01

The goal of this project is the development of radiopharmaceuticals which localize selectively in the normal myocardium and which can be used to assess myocardial perfusion and function with external detection systems. The availability of T1-201 as a myocardial imaging agent makes it possible to visualize compromised myocardium as an area of decreased radionuclide uptake. However, the long physical and biologic half-lives of this nuclide, as well as the low energy of its gamma emission and its cost, suggest a need to develop radiodiagnostic agents which have a similar myocardial distribution but employ a less expensive radioisotope with better decay properties. An approach developed in this proposal involves the use of cardioselective sympatholytic agents into which a suitable radionuclide can be incorporated. The two types of compounds to be investigated are the beta adrenoceptor antagonists and the catecholamine depleting agents. The radiolabeled products will be evaluated in normal and in experimentally infarcted animals, and their pharmacokinetics compared with those of T1-201. The most promising radiopharmaceuticals will subsequently be tested in larger animals having myocardial pathology

Synthesis and labeling 5'-O-(4-4'-dimetoxytrityl) -2,3-anhidrothymidine for preparation of radiopharmaceutical [18F]FLT

International Nuclear Information System (INIS)

Purwoko; Maskur; Chaeruman; Sugiarto, Yono

2013-01-01

It is has been known that the compound of 3'-deoxy-3,-( 18 F] Fluorothymidine or ( 18 F] FLT is a thymidine derivative radiopharmaceutical used for cancer detection based on DNA metabolism. Synthesis and labeling of 5'-0-(4,4 '-dimetoxytrityl) -2,3' anhidrothymidine precursor for preparation of the radiopharmaceutical [ 18 F]FL T was carried out. The precursor was synthesized in similar manner and procedure literature and it have been obtained a crystalline product with total yield of 32,4 %. The chemical purity of the product which determined by HPLC was found to be more than 95%. Characterization of the product was done by observing the results of the LC / MS and 1 H-NMR test, the resulted data were found to be very closed to those reported in the literature. Labeling of the precursor was done by nucleophilic fluorination reactions using 18 Fluoride at 160 °C for 15 minutes with kryptofix 2.2.2 catalyst followed hydrolysis using HCI at 100 °C for 10 minutes and then neutralized with NaOH. Purification [ 18 F]FLT was performed by single cartridge Alumina-N as a substitute HPLC methods. The results have been obtained a label compound [ 18 F]FLT with high purity as a bulk for preparation of the radiopharmaceutical [ 18 F]FLT. The label compound of [ 18 F]FLT undergone a quality test which included a clarity, pH and a radiochemical purity. The results of quality control on four batches of [ 18 F]FLT showed that these products were colorless clear solution with pH between 6.0-7.5, and radiochemical purity 97.93 ± 1,48% and showed that the label compounds have been obtained [ 18 F]FLT-free particles form a clear solution with a pH between 6,0 - 7,5, radiochemical purity of 97.93 ± 1,48 %, radiochemical yields 8.18 ± 1.54% (decay uncorrected) and processing time 73 ± 4 minutes. (author)

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

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。

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

IPENS's social role in scientific and technological development of radioisotope and radiopharmaceutical production - (1950 -1980)

International Nuclear Information System (INIS)

Gordon, Ana Maria P.L.

2009-01-01

Some facts and figures are present in the existent interaction between the Instituto de Pesquisas Energeticas e Nucleares (IPEN) and the medical community. Among other characteristics, the IPEN has a permanent seat in the Biology and Nuclear Medicine Society and, the present Radiopharmacy Center, has had the continuous concern, since the Instituto de Energia Atomica (IEA) creation until today (2009), to perform an excellent approach with the medical faculty. In the past, some physicians would complete their courses in Europe and in the United States of America, and there noticed the importance of radioisotopes applications in medicine, mainly, in the beginning of these activities, with the I-131. Returning to Brazil, they requested that the former IEA, today IPEN researchers used the research reactor IEA-R1, installed in Sao Paulo, at Universidade Sao Paulo (USP) campus, for radioisotopes production. Then, in the late 1959, the first production line from the I-131 took place. The IPEN starts to accomplish what was planned as one of its targets, at the act of its official creation on August 31, 1956. From 1961 on, there was a continuous flux of I-131 and other radiopharmaceuticals production. The recovery and analysis of these happenings, in the Brazilian society cultural historic context, were partially published in different previous works. Nevertheless, history is dynamic and gains new interpretations, in the present research, from the reading of novel research sources, both primary and secondary, not explores so far - reports, interviews with IPEN researchers and papers published or divulged in meetings, either scientific or bureaucratic. This research is part of project supported by the Fundacao de Amparo a Pesquisa do Estado de Sao Paulo (FAPESP), with the aim, among others, of contributing for the analysis of the transformations occurred in all of the IPEN research lines, plus the social role of this institution for science and technology development. The

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

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

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.

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

International Nuclear Information System (INIS)