Radiopharmacy
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Radiopharmacy
Nuclear pharmacy, also known as radiopharmacy, involves preparation of radioactive materials for patient administration that will be used to diagnose and treat specific diseases in nuclear medicine. It generally involves the practice of combining a radionuclide tracer with a pharmaceutical component that determines the biological localization in the patient. Radiopharmaceuticals are generally not designed to have a therapeutic effect themselves, but there is a risk to staff from radiation exposure and to patients from possible contamination in production. Due to these intersecting risks, nuclear pharmacy is a heavily regulated field. The majority of diagnostic nuclear medicine investigations are performed using technetium-99m. History The concept of nuclear pharmacy was first described in 1960 by Captain William H. Briner while at the National Institutes of Health (NIH) in Bethesda, Maryland. Along with Mr. Briner, John E. Christian, who was a professor in the School of Pharmacy a ...
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Radionuclide Generator
A radionuclide generator is a device which provides a local supply of a short-lived radioactive substance from the decay of a longer-lived parent radionuclide. They are commonly used in nuclear medicine to supply a radiopharmacy. The generator provides a way to separate the desired product from the parent, typically in a process that can be repeated several times over the life of the parent. Use of a generator avoids the challenge of distributing short-lived radionuclides from the original production site (typically a nuclear reactor) to individual users; the loss of activity due to decay in transit can result in too little being supplied or the need for much larger initial quantities to be sent out (incurring additional production and transport costs). An alternative to generators for on-site production of radionuclides is a cyclotron, though it is uncommon that the same radionuclide can be provided by both methods. It is feasible to have cyclotrons at larger centres, but they are ...
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Chemical Bond
A chemical bond is a lasting attraction between atoms or ions that enables the formation of molecules and crystals. The bond may result from the electrostatic force between oppositely charged ions as in ionic bonds, or through the sharing of electrons as in covalent bonds. The strength of chemical bonds varies considerably; there are "strong bonds" or "primary bonds" such as covalent, ionic and metallic bonds, and "weak bonds" or "secondary bonds" such as dipole–dipole interactions, the London dispersion force and hydrogen bonding. Strong chemical bonding arises from the sharing or transfer of electrons between the participating atoms. Since opposite electric charges attract, the negatively charged electrons surrounding the nucleus and the positively charged protons within a nucleus attract each other. An electron positioned between two nuclei will be attracted to both of them, and the nuclei will be attracted toward electrons in this position. This attraction constitu ...
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Directive (European Union)
A directive is a legal act of the European Union that requires member states to achieve a particular result without dictating the means of achieving that result. Directives first have to be enacted into national law by member states before their laws are ruling on individuals residing in their countries. Directives normally leave member states with a certain amount of leeway as to the exact rules to be adopted. Directives can be adopted by means of a variety of legislative procedures depending on their subject matter. The text of a draft directive (if subject to the co-decision process, as contentious matters usually are) is prepared by the Commission after consultation with its own and national experts. The draft is presented to the Parliament and the Council—composed of relevant ministers of member governments, initially for evaluation and comment and then subsequently for approval or rejection. Justification There are justifications for using a directive rather than a ...
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European Union
The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been described as a '' sui generis'' political entity (without precedent or comparison) combining the characteristics of both a federation and a confederation. Containing 5.8per cent of the world population in 2020, the EU generated a nominal gross domestic product (GDP) of around trillion in 2021, constituting approximately 18per cent of global nominal GDP. Additionally, all EU states but Bulgaria have a very high Human Development Index according to the United Nations Development Programme. Its cornerstone, the Customs Union, paved the way to establishing an internal single market based on standardised legal framework and legislation that applies in all member states in those matters, and only those matters, where the states have agreed to act ...
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Asepsis
Asepsis is the state of being free from disease-causing micro-organisms (such as pathogenic bacteria, viruses, pathogenic fungi, and parasites). There are two categories of asepsis: medical and surgical. The modern day notion of asepsis is derived from the older antiseptic techniques, a shift initiated by different individuals in the 19th century who introduced practices such as the sterilizing of surgical tools and the wearing of surgical gloves during operations. The goal of asepsis is to eliminate infection, not to achieve sterility. Ideally, a surgical field is sterile, meaning it is free of all biological contaminants (e.g. fungi, bacteria, viruses), not just those that can cause disease, putrefaction, or fermentation. Even in an aseptic state, a condition of sterile inflammation may develop. The term often refers to those practices used to promote or induce asepsis in an operative field of surgery or medicine to prevent infection. History The modern concept of asepsis evol ...
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Radiation Safety
Radiation protection, also known as radiological protection, is defined by the International Atomic Energy Agency (IAEA) as "The protection of people from harmful effects of exposure to ionizing radiation, and the means for achieving this". Exposure can be from a source of radiation external to the human body or due to internal irradiation caused by the ingestion of radioactive contamination. Ionizing radiation is widely used in industry and medicine, and can present a significant health hazard by causing microscopic damage to living tissue. There are two main categories of ionizing radiation health effects. At high exposures, it can cause "tissue" effects, also called "deterministic" effects due to the certainty of them happening, conventionally indicated by the unit gray and resulting in acute radiation syndrome. For low level exposures there can be statistically elevated risks of radiation-induced cancer, called " stochastic effects" due to the uncertainty of them happening, c ...
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Good Manufacturing Practice
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality managemen ...
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International Atomic Energy Agency
The International Atomic Energy Agency (IAEA) is an intergovernmental organization that seeks to promote the peaceful use of nuclear energy and to inhibit its use for any military purpose, including nuclear weapons. It was established in 1957 as an autonomous organization within the United Nations system; though governed by its own founding treaty, the organization reports to both the General Assembly and the Security Council of the United Nations, and is headquartered at the UN Office at Vienna, Austria. The IAEA was created in response to growing international concern toward nuclear weapons, especially amid rising tensions between the foremost nuclear powers, the United States and the Soviet Union. U.S. President Dwight D. Eisenhower's " Atoms for Peace" speech, which called for the creation of an international organization to monitor the global proliferation of nuclear resources and technology, is credited with catalyzing the formation of the IAEA, whose treaty came into ...
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Ionising Radiation
Ionizing radiation (or ionising radiation), including nuclear radiation, consists of subatomic particles or electromagnetic waves that have sufficient energy to ionize atoms or molecules by detaching electrons from them. Some particles can travel up to 99% of the speed of light, and the electromagnetic waves are on the high-energy portion of the electromagnetic spectrum. Gamma rays, X-rays, and the higher energy ultraviolet part of the electromagnetic spectrum are ionizing radiation, whereas the lower energy ultraviolet, visible light, nearly all types of laser light, infrared, microwaves, and radio waves are non-ionizing radiation. The boundary between ionizing and non-ionizing radiation in the ultraviolet area is not sharply defined, as different molecules and atoms ionize at different energies. The energy of ionizing radiation starts between 10 electronvolts (eV) and 33 eV. Typical ionizing subatomic particles include alpha particles, beta particles, and neutrons. Th ...
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Regulatory Agency
A regulatory agency (regulatory body, regulator) or independent agency (independent regulatory agency) is a government authority that is responsible for exercising autonomous dominion over some area of human activity in a licensing and regulating capacity. These are customarily set up to strengthen safety and standards, and/or to protect consumers in markets where there is a lack of effective competition. Examples of regulatory agencies that enforce standards include the Food and Drug Administration in the United States and the Medicines and Healthcare products Regulatory Agency in the United Kingdom; and, in the case of economic regulation, the Office of Gas and Electricity Markets and the Telecom Regulatory Authority in India. Legislative basis Regulatory agencies are generally a part of the executive branch of the government and have statutory authority to perform their functions with oversight from the legislative branch. Their actions are often open to legal review. ...
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Isotope
Isotopes are two or more types of atoms that have the same atomic number (number of protons in their nuclei) and position in the periodic table (and hence belong to the same chemical element), and that differ in nucleon numbers (mass numbers) due to different numbers of neutrons in their nuclei. While all isotopes of a given element have almost the same chemical properties, they have different atomic masses and physical properties. The term isotope is formed from the Greek roots isos ( ἴσος "equal") and topos ( τόπος "place"), meaning "the same place"; thus, the meaning behind the name is that different isotopes of a single element occupy the same position on the periodic table. It was coined by Scottish doctor and writer Margaret Todd in 1913 in a suggestion to the British chemist Frederick Soddy. The number of protons within the atom's nucleus is called its atomic number and is equal to the number of electrons in the neutral (non-ionized) atom. Each atomic numbe ...
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Fluorine-18
Fluorine-18 (18F) is a fluorine radioisotope which is an important source of positrons. It has a mass of 18.0009380(6) u and its half-life is 109.771(20) minutes. It decays by positron emission 96% of the time and electron capture 4% of the time. Both modes of decay yield stable oxygen-18. Natural occurrence is a natural trace radioisotope produced by cosmic ray spallation of atmospheric argon as well as by reaction of protons with natural oxygen: 18O + p → 18F + n.18O">sup>18Oater with high energy protons (typically ~18 MeV). The fluorine produced is in the form of a water solution of 18F.html" ;"title="sup>18F">sup>18F luoride, which is then used in a rapid chemical synthesis of various radio pharmaceuticals. The organic oxygen-18 pharmaceutical molecule is not made before the production of the radiopharmaceutical, as high energy protons destroy such molecules ( radiolysis). Radiopharmaceuticals using fluorine must therefore be synthesized after the fluorine-18 has been p ...
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