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Topic: Radiopharmaceutical


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In the News (Sun 6 Dec 09)

  
  WAIS Document Retrieval
315.2 and 601.31 defined a diagnostic radiopharmaceutical as an article that is intended for use in the diagnosis or monitoring of a human disease or manifestation of disease and that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons.
For example, a diagnostic radiopharmaceutical might be used to locate and outline a normal parathyroid gland; while this information might not directly result in disease diagnosis and might not be demonstrated to improve patient management, it could indirectly assist a physician in planning and performing surgery to remove a mass in the thyroid gland.
However, the mass of a diagnostic radiopharmaceutical may be a relevant factor in FDA's determination of the type of pharmacology, toxicology, clinical adverse event monitoring, and radiation safety data needed to establish the safety of a diagnostic radiopharmaceutical.
www.fda.gov /cder/regulatory/pet/frmay17.htm   (11065 words)

  
 Procedure Radiology-Info.org
The function of the radiopharmaceutical is that its radioactive component produces signals that are recorded by the PET scanner.
Regardless of the radiopharmaceutical that is used, the PET scan procedure is a safe one with the only pain coming from the injection of the radiopharmaceutical into the patient.
In order for the radiopharmaceutical to effectively travel to its intended destination, the patient is usually asked to rest quietly and to avoid significant movement or talking, as these actions may alter the localization of the radiopharmaceutical.
www.radiology-info.org /nuclear-medicine-positron-emission-tomography/procedure.html   (2084 words)

  
 Radiopharmaceutical composition based on technetium-99m and reagent for making it - Patent 4451451
Radiopharmaceutical compositions containing complexes of technetium-99m with a complexing agent are prone to time and activity-related decomposition and formation of pertechnetate.
It is an object of this invention to provide a radiopharmaceutical composition comprising technetium-99m present in a valency state greater than 0 and less than 7, stabilized by means of an agent which is nontoxic and which does not spoil the distribution pattern of the technetium-99m.
Radiopharmaceutical compositions containing up to 500 mCi of Tc-99m may be stabilized by from 0.1 to 10 mg, preferably 0.5 to 6 mg, of the stabilizing agent.
www.freepatentsonline.com /4451451.html   (3243 words)

  
 Austin Radiological Association - Radiology Services & Exams - Pediatric Exams - Nuclear Medicine   (Site not responding. Last check: 2007-11-02)
For a short time, the radiopharmaceutical emits gamma rays, which are a type of x-ray similar to the x-rays used to make plain radiographs.
The radiopharmaceutical is injected with a small needle through the skin into the spinal canal at the curve of the lower back.
It is performed once by having the radiopharmaceutical injected while your child is having a seizure (this is the ictal part), and once when he or she is not having a seizure (this is the interictal part).
www.ausrad.com /rse_le_p_nm.shtml   (4804 words)

  
 BioMed Central | Full text | 188Re radiopharmaceuticals for radiosynovectomy: evaluation and comparison of tin colloid, ...
Radiopharmaceutical particle size must be small enough to be phagocyted by the superficial cells of the sinovium, but not so small as to facilitate a fast biological clearance by diffusion from the joint [2,3].
Radiopharmaceutical leakage from the knee was evaluated by the acquisition of scintigraphic images over 48 hr after intraarticular administration of the radiolabeled preparations to New Zealand rabbits.
From the point of view of the radiological security of the patient, the best radiopharmaceutical is that one with a greater percentage of the injected dose retained in the joint because a smaller activity amount had to be injected to obtain the desired radiation dose.
www.biomedcentral.com /1471-2385/4/1   (3429 words)

  
 657 IAC Chapter 16 Nuclear Pharmacy Practice   (Site not responding. Last check: 2007-11-02)
It is also unlawful for any person to provide radiopharmaceutical services unless the person is a pharmacist or a person acting under the direct supervision of a pharmacist acting in accordance with the provisions of Iowa Code chapter 155A, board rules and rules of the environmental protection commission.
“Radiopharmaceutical quality assurance” means, but is not limited to, the performance of appropriate chemical, biological and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine the radiopharmaceuticals' suitability for use in humans and animals, including internal test assessment authentication of product history and the keeping of proper records.
A license to operate a pharmacy providing radiopharmaceutical services shall be issued only to a qualified nuclear pharmacist who shall be the pharmacist in charge of the pharmacy.
www.state.ia.us /ibpe/rules_laws/ch16.html   (1039 words)

  
 Nuclear Medicine
It is absolutely necessary to have a radiopharmaceutical which precisely localizes the radioactivity to the organ and the physiologic function that you want to study.
After the radiopharmaceutical is localized in the lungs, six (6) images are made including the anterior, posterior, both laterals and both posterior oblique views.
This radiopharmaceutical moves through the liver fairly rapidly so it is not possible to get multidirectional views and most of these studies are done with sequential imaging in the anterior projection.
radiology.med.sc.edu /4nucmed.htm   (4836 words)

  
 RadSafe/Chapter 2 Radiopharmaceutical Therapy   (Site not responding. Last check: 2007-11-02)
Prior to the administration of any radiopharmaceutical therapy procedure, the authorized user shall sign and date an order which specifies the patient, the radiopharmaceutical, the dosage, and the route of administration.
Radiopharmaceutical therapy procedures at the Medical College of Georgia Health Inc are performed in the Nuclear Medicine Department.
Radiopharmaceutical therapy doses at the Georgia Radiation Therapy Center are administered by a Radiation Therapy Resident or Authorized User in the presence of a representative from the Radiation Safety Office or a therapy physicist.
www.mcg.edu /Services/ehs/radsafe/thmanual/Radiopharm.htm   (681 words)

  
 GAO-05-733R, Medicare: Radiopharmaceutical Purchase Prices for CMS Consideration in Hospital Outpatient Rate-Setting
Radiopharmaceuticals have two components: a medicine or pharmaceutical agent, which is nonradioactive, and a radioisotope, which is radioactive.
For two radiopharmaceutical products, our data suggest that it may be more meaningful to estimate their purchase prices per dose rather than per billing unit.
Although it is possible for radiopharmaceuticals in our survey to be purchased in different types of doses--unit doses, multidoses, and kits for doses prepared in-house--as a practical matter, most radiopharmaceuticals are purchased as unit doses, and we have added information on that to the report.
www.gao.gov /htext/d05733r.html   (2934 words)

  
 Austin Radiological Association - Radiology Services & Exams - Adult Exams - Nuclear Medicine   (Site not responding. Last check: 2007-11-02)
The radiopharmaceutical is injected with a small needle through the lower back into the spinal canal.
The radiopharmaceutical is injected at the site of the tumor, or the site where the tumor was removed.
The radiopharmaceutical is injected into a vein on the first day of the study.
www.ausrad.com /rse_le_nm.shtml   (3384 words)

  
 201 KAR 2:215. Nuclear pharmacy services.
This includes nonradioactive reagent kits and nuclide generators which are intended to be used in the preparation of any such substance, but does not include drugs which are carbon-containing compounds or potassium-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides.
      (4) "Radiopharmaceutical quality assurance" means the performance of appropriate chemical, biological and physical tests on radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, and it shall include, for example, internal test assessment, authentication of product history and the keeping of proper records.
For nuclear pharmacies handling radiopharmaceuticals exclusively, the Kentucky Board of Pharmacy may waive regulations pertaining to pharmacy licenses for nonradiopharmaceuticals which requirements do not pertain to the practice of nuclear pharmacy.
www.lrc.ky.gov /kar/201/002/215.htm   (1502 words)

  
 Radiopharmacology - Wikipedia, the free encyclopedia
Radiopharmacology is the study and preparation of radiopharmaceuticals, which are radioactive pharmaceuticals.
Radiopharmaceuticals are used in the field of nuclear medicine as tracers in the diagnosis and treatment of many diseases.
In the book Technetium by Klaus Schwochau, 31 different radiopharmaceuticals based on Tc-99m are listed for imaging and functional studies of the brain, myocardium, thyroid, lungs, liver, gallbladder, kidneys, skeleton, blood and tumors.
en.wikipedia.org /wiki/Radiopharmaceutical   (193 words)

  
 Dosimetric Consequences of Radiopharmaceutical Infiltrations   (Site not responding. Last check: 2007-11-02)
Radiopharmaceutical infiltrations were assessed in a rat model.
Particulate and nonparticulate radiopharmaceuticals were injected subcutaneously or intradermally into an anesthetized shaved rat model.
The rate of release of the nine infiltrations per radiopharmaceutical per injection type were measured from computer data acquired with a gamma camera up to 24 hours after administration.
www.extravasation.org.uk /Dosi.htm   (332 words)

  
 GOOD FOR YOUR HEALTH, GOOD FOR YOUR WALLET
"The NIST radiopharmaceutical research program is one of our most successful NIST/industry collaborations in that it meets an important industry need and, at the same time, serves to increase public confidence in the quality of diagnostic and therapeutic pharmaceuticals," says Bert Coursey, chief of the NIST Ionizing Radiation Division.
Without NIST radiopharmaceutical standards, patients would have to repeat 1 percent of diagnostic procedures and 3 percent of therapeutic procedures due to decreased accuracy in radioactive drug dosages.
Without NIST radiopharmaceutical standards, the accuracy of radioactive drugs would decrease by 10 to 15 percent, according to medical experts interviewed for the study.
www.nist.gov /public_affairs/releases/n97-30.htm   (612 words)

  
 TITLE 16   (Site not responding. Last check: 2007-11-02)
The term 'radiopharmaceutical' also includes any biological product which is labeled with a radionuclide or intended solely to be labeled with a radionuclide.
A radiopharmaceutical shall be dispensed only upon receipt of a prescription from such licensed practitioner.
Otherwise, a radiopharmaceutical may be transferred to a person who is authorized to possess and use such drug for non-clinical applications.
www.state.nm.us /pharmacy/part18.html   (1395 words)

  
 PET (Positron Emission Tomography) - My Child Has - Children's Hospital Boston
The type of radiopharmaceutical selected is designed to go to the part of the body that is being tested.
During this time, while the radiopharmaceutical is circulating within the body, it is extremely important for you/your child to be very quiet; no talking, reading, or sleeping.
Once the radiopharmaceutical is injected, the needle is withdrawn and a gauze bandage with adhesive tape is placed over the site of the injection.
www.childrenshospital.org /az/Site2154/mainpageS2154P0.html   (896 words)

  
 pharmacy.htm
Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans including internal test assessment, authentication of product history and the keeping of proper records.
Radiopharmaceuticals are to be dispensed only upon a prescription drug order, from a practitioner authorized to possess, use, and administer radiopharmaceuticals.
Radiopharmaceuticals shall be dispensed/transferred only to a licensed practitioner authorized by the Nuclear Regulatory Commission and/or the Mississippi State Department of Health, Division of Radiological Health to possess, use and administer such drug.
www.mbp.state.ms.us /pharma29.htm   (1198 words)

  
 HCV Infections From a Contaminated Radiopharmaceutical Used in Myocardial Perfusion Studies
These radiopharmaceutical products are often prepared in commercial nuclear pharmacies and distributed to hospitals or outpatient clinics for administration.14 Although biological materials are not used in the preparation of radionuclides for myocardial perfusion studies, nuclear pharmacies may process blood for radiolabeled blood cell studies.
The radiopharmaceutical used was Tc 99m sestamibi, which was prepared by a nuclear pharmacy that also prepared radiopharmaceuticals for other health care facilities in the state.
A case was defined as evidence of HCV infection (presence of HCV RNA with either symptoms of acute viral hepatitis or elevated serum aminotransferase levels) in a person who underwent a myocardial perfusion study on October 14-15, 2004.
natap.org /2006/HCV/120606_08.htm   (3408 words)

  
 MSD: Radiopharmaceutical and Molecular Nuclear Medicine Science Research
The substrate molecules can be tailored to fulfill a specific need and labeled with appropriate radioisotopes to become measurable in real time in the body on their way to, and in interaction with their targets allowing the analysis of molecular function in homeostatic control in health and disease.
The current Radiopharmaceutical and Molecular Nuclear Medicine programs encourage development of new generation of radiolabeled molecules and technologies for molecular delivery of radioisotopes to the disease-target-sites with a high degree of precision, recognition, and target selectivity.
It is expected that radiopharmaceutical and molecular nuclear medicine techniques will permit analysis of the molecular elements as markers of genetic manipulations, biological transformations and progression of the disease, and will provide insights to molecular pathways of disease and gene function.
www.doemedicalsciences.org /rmnms.shtml   (694 words)

  
 Converting Energy to Medical Progress: Radiopharmaceutical Energy Reveals World of Human Biology
The special ability of radiopharmaceuticals to visualize human biology, both healthy and diseased, arises from their distribution through the body as "radiotracers." Nearly all radiopharmaceuticals (i.e., medically useful radiotracers) and imaging systems described here were discovered, designed, or developed by scientists supported by the BER Medical Sciences program during the past 50 years.
The radiopharmaceutical, similar to the mineral in bone, accumulates at bone tumors (dark spots) because the diseased bone has faster mineral turnover.
Once a radiopharmaceutical is injected into a patient, the carrier molecule travels through the body until it interacts with its target cell, tissue, or organ system.
www.doemedicalsciences.org /pubs/sc0033/radio.shtml   (757 words)

  
 Drug Targeting of a Peptide Radiopharmaceutical through the Primate Blood-Brain Barrier In Vivo with a Monoclonal ...
Peptide radiopharmaceuticals have potential for diagnostic imaging (1).
the peptide radiopharmaceutical is monobiotinylated and, in parallel,
Fischman, A.J., J.W. Babich, and H.W. Strauss (1993) Peptide radiopharmaceuticals.
www.jci.org /cgi/content/full/100/7/1804   (5352 words)

  
 Board of Pharmacy_855_042
(4) A "Radiopharmaceutical" is any substance defined as a drug in Section 201(g)(1) of the federal Food, Drug and Cosmetic Act which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any such drug which is intended to be made radioactive.
This definition includes nonradioactive reagent kits and nuclide generators which are intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds or potassium-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides.
(5) "Radiopharmaceutical Quality Assurance" means, but is not limited to, the performance of appropriate chemical, biological and physical tests on radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment authentication of product history and the keeping of proper records.
arcweb.sos.state.or.us /rules/OARS_800/OAR_855/855_042.html   (1305 words)

  
 Radiopharmaceutical Sciences Council
The Radiopharmaceutical Sciences Council is made up of members of the Society of Nuclear Medicine who have a common interest in the radiopharmaceutical sciences.
The Radiopharmaceutical Sciences Council encourages all professionals within SNM to consider being members, as your input is needed to help promote and develop the many aspects of the Radiopharmaceutical Sciences.
It is the intention of the Radiopharmaceutical Sciences Council to represent the following groups of professionals.
interactive.snm.org /index.cfm?PageID=3206   (205 words)

  
 Lymphoseek: A Molecular Radiopharmaceutical for Sentinel Node Detection -- Wallace et al. 10 (5): 531 -- Annals of ...
structure of the radiopharmaceutical is depicted in Fig.
Radiopharmaceutical explanations of distal node uptake are (1)
increase the receptor affinity of the radiopharmaceutical by
www.annalssurgicaloncology.org /cgi/content/full/10/5/531   (3155 words)

  
 Chapter 246-239 WAC   (Site not responding. Last check: 2007-11-02)
If the referring physician or individual receiving the radiopharmaceutical misadministration cannot be reached within twenty-four hours, the licensee shall notify the individual as soon as possible thereafter.
To meet the requirements of this section, the notification of the individual receiving the radiopharmaceutical misadministration may be made instead to that individual's responsible relative or guardian, when appropriate.
(b) A brief description of both the radiopharmaceutical misadministration and the consequences, as they may affect the individual, and a statement informing the individual that the report submitted to the department can be obtained from the licensee.
www.doh.wa.gov /ehp/rp/wac/246-239.htm   (3264 words)

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