• Title/Summary/Keyword: 방사성의약품

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Suggestion for Good Manufacturing Practice of Radiopharmaceuticals (우수방사성의약품 제조관리를 위한 제언)

  • Shin, Byungchul;Lee, Sangbock
    • Journal of the Korean Society of Radiology
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    • v.7 no.6
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    • pp.397-402
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    • 2013

  • This study suggests considerations for legislation of radiopharmaceutical manufacturing practice according as the Korea Pharmaceutical Affairs Act and guidelines on foreign radiopharmaceutical manufacturing practice. Pharmaceuticals should be verified safety, effectiveness, and uniformity. Therefore, it is expected that the efficiency of the administration of radiopharmaceuticals increase and nation's health promote if rational manufacturing management to consider of radiopharmaceutical properties is legislated.

  • https://doi.org/10.7742/jksr.2013.7.6.397 인용 PDF KSCI

Molar activity of radiopharmaceuticals

  • Choe, Yearn Seong
    • Journal of Radiopharmaceuticals and Molecular Probes
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    • v.4 no.1
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    • pp.22-25
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    • 2018

  • Radiopharmaceuticals are used for diagnosis or therapy of diseases. According to the recent consensus nomenclature rules for radiopharmaceutical chemistry, specific activity is defined as the radioactivity per gram of radiolabeled compound and molar activity as the radioactivity per mole of radiolabeled compound. In this review, molar activity of radiopharmaceuticals is discussed in terms of its significance in nuclear imaging as well as its measurement methods.

  • https://doi.org/10.22643/JRMP.2018.4.1.22 인용 PDF KSCI

Quality Control Tests and Acceptance Criteria of Diagnostic Radiopharmaceuticals (진단용 방사성의약품의 품질관리시험 및 기준)

  • Park, Jun Young
    • Korean Journal of Clinical Laboratory Science
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    • v.53 no.1
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    • pp.1-10
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    • 2021

  • Radiopharmaceuticals are drugs that contain radioisotopes and are used in the diagnosis, treatment, or investigation of diseases. Radiopharmaceuticals must be manufactured in compliance with good manufacturing practice regulations and subjected to quality control before they are administered to patients to ensure the safety of the drug. Radiopharmaceuticals for administration to humans need to be sterile and pyrogen-free. Hence, sterility tests and membrane filter integrity tests are carried out to confirm the asepticity of the finished drug product, and a bacterial endotoxin test conducted to assess contamination, if any, by pyrogens. The physical appearance and the absence of foreign insoluble substances should be confirmed by a visual inspection. The chemical purity, residual solvents, and pH should be evaluated because residual by-products and impurities in the finished product can be harmful to patients. The half-life, radiochemical purity, radionuclidic purity, and strength need to be assessed by analyzing the radiation emitted from radiopharmaceuticals to verify that the radioisotope contents are properly labeled on pharmaceuticals. Radiopharmaceuticals always carry the risk of radiation exposure. Therefore, the time taken for quality control tests should be minimized and care should be taken to prevent radiation exposure during handling. This review discusses the quality control procedures and acceptance criteria for a diagnostic radiopharmaceutical.

  • https://doi.org/10.15324/kjcls.2021.53.1.1 인용 PDF KSCI

Evaluation of the Effects of Interfering Factors on the Bacterial Endotoxin Testing of Radiopharmaceuticals (방사성의약품의 박테리아 엔도톡신 시험에서 반응간섭인자들의 영향에 대한 평가)

  • Jun Young PARK
    • Korean Journal of Clinical Laboratory Science
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    • v.56 no.2
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    • pp.171-180
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    • 2024

  • The endotoxin test is based on the reaction between Limulus Amebocyte Lysate (LAL) and the lipopolysaccharides of Gram-negative bacteria. In this study, we sought to identify factors that interfere with the LAL testing of radiopharmaceuticals and evaluated acceptable ranges. A gel-clot LAL test and a chromogenic LAL test were used as endotoxin tests. We compared the performances of the EndosafeⓇ LAL and recombinant EndosafeⓇ Recombinant Cascade Reagent (rCR) cartridges for the chromogenic test. The factors that interfered with 68Ga-DOTATOC injection were pH, 4-(2-hydroxyethyl) piperazine-1-ethanesulfonic acid (HEPES) buffer, and organic solvents, especially ethanol. However, interference by these factors was overcome by diluting the 68Ga-DOTATOC injection tenfold. In addition, no interference was observed at pH values between 4 and 8, at a HEPES concentration of 2,000 ㎍/mL, or an ethanol concentration of <1%. Furthermore, results showed that interfering factors had similar effects on the performances of the EndosafeⓇ LAL and EndosafeⓇ rCR cartridges. The results of this study are expected to be useful for evaluating factors that interfere with the endotoxin testing of new radiopharmaceuticals.

  • https://doi.org/10.15324/kjcls.2024.56.2.171 인용 PDF