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Saudi Journal of Medical and Pharmaceutical Sciences (SJMPS)
Volume-5 | Issue-04 | 326-336
Review Article
Assessments of Regulatory managements of Radiopharmaceuticals Systematic Literature Review
Assen M
Published : April 30, 2019
DOI : 10.36348/sjmps.2019.v05i04.010
Abstract
Introduction: Radiopharmaceuticals are special class of pharmaceuticals and utmost care should be taken for their handling, storage, dispensing and use. The characteristic which sets them apart from pharmaceuticals includes their short half-life, inherent hazardous nature of radioisotope, issue of maintaining sterility with radiation safety simultaneously, storage, transport and waste disposal issues and the fact that minute change in dose may cause faulty diagnosis or even over exposure. Therefore the guidelines applicable to pharmaceuticals are not relevant for radiopharmaceutical and calls for separate regulatory setup for radiopharmaceuticals. Objectives: To review regulatory managements of radiopharmaceuticals. Methods: Systematic literature review in methodology was used. The review was conducted using reliable healthcare internet database namely; Google scholar, hinari and PubMed central. Ten scientific articles were scrutinized to obtain results for the review. Result: The results of this review showed that a total of ten articles were reviewed which talks about the regulatory management of radiopharmaceuticals of different guidelines and different regulatory bodies of different countries and causes and consequences of poor regulatory control. Conclusion: For good quality of radiopharmaceuticals there should be quality management system should be implemented, documented, and duly maintained; effectiveness should be continuously improved in accordance with the requirements of professional, regulatory, and accrediting bodies.
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