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Substandard and falsified medicine screening technologies
AAPS Open Pub Date : 2019-07-08 , DOI: 10.1186/s41120-019-0031-y
Lukas Roth , Kevin B. Biggs , Daniel K. Bempong

Substandard and falsified medicine screening technologies are invaluable tools for post-marketing surveillance of medicine quality, particularly in low- and middle-income countries. National Regulatory Authorities and their partners leverage screening technologies to detect substandard and falsified medicines in the field and eliminate them from the medical product supply chain. An arsenal of different screening technologies has been developed to evaluate a variety of medicine quality attributes and performance characteristics, applying visual, physical and chemical analyses. Selecting the most effective screening technologies for a given quality challenge requires consideration of several practical, technical, and scientific factors, such as the type of medicines screened, the requirements of the screening technology, and the type of information needed. More widespread adoption of screening technologies will be facilitated by improved workforce development, technological advancements, and the development of a more robust supporting regulatory framework.

中文翻译:

不合格和伪造的药物筛查技术

不合格和伪造的药物筛查技术是上市后监测药品质量的宝贵工具,特别是在中低收入国家。国家监管机构及其合作伙伴利用筛选技术来检测现场的不合格和伪造药品,并将其从医疗产品供应链中消除。已经开发出各种不同的筛选技术,通过视觉,物理和化学分析来评估各种药物质量属性和性能特征。针对给定的质量挑战选择最有效的筛查技术需要考虑一些实际,技术和科学因素,例如筛查的药物类型,筛查技术的要求,以及所需信息的类型。改进的劳动力开发,技术进步以及更强大的支持性监管框架的发展将促进筛查技术的更广泛采用。
更新日期:2019-07-08
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