Risk assessment of supply chain for pharmaceutical excipients with AHP-fuzzy comprehensive evaluation

被引:25
|
作者
Li, Maozhong [1 ,2 ]
Du, Yunai [3 ]
Wang, Qiyue [3 ]
Sun, Chunmeng [3 ]
Ling, Xiang [3 ]
Yu, Boyang [1 ,4 ]
Tu, Jiasheng [3 ]
Xiong, Yerong [3 ,5 ]
机构
[1] China Pharmaceut Univ, Sch Int Pharmaceut Business, 639 Longmian Rd, Nanjing 211198, Jiangsu, Peoples R China
[2] China Food & Drug Adm, Drug Registrat Div, Beijing, Peoples R China
[3] China Pharmaceut Univ, Sch Pharm, Dept Pharmaceut, State Key Lab Nat Med, 24 Tong Jia Xiang, Nanjing 210009, Jiangsu, Peoples R China
[4] China Pharmaceut Univ, Sch Tradit Chinese Pharm, Nanjing 211198, Jiangsu, Peoples R China
[5] China Pharmaceut Univ, Sch Sci, Nanjing 210009, Jiangsu, Peoples R China
关键词
AHP-fuzzy comprehensive evaluation; pharmaceutical excipients; quantitative risk assessment; risk assessment; supply chain; DECISION-SUPPORT; DELIVERY; MANAGEMENT;
D O I
10.3109/03639045.2015.1075027
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
As the essential components in formulations, pharmaceutical excipients directly affect the safety, efficacy, and stability of drugs. Recently, safety incidents of pharmaceutical excipients posing seriously threats to the patients highlight the necessity of controlling the potential risks. Hence, it is indispensable for the industry to establish an effective risk assessment system of supply chain. In this study, an AHP-fuzzy comprehensive evaluation model was developed based on the analytic hierarchy process and fuzzy mathematical theory, which quantitatively assessed the risks of supply chain. Taking polysorbate 80 as the example for model analysis, it was concluded that polysorbate 80 for injection use is a high-risk ingredient in the supply chain compared to that for oral use to achieve safety application in clinic, thus measures should be taken to control and minimize those risks.
引用
收藏
页码:676 / 684
页数:9
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