加拿大卫生部对加拿大市场上的重组人胰岛素、人胰岛素类似物和猪胰岛素药物产品中的含量进行监管核查,采用经过验证的药典方法而非非验证方法。

IF 4.1 Q2 ENDOCRINOLOGY & METABOLISM
Barry Lorbetskie, Stewart Bigelow, Lisa Walrond, Agnes V Klein, Shih-Miin Loo, Nancy Green, Michael Rosu-Myles, Xu Zhang, Huixin Lu, Michel Girard, Simon Sauvé
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引用次数: 0

摘要

背景:对于糖尿病治疗计划而言,胰岛素药物产品的一致性和质量对患者的健康至关重要。由于胰岛素等生物药物是复杂的异质产品,因此药物产品评估方法必须经过仔细验证才能使用。因此,国家主管机构对这些标准进行了严格的评估和监督。因此,报告中描述的胰岛素含量明显低于其标签声称的含量是一个值得关注的问题。过去一份分析加拿大胰岛素药物产品的出版物提出了这一问题,因此,消费者和主要患者组织要求对其进行澄清:为了解决这些问题,本研究采用药典和非药典反相高效液相色谱法(RP-HPLC)独立分析了从加拿大当地药店购买的胰岛素药物产品,包括人胰岛素、胰岛素类似物和猪胰岛素:结果:我们证明了在评估胰岛素质量时使用适用方法的重要性。在初步筛查中,除两种胰岛素类似物--地特米胰岛素和德谷胰岛素外,所有产品都出现了预期的胰岛素峰值。进一步的调查表明,这并不是胰岛素含量低造成的,而是溶剂条件不足造成的。当使用经过验证的特定类型药典 RP-HPLC 方法对药物产品的胰岛素含量进行适当评估时,其值与标签声称的含量一致:由于超过一百万加拿大人每天都在使用胰岛素药物产品,因此研究人员和期刊必须使用符合目的的方法提供数据,读者也必须严格评估这些报告。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Regulatory Verification by Health Canada of Content in Recombinant Human Insulin, Human Insulin Analog, and Porcine Insulin Drug Products in the Canadian Market Using Validated Pharmacopoeial Methods Over Nonvalidated Approaches.

Background: For diabetes mellitus treatment plans, the consistency and quality of insulin drug products are crucial for patient well-being. Because biologic drugs, such as insulin, are complex heterogeneous products, the methods for drug product evaluation should be carefully validated for use. As such, these criteria are rigorously evaluated and monitored by national authorities. Consequently, reports that describe significantly lower insulin content than their label claims are a concern. This issue was raised by a past publication analyzing insulin drug products available in Canada, and, as a result, consumers and major patient organizations have requested clarification.

Methods: To address these concerns, this study independently analyzed insulin drug products purchased from local Canadian pharmacies-including human insulin, insulin analogs, and porcine insulin-by compendial and noncompendial reversed-phase high-performance liquid chromatography (RP-HPLC) methods.

Results: We demonstrated the importance of using methods fit for purpose when assessing insulin quality. In a preliminary screen, the expected insulin peak was seen in all products except two insulin analogs-insulin detemir and insulin degludec. Further investigation showed that this was not caused by low insulin content but insufficient solvent conditions, which demonstrated the necessity for methods to be adequately validated for product-specific use. When drug products were appropriately assessed for content using the validated type-specific compendial RP-HPLC methods for insulin quantitation, values agreed with the label claim content.

Conclusions: Because insulin drug products are used daily by over a million Canadians, it is important that researchers and journals present data using methods fit for purpose and that readers evaluate such reports critically.

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来源期刊
Journal of Diabetes Science and Technology
Journal of Diabetes Science and Technology Medicine-Internal Medicine
CiteScore
7.50
自引率
12.00%
发文量
148
期刊介绍: The Journal of Diabetes Science and Technology (JDST) is a bi-monthly, peer-reviewed scientific journal published by the Diabetes Technology Society. JDST covers scientific and clinical aspects of diabetes technology including glucose monitoring, insulin and metabolic peptide delivery, the artificial pancreas, digital health, precision medicine, social media, cybersecurity, software for modeling, physiologic monitoring, technology for managing obesity, and diagnostic tests of glycation. The journal also covers the development and use of mobile applications and wireless communication, as well as bioengineered tools such as MEMS, new biomaterials, and nanotechnology to develop new sensors. Articles in JDST cover both basic research and clinical applications of technologies being developed to help people with diabetes.
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