甲基化物产品的价格和质量
Aditya Narayan1, Ben Teasdale2, A J Hudspeth3
1Stanford University School of Medicine, Stanford, California.
通用甲基化物产品显示出重大质量问题,包括致癌物质污染和不一致的溶解. 对产品质量的透明度可以提高仿制药的安全性,而不会增加成本.
科学领域:
- 制药科学 制药科学
- 药品质量和安全 药品质量和安全
- 仿制药制造 仿制药制造 仿制药制造
背景情况:
- 通用药市场面临着激烈的价格竞争,可能会损害制造质量.
- 甲基酸盐是广泛用于治疗ADHD等疾病的药物.
研究的目的:
- 为了评估仿制甲基化物产品的质量.
- 为了研究溶解的变化和N-nitroso-methylphenidate的存在.
主要方法:
- 立即释放 (IR) 和延长释放 (ERT,ERC) 甲基酸盐配方的采集样本.
- 分析了溶解配置,并测试了N-nitroso-methylphenidate污染的情况.
- 产品成本和质量属性的比较.
主要成果:
- 与品牌产品相比,在24种通用延长释放片中的12种中观察到溶解的显著差异.
- 一种可能的致癌物N-nitroso-methylphenidate在15种通用即时释放产品中的7种超出了监管限制.
- 没有发现有或没有高N-nitroso-methylphenidate的产品之间的显著价格差异.
结论:
- 独立测试显示,仿制甲基酸产品的质量存在重大问题.
- 提高产品质量的透明度可能会在没有额外费用的情况下提高仿制药的标准.
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