基于风险的评估,以确定通过皮下注射给药的生物器械组合产品的药理学可比性要求
Mark Klitgaard Nøhr1, Shaik Rizwan Waheed2, Rasmus Juul Kildemoes3
1Regulatory Affairs, Chemistry, Manufacturing and Controls, Novo Nordisk A/S, Søborg, Denmark.
The AAPS journal
|September 4, 2024
概括
一个新的基于风险的过程有助于评估生物设备组合产品的质量,安全性和有效性. 这种方法有助于监管部门的批准,并管理亲肠道药物的制造变化.
科学领域:
- 制药科学 制药科学
- 生物技术是生物技术.
- 监管科学 监管科学
背景情况:
- 大分子药物治疗和生物设备组合产品 (如预填注射器,自喷器) 的进步改变了疾病治疗和亲肠道药物管理.
- 确保产品质量,安全性和有效性对于新组合产品的监管批准以及管理批准后的变化至关重要.
研究的目的:
- 提出一种标准化,基于风险的流程,用于评估变化对生物设备组合产品的影响.
- 为确定与化学,制造和控制 (CMC) 变化相关的适当监管行动提供框架.
主要方法:
- 开发了一种风险评估方法,标准化了CMC风险因素和药物动力学风险因素的评估,并加权得分.
- 使用二维风险网格来整合CMC和药物动力学风险,指导监管建议.
- 用三个案例研究 (两个临床,一个批准后) 来说明风险评估过程的应用和有效性.
主要成果:
- 提出的基于风险的过程提供了一个结构化的方法来评估CMC变化对组合产品质量,安全性和有效性的潜在影响.
- 该方法方便确定必要的监管行动,确保产品在其整个生命周期中的完整性.
- 案例研究表明了风险评估的实际应用,强调了其在组合产品决策中的有用性.
结论:
- 基于风险的评估框架是赞助商导航生物设备组合产品的监管要求的宝贵工具.
- 这种方法支持有关CMC变化的知情决策,最终有助于患者安全和治疗疗效.
- 标准化的方法提高了组合产品监管审查过程中的一致性和可预测性.
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