复杂局部配方的风病学:通过设计方法对方法优化和验证的分析质量方法
Lucas Chiarentin1,2,3, Catarina Cardoso2, Margarida Miranda2,3,4
1Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal.
Pharmaceutics
|July 29, 2023
概括
通过设计 (AQbD) 的分析质量原则被用于开发和验证局部奶油的风病学方法. 这种方法确保了仿制药产品可靠的微观结构等价性文档.
科学领域:
- 制药科学 制药科学
- 类风病学 类风病学 类风病学
- 分析化学 分析化学
背景情况:
- 局部半固体配方需要对微观结构等价性进行强有力的风学表征.
- 仿制药制造商在开发和验证类风病学方法方面面临着挑战.
- 监管标准强调产品质量的修形学性质.
研究的目的:
- 应用设计时分析质量 (AQbD) 原则来开发和验证局部奶油的风病学方法.
- 为复杂的半固体配方建立可靠和有效的类风学方法.
- 为了满足对微观结构等价性文档的监管要求.
主要方法:
- 使用石川图和故障模式,效应和关键性分析 (FMECA) 的风险评估.
- 确定关键方法变量 (CMV),包括样本应用,温度控制和休息时间.
- 在旋转,爬行回收和振荡测量中应用2^3全因数设计.
- 方法开发遵循ICH Q8-Q10和Q14指南.
- 根据ICH Q2 (R2) 指南进行方法验证.
主要成果:
- 采样应用,温度控制和休息时间被确定为关键方法变量.
- 开发的风湿学方法表现出足够的精度 (RSD<15%) 和选择性.
- AQbD为方法开发和验证提供了一个系统的框架.
结论:
- AQbD是开发和验证局部奶油类风湿学方法的合适方法.
- 经过验证的方法确保了微观结构等价性可靠的风学数据.
- 这项研究支持仿制药制造商满足监管期望.
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