建立一个平台的方法,用于物理外观评估的新亲肠道药品的药品
Ying Wan1, Walter Wasylaschuk2, Joseph Straub3
1Analytical Research and Development, Merck & Co., Inc., West Point, Pennsylvania, USA. ying.wan@merck.com.
The AAPS journal
|March 27, 2025
概括
选择正确的身体外观 (PA) 测试方法对肠道药物,特别是疫苗至关重要. 本研究提供了一个决策表来指导方法选择,提高GMP测试的一致性和效率.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 质量控制 质量控制 质量控制
背景情况:
- 身体外观 (PA) 是关键的质量属性,亲肠道药物,在释放和稳定性测试期间评估.
- PA评估包括可见颗粒,清晰度和颜色,使用可用的综合方法.
- 在选择适当的PA方法方面存在挑战,原因是药物特性多样化和缺乏药物库指导,特别是对于像疫苗这样的复杂生物制品.
研究的目的:
- 为了应对选择适当的PA方法来选择亲肠道药品的挑战.
- 提供有关PA方法选择和新亲肠道产品规范设置的指导.
- 引入一个决策表,以促进平台PA方法的开发和简化GMP测试.
主要方法:
- 对PA测试 (可见颗粒,清晰度,颜色) 的综合性一般方法章节的审查.
- 基于药物外观特性的PA方法选择的决策表的开发.
- 一个案例研究,展示了黄的疫苗辅助剂的决策表的应用.
主要成果:
- 决策表有助于选择合适的PA方法,特别是当由于颜色或度而难以视觉比较时.
- 仪器清晰度和视觉定性方法被确定为挑战样本的合适选择.
- 对于具有相似外观特性的测试物品,可以开发平台PA方法,减少文档和提高效率.
结论:
- 适当的PA方法选择对于可靠的结果和适当的规范设置在亲口药品质量控制中至关重要.
- 拟议的决策表提供了实际见解和对PA方法选择的系统方法.
- 实施平台PA方法提高了一致性,效率,并减少了GMP测试中的准备时间.
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