基于风险的使用中的兼容性评估的实用工具
Bruce D Mason1, Kris Lowe1, Jinquan Dong1
1Drug Product and Device Development, Takeda Pharmaceuticals U.S.A., Inc. 200 Shire Way, Lexington, MA 02421, USA.
Journal of pharmaceutical sciences
|August 9, 2023
概括
药物开发需要使用兼容性研究. 一个新的风险评估工具有助于确定是否需要对临床试验期间组件变化进行测试,从而可能节省大量的时间和资源.
科学领域:
- 制药科学 制药科学
- 药物开发 药物开发
- 临床试验 临床试验
背景情况:
- 使用中的兼容性研究对于药物产品在使用过程中的质量至关重要.
- 临床试验期间药物输送组件的变化可能会导致延迟,需要进行广泛的评估.
- 对于这些变化,缺乏基于科学的标准化风险评估方法.
研究的目的:
- 开发一种风险评估工具,用于评估在临床试验期间药物输送组件发生变化时是否需要使用中的测试.
- 在这种情况下,为决策提供标准化,基于科学的方法.
- 加快药物开发时间表,减少不必要的测试.
主要方法:
- 开发基于ExcelTM的半定量风险评估工具.
- 基于多家公司在不同药物产品和地区进行兼容性研究的经验的工具.
- 应用该工具来加快决策和减少在低风险情况下的测试.
主要成果:
- 风险评估工具有助于确定在药物输送组件发生变化后是否需要使用时测试.
- 该工具的实施可以加快决策和减少测试要求.
- 在开发周期中,可以节省至少6-9个月的时间.
结论:
- 开发的风险评估工具为在临床试验期间管理组件变化提供了实际解决方案.
- 它使得有效的,基于科学的评估,节省时间和资源.
- 该工具可以适应各种药物产品,剂量方案,并且可以使资源有限的公司受益.
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