药品压力测试中的质量平衡:原则和实际应用的审查
Stacey Marden1, John M Campbell2, Neal Adams3
1Advanced Drug Delivery, Pharmaceutical Sciences, R&D, Astrazeneca, Boston, 35 Gatehouse Dr., Waltham, Massachusetts, 02451, USA. stacey.marden@astrazeneca.com.
The AAPS journal
|August 22, 2024
概括
压力测试或强制降解对于药物开发至关重要. 本研究提供了关于在制药强制降解研究中评估质量平衡的实际指导,以确保监管合规.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 药物开发 药物开发
背景情况:
- 强制降解研究对于了解药物物质和产品稳定性至关重要.
- 稳定性指示方法 (SIMs) 对于在药物生命周期中检测降解产品至关重要.
- 质量平衡评估是SIM开发中的监管期望.
研究的目的:
- 为评估和解释制药强制降解中的质量平衡提供基于科学的方法的实际审查.
- 解决各制药公司质量平衡评估方法的变化问题.
- 促进制药科学家和卫生当局之间关于质量平衡的共同理解.
主要方法:
- 收集了10家制药公司关于质量平衡评估实践的意见.
- 审查了基于科学的方法和质量平衡评估的技术细节.
- 用现实世界的案例研究演示了各种质量平衡计算.
主要成果:
- 突出了质量平衡评估的关键概念和实际计算.
- 提出了调查质量平衡不良结果的建议.
- 为制药强制降解中的质量平衡提供了综合参考.
结论:
- 标准化质量平衡评估改善了卫生当局的审查过程.
- 对质量平衡的共同理解有助于更顺的监管提交.
- 这项工作是制药科学家和监管机构的宝贵资源.
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