通过肠道食管口服药物管理:体外检测
Selina Wilson1, Julianne Farabaugh2, Yemin Liu3
1Eli Lilly and Company, Indianapolis, Indiana, 46285, USA.
The AAPS journal
|April 4, 2024
概括
通过肠道食管 (EFT) 进行口服药物的使用需要进行特定的测试,以确保患者的安全. 这一行业的观点提出基于风险的测试,以制定明确的标签说明EFT药物管理.
科学领域:
- 制药科学 制药科学
- 临床药房实践 临床药房实践
- 药物输送系统 药物输送系统
背景情况:
- 肠道食管 (EFT) 对无法吞口服药物的患者至关重要.
- 通过EFT通过口服药品的非标签使用对患者和护理人员构成重大风险.
- 目前的做法缺乏标准化,数据支持的安全EFT药物管理指令.
研究的目的:
- 通过EFT进行口服药物产品必要测试的行业观点.
- 为制定产品特定标签说明提出基于风险的方法.
- 解决对EFT药物管理的数据支持指导的需求,包括儿科和新生儿群体.
主要方法:
- 审查监管机构通过EFT对药物管理的建议.
- 关于口服药品基于风险的测试策略的建议.
- 在测试方案中考虑新生儿和儿科患者群体的特殊需求.
主要成果:
- 通过EFT识别与非标签口服药物管理相关的风险.
- 在产品标签上生成数据支持或建议不使用EFT的框架.
- 强调基于风险的测试方法和指令开发.
结论:
- 数据支持的产品特定说明对于通过EFT安全口服药物管理至关重要.
- 基于风险的测试策略可以减轻潜在的患者和护理人员风险.
- 测试方案应涵盖多样化的患者群体,包括新生儿和儿科.
关键词:
在体外试验试验进入肠道的管理.胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃肠胃鼻胃鼻胃的情况更多相关视频
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