从动物对人类的剂量推断中的实际考虑
Anthony J Hickey1, Sara E Maloney1, Phillip J Kuehl2
1Department of Technology Advancement and Commercialization, RTI International, Research Triangle Park, North Carolina, USA.
将吸入的药物剂量从动物输送到人类是复杂的,因为生物差异. 了解物种特异性因素对于药物开发中准确的肺沉积估计至关重要.
科学领域:
- 药理学和毒理学 药理学和毒理学
- 药物输送系统 药物输送系统
- 比较生理学比较生理学
背景情况:
- 动物研究是药物开发和监管审查的基石,已有实践跨越近一个世纪.
- 现有各种实验系统用于产生液体和固体气溶,用于动物吸入的研究.
研究的目的:
- 突出在吸入药物输送中从动物推断肺部沉积剂量到人类的挑战.
- 强调需要仔细考虑物种特异性的变量在剂量调整.
主要方法:
- 摘要没有详细说明具体的实验方法,但讨论了气溶沉积和物种比较的原则.
- 专注于影响不同物种空气动力学行为和肺部沉积的因素.
主要成果:
- 由于物种之间存在显著的遗传,解剖学,生理学和生物学差异,外推是具有挑战性的.
- 吸入药物输送推断受气溶特性,输送系统以及特定物种的解剖学和肺功能的影响.
结论:
- 精确的剂量缩放需要承认配方,输送系统和特定物种的生物学因素.
- 对吸入药物输送外推的审查对于可靠的药物产品开发至关重要.
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