玻璃微针:使用设计质量方法进行监管批准的案例研究
Ziad Sartawi1, Caroline Blackshields1, Arefe Ariamanesh1
1School of Pharmacy, University College Cork, Cork, T12 K8AF, Ireland.
Advanced materials (Deerfield Beach, Fla.)
|November 11, 2023
概括
本研究概述了使用设计质量的微针药物输送的监管批准. 一个新的100%药物微针,ArrayPatch,显示了有效的局部输送和改善药理动学的承诺.
科学领域:
- 制药科学 制药科学
- 生物技术是生物技术.
- 材料科学 材料科学 材料科学
背景情况:
- 微针技术为药物输送提供了一个有前途的途径,使治疗药物能够通过皮肤输送.
- 通过设计质量 (QbD) 方法对于导航新型药物输送系统的监管环境至关重要.
- 完全由治疗剂制造的微针的开发消除了对辅助剂的需求,简化了配方,并可能提高了安全性.
相关概念视频
Quality Assurance
Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
Glassware Calibration
Accurate calibration of glassware, such as volumetric flasks, pipettes, and burettes, is essential to ensure accurate measurements in the analytical laboratory. Calibration helps maintain consistency across measurements and prevents errors arising from inaccurate volumes.
Volumetric flasks: Volumetric flasks are designed to prepare aqueous solutions of precise volumes accurately with a calibration line on the neck. To calibrate a volumetric flask, it is important to fill it with distilled...
Volumetric flasks: Volumetric flasks are designed to prepare aqueous solutions of precise volumes accurately with a calibration line on the neck. To calibrate a volumetric flask, it is important to fill it with distilled...


