拉曼光谱作为加速复杂药品开发的工具
Panagiota Zarmpi1, Dimitrios Tsikritsis2, Andrew C Watson3
1Department of Life Sciences, University of Bath, Claverton Down, Bath BA2 7AY, UK; School of Chemistry & Chemical Engineering, University of Surrey, Guildford GU2 7XH, UK.
概括
拉曼光谱提供了一种评估局部仿制药的新方法, 这种方法有助于确定通用皮肤药物是否与原始药物相当,从而改善患者获得负担得起的治疗.
科学领域:
- 监管科学
- 制药科学
- 皮肤病学
- 分析化学
背景情况:
- 由于缺乏皮肤药物动力学的体内方法,很难评估局部仿制药物.
- 目前的方法需要漫长而昂贵的临床试验, 阻碍了仿制药的开发和患者获得负担得起的药物.
研究的目的:
- 用拉曼光谱来评估复杂的局部仿制药物的新型监管科学工具.
- 展示拉曼光谱在确定通用和参考列表中的局部配方之间的潜力.
主要方法:
- 使用拉曼光谱法量化皮肤中的时间空间配置.
- 分析了光谱数据以提取药物动力学指标,以比较不同的局部配方 (凝和溶液).
主要成果:
- 拉曼光谱成功量化了药物在皮肤内及其作用部位附近的分布.
- 提取了药理动力学指标,使不同配方能够进行比较.
结论:
- 拉曼光谱为评估局部仿制药物提供了客观有效的方法.
- 这种技术有可能简化生物等价性评估过程,促进复杂的通用局部产品的开发,并提高患者获得负担得起的治疗的机会.
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