Q1和Q2选择,Q3,IVRT,IVPT,局部仿制药物的药理动力学和药理动力学评估
Feng Jie1,2, Om Shelke1, Zhu Yijie1
1R&D Center, Sinomune Pharmaceutical Co., Ltd, Wuxi, Jiangsu, China.
Drug development and industrial pharmacy
|April 3, 2025
概括
开发通用局部半固体需要严格的Q1/Q2/Q3生物等价性表征. 这项研究展示了一个逐步的过程,证实了Fluticasone Propionate奶油0.05%的生物等价性.
科学领域:
- 制药科学 制药科学
- 皮肤病学 皮肤病学
- 通用药物开发公司
背景情况:
- 局部半固体是复杂的配方,需要进行彻底的生物等价性研究.
- 确定药物等价性 (Q1/Q2/Q3) 对通用局部产品的开发至关重要.
研究的目的:
- 为了提供一个详细的,逐步示例,开发通用日用产品.
- 展示Q1/Q2成分选择和Q3结构评估的过程.
- 为了确认通用Fluticasone Propionate奶油0.05%的生物等价性和安全性.
主要方法:
- 配方开发涉及文献搜索和Q1/Q2成分选择的逆向工程.
- 进行了物理化学表征 (Q3),体外释放 (IVRT) 和体外透 (IVPT) 研究.
- 进行了人类的药理动力学 (PK) 和药理动力学 (PD) 研究,以确定生物等价性.
主要成果:
- Q1/Q2/Q3表征证实了试验和参考产品之间的药物等价性.
- 实验室研究表明,可比的释放和透概况.
- 在PK/PD研究中,PK/PD对Cmax和Tmax等关键参数的90%置信区间为84.67%-101.09%的生物等价性.
结论:
- 开发的通用Fluticasone Propionate奶油0.05%在药学上相当于创新者产品 (Cutivate®奶油0.05%).
- 通用配方表现出有利的安全性,支持其使用.
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