基于推土距离（EMD）算法的群体生物等效性统计方法评价眼用乳剂粒径分布的一致性

徐千姿; 梁月茹; 赵忠卫; 沈雁

doi:10.11665/j.issn.1000-5048.20220608

基于推土距离（EMD）算法的群体生物等效性统计方法评价眼用乳剂粒径分布的一致性

1.
中国药科大学药学院药剂系，南京 210009
2.
深圳奥祺生物医药有限公司，深圳 518057

基金项目: 国家自然科学基金资助项目（No.81972892）

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出版历程
- 收稿日期: 2022-04-24
- 修回日期: 2022-11-20
- 刊出日期: 2022-12-24

Population bioequivalence statistical method based on earth mover′s distance for evaluation of particle size distribution consistency of ophthalmic emulsion

1.
Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University, Nanjing 210009
2.
Shenzhen Aoqi Biological Medicine Co., Ltd, Shenzhen 518057, China

Funds: This study is supported by the National Natural Science Foundation of China (No.81972892)

摘要

摘要: 群体生物等效性是FDA推荐的可用于纳米制剂产品粒径等效性的统计分析方法，但当粒径分布呈现多峰等复杂分布时，传统考察参数D50、SPAN则不再适用。推土距离是评估分布之间差异的新的度量方法。本研究以环孢素眼用乳剂为研究对象，提出了基于推土距离（EMD）的群体生物等效性统计分析方法，并对比不同制备工艺下乳剂产品粒径分布一致性结果以验证方法的可行性。结果显示，该统计方法可以有效拒绝不等效产品，通过等效产品，这为仿制制剂处方研究、工艺开发及优化提供一种方案，具有良好的应用价值。
- 推土距离 /
- 群体生物等效性 /
- 粒径分布
Abstract: Population bioequivalence (PBE) is a statistical approach recommended by FDA to evaluate the consistency of particle size distribution of numerous nanoparticle products.However, when particle size distribution (PSD) profile exhibits multiple peaks or other complex distributions, the traditional descriptors D50 and SPAN are no longer suitable to describe PSD.Earth mover's distance (EMD) is a new statistical metric for assessing the difference between distributions.In this study, we used EMD to measure the discrepancy between PSD and then PBE was applied to perform statistical test to establish equivalence.Our results showed that the proposed method can effectively reject an unequivalent product and pass an equivalent product, thus indicating its helpfulness in guiding the optimization of formulation and preparation process.
- earth mover's distance /
- population bioequivalence /
- particle size distribution

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参考文献(19)

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基于推土距离（EMD）算法的群体生物等效性统计方法评价眼用乳剂粒径分布的一致性

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出版历程

Population bioequivalence statistical method based on earth mover′s distance for evaluation of particle size distribution consistency of ophthalmic emulsion

计量

出版历程

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