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

XU Qianzi; LIANG Yueru; ZHAO Zhongwei; SHEN Yan

doi:10.11665/j.issn.1000-5048.20220608

Journal of China Pharmaceutical University > 2022 > 53(6): 698-704. > DOI: 10.11665/j.issn.1000-5048.20220608

XU Qianzi, LIANG Yueru, ZHAO Zhongwei, SHEN Yan. Population bioequivalence statistical method based on earth mover′s distance for evaluation of particle size distribution consistency of ophthalmic emulsion[J]. Journal of China Pharmaceutical University, 2022, 53(6): 698-704. DOI: 10.11665/j.issn.1000-5048.20220608

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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)

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Received Date: April 24, 2022
Revised Date: November 20, 2022

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Abstract

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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