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| 溶出度f1/f2相似因子× | 体外-体内相关性× | |
|---|---|---|
| 领域 | 药理学 | 药理学 |
| 方法族 | Process / pipeline | Process / pipeline |
| 起源年份≠ | 1996 | 1995 |
| 提出者≠ | James Moore and Hector Flanner | Gordon Amidon |
| 类型≠ | similarity testing | bioavailability prediction |
| 开创性文献≠ | Moore, J. W., & Flanner, H. H. (1996). Mathematical comparison of dissolution profiles. Pharmaceutical Technology, 20(6), 64-74. link ↗ | Amidon, G. L., Lennernäs, H., Shah, V. P., & Crison, J. R. (1995). A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharmaceutical Research, 12(3), 413-420. DOI ↗ |
| 别名≠ | f1, f2, similarity factor | IVIVC |
| 相关 | 3 | 3 |
| 摘要≠ | The f1 and f2 factors are dimensionless statistical measures developed by Moore and Flanner to quantify the similarity between two dissolution profiles. Adopted by regulatory agencies (FDA, EMA) as the gold standard for comparing dissolution curves, these factors enable rapid assessment of whether formulation changes significantly impact drug release. | IVIVC is a mathematical relationship between in vitro and in vivo properties of a drug, developed to predict oral bioavailability from dissolution data. Introduced by Amidon and colleagues in the 1995 Biopharmaceutics Classification System, it bridges laboratory measurements and clinical outcomes to streamline drug development. |
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