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| 溶出度f1/f2相似因子× | 米氏动力学× | |
|---|---|---|
| 领域 | 药理学 | 药理学 |
| 方法族 | Process / pipeline | Process / pipeline |
| 起源年份≠ | 1996 | 1913 |
| 提出者≠ | James Moore and Hector Flanner | Leonor Michaelis and Maud Menten |
| 类型≠ | similarity testing | mechanistic model |
| 开创性文献≠ | Moore, J. W., & Flanner, H. H. (1996). Mathematical comparison of dissolution profiles. Pharmaceutical Technology, 20(6), 64-74. link ↗ | Michaelis, L., & Menten, M. L. (1913). Die Kinetik der Invertinwirkung. Biochemische Zeitschrift, 49, 333-369. link ↗ |
| 别名 | f1, f2, similarity factor | MM kinetics, Michaelis constant, Vmax |
| 相关≠ | 3 | 2 |
| 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. | Michaelis-Menten kinetics describes the rate of enzyme-catalyzed reactions as a function of substrate concentration. Developed by Leonor Michaelis and Maud Menten in 1913, this foundational framework models enzyme catalysis through the rapid-equilibrium approximation and enables prediction of drug metabolism rates in pharmacokinetics. |
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