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| Συντελεστής Ομοιότητας Διάλυσης f1/f2× | Συσχέτιση In Vitro-In Vivo× | |
|---|---|---|
| Πεδίο | Φαρμακολογία | Φαρμακολογία |
| Οικογένεια | Process / pipeline | Process / pipeline |
| Έτος προέλευσης≠ | 1996 | 1995 |
| Δημιουργός≠ | James Moore and Hector Flanner | Gordon Amidon |
| Τύπος≠ | similarity testing | bioavailability prediction |
| Θεμελιώδης πηγή≠ | 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 ↗ |
| Εναλλακτικές ονομασίες≠ | f1, f2, similarity factor | IVIVC |
| Συναφείς | 3 | 3 |
| Σύνοψη≠ | 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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