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f1/f2 類似度因子(Dissolution f1/f2 Similarity Factor)×インビトロ-インビボ相関×
分野薬理学薬理学
系統Process / pipelineProcess / pipeline
提唱年19961995
提唱者James Moore and Hector FlannerGordon Amidon
種類similarity testingbioavailability prediction
原典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 ↗
別名f1, f2, similarity factorIVIVC
関連33
概要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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ScholarGate手法を比較: Dissolution f1/f2 Similarity · In Vitro-In Vivo Correlation. 2026-06-20に以下より取得 https://scholargate.app/ja/compare