手法を比較

	インビトロ-インビボ相関	f1/f2 類似度因子（Dissolution f1/f2 Similarity Factor）
分野	薬理学	薬理学
系統	Process / pipeline	Process / pipeline
提唱年	1995	1996
提唱者	Gordon Amidon	James Moore and Hector Flanner
種類	bioavailability prediction	similarity testing
原典	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.	Moore, J. W., & Flanner, H. H. (1996). Mathematical comparison of dissolution profiles. Pharmaceutical Technology, 20(6), 64-74.
別名	IVIVC	f1, f2, similarity factor
関連	3	3
概要	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.	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.