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용출 f1/f2 유사도 계수×Michaelis-Menten 동역학×
분야약리학약리학
계열Process / pipelineProcess / pipeline
기원 연도19961913
창시자James Moore and Hector FlannerLeonor Michaelis and Maud Menten
유형similarity testingmechanistic model
원전Moore, 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 ↗
별칭f1, f2, similarity factorMM kinetics, Michaelis constant, Vmax
관련32
요약The 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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