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In Vitro–In Vivo Correlation: Importance of …
In Vitro In vivo Correlation: Importance of Dissolution in IVIVC. J-M. Cardot1, E. Beyssac, and M. Alric Univ. Clermont 1, Biopharmaceutical Department, e-mail: UFR Pharmacie, 28 Place Henri Dunant, 38, F-630001 Clermont-Ferrand, France Introduction Level B. C. orrelations between in vitro and in vivo data (IVIVC) A Level B IVIVC uses the principles of statistical are often used during pharmaceutical development in moment analysis. The mean in vitro dissolution order to reduce development time and optimize the time is compared either to the mean residence formulation. A good correlation is a tool for predicting in time or to the mean in vivo dissolution time . A. vivo results based on in vitro data. IVIVC allows dosage form Level B correlation does not uniquely reflect the optimization with the fewest possible trials in man,fixes actual in vivo plasma level curve, because a num- dissolution acceptance criteria,and can be used as a surro- ber of different in vivo curves will produce similar gate for further bioequivalence studies;it is also recom- mean residence time values.
16 Dissolution Technologies | FEBRUARY 2007 many formulations,each of them giving one pair of data (vitro and vivo). It is obvious that level B or C needs more data and,as they do not use all the information related to
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