During the development of a generic sustained-release dosage form, an in vivo pilot study is often performed. This pilot study could be the starting point to set up an IVIVC. Thanks to the relationship established between in vitro data and in vivo curve, a predictive in vitro model could be determined allowing calculation of an optimal dissolution curve. Based on those available tools, using a design of experiment, the formulation can be optimized with a minimum of effort. The target is to develop a formulation whose dissolution is as close as possible to the calculated optimal dissolution curve. This approach demonstrates that it is possible to improve the selection of the best formulation and minimize the risk in the bioequivalence final study using the in vivo profile observed during the pilot study and the IVIVC.
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