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Development of in vitro/in vivo correlation for long-acting injectable suspensions via bootstrapping
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Development of in vitro/in vivo correlation for long-acting injectable suspensions via bootstrapping
Abstract In vitro/in vivo correlation (IVIVC) is of great importance to expedite the development life-cycles for pharmaceutical industry and possibly to reduce the burden for regulatory assessment, especially for long-acting injectable (LAI) drug products. However, owing to the inherent complexity and relative novelty, no regulatory guidance is available for IVIVC development of LAIs. Moreover, LAI dosage forms are prone to exhibit much higher i…
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