In Vitro–In Vivo Correlations for Modified Release Formulations

This chapter provides an insight into the process of in vitro–in vivo correlation (IVIVC) development by presenting with appropriate examples: definitions and different correlation levels, generation of in vivo and in vitro data, IVIVC methodology, IVIVC applications, and some limitations of IVIVC. IVIVC may be applied for all dosage forms and routes of administration. The development of an effective IVIVC demands a well-designed and scientifically based approach. Use of biopharmaceutical classification system in the scope of IVIVC is questionable. A linear relation should be achieved using the slope as the time scaling factor that is applied in the IVIVC development. There are two primary strategies for validating the IVIVC model: internal predictability, and external predictability. The in vitro dissolution test is widely used as a quality control tool to enable the differentiation between acceptable and unacceptable batches of the drug product using appropriately set specifications, thus ensuring batch-to-batch consistency.