The Role of In Vitro–In Vivo Correlation in Product Development and Life Cycle Management
Shoufeng Li, Martin Mueller‐Zsigmondy, Hequn Yin · 2007
The in vitro dissolution and in vivo absorption/dissolution profiles play a key role in the development of an in vitro–in vivo correlation (IVIVC). There is a tremendous scientific and practical value when an IVIVC can be established using human pharmacokinetic (PK) data, but this often involves a cross-functional team of scientists from formulation, dissolution, and clinical PK development. A major advantage of convolution-based methods for IVIVC is that no additional in vivo data such as intravenous injections or oral solutions are required. Whenever appropriate, polynomial functions can be used to obtain nonlinear IVIVC. If there are factors other than in vivo dissolution contributing to the absorption, the usefulness of the IVIVC obtained by nonlinear regression can be very limited. In the early days of IVIVC, it was suggested that a correlation should be implemented only for comparable data, where comparison was made between actual data measured in vitro, simulated in vivo data, and vice versa.