In Vitro?In Vivo Correlation (IVIVC): A Strategic Tool in Drug Development

In vitro in vivo correlations (IVIVC) play a key role in the drug development and optimization of formulation which is certainly a time consuming and expensive process. Formulation optimization requires alteration in formulation, composition, equipments, batch sizes and manufacturing process. If such types of one or more changes are applied to the formulation, the in vivo bioequivalence studies in human may required to be done to prove the similarity of the new formulation which will not only increase the burden of carrying out a number of bioequivalence studies but eventually increase the cost of the optimization process and ultimately marketing of the new formulation. To overcome these problems it is desirable to develop in vitro tests that reflect can bioavailability data. IVIVC can be used in the development of new pharmaceuticals to reduce the number of human studies during the formulation development. Thus, the main objective of an IVIVC is to serve as a surrogate for in vivo bioavailability and to support biowaivers.