In Vitro in Vivo Correlation?

An in vitro – in vivo correlation (IVIVC) is defined by the U.S Food and Drug Administration (FDA) as a predictive mathematical model describing the relationship between the in vitro property of an oral dosage form and relevant in vivo response.

What is the significance of IVIVC?

IVIVC can be used in the development of new pharmaceuticals to reduce the number of human studies during the formulation development as the main objective of an IVIVC is to serve as a surrogate for in vivo bioavailability and to support biowaivers.

What is Level B correlation?

IVIVC  The clinical study was designed to support a level A correlation  In a linear correlation, the in-vitro dissolution and in-vivo input curves may be directly super-imposable or may be made to be super-imposable by the use of a scaling factor  e.g., if the dissolution is faster than the in vivo input rate then ...