IN VITRO-IN VIVO
The in vitro-in vivo correlation
(IVIVC) is a scientific approach to describe the relationship
an in vitro property of a
dosage form (e.g., the rate or extent of drug release) and
in vivo response (e.g., plasma
drug concentration or amount of drug absorbed). This resulting
mathematical model is then used to predict the performance
change from a modified product.
An IVIVC is a very important step in the development and
submission of an extended release
product. Both the FDA and EMEA recommend to develop the product
specific IVIVC in the
expectation that the information will be useful in establishing
dissolution specifications and will
permit formulation and manufacturing changes without an in
vivo bioequivalence study.
BioVista has a wide experience in the development and validation
of the IVIVC, as well in the
design of studies for generation such a relationship.
Our IVIVC services include: