IVIVC and BCS: A Regulatory Perspective

IVIVC model can be developed by defining the correlations in vitro dissolution as in vivo input rate. A successful IVIVC model can be developed if in-vitro dissolution is rate limiting step in the sequences of events leading to appearance of drug in systemic circulation following or other routes of administration. Thus the dissolution test can be utilized as a surrogate for bioequivalence studies (involving human subjects) if developed IVIVC is predictive of in-vivo performance of drug product. For orally administered drugs, IVIVC is expected for highly permeable drugs or drugs under dissolution rate limited conditions, which is supported by biopharmaceutical classification system. The pharmaceutical industry has been striving to find ways to saving precision resources. The expensive clinical trials has been avoided with use of IVIVCs. IVIVC can be applied in drug delivery at various stages of development, the most critical application with respect to cost saving is the biowavers. BCS based biowavers are applicable to marketed formulations when drug substance is highly soluble and highly permeable. (BCS class I)