http://dx.doi.org/10.4314/tjpr.v11i2.20
Abstract
Drug
development is a very laborious and expensive process.
One of the major reasons for failure during the clinical
phases of drug development is inadequate pharmacokinetic
data on the drug candidate. Therefore, it would be
advantageous if the pharmacokinetic properties of drug
candidates be predicted beforehand. One major obstacle
in making such predictions is the inability to
appropriately scale the in-vitro data to the in-vivo
situation. Results from in-vitro in-vivo correlation (IVIVC)
studies have been used to select the appropriate
excipients and optimize the manufacturing processes for
quality control purposes, and for characterizing the
release patterns of newly formulated immediate release,
and modified-release products relative to the
references. In recent years, the concept and application
of the IVIVC for pharmaceutical dosage forms have been a
major focus of attention in the pharmaceutical industry,
academia and regulatory agencies. Hence, this article
highlights the importance of appropriate selection of
IVIVC level with respect to the Biopharmaceutical
Classification System (BCS) and also covers examples of
BCS-based IVIVCs of drugs/products with different types
of release profiles.
Keywords: In vitro/In vivo correlation, Biopharmaceutical
Classification System, Drug Delivery.