Sundaramoorthi Nainar1,
Kingston Rajiah2 
,
Santhosam Angamuthu1,
D Prabakaran1,
Ravisekhar Kasibhatta1
For correspondence:- Kingston Rajiah Email: kingrajiah@gmail.com Tel:+0060146400547
Received: 5 May 2011 Accepted: 29 February 2012 Published: 24 April 2012
Citation: Nainar S, Rajiah K, Angamuthu S, Prabakaran D, Kasibhatta R. Biopharmaceutical Classification System in In-vitro/In-vivo Correlation: Concept and Development Strategies in Drug Delivery. Trop J Pharm Res 2012; 11(2):319-329 doi: 10.4314/tjpr.v11i2.20
© 2012 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..
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.
Fulltext in PDF