Journal :   Research Journal of Pharmacy and Technology

Volume No. :   2

Issue No. :  1

Year :  2009

Pages :   72-79

ISSN Print :  0974-3618

ISSN Online :  0974-360X


Registration

Allready Registrered
Click to Login

IVIVC and BCS: A Regulatory Perspective



Address:   AV Bhosale, SR Hardikar, Naresh Patil*, Rajesh Jagtap, Nilesh Jamdade, and Bhavin Patel
Dept. of Pharmaceutics, PDEA’S SGRS College of Pharmacy, Saswad
*Corresponding Author
DOI No:

ABSTRACT:
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)
KEYWORDS:
IVIVC, BCS, Regulatory Perspective, biopharmaceutical classification system.
Cite:
AV Bhosale, SR Hardikar, Naresh Patil, Rajesh Jagtap, Nilesh Jamdade, Bhavin Patel. IVIVC and BCS: A Regulatory Perspective. Research J. Pharm. and Tech. 2(1): Jan.-Mar. 2009; Page 72-79.
[View HTML]      [View PDF]



Visitor's No. :   363008