Journal :   Research Journal of Pharmacy and Technology

Volume No. :   1

Issue No. :  3

Year :  2008

Pages :   144-151

ISSN Print :  0974-3618

ISSN Online :  0974-360X


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Biopharmaceutics Classification System (BCS) and Biowaivers: Role in Drug Product Design



Address:   Anshu Sharma*1, CP Jain1 and MS Ashawat2
1Department of Pharmaceutical Sciences, M.L.S. University Udaipur(Rajasthan)
2B.N. Girls College of Pharmacy, Udaipur, (Rajasthan)
* Corresponding Author
DOI No:

ABSTRACT:
The introduction of the Biopharmaceutics Classification System (BCS) into the Food and Drug Administration is a major step forward to classify the biopharmaceutical properties of drugs and drug products. Based on the mechanistic approaches to the drug absorption and dissolution process, the BCS enables the regulatory bodies to simplify and improve the drug approval process. The knowledge of BCS of drug in a formulation can also be utilized by the formulation scientist to develop a more optimized dosage form.
KEYWORDS:
Biopharmaceutics Classification System, Biowaivers, IVIVC, solubility.
Cite:
Anshu Sharma, CP Jain, MS Ashawat. Biopharmaceutics Classification System (BCS) and Biowaivers: Role in Drug Product Design. Research J. Pharm. and Tech. 1(3): July-Sept. 2008; Page 144-151.
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