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Abstract

THE BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS): REVIEW

Peeush Singhal*, Ritu Vishnoi Singhal, Vijay Jyoti Kumar, Anurag Verma, R. D. Kaushik

ABSTRACT

Biopharmaceutics Classification System (BCS) is Scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability.firstly The fundamental basis established by Dr. Gordon Amidon for which he has got Distinguished Science Award (Aug ’06, FIP)after that Guidance provided by the U.S. Food and Drug Administration for predicting the intestinal drug absorption. First introduced into regulatory decision-making process in the guidance document on Immediate Release Solid Oral Dosage Drug development tool that allows estimation of the contributions of 3 major factors, that affect oral drug absorption from immediate release solid oral dosage forms, Dissolution, Solubility, Intestinal permeability. The present studies highlits the principle objectives, benefits, classification and application of BCS.

Keywords: BCS; BDDCS; Solubility; Bioequivalence; Biopharmaceutics.


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