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Title of Journal: Pharm Res

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Abbravation: Pharmaceutical Research

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Springer US

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DOI

10.1007/s40501-016-0089-2

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1573-904X

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The BCS BDDCS and Regulatory Guidances

Authors: MeiLing Chen Gordon L Amidon Leslie Z Benet Hans Lennernas Lawrence X Yu
Publish Date: 2011/04/14
Volume: 28, Issue: 7, Pages: 1774-1778
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Abstract

The BCS Biopharmaceutics Classification System based on aqueous solubility and intestinal permeability has been widely used since 1995 to predict drug absorption during the course of pharmaceutical development 1 However as will be discussed subsequently in more detail when the BCS concepts were initiated now more than 15 years ago the term “intestinal permeability” was used interchangeably with both measures of rate and extent of absorption believing from the data available at that time that permeability/absorption rate and extent are correlated The BCS has also been utilized by regulatory authorities to determine whether in vivo bioequivalence studies may be waived for drug products in immediate release solid oral dosage forms 23 For example the US FDA currently grants waiver of in vivo bioequivalence studies for BCS Class 1 highly soluble and highly permeable drugs that are formulated in rapidly dissolving immediate release products 2 In 2005This paper was written partly based on the discussions from an Open Forum held at the 2010 PSWC/AAPS Annual Meeting New Orleans The opinions expressed in this article do not necessarily represent the views or policies of the US Food and Drug Administration

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