The Biopharmaceutics Classification System

A class 1 drug can obtain a waiver for bioequivalence studies for immediate release solid dose oral formulations if (1) the drug is stable in the gastrointestinal tract (2) excipients used in the immediate release (IR) solid oral dosage forms have no significant effect on the rate and extent of oral drug 

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Fig. 12 Illustration of the Biopharmaceutical Classification System (BCS), which classifies drug absorption potential on the basis of aqueous solubility or membrane permeability. (Copyright 2000 Saguaro Technical Press, Inc., used with permission.)...

Lentz, K. A. Hayashi, J. Lucisano, L. J. Polli, J. E., Development of a more rapid, reduced serum culture system for Caco-2 monolayers and application to the biopharmaceutics classification system, Int. J. Pharm. 200, 41-51 (2000). 

Fig. 7.5. The Biopharmaceutics Classification System (BCS) provides a scientific basis for predicting intestinal drug absorption and for identifying the rate-limiting step based on primary biopharmaceutical properties such as solubility and effective intestinal permeability (Pefr). BCS serves as a product control instrument. The BCS divides drugs into four different classes based on their solubility and...

Based on their solubility and intestinal permeability characteristics, drugs have been classified into one of four categories according to the Biopharmaceutics Classification System (BCS) proposed by Amidon et al. [49]. 

Fig. 15.5. The biopharmaceutics classification system (BCS). Drug-like molecules are grouped into four BCS classes based on their solubility and permeability. A drug is regarded as a highly soluble compound if the maximum dose given orally is soluble in 250 mL fluid in the...

Kramer J. The biopharmaceutics classification system—an overview of the current status in relation to IR and MR dosage forms. 1st International Conference on Bioavailability, Bioequivalence and Dissolution Testing, London, 2002. 

Workshop on the Biopharmaceutics Classification System Scientific and Regulatory Aspects in Practice, London, 2001. 

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