BIOPHARMACEUTICS DRUG DISPOSITION CLASSIFICATION SYSTEM: AN EXTENSION OF BIOPHARMACEUTICS CLASSIFICATION SYSTEM

Abstract

The Biopharmaceutics Classification System (BCS) was developed for prediction of in vivo pharmacokinetic performance of drug products from measurements of permeability and solubility. If the permeability criteria changed with metabolism criteria than it may be useful in predicting overall drug disposition, including routes of drug elimination and the effects of efflux and absorptive transporters on oral drug absorption, importance of food effects, and transporter effects on post absorption systemic drug concentrations following oral and intravenous dosing known as Biopharmaceutics drug disposition classification system (BDDCS). The drugs that have high permeability but poor metabolism are generally hydrophilic molecules with low molecular weight are likely to be absorbed by active transport mechanisms. Suggesting that drugs have extensive metabolism are highly absorbed. BDDCS using elimination criteria may expand the number of Class 1 drugs eligible for a biowaiver of in vivo bioequivalence (BE) studies and provide predictability of drug disposition profiles for Classes 2, 3, and 4 compounds.