![]() Evaluation of In Vitro Equivalence for Drugs Containing BCS Class II Compound Ketoprofen I. Small fraction of drugs on the list, the perme. BCS has been effectively implanted by drug regulatory agencies around the world, and widely practiced by the pharmaceutical industry.īCS Class I: High solubility, high perme- ability drugs. Today, the BCS has generated remarkable impact on the global pharmaceutical sciences arena, in drug discovery, development and regulation, and an extensive validation/discussion of the BCS is continuously published in the literature. The BCS classified compounds into one of four biopharmaceutical classes according to water solubility and membrane permeability characteristics. The BCS broadly allowed the prediction of human absorption, Fraction absorbed ( F abs) and the rate‐limiting step in the intestinal absorption process of drugs following oral administration. Food and Drug Administration (FDA) was initiated to establish a database of human jejunal permeabilities based on a Biopharmaceutics Classification System (BCS). In the early 1990s, a collaborative research effort between academia and the U.S.
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