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1 Biopharmaceutics Classification Systems

1 Biopharmaceutics Classification Systems

The Biopharmaceutics Classification System (BCS) is a classification system that aims to improve, simplify, and speed up drug development. Initially, the BCS was defined to speed up FDA approval of immediate releasing oral dosage forms. It is a science-based approach to predict in vivo performance from characterizing drugs in vitro and helps to waive the requirement to conduct a bioequivalence study.

The BCS characterizes drugs into four classes according to their FDA solubility and


The main purposes of the BCS classification is to improve the efficiency of drug development and meet the challenges of formulation design, allow prediction of in vivo pharmacokinetic performance of drug products from measurements of permeability (determined as the extent of oral absorption) and solubility, and for biowaiver status granting of in vivo bioequivalence studies.

Maybe a image according to MeltPrep CI There is a typo in Class II. It should be High Permeability

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