Application of the biopharmaceutical classification system in clinical drug development--an industrial view.

The biopharmaceutical classification system (BCS) classifies compounds based on their solubility and permeability. Regulatory agencies and health organizations have utilized this classification system to allow dissolution to be used to establish bioequivalence for highly soluble and highly permeable compounds. The pharmaceutical industry has taken advantage of this and BCS-based waivers are becoming more routine and result in significant savings. Further, there is strong scientific rationale to allow BCS-based waivers for even more compounds to realize even more savings. Yet just as clear as the benefits are the barriers that limit application: lack of international regulatory harmonization, uncertainty in regulatory approval, and organizational barriers within the pharmaceutical industry. Once these barriers are overcome and additional applications are fully allowed, the full benefits of BCS applications will be realized.