Comparison of Two Biopharmaceutics Classification Systems and Discussion of Their Applications / 中国药学杂志

ABSTRACT

OBJECTIVE: To compare the difference between two kinds of biopharmaceutics classification systems and their applications. METHODS: Literatures and guidelines on biopharmaceutics classification system(BCS) and biopharmaceutics drug disposition classification system(BDDCS) were collected, the differences in conception, classification criteria, and application were compared, and problems which should be paid attention to in application were summarized. RESULTS:A lot of issues such as solubility, permeability, extent of metabolism and so on are involved in the application of BCS and BDDCS. Different classification criteria may have different results. The recognition for the two kinds of pharmaceutics classification systems by different administration organizations is not yet completely consistent. CONCLUSION:BCS and BDDCS play important roles in understanding the properties of drugs, especially in drug development and evaluation of generic drug conformance, however, the source of data should be identified when quoting the data. Possible risks should be considered for rational use of the data.