Research methods for bioequivalence and its application in Chinese materia medica preparation products / 中草药

ABSTRACT

Bioequivalence has an important role in the new drug research, development of non-patent medicine, and post-marketing evaluation of drugs and is an essential step in the standardization and modernization of Chinese materia medica (CMM). With the acceleration of modernization of CMM, CMM preparation products made by different manufacturers differ in quality, resulting in different effects. Therefore, it is very important to strengthen the application of bioequivalent study in CMM preparation products to ensure the effectiveness and safety. In this paper, the research methods of the biological equivalence were introduced systematically, and the significance of the "component structure theory" to the study on biological equivalent of the CMM preparations has been elaborated, in order to improve the evaluation system of the biological equivalent for CMM preparations.