Bioavailability and Bioequivalence Studies for Chinese Medicines: Challenge and Opportunity

Abstract

Advanced discussions of the current issues and analyzing the novel approaches of bioavailability & bioequivalence Advanced analytical technologies have provided approaches in analyzing the bioactivities of single component drugs, while the complexity of chemical composition in multi-component drugs makes it diffi cult in identifying the chemical and biological basis underlying the pharmacological actions. Various measures have been developed and systems biology and OMICS are meaningful philosophy and technologies for this purpose. As one of the specifi c methods, the recent development of combining pharmacokinetics with network pharmacology approaches has been proved to be a useful tool in the study of multi-component drugs. In vivo pharmacokinetics is able to identify the compounds in multi-component drugs that accounts for the drug-response and the pharmacokinetic profi le of multi-component drugs could elucidate the possible interaction between diff erent components. Th e pharmacokinetic profi le could preferably determine the material basis of multi-components drug actions. Network pharmacology is useful in illustrating the regulatory network of a single component drug, and is also a powerful means of understanding the interaction of multi-components drugs. With data mining technology, the possible targets of each component that are identifi ed in pharmacokinetics could be included. Th e protein-protein interaction induced by multi-components drugs can be analyzed by bioinformatics soft ware. Th is helps to identify molecular basis of multi-component drugs in treating human diseases. In a word, the combination of advanced integrated and specifi c methodologies is a novel and powerful approaches in evaluating the chemical and biological basis of multi-components drugs including Chinese Medicine formulae.