Advantage and progress of model-induced drug development in traditional Chinese medicine / 中国药房

ABSTRACT

Model-induced drug development （MIDD） is a mathematical and statistical method for constructing， validating and utilizing disease model， drug exposure-response model and pharmaceutical model to promote drug development. With the development of pharmaceutical technology， MIDD is widely used in the field of traditional Chinese medicine and has high practical value. This article summarizes the relevant literature at home and abroad， and finds that MIDD has the advantages of improving the research and development efficiency of traditional Chinese medicine， quickly identifying the applicable population of traditional Chinese medicine， predicting the interaction of drugs， and optimizing the dosage. MIDD has been applied in the studies of effective components of traditional Chinese medicine， quantitative design of prescription， dosage form and preparation process， pilot scale- up， quality and safety， regulatory decision-making and evaluation， etc.