Research On Druggability Risk Management Of New Traditional Chinese Medicine

New traditional Chinese medicine(TCM)R&D are faced with great druggability risks.If we can implement risk management on new TCM R&D effectively to avoid the risk faced in the process of new drug R&D,we will reduce the failure rate.It cannot only cut the investment of R&D significantly,but also improve the success rate of drug R&D that will bring huge social benefits and economic benefits.There are many reasons for failing of approving the registration of new TCM.Some are common,while the others are rare.Whatever the reason is,it can lead to a failure directly.Therefore,researchers have to identify and prevent potential risks in the process of new drug R&D.A large number of literature data were reviewed in this paper,and the possible causes for the failure of new TCM R&D were identified.According to the basic process for registration and declaration of new TCM,the risks of new TCM were divided into two categories.One was the kind of factor that could result in the failure of clinical trial applications,including drug R&D project issues,component rationality issues,indications identify issues,non-clinical safety issues,the rationality of process determination issues,quality standards and stability studies,standardization and authenticity of the research materials and pharmacokinetic issues,etc.Another major category included the disapproval of production,registration and applications.They were validity issues,safety issues,legality and compliance issues,craft and prescription issues,standardization and authenticity of the research materials,etc.Based on the R&D cycle and process of new TCM,the risk factors affecting the R&D of new TCM were evaluated by analytic hierarchy process(AHP)according to the two stages of pre-clinical study and clinical study.Through the construction of structural model,calculation of single order,calculation of total order of hierarchy,consistency test and other steps,the index weight values of the first-level risk factors and second-level risk factors in the two stages were calculated successfully,and the weight values of these risk factors were systematically compared and sorted.In order to reduce the risk of new TCM R&D and improve the success rate of registration and application of new TCM.For the two stages of pre-clinical study and clinical study of new TCM,according to the ranking order of first-level risk factors(second-level risk factors are based on the order of risk identification),the author puts forward corresponding control strategies for 9 aspects and 41 risk points in the pre-clinical research of new TCM,and 5 aspects and 18 risk points in the clinical research of new TCM,so as to provide reference for researchers of new TCM in the future research work.