Design for Tolerance Trial of Traditional Chinese Medicine for Intravenous Drip in Human Body / 中药新药与临床药理

ABSTRACT

Intravenous preparations take more risk than oral preparation and externally applied agent.In phaseⅠtoler- ance trial of intravenous preparations of TCM on human subjects,minimum dose and maximum dose should be decided in light of data derived from preclinical pharmacodynamic and toxicological experiments,combined with practical situation in clinic.Dose-ascending coefficient of the should be reasonable.During the application of intravenous preparations of TCM in tolerance trial,clinical monitoring must be done to ensure the safety of subjects.Overall and integrated observa- tional indices should be designed on the basis of the features of preparation types,administration methods,the nature of medicine,etc.,so as to provide full-scale data for safe dose range,concentration of the preparation,dripping veloci- ty and possible adverse reactions,etc.