Latest Progress of Clinical Pharmacology in Innovative Drug Development / 世界科学技术-中医药现代化

ABSTRACT

Under the traditional “empirical trial design”,innovative drug development cannot make comprehensive use of the existing information from previous studies.The development efficiency is low.And it is easy to cause safety issues.Therefore,it is particularly necessary to explore and establish new models,more efficient and safer strategies for the clinical development of innovative drugs.In recent years,the “knowledgeable” clinical research strategy for new drug has been proposed and practiced by the FDA and EMEA.It employed the model and the simulation technology to quantitatively analyze and predict exposure/response relationships of innovative drug and its influence factors in patients.It helped in obtaining sufficient information from clinical data at the same time,to minimize the required number of subjects,and to ensure the safety of subjects in clinical trials.