Analysis of failures in the research and development of new drugs
YANG Zhi-min
FENG Yi
Abstract：We systemically analyzed the review results and failed reasons in applications for investigational new drugs. The aim of this paper was to analyze the main factors that led to failures in the research and develop-ment of new drugs. The results have shown that 11.4% applications were not approved by SFDA. In which 41% applications had no suitable and good clinical advantages, 29% applications had no adequate and good preclinical safety data to support the clinical trials.
Keywords：investigational new drugresearch and developmentfailure
Publication Date：2010-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：3( 17-19 )