General considerations and case analysis of nonclinical research of new drugs
XU Yang-mei
WAN Jiang-fan
NI Sui-ying
HE Jing-long
XIE Lei
CHENG Bin
Abstract：Nonclinical research is a crucial link in the process of drug development and registration,which runs through the whole process of new drug development.This paper will elaborate the general considerations and concerns in the process of nonclinical research of new drugs according to relevant laws,regulations and technical guidelines on domestic drug registration,ICH guidelines,and drug review practices.It will also discuss common issues in nonclinical research through case analysis,in order to provide references for nonclinical research of new drug research and development enterprises or institutions.
Keywords：new drug researchnonclinical researchgeneral considerationscase analysis
Publication Date：2025-10-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 2192-2198 )