General considerations and issues of special concern about the nonclinical study of modified new drugs
DAI Xue-dong
SUN Tao
HUANG Fang-hua
WANG Qing-li
Abstract：The general considerations of the research and development of modified new drugs and issues of special concern about different types of modified drugs are preliminary discussed from a nonclinical perspective,in combination with our review practice and related technical guidelines abroad.
Keywords：nonclinical studychange the route of administrationenantiomerdrug combinationsnew indication
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 2121-2127 )