Advance in studies of acute drug toxicity
WANG Qing-li
WANG Hai-xue
MA Lei
Abstract：Traditionally, single dose toxicity studies in animals, programmed in early phase of new drug development, are usually required for any pharmaceuticals intended for human use. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use (ICH) and the guideline M3 discussed the scientific background of the study, and recommended the development strategies and requirements for registration. In recent years, with the share of nonclinical safety studies conducted between companies and the consideration of the 3Rs principles, suggestions in refining the single dose toxicity study were presented.
Keywords：acute toxicitysingle dose toxicityLD_(50)
Publication Date：2009-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：4( 2024-2027 )