Jh. Dean et al., THE INTEGRATION OF IMMUNOTOXICOLOGY IN DRUG DISCOVERY AND DEVELOPMENT- INVESTIGATIVE AND IN-VITRO POSSIBILITIES, Toxicology in vitro, 8(5), 1994, pp. 939-944
The development of new pharmaceuticals requires a tremendous investmen
t of time and resources. The early integration of investigative toxico
logy studies and new toxicological methods, such as immunotoxicologica
l studies, into the selection of new drug candidates facilities compou
nd safety evaluation, reduces risk, and improves development cycle tim
e. Experience at Sterling Winthrop Inc. has led us to believe that imm
unotoxicology assessment represents an important and useful tool in dr
ug discovery and development, but that it should not be applied as a r
outine screening procedure. Instead, immunotoxicity evaluation should
be initiated as a response to knowledge about the class of drug under
investigation, or when data from other studies suggest an effect on th
e immune system. Three examples of this approach are given and each on
e demonstrates the potential of in vitro immunotoxicology assays to re
duce the time, resources and animal use required in the discovery and
development of new drug candidates.