THE INTEGRATION OF IMMUNOTOXICOLOGY IN DRUG DISCOVERY AND DEVELOPMENT- INVESTIGATIVE AND IN-VITRO POSSIBILITIES

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.