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

The development of new pharmaceuticals requires a tremendous investment of time and resources. The early integration of investigative toxicology studies and new toxicological methods, such as immunotoxicological studies, into the selection of new drug candidates facilities compound safety evaluation, reduces risk, and improves development cycle time. Experience at Sterling Winthrop Inc. has led us to believe that immunotoxicology assessment represents an important and useful tool in drug discovery and development, but that it should not be applied as a routine 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 the immune system. Three examples of this approach are given and each one demonstrates the potential of in vitro immunotoxicology assays to reduce the time, resources and animal use required in the discovery and development of new drug candidates.