Translational Research: Pre-Clinical Development

The pre-clinical development of a potential therapeutic agent involves the manufacturing and formal testing of ADMET properties in preparation for submission to a regulatory agency for human trials. Rigorous efficacy studies of a pre-clinical lead candidate may also be conducted. These processes require regulatory expertise in their design, good manufacturing practices (GMP) manufacturing, and good laboratory practice (GLP) toxicology studies as well as consideration of future clinical trial design.