Covance has initiated integrated radiolabeled clinical pharmacology studies, in compliance with FDA guidance on Metabolites in Safety Testing (MIST). Recent MIST guidance requires earlier human absorption, metabolism and excretion (AME) testing, in support of investigative new drug/clinical trial application submissions.
Robert Kochan, Senior Research Scientist and Radiation Safety Officer of clinical pharmacology at Covance, said: Integrated human AME services are designed to help reduce the time and cost of drug development by integrating clinical pharmacology AME study conduct and data management services with bioanalytical chemistry and drug metabolism.
The results of AME studies provide information about the disposition of a drug by direct characterization of the compound’ pharmacokinetics, and information related to AME characteristics. Stringent data requirements for AME studies demand extensive radiochemical and chemical analysis to obtain definitive metabolite disposition data in humans, the company said.