Project Overview: The client requested Cardno ChemRisk to provide ADE limits for endogenous compounds, including amino acids, fatty acids and nucleic acids. Our task was to review clinical and nonclinical data for these classes of endogenous compounds and to establish a harmonized approach to identify exposure limits for IV infusion.
Our Approach: We reviewed information provided by innovator and available data to derive patient exposure limits according to FDA and ICH guidelines. We identified several endogenous compound class-specific concerns such as cardiovascular-related health risks and risk of fatty emboli based on critical micelle concentration.
Our Value: We derived ADE values for endogenous compounds requested by the client. Additionally, we developed a harmonized framework approach to determining ADE values for additional compounds in the compound classes evaluated. Further, we are representing the client in effort to harmonize our methodology with other pharmaceutical stake holders. The resulting methodology will be published in the peer-reviewed literature.