This mini-review describes the Chemistry, Manufacturing and Control activities associated with the
manufacture of [14C]-labeled drug substance and subsequent drug compounding activities to generate clinical trial
material utilized in human absorption, distribution, metabolism, and excretion clinical studies. Due to the unstable
nature and increased decomposition rates observed with [14C]-labeled compounds, the manufacture, testing, release,
formulation, and regulatory filings are uniquely challenging. A case study of the cardiac myosin activator
AMG 423 (omecamtiv mercarbil), utilized in a dual oral/intravenous infusion clinical study is presented.
Keywords: Chemistry, Manufacturing and Control (CMC), current Good Manufacturing Practice (cGMP), [14C]-Labeled Drug, Omecamtiv
Mercarbil, AMG 423, human Absorption, Distribution, Metabolism, and Excretion (hADME), ICH Guidance, FDA Regulations.
Rights & PermissionsPrintExport