14C-Radiolabelled Human AME: A Review of Clinical Mass Balance Rates and Routes of Elimination

Poster Authors:

Jessica Richardson¹, Ray Cooke¹, Claire Broughton¹, Eleanor Barton¹, Hayley Bradshaw¹, Grace Scott¹, Gemma Bullen-Clerkson¹, Jack Cairns¹, Rebecca Simmonds¹, Iain Shaw²

¹Pharmaron UK Ltd, Rushden, UK

²Quotient Sciences, Nottingham, UK

It has been over 13 years since the initial FDA MIST guidance (2008) came out outlining the importance of evaluating the safety of human metabolites. The FDA stance resulted in an increase in the number of radiolabelled clinical studies being performed. These studies allowed the determination of rates and routes of elimination (mass balance) for drug related material and the identification of major human metabolites. 

Since January 2014 Pharmaron has conducted mass balance analysis on over 80 hAME studies. This poster summarises the study process, and routes of recovery of radioactivity, depicts the rates of elimination and highlights the individual mean cumulative total recovery as well as the wide range of rates of excretion in urine and feces.