ISSX 2022: A Decade of Human ADME at Quotient Sciences: Reviewing Key Study Design Variables and Outcomes

With a draft FDA guidance (Clinical Pharmacology Considerations for Human Radiolabelled mass Balance Studies, FDA, May 2022 ) under review there is currently considerable interest in the design and conduct of human mass balance studies. 

In the last 10 years Quotient Sciences have performed close to 200 radiolabelled studies. In that period, study designs have (where required) been adapted to address the challenges presented by new drug candidates, to benefit from new technologies and with a better understanding of how to interpret the data that can be generated from the analysis of collected samples. This poster reviews some of the outcomes from those programs. 

Presented as part of the 2022 The International Society for the Study of Xenobiotics (ISSX) conference in Seattle, WA, USA.