The client needed to rerun a mass balance study due to poor radioactivity recovery
Root cause for poor recovery was undetermined
Approach
Specialized adhesion testing for all collection materials performed prior to study start to ensure no loss of study drug on the containers; this led to using additive for all urine collections
Dosing solution analysis completed immediately prior to dosing to ensure proper dose administered
Dosing solution residual analysis completed after dosing to determine any remaining radioactivity that was then subtracted from administered dose
Real time scintillation counting performed on site to allow for daily recovery results to be sent to the client for review to prevent premature release of participants
Benefits
Radioactivity recovery was >95% and study was successfully submitted to the FDA
