Mass Balance Study
Team Approach
Scientific Expertise
Customer Focus
Need
- 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