Table 1: Clinical CRO transfer-related activities.
| Activity | Organization |
|---|---|
| Transfer of radiolabeled formulation method | Takeda |
| Transfer of analytical method | Takeda |
| CRO visit for any trouble shooting during the mock run | Takeda |
| Generation of formulation batch records (mock and real runs) | CRO |
| QC data and release | CRO |
| Review of batch records | Takeda |