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 |