Table 7: Timelines of traditional method in API and formulation portions.
| Activity | Time, month |
|---|---|
| Develop radio-synthetic route | 2 |
| GMP synthesis at CMO | 5-7 |
| Radiolabeled formulation and stability study | 1-2 |
| Write CMC radiolabeled portion for IND Amendment | 1 |
| Mock run, review of batch records | 1 |
| Total | 10-13 |