Table 2: Timelines of microtracer dose-AMS method.
Activity | Time, month |
---|---|
Preparation of [14C]-API | 1-3 |
Develop and prepare spiking solution | 1 |
Radiolabeled formulation and stability study | 1-2 |
Write CMC radiolabeled portion for IND Amendment | 1 |
Mock run, review of batch records | 1 |
Total | 5-8 |