Table 4 Mock clinical formulation stability design using HPLC-AMS
From: CMC development of [14C]-labeled sotorasib for the conduct of microtracer human ADME study
Mock dose preparation | Testing site | Test purpose | Storage temperature | Time points | ||
|---|---|---|---|---|---|---|
T0 | T24h | T48h | ||||
AMS site | AMS site | In-use stability | Below 30 °C, protected from light | x | x | x |
Clinical site | AMS site | Shipping mitigation | - | x | - | |