Test Item - Stability
To ensure the nature of the test and reference items remains unchanged throughout the study, the Study Director also needs to know their stability under storage and under the test conditions.
The Study Director needs to consider if the test item is administered or applied in a vehicle. A vehicle is an agent which serves as a carrier to mix, dispense or solubilise the test item or reference item to facilitate the administration or application to the test system.
If so the mixture's:
- Homogeneity
- Concentration
- Stability
has to be considered.
This has to be considered to determine whether the vehicle affects the item's delivery.
These additional data are required for inclusion in the final report.
