Table 1.
Attributes | Level 1 | Level 2 | Level 3 | Level 4 | Level 5 | |
---|---|---|---|---|---|---|
1 | Storage | Refrigerator (must be stored in the refrigerator) |
Refrigerator (must be stored in the refrigerator) |
Refrigerator (must be stored in the refrigerator) |
Room Temp (store at room temperature) |
Room Temp (store at room temperature) |
1b | Preparation | Mix (mix the medicine before use) |
Ready to Use (no mixing required) |
Mix, Then Room Temp (mix the medicine before use; once mixed can be stored at room temperature) |
Mix (mix the medicine before use) |
Ready to Use (no mixing required) |
2 | Injection device | Injection Device (continuous push on the button/plunger while injecting) |
Autoinjector (single push of the button to inject) |
Needle Free Device (pushes medicine through the skin using high pressure) |
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3 | Maintenance | Single Use, Disposable Syringe (throw away after one use) |
Multi Use, Disposable Pen (use for up to 28 days, then throw away) |
Multi Use, Disposable Pen (use for up to 28 days, then throw away) |
Multi Use, Reusable Pen (use for up to 28 days, then replace cartridge) |
Multi Use, Reusable Pen (use for up to 28 days, then replace cartridge) |
3b | Dose setting | Pre-Set Dose (dose is already pre-set) |
Set the Dose (must set the dose each time) |
Dose Memory (set the dose the first time, then device remembers it) |
Set the Dose (must set the dose each time) |
Dose Memory (set the dose the first time, then device remembers it) |
4 | Injection schedule | Once Daily | Once Weekly | Once Every 2 Weeks | Once a Month |