Table 5.
Potential Therapy Selection Criteria
| Criterion | Rationale |
|---|---|
| FDA approval | Therapies approved for human use more readily translate to clinical studies |
| Efficacy | Therapies with efficacy in previous experimental TBI studies are more likely to prove successful in further pre-clinical testing |
| PD/PK in species | Facilitates dose and time and route of administration selection |
| BBB permeability | Increases likelihood of achieving therapeutic levels in brain |
| Human use | Therapies with long histories of use in humans are less likely to have significant negative side effects |
| Known targets/Mechanisms | Facilitates monitoring of dose and time/route of administration efficacy; therapies with multiple targets/mechanisms may act on multiple deleterious pathways |
| Novelty | High risk/high reward |
BBB, blood–brain barrier; FDA, Food and Drug Administration; PD/PK, pharmacodynamics/pharmacokinetics.