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| No. | Criteria |
|---|---|
| 1 |
Narrow therapeutic range/index |
| 2 |
Drug toxicity may lead to hospitalization, irreversible organ damage, and even death |
| 3 |
No clearly defined clinical parameter that allows dose adjustments |
| 4 |
Correlation exists between serum concentration and efficacy as well as toxicity |
| 5 |
Unpredictable relationship between dose and clinical outcome |
| 6 | Difficult to predict pharmacokinetics (e.g. non-linear pharmacokinetics) |
