Table 2.
Summaries of observed data of ziprasidone
| Posology | Observed data | Simulated data | |||||
|---|---|---|---|---|---|---|---|
| Scheme | Dose | n | Study reference | Population | Duration of the study (h) | Age | Proportion of female |
| i.v. single dose | 20 mg | 7 | 31 | Healthy adult volunteers | 36 | 20–50 | 0.50 |
| Oral single dose | 20 mg | 12 | 38 | Healthy adult volunteers | 36 | 20–45 | 0.00 |
| Oral single dose | 5 mg | 6 | 43 | Healthy adult volunteers | 72 | 20–29 | 0.00 |
| Oral single dose | 20 mg | 8 | 43 | Healthy adult volunteers | 72 | 20–45 | 0.00 |
| Oral single dose | 20 mg | 8 | 43 | Healthy adult volunteers | 72 | 18–34 | 0.00 |
| Oral single dose | 20 mg | 7 | 43 | Healthy adult volunteers | 72 | 22–40 | 0.00 |
| Oral single dose | 20 mg | 8 | 44 | Healthy adult volunteers | 72 | 19–31 | 0.00 |
| Oral single dose | 40 mg | 8 | 44 | Healthy adult volunteers | 72 | 19–31 | 0.00 |
| Oral single dose | 80 mg | 8 | 44 | Healthy adult volunteers | 72 | 19–31 | 0.00 |
| Oral single dose | 20 mg | 16 | 42 | Healthy adult volunteers | 12 | 18–44 | 0.5 |
| Oral twice daily dose, SS | 5 mg | 6 | 43 | Healthy adult volunteers | 72 | 20–29 | 0.00 |
| Oral twice daily dose, SS | 20 mg | 6 | 43 | Healthy adult volunteers | 72 | 20–45 | 0.00 |
| Oral twice daily dose, SS | 40 mg | 6 | 43 | Healthy adult volunteers | 72 | 18–34 | 0.00 |
| Oral twice daily dose, SS | 60 mg | 6 | 43 | Healthy adult volunteers | 72 | 22–40 | 0.00 |
| Oral twice daily dose, SS | 40 mg | 14 | 43 | Healthy adult volunteers | 72 | 20–42 | 0.75 |
| Oral twice daily dose, SS | 20 mg | 16 | 37 | Healthy adult volunteers | 180 | 18–44 | 0.5 |
| Oral single dose | 5 mg | 8 | 45 | Paediatric | 32 | 6–9 | 0.5 |
| Oral single dose | 10 mg | 7 | 45 | Paediatric | 32 | 9–15 | 0.5 |
| Oral single dose | 20 mg | 8 | 45 | Paediatric | 32 | 15–16 | 0.5 |
| Oral single dose | 20 mg | 16 | 37 | Geriatric | 12 | 65–76 | 0.5 |
| Oral twice daily dose, SS | 20 mg | 16 | 37 | Geriatric | 180 | 65–76 | 0.5 |
| Oral twice daily dose, SS | 40 mg | 3 | 46 | Non‐pregnant women = baseline | 72 | 20–45 | 1.00 |
| Oral twice daily dose, SS | 40 mg | 3 | 46 | Pregnant women—GA = 6 weeks | 72 | 20–45 | 1.00 |
| Oral twice daily dose, SS | 40 mg | 3 | 46 | Pregnant women—GA = 20 weeks | 72 | 20–45 | 1.00 |
| Oral twice daily dose, SS | 40 mg | 3 | 46 | Pregnant women—GA = 34 weeks | 72 | 20–45 | 1.00 |
GA, gestational age in week; i.v., intravenous; SS, steady‐state
Note: 10 virtual trials were conducted, 10 subjects per trial, randomly selected by the simulator such that the proportion of female and age were fitted to match the observed data.