| • Blinded-randomized testing in rodents with models of focal cerebral infarction |
| • Replication of results in at least two laboratories with adequate physiological monitoring |
| • Studies in permanent and reperfusion models |
| • Testing in male and female animals |
| • Rat behavioural and histological studies for at least 1 month after focal occlusion |
| • Use of a route of drug administration that is feasible for clinical development, to ensure agents cross the blood–brain barrier |
| • Toxicological studies in several species, including intact animals and animals with stroke |
| • Testing in primate models, including behaviour, sensorimotor and cognitive function, for drugs showing promise in rat models |
| • Careful dose–response studies |
| • Time window studies showing benefit at delayed time points after stroke onset |