Types of Qualitative Safety and Toxicity Testing

Acute Tests

2 routes, determine no-effect dose and MTD, ~acute dose that is lethal to 50% of animals

Number of Species in Acute Tests

2

Subacture/Sub-Chronic Tests

3 doses, determine biological/physiological effects (longer intended use, longer subacute test)

Number of Species in Subacute/Sub-Chronic Tests

2

Chronic Tests

> 6 months, required when drug is proposed to be used for prolonged periods, determines the same endpoints as subacute toxicity tests

Number of Species in Chronic Tests

1 rodent and 1 nonrodent

Reproductive Tests

examines impact on animal mating behavior, reproduction, parturition, progeny, birth defects, postnatal development

Number of Species in Reproductive Tests

2 (rodents/rabbits)

Carcinogenic Potential Tests

2 years, determines gross and histological pathology

Number of Species in Carcinogenic Potential Tests

2

Mutagenic Potential Tests

tests on genetic stability, dominant lethal test and clastogenicity in mice

Species in Mutagenic Potential Tests

bacteria or mammalian cells