Acute, subchronic & chronic toxicity tests
To determine effects of the drug/chemical during various lengths of exposure
Pharmacokinetic & Toxicokinetic Tests
To explore the absorption, distribution, metobolism, storage and exretion of the drug/chemical
Development Toxicity Tests (teratogenicity)
To evaluate the capacity of the drug/chemical to cause abnormalities in the embryo and foetus
Reproductive Toxicity Tests
To assess the effect of the drug/chemical on fertility and fecundity
Carcinogenicity Tests
To examine the potential of the drug/chemical to cause benign or malignant tumours, to shorten the appearance of spontaneous tumours or increase their multiplicity
Basics of toxicology Testing for Human Safety Evaluation
- Do toxicity tests before clinical studies
- Use higher levels of the drug/chemical than humans will experience
- Check that higher exposure does not cause serious or irreversible toxicity
- Show that exposure in animal tests at 5-fold>than that in humans is safe
- “no effect level”
- Presume that animal toxicity does not predict human toxicity, unless proven otherwise
- Need information on the mechanism of toxicity
- Safety data must justify human exposure
The following aspects of the results of toxicity studies should be considered
- The onset, severity and duration of toxic effects
- Causes of death
- Relationship to pharmacologic effects
- Degree of reversibility (or irreversibility) of findings
- Species- or gender-related differences
- Nature and severity of target organ toxicity
- Dose- and Exposure- repsonse relationships
- No-Adverse-Effect Levels (NOAELs)
- Maximum Tolerated Doses (MTDs)
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