Vaccine toxicology toxicity studies

Most toxicological test procedures were never intended for vaccines. However, the requirement to test the pharmacokinetics, pharmacodynamics and reproductive toxicity for human vaccines means, that at least the basic rationale of these studies also applies to vaccines. The test methods may vary considerably. 

The toxicology study should include an evaluation of the immune response, which will provide evidence that the vaccine was dosed, show that the species is responsive to the vaccine, and might allow the correlation between a toxic effect and the immune response induced. For further details, see References 4, 15, 16, 22. 

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