Exceptions and Variations for Biological Products

The standard test procedures described below have been established to assess pharmacological and safety features of chemical compounds, such as drugs and newly introduced excipients. With some qualifications these tests are also used for biological pharmaceuticals, which act pharmacologically (as opposed to an immunological mode of action) and are applied frequently or in regular, short intervals, e.g. cytokines or blood clotting factors. 

The choice of test animals presents a major difficulty if the repeated application of the biological product results in immunological reactions. Tests exceeding four weeks should be carried out in immunological 

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. 

for example, reproductive toxicity studies are required for vaccines, the trial duration and details of clinical and pathological investigations of standard trial procedures may be adopted, whereas the dosing must be chosen individually for each product to be tested and should be justified in the study protocol. Most likely it will be similar to the clinical use of the vaccine. 

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