Characterisation of test substances (e.g. chemicals) is generally easier than characterisation of the test system (e.g. cells, tissues, organs, animals) to which they are applied, with some exceptions such as early candidate molecules in pharmaceutical research. As much information as possible should be provided to the animal facility. This may include:
- the origin, purity, solubility and batch number of the substance
- any necessary pre-treatment before administration to the animals, such as dilution or mixing with adjuvant
- its likely palatability if given orally in feed or water (which may cause artefacts in observations of body weight)
- storage conditions before use
- routines for disposal of surplus material
- health risks on human exposure, and the likely effects of substances that leak to, or are knowingly released into, the environment. Technical data sheets should always be provided if these are available.
Immunisation protocols should be refined to prevent unnecessary pain and suffering caused by the use of adjuvants (see the references below).
When calculating the dose to be used, particularly if this is based upon human data, allometric scaling should be used, to take into account the large differences in metabolic rate between animals of different body mass.
Desirable characteristics of a dosing formulation and its preparation
Cassotta et al. (2022): A worldwide survey on the use of animal-derived materials and reagents in scientific experimentation
Cassotta et al. (2022): A worldwide survey on the use of animal-derived materials and reagents in scientific experimentation
Guidance for dose selection in DART studies to refine and reduce animal use (NC3Rs, 2024)
Recommendations to accelerate the replacement of animal-derived antibodies (NC3Rs, 2024)
Clinical molecules: a library from AstraZeneca of clinic-ready molecules demonstrating target engagement and tolerability through Phase 2 research.