Fit for purpose	An assessment of whether the method and the endpoints are suitable and adequate for the purpose for which the test was designed.
CoU	A description of the circumstances under which a 3Rs testing approach (replacement, reduction, and refinement of animals used in research, teaching, testing, and exhibition) is applied in the assessment of human or veterinary medicinal products and the limitations within which the available data adequately support the use of the 3Rs testing approach.