Progress towards the Replacement of the Rabbit Blood Sugar Test for the Quantitative Determination of the Biological Activity of Insulins (USP <121>) with an In Vitro Assay.

For the quantification of insulin activity, United States Pharmacopeia (USP) general chapter <121> continues to require the rabbit blood sugar test. For new insulin or insulin analogue compounds, those quantitative data are expected for stability or comparability studies. At Sanofi, many rabbits were used to fulfil the authority's requirements to obtain quantitative insulin bioactivity data until the in vivo test was replaced.