3R's applied to in vivo biological activity of recombinant human erythropoietin assay.

ABSTRACT.- An enhanced protocol for the evaluation of in vivo biological activity of recombinant human erythropoietin (rhEPO) assay in mice is described, following European Pharmacopoeia (Ph. Eur.) version 10.0 guideline and optimized by applying the principles of Replacement, Reduction and Refinement (3Rs) in animal experimentation. In Laboratory Animal Science, one of the main principles is to optimize the experimental protocols in order to achieve the best results with the lowest number of animals and refine the procedures to avoid unnecessary suffering.