title: Preclinical safety testing of monoclonal antibodies: the significance of species relevance.
abstract: Selecting a pharmacologically relevant animal species for testing the safety and toxicity of novel monoclonal antibody (mAb) therapies to support clinical testing can be challenging. Frequently, the species of choice is the primate. With the increased number of mAbs in the pharmaceutical pipeline, this has significant implications for primate use, and so raises several important scientific, ethical and economic issues. Here, following a recent international workshop held to debate this topic, we discuss issues in the preclinical testing of mAbs, with a particular focus on species relevance and primate use, and provide suggestions for how these issues might be addressed.
authors.affiliation: National Centre for the Replacement, Refinement and Reduction of Animals in Research, 20 Park Crescent, London W1B 1AL, UK. kathryn.chapman@nc3rs.org.uk
authors.forename: Kathryn
authors.initials: K
authors.lastname: Chapman
authors.forename: Nick
authors.initials: N
authors.lastname: Pullen
authors.forename: Mark
authors.initials: M
authors.lastname: Graham
authors.forename: Ian
authors.initials: I
authors.lastname: Ragan
mesh_terms: D000818:Animals; D030801:Animals, Genetically Modified; D000911:Antibodies, Monoclonal / Q000494:pharmacology* / Q000633:toxicity; D004353:Drug Evaluation, Preclinical; D011323:Primates; D018675:Toxicity Tests
chemical_list: D000911:Antibodies, Monoclonal