title: Pre-clinical strategies and safety issues in developing therapeutic monoclonal antibodies.
abstract: Although mAbs present a different set of challenges from other product classes, and the pre-clinical safety evaluation may need to be more extensive than for other medicinal products to overcome the limited predictive value of conventional pre-clinical test systems, the level of risk associated with first administration to human subjects can be effectively mitigated. This article seeks to provide a systematic approach to identifying and addressing the pertinent risks relative to the characteristics of the particular mAb product before the first administration to human subjects.
authors.affiliation: bioLOGICA Consulting & NDA Advisory Board, France. paul.chamberlain@biologicaconsulting.com
authors.forename: Paul
authors.initials: P
authors.lastname: Chamberlain
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D018570:Risk Assessment; D012307:Risk Factors
chemical_list: D000911:Antibodies, Monoclonal