title: Regulatory Affairs introduction.
authors.forename: James D
authors.initials: JD
authors.lastname: Green
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized; D017321:Clinical Trials, Phase I as Topic; D004353:Drug Evaluation, Preclinical / Q000009:adverse effects*; D064420:Drug-Related Side Effects and Adverse Reactions; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D051381:Rats
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C509303:TGN-1412