title: Points to consider in the manufacture and testing of monoclonal antibody products for human use (1997). U.S. Food and Drug Administration Center for Biologics Evaluation and Research.
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000096:biosynthesis / Q000737:chemistry / Q000627:therapeutic use; D017321:Clinical Trials, Phase I as Topic / Q000592:standards; D017322:Clinical Trials, Phase II as Topic / Q000592:standards; D017326:Clinical Trials, Phase III as Topic / Q000592:standards; D004353:Drug Evaluation, Preclinical; D006801:Humans; D018796:Immunoconjugates / Q000737:chemistry / Q000627:therapeutic use; D011786:Quality Control; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000911:Antibodies, Monoclonal; D018796:Immunoconjugates