Development and regulation of monoclonal antibody products: Challenges and opportunities

Cancer and Metastasis Reviews

Volumn 24, Issue 4, 2005, Pages 569-584

  Weinberg, Wendy C ^a   Frazier Jessen, Michelle R ^a   Wen, Jin Wu ^a   Weir, Andrea ^a   Hartsough, Melanie ^a   Keegan, Patricia ^a   Fuchs, Chana ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Biologies License Application (BLA); Cancer therapy; Clinical trials; Immunogenicity; Investigational New Drug (IND); Monoclonal antibodies

Indexed keywords

ALEMTUZUMAB; ARCITUMOMAB TC 99M; BEVACIZUMAB; CAPROMAB PENDETIDE IN 111; CETUXIMAB; EFALIZUMAB; GEMTUZUMAB OZOGAMICIN; IBRITUMOMAB TIUXETAN; INFLIXIMAB; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY B.72.3 IN 111; NOFETUMOMAB TC 99M; ONCOSCINT; RITUXIMAB; TOSITUMOMAB I 131; TRASTUZUMAB; UNCLASSIFIED DRUG; VERLUMA;

CANCER; CANCER DIAGNOSIS; CANCER IMMUNOTHERAPY; CROHN DISEASE; DISEASE MODEL; DRUG CONJUGATION; DRUG DESIGN; DRUG EFFICACY; DRUG EXPOSURE; DRUG MANUFACTURE; DRUG MECHANISM; DRUG QUALITY; DRUG SAFETY; DRUG SCREENING; DRUG SPECIFICITY; DRUG SYNTHESIS; DRUG TARGETING; HUMAN; IMMUNOGENICITY; NONHUMAN; PRIORITY JOURNAL; PSORIASIS; REVIEW; RHEUMATOID ARTHRITIS; SCIENCE;

ANIMALS; ANTIBODIES, MONOCLONAL; DRUG AND NARCOTIC CONTROL; DRUG EVALUATION, PRECLINICAL; HUMANS;

EID: 30744440090     PISSN: 01677659     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10555-005-6196-y     Document Type: Review

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