Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides - Harmonized terminology and tactical recommendations

AAPS Journal

Volumn 16, Issue 4, 2014, Pages 658-673

  Shankar, G ^a   Arkin, S ^b   Cocea, L ^c   Devanarayan, V ^d   Kirshner, S ^e   Kromminga, A ^f   Quarmby, V ^g   Richards, S ^h   Schneider, C K ^i,j   Subramanyam, M ^k   Swanson, S ^l   Verthelyi, D ^e   Yim, S ^e  

^a JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^b PFIZER INC   (United States)

^c HEALTH CANADA   (Canada)

^d ABBVIE INC   (United States)

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

^f IPM BIOTECH GmbH   (Germany)

^g GENENTECH INC   (United States)

^h SANOFI   (France)

ⁱ Danish Health and Medicines Authority   (Denmark)

^j INSTITUTE OF INFECTION IMMUNOLOGY   (Germany)

^k BIOGEN   (United States)

^l AMGEN INC   (United States)

more..

Author keywords

anti drug antibody; clinical relevance; harmonization

Indexed keywords

DRUG ANTIBODY; NEUTRALIZING ANTIBODY; PEPTIDES AND PROTEINS; PEPTIDE; PROTEIN;

ANTIBODY DETECTION; ANTIBODY RESPONSE; ANTIBODY TITER; ANTIGEN BINDING; BINDING AFFINITY; BINDING SITE; CLINICAL EFFECTIVENESS; CROSS REACTION; DATA ANALYSIS; DRUG EFFICACY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; MEDICAL TERMINOLOGY; NONHUMAN; ORGANIZATIONAL DOWNSIZING; ORGANIZATIONAL EFFICIENCY; PATIENT ASSESSMENT; PHYSICIAN ATTITUDE; PROFESSIONAL COMPETENCE; PROFESSIONAL KNOWLEDGE; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK FACTOR; ANTIBODY PRODUCTION; DRUG EFFECTS; IMMUNOLOGY; NOMENCLATURE; PRACTICE GUIDELINE;

ANTIBODY FORMATION; GUIDELINES AS TOPIC; HUMANS; PEPTIDES; PROTEINS; TERMINOLOGY AS TOPIC;

EID: 84903597970     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-014-9599-2     Document Type: Review

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