A white paper-consensus and recommendations of a global harmonization team on assessing the impact of immunogenicity on pharmacokinetic measurements

AAPS Journal

Volumn 16, Issue 3, 2014, Pages 488-498

  Sailstad, J M ^a   Amaravadi, L ^b   Clements Egan, A ^c   Gorovits, B ^d   Myler, H A ^e   Pillutla, R C ^e   Pursuhothama, S ^b   Putman, M ^f   Rose, M K ^g   Sonehara, K ^h   Tang, L ⁱ   Wustner, J T ^j  

^a Sailstad and Associates Inc   (United States)

^b BIOGEN   (United States)

^c JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^d PFIZER INC   (United States)

^e BRISTOL MYERS SQUIBB   (United States)

^f QPS   (Netherlands)

^g DR REDDY'S LABORATORIES LTD   (India)

^h Sumika Chemicals Analysis Service Ltd   (Japan)

ⁱ SANOFI   (France)

^j Morphotek Inc   (United States)

more..

Author keywords

global bioanalysis consortium; immunogenicity; pharmacodynamic; pharmacokinetic; risk based approach

Indexed keywords

ADALIMUMAB; AGALSIDASE BETA; BETA1A INTERFERON; CERTOLIZUMAB PEGOL; DENOSUMAB; DESULFATOHIRUDIN; DRUG ANTIBODY; ETANERCEPT; EXENDIN 4; GOLIMUMAB; INFLIXIMAB; INTERFERON BETA SERINE; LEPIRUDIN; NATALIZUMAB; OCTREOTIDE; PALIVIZUMAB; PANITUMUMAB; RITUXIMAB; BLOCKING ANTIBODY;

ALLERGIC REACTION; ANTIBODY DETECTION; ANTIBODY TITER; ANTIGEN ANTIBODY COMPLEX; AREA UNDER THE CURVE; CONSENSUS; DRUG ACCUMULATION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EFFICACY; DRUG EXPOSURE; DRUG HALF LIFE; HUMAN; IMMUNOASSAY; IMMUNOGENICITY; LOW DRUG DOSE; MAXIMUM PLASMA CONCENTRATION; MULTIPLE SCLEROSIS; NONHODGKIN LYMPHOMA; NONHUMAN; PRACTICE GUIDELINE; PROCESS DEVELOPMENT; QUANTITATIVE ANALYSIS; REVIEW; RHEUMATOID ARTHRITIS; VALIDATION PROCESS; ANIMAL; DRUG LEGISLATION; DRUG THERAPY; IMMUNOLOGY; PHARMACOKINETICS; STANDARDS;

ALLERGY AND IMMUNOLOGY; ANIMALS; ANTIBODIES, BLOCKING; CONSENSUS; DRUG THERAPY; HUMANS; LEGISLATION, DRUG; PHARMACOKINETICS;

EID: 84900333804     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-014-9582-y     Document Type: Review

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