Bioanalytical approaches to quantify "total" and "free" therapeutic antibodies and their targets: Technical challenges and PK/PD applications over the course of drug development

AAPS Journal

Volumn 13, Issue 1, 2011, Pages 99-110

  Lee, Jean W ^a   Kelley, Marian ^b   King, Lindsay E ^c   Yang, Jihong ^d   Salimi Moosavi, Hossein ^a   Tang, Meina T ^d   Lu, Jian Feng ^a   Kamerud, John ^e   Ahene, Ago ^f   Myler, Heather ^g   Rogers, Cindy ^h  

^a AMGEN INC   (United States)

^b MKelley Consulting LLC   (United States)

^c PFIZER INC   (United States)

^d GENENTECH INC   (United States)

^e Dept of Stat and Clin Programming   (United States)

^f Pharmargo LLC   (United States)

^g BRISTOL MYERS SQUIBB   (United States)

^h Genzyme   (United States)

Author keywords

Ligand binding assays; Monoclonal antibody biotherapeutics; PK PD; Target biomarkers; Total and free assays

Indexed keywords

ACID; ALCOHOL; MEMBRANE RECEPTOR; MONOCLONAL ANTIBODY; UREA;

ALKALINITY; ANALYTIC METHOD; BIOLOGICAL THERAPY; CONCENTRATION (PARAMETERS); DILUTION; DISSOCIATION; DRUG SAFETY; DRUG TARGETING; ENZYME LINKED IMMUNOSORBENT ASSAY; EX VIVO STUDY; FREEZING; IN VIVO STUDY; INCUBATION TIME; LIGAND BINDING; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; PHARMACODYNAMICS; PHARMACOKINETICS; QUANTITATIVE ANALYSIS; REVIEW; SOLID PHASE EXTRACTION; THAWING;

ALGORITHMS; ANIMALS; ANTIBODIES, MONOCLONAL; DRUG DESIGN; HUMANS; LIGANDS; RECEPTORS, DRUG;

EID: 79951980085     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-011-9251-3     Document Type: Review

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