Pharmacokinetic, pharmacodynamic and immunogenicity comparability assessment strategies for monoclonal antibodies

Trends in Biotechnology

Volumn 28, Issue 10, 2010, Pages 509-516

  Putnam, Wendy S ^a   Prabhu, Saileta ^a   Zheng, Yanan ^a   Subramanyam, Meena ^b   Wang, Yow Ming C ^c  

^a GENENTECH INC   (United States)

^b BIOGEN   (United States)

^c AMGEN INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL CHARACTERIZATION; BIOLOGICAL PRODUCTS; DEVELOPMENT PROCESS; IMMUNOGENICITY; IN-VIVO; MANUFACTURING PROCESS; POTENTIAL IMPACTS; REGULATORY GUIDANCE; RISK-BASED APPROACH;

MONOCLONAL ANTIBODIES; PHARMACOKINETICS; SAFETY TESTING;

SURFACE PLASMON RESONANCE;

BETA1A INTERFERON; BIOLOGICAL PRODUCT; IMMUNOGLOBULIN G; INSULIN; MONOCLONAL ANTIBODY; RECOMBINANT ALPHA2A INTERFERON; RECOMBINANT ALPHA2B INTERFERON; ROMIPLOSTIM;

AREA UNDER THE CURVE; BIOEQUIVALENCE; BIOLOGICAL ACTIVITY; DRUG BINDING; DRUG BIOAVAILABILITY; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG FORMULATION; DRUG HALF LIFE; GLYCOSYLATION; GOOD MANUFACTURING PRACTICE; HUMAN; HYPOTENSION; IMMUNOGENICITY; MULTIPLE SCLEROSIS; NONHUMAN; PRIORITY JOURNAL; REVIEW; THROMBOCYTOPENIC PURPURA;

ANIMALS; ANTIBODIES, MONOCLONAL; BIOLOGICAL PRODUCTS; BIOTECHNOLOGY; HUMANS;

EID: 77956873702     PISSN: 01677799     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.tibtech.2010.07.001     Document Type: Review

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