Bioanalytical considerations in the comparability assessment of biotherapeutics

Bioanalysis

Volumn 3, Issue 6, 2011, Pages 613-622

  Lee, Jean W ^a   Wang, Yow Ming ^a   Moxness, Michael ^a   DeSilva, Binodh ^a,b  

^a AMGEN INC   (United States)

^b BRISTOL MYERS SQUIBB   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; AREA UNDER THE CURVE; BINDING AFFINITY; BIOASSAY; BIOCOMPATIBILITY; BIOEQUIVALENCE; BIOLOGICAL THERAPY; BIOTECHNOLOGICAL PROCEDURES; BIOTRANSFORMATION; CROSS REACTION; DECISION MAKING; DRUG DISPOSITION; DRUG SURVEILLANCE PROGRAM; HUMAN; IMMUNOGENICITY; LIQUID CHROMATOGRAPHY; MAXIMUM PLASMA CONCENTRATION; MICHAELIS MENTEN KINETICS; NONHUMAN; PHARMACODYNAMICS; PHARMACOKINETICS; PROTEIN BINDING; PROTEIN DEGRADATION; PROTEIN DENATURATION; REVIEW; TANDEM MASS SPECTROMETRY;

ANIMALS; BIOLOGICAL PRODUCTS; BIOTECHNOLOGY; CHEMISTRY TECHNIQUES, ANALYTICAL; HUMANS; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; VALIDATION STUDIES AS TOPIC;

EID: 79953082847     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.11.25     Document Type: Review

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