Bioanalytical strategy used in development of pharmacokinetic (PK) methods that support biosimilar programs

mAbs

Volumn 6, Issue 5, 2014, Pages 1178-1189

  Colbert, Alex ^a   Umble Romero, Amber ^a   Prokop, Samantha ^a   Chow, Vincent Fung Sing ^a   Wong, Teresa ^a   DeSimone, Danielle ^a   Zhou, Lei ^a   Pederson, Susan ^a  

^a AMGEN INC   (United States)

Author keywords

Bioanalytical; Biosimilar; Biotherapeutics; Comparability; Pharmacodynamics; Pharmacokinetic; Recombinant

Indexed keywords

BIOSIMILAR AGENT;

ANALYTIC METHOD; ANALYTICAL PARAMETERS; ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; CHEMICAL ANALYSIS; COMPARATIVE STUDY; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG EFFICACY; DRUG SAFETY; EXPERIMENTAL DESIGN; FEMALE; HUMAN; IN VIVO STUDY; LIMIT OF QUANTITATION; MALE; NONHUMAN; PHARMACOKINETIC ASSAY; PRODUCT DEVELOPMENT; QUANTITATIVE ANALYSIS;

EID: 84913543892     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.4161/mabs.32114     Document Type: Article

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