Quality assessment of bioanalytical quantification of monoclonal antibody drugs

Therapeutic Delivery

Volumn 2, Issue 3, 2011, Pages 383-396

  Lee, Jean W ^a   Kelley, Marian ^b  

^a AMGEN INC   (United States)

^b MKelley Consulting LLC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

IMMUNOGLOBULIN FC FRAGMENT; IMMUNOGLOBULIN G; MONOCLONAL ANTIBODY; REAGENT; RECOMBINANT PROTEIN;

ACCURACY; ANALYTIC METHOD; ANALYTICAL PARAMETERS; AREA UNDER THE CURVE; CALIBRATION; DILUTION; DRUG DETERMINATION; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG QUALITY; DRUG SAFETY; DRUG SCREENING; DRUG STABILITY; DRUG STRUCTURE; DRUG TARGETING; FOOD AND DRUG ADMINISTRATION; IC 50; LIGAND BINDING; LINEAR SYSTEM; PHARMACODYNAMICS; PHARMACOKINETICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; REGRESSION ANALYSIS; REPRODUCIBILITY; REVIEW; SENSITIVITY AND SPECIFICITY; STANDARDIZATION; STATISTICAL MODEL; THERMOSTABILITY; TOXICOKINETICS;

EID: 79952655910     PISSN: 20415990     EISSN: 20416008     Source Type: Journal    
DOI: 10.4155/tde.10.99     Document Type: Review

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