Assessment of incurred sample reanalysis for macromolecules to evaluate bioanalytical method robustness: Effects from imprecision

AAPS Journal

Volumn 13, Issue 2, 2011, Pages 291-298

  Thway, Theingi M ^a   Eschenberg, Michael ^a   Calamba, Dominador ^a   MacAraeg, Chris ^a   Ma, Mark ^a   Desilva, Binodh ^a,b  

^a AMGEN INC   (United States)

^b BRISTOL MYERS SQUIBB   (United States)

Author keywords

incurred sample reanalysis; LBA; sample size selection; statistical analysis; total error

Indexed keywords

ACCURACY; ANALYTIC METHOD; ANALYTICAL ERROR; ARTICLE; CONTROLLED STUDY; FREEZE THAWING; INCURRED SAMPLE REANALYSIS; LIGAND BINDING; MACROMOLECULE; PROBABILITY; QUALITY CONTROL; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; SIMULATION; VALIDATION PROCESS;

COMPUTER SIMULATION; LIGANDS; MACROMOLECULAR SUBSTANCES; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; REPRODUCIBILITY OF RESULTS;

EID: 79957455956     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-011-9271-z     Document Type: Article

References (8)

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