A novel gamma-fitting statistical method for anti-drug antibody assays to establish assay cut points for data with non-normal distribution

Journal of Immunological Methods

Volumn 352, Issue 1-2, 2010, Pages 161-168

  Schlain, Brian ^a   Amaravadi, Lakshmi ^a   Donley, Jean ^a   Wickramasekera, Ananda ^a   Bennett, Donald ^a   Subramanyam, Meena ^a  

^a BIOGEN   (United States)

Author keywords

ADA assays; Cut point; Gamma distribution; Immunogenicity; Nonparametric; Screening assay

Indexed keywords

DRUG ANTIBODY;

ACCURACY; ANALYTICAL ERROR; ANALYTICAL PARAMETERS; ARTICLE; COMPUTER SIMULATION; CONTROLLED STUDY; DATA ANALYSIS; IMMUNOASSAY; IMMUNOGENICITY; INTERMETHOD COMPARISON; NONHUMAN; NORMAL DISTRIBUTION; PRIORITY JOURNAL; REFERENCE VALUE; STATISTICAL ANALYSIS; STATISTICAL MODEL;

ANIMALS; ANTIBODIES, NEUTRALIZING; BIOTRANSFORMATION; COMPUTER SIMULATION; DATA INTERPRETATION, STATISTICAL; DIAGNOSTIC ERRORS; DRUG THERAPY; HUMANS; NORMAL DISTRIBUTION; PHARMACOLOGICAL PROCESSES; REFERENCE VALUES; STATISTICS, NONPARAMETRIC;

EID: 71749086841     PISSN: 00221759     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jim.2009.10.012     Document Type: Article

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