Monocyte activation test for pro-inflammatory and pyrogenic contaminants of parenteral drugs: Test design and data analysis

Journal of Immunological Methods

Volumn 288, Issue 1-2, 2004, Pages 165-177

  Gaines Das, Rose E ^a   Brügger, Peter ^b   Patel, Mehul ^c   Mistry, Yogesh ^a   Poole, Stephen ^a  

^a NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

^b NOVARTIS PHARMA AG   (Switzerland)

^c BAXTER HEALTHCARE CORPORATION   (United States)

Author keywords

Bacterial endotoxin; Bacterial endotoxins test; BET; Bioassay design; ELISA; Endotoxin units; Enzyme linked immunosorbent assay; EU; IL; In vitro monocyte activation test; Interleukin; Interleukin 6; International unit; IU; LAL; Limulus amoebocyte lysate; Pyrogens

Indexed keywords

CYTOKINE; ENDOTOXIN; INTERLEUKIN 6; PYROGEN; VACCINE;

ARTICLE; CELL ACTIVATION; CELL ASSAY; CELL CULTURE; CONTAMINATION; CONTROLLED STUDY; CULTURE MEDIUM; DATA ANALYSIS; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; HUMAN; HUMAN CELL; IN VITRO STUDY; MOLECULE; MONOCYTE; NONHUMAN; PERIPHERAL BLOOD MONONUCLEAR CELL; PRIORITY JOURNAL; RABBIT;

CELL CULTURE TECHNIQUES; DATA INTERPRETATION, STATISTICAL; DRUG CONTAMINATION; ENDOTOXINS; HUMANS; INJECTIONS, INTRAVENOUS; MONOCYTES; RESEARCH;

BACTERIA (MICROORGANISMS); LIMULUS; ORYCTOLAGUS CUNICULUS;

EID: 2942562625     PISSN: 00221759     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jim.2004.03.002     Document Type: Article

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