Assay formats: Recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team

AAPS Journal

Volumn 16, Issue 2, 2014, Pages 194-205

  Dudal, Sherri ^a,b   Baltrukonis, Daniel ^c   Crisino, Rebecca ^d   Goyal, M Jaya ^e   Joyce, Alison ^c   Österlund, Karolina ^f   Smeraglia, John ^g   Taniguchi, Yoshitaka ^h   Yang, Jihong ⁱ  

^a NOVARTIS PHARMA AG   (Switzerland)

^b F HOFFMANN LA ROCHE LTD   (Switzerland)

^c PFIZER INC   (United States)

^d Janssen Research and Development LLC   (United States)

^e BIOGEN   (United States)

^f Gyros AB   (Sweden)

^g UCB PHARMA   (Belgium)

^h TORAY RESEARCH CENTER INC   (Japan)

ⁱ GENENTECH INC   (United States)

Author keywords

assay format; biotherapeutic; large molecule; platform; technology

Indexed keywords

AMPLIFIED LUMINESCENT PROXIMITY HOMOGENEOUS ASSAY; BIOASSAY; CHEMILUMINESCENCE ANALYZER; COMPACT DISK; DISSOCIATION ENHANCED LUMINESCENT IMMUNOASSAY; ENZYME LINKED IMMUNOSORBENT ASSAY; HUMAN; IMMUNOASSAY; IMMUNOASSAY ANALYZER; INTERMETHOD COMPARISON; MACROMOLECULE; MESOSCALE DISCOVERY SECTOR IMAGER; MOLECULAR INTERACTION; POLYMERASE CHAIN REACTION; QUALITY CONTROL; RADIOIMMUNOASSAY; RECEPTOR BINDING ASSAY; REVIEW; SENSITIVITY ANALYSIS; STANDARDIZATION;

COOPERATIVE BEHAVIOR; ENZYME-LINKED IMMUNOSORBENT ASSAY; LIGANDS; POLYMERASE CHAIN REACTION; PRACTICE GUIDELINES AS TOPIC; RADIOIMMUNOASSAY;

EID: 84895861201     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-013-9552-9     Document Type: Review

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