Validation of a gyrolab™ assay for quantification of rituximab in human serum

Journal of Pharmacological and Toxicological Methods

Volumn 65, Issue 3, 2012, Pages 107-114

  Liu, Xiaodong F ^a   Wang, Xun ^a   Weaver, Roni J ^a   Calliste, Laurelle ^a   Xia, Christina ^a   He, Yuyan J ^a   Chen, LingSing ^a  

^a Translational Medicine Department   (United States)

Author keywords

Gyrolab; Immunoassay; Methods; Pharmacokinetics; Rituximab; Validation

Indexed keywords

RITUXIMAB;

ACCURACY; ARTICLE; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DETERMINATION; ENZYME LINKED IMMUNOSORBENT ASSAY; FREEZE THAWING; HUMAN; IMMUNOASSAY; INSTRUMENT VALIDATION; INTERMETHOD COMPARISON; LIMIT OF QUANTITATION; PROCESS DEVELOPMENT; PROCESS OPTIMIZATION; QUANTITATIVE ASSAY; SENSITIVITY ANALYSIS;

ANTIBODIES; ANTIBODIES, MONOCLONAL, MURINE-DERIVED; BLOOD CHEMICAL ANALYSIS; DRUG DISCOVERY; HUMANS; IMMUNOASSAY; REPRODUCIBILITY OF RESULTS;

ALEXA; RATTUS;

EID: 84862794628     PISSN: 10568719     EISSN: 1873488X     Source Type: Journal    
DOI: 10.1016/j.vascn.2012.03.001     Document Type: Article

References (11)

1. Berinstein N.L., Grillo-López A.J., White C.A., Bence-Bruckler I., Maloney D., Czuczman M., et al. Association of serum rituximab (IDEC-C2B8) concentration and anti-tumor response in the treatment of recurrent low-grade or follicular non-Hodgkin's lymphoma. Annals of Oncology 1988, 9:995-1001.
2. Blasco H., Lalmanach G., Godat E., Maurel M.C., Canepa S., Belghazi M., et al. Evaluation of a peptide ELISA for the detection of rituximab in serum. Journal of Immunological Methods 2007, 325:127-139.
3. DeSilva B., Smith W., Weiner R., Kelley M., Smolec J., Lee B., et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharmaceutical Research 2003, 20:1885-1900.
4. Hampson G., Ward T.H., Cummings J., Bayne M., Tutt A.L., Cragg M.S., et al. Validation of an ELISA for the determination of rituximab pharmacokinetics in clinical trials subjects. Journal of Immunological Methods 2010, 360:30-38.
5. Antibodies: A laboratory manual 1988, 658-681. Cold Spring Harbor Laboratory Press, New York. E. Harlow, D. Lane (Eds.).
6. Honda N., Lindberg U., Andersson P., Hoffmann S., Takei H. Simultaneous multiple immunoassays in a compact disc-shaped microfluidic device based on centrifugal force. Clinical Chemistry 2005, 51:1955-1961.
7. Iacona I., Lazzarino M., Avanzini M.A., Rupolo M., Arcaini L., Astori C., et al. Rituximab (IDEC-C2B8): Validation of a sensitive enzyme-linked immunoassay applied to a clinical pharmacokinetic study. Therapeutic Drug Monitoring 2000, 22:295-301.
8. Mora J.R., Obenauer-Kutner L., Patel V. Application of the gyrolab™ plateform to ligand-binding assays: A user's perspective. Bioanalysis 2010, 2:1711-1715.
9. Smolec J., DeSilva B., Smith W., Weiner R., Kelly M., Lee B., et al. Bioanalytical method validation for macromolecules in support of pharmacokinetic studies. Pharmaceutical Research 2005, 22:1425-1431.
10. Viswanathan C.T., Bansal S., Booth B., DeStefano A.J., Rose M.J., Sailstad J., et al. Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays. The AAPS Journal 2007, 9:E30-E42.
11. Weiner G.J. Rituximab: Mechanism of action. Seminars in Hematology 2010, 47:115-123.