"Fit-for-purpose" method validation and application of a biomarker (C-terminal telopeptides of type 1 collagen) in denosumab clinical studies

AAPS Journal

Volumn 11, Issue 2, 2009, Pages 385-394

  Wang, Jin ^a   Lee, Jean ^a   Burns, Daniel ^a   Doherty, David ^a   Brunner, Laura ^a   Peterson, Mark ^a   DeSilva, Binodh ^a  

^a AMGEN INC   (United States)

Author keywords

Bone resorption marker; Commercial immunoassay kit; Method validation; Pharmacodynamic (PD) biomarker; Serum C terminal telopeptides of type 1 (CTx)

Indexed keywords

CARBOXY TERMINAL TELOPEPTIDE; DENOSUMAB;

ACCURACY; ARTICLE; CONTROLLED STUDY; DIAGNOSTIC KIT; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG EFFICACY; FEMALE; FREEZE THAWING; HUMAN; IMMUNOASSAY; IMMUNOREACTIVITY; INTERMETHOD COMPARISON; MALE; OSTEOLYSIS; PHARMACOLOGICAL PARAMETERS; PROTEIN BLOOD LEVEL; QUALITY CONTROL; RELIABILITY; ROOM TEMPERATURE; VALIDITY;

ANTIBODIES, MONOCLONAL; BIOLOGICAL MARKERS; BONE RESORPTION; CALIBRATION; COLLAGEN TYPE I; FEMALE; HUMANS; IMMUNOASSAY; LINEAR MODELS; LOGISTIC MODELS; MALE; PEPTIDES; QUALITY CONTROL; RANK LIGAND; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; ROBOTICS;

EID: 68249144517     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-009-9115-2     Document Type: Article

References (22)

1. Fink E, Cormier C, Steinmetz P, Kindermans C, Le Bouc Y, Souberbielle JC. Differences in the capacity of several biochemical bone markers to assess high bone turnover in early menopause and response to alendronate therapy. Osteoporos Int. 2000;11:295.
2. Delmas PD. Markers of bone turnover for monitoring treatment of osteoporosis with antiresorptive drugs. Osteoporos Int. 2000;11(Suppl 6):S66.
3. Cremers S, Garnero P. Biochemical markers of bone turnover in the clinical development of drugs for osteoporosis and metastatic bone disease: Potential uses and pitfalls. Drugs. 2006;66:2031.
4. Bekker PJ, Holloway DL, Rasmussen AS, Murphy R, Martin SW, Leese PT, et al. A single-dose placebo-controlled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal women. J Bone Miner Res. 2004;19:1059.
5. Christgau S, Bitsch-Jensen O, Hanover Bjarnason N, Gamwell Henriksen E, Qvist P, Alexandersen P, et al. Serum CrossLaps for monitoring the response in individuals undergoing antiresorptive therapy. Bone. 2000;26(5):505-11.
6. Rosenquist C, Fledelius C, Christgau S, Pedersen BJ, Bonde M, Qvist P, et al. Serum CrossLaps one step ELISA. First application of monoclonal antibodies for measurement in serum of bone-related degradation products from C-terminal telopeptides of type I collagen. Clin Chem. 1998;44:2281.
7. Lee JW, Devanarayan V, Barrett YC, Allinson J, Fountain S, Keller S, et al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm Res. 2006;23:312.
8. 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. Pharm Res. 2003;20:1885-900.
9. Lee JW, O'Brien P, Pan P, Xu R. Development and validation of ligand binding assays for biomarkers. In: Khan M, Findlay JWA, editors. Ligand-binding assays: Development, validation and implementation in the drug development arena. NY, NY: Wiley; 2009 (in press).
10. NCCLS. Application of biochemical markers of bone turnover in the assessment and monitoring of bone disease; approved guideline. NCCLS document C48-A; 2004. ISBN 1-56238-539-9.
11. Kit insert. http://www.idsplc.com/en-us/products/product.php?id=8521. Accessed 11/9/08.
12. Shah VP. The history of bioanalytical method validation and regulations: evolution of a guidance document on bioanalytical method validation. J AAPS. 2007;9(1):E43-7.
13. Findlay JWA, Smith WC, Lee JW, Nordblom GD, Das I, DeSilva BS, et al. Validation of immunoassays for bioanalysis: A pharmaceutical industry perspective. J Pharm Biomed Anal. 2000;21:1249-73.
14. FDA. Guidance for industry on bioanalytical method validation: availability. Fed Regist. 2001;66:28526-7.
15. NCCLS. Protocols for determination of limits of detection and limits of quantitation; approved guideline. NCCLS document EP17-A; 2004. ISBN 1-56238-551-8.
16. Colburn W, Lee J. Biomarkers, validation and pharmacokinetic-pharmacodynamic modelling. Clin Phamacokinet. 2003;42(12):997-1022.
17. Lee J, Ma H. Specificity and selectivity evaluations of ligand binding assay of protein therapeutics against concomitant drugs and related endogenous proteins. J AAPS. 2007;9(2):E164-70.
18. Lee JW, Hall M. Method validation of protein biomarkers in support of drug development or clinical diagnosis/prognosis. J Chromatogr B. 2009;877:1259-71 (special issue "Quantitative analysis of biomarkers by LC-MS/MS").
19. Rosenquist C, Eledelius C, Christgau S, Pedersen BJ, Bonde M, Qvist P, et al. Serum CrossLaps one step ELISA. First application of monoclonal antibodies for measurement in serum of bone-related degradation products from C-terminal telopeptides of type I collagen. Clin Chem. 1998;44(11):2281-9.
20. Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, et al. Workshop/conference report - quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays. J AAPS. 2007;9(1):E30-42.
21. Lee J, Wu Y, Wang J. Fit for purpose method validation and assays for biomarker characterization to support drug development. In: Bleravins M, Rhbari R, Jurima-Romet M, Carini C, editors. Biomarkers in drug development: A handbook of practice, application and strategy. New York: Wiley; 2009 (in press).
22. Guidance for Industry Statistical Approaches to Establishing Bioequivalence. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), January 2001.