Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: A conference report

Pharmaceutical Research

Volumn 22, Issue 4, 2005, Pages 499-511

  Lee, Jean W ^a   Weiner, Russ S ^b   Sailstad, Jeff M ^c   Bowsher, Ronald R ^d   Knuth, Dean W ^e   O'Brien, Peter J ^f   Fourcroy, Jean L ^g   Dixit, Rakesh ^h   Pandite, Lini ⁱ   Pietrusko, Robert G ^j   Soares, Holly D ^k   Quarmby, Valerie ^l   Vesterqvist, Ole L ^b   Potter, David M ^k   Witliff, James L ^m   Fritche, Herbert A ⁿ   O'Leary, Timothy ^o   Perlee, Lorah ^p   Kadam, Sunil ^f   Wagner, John A ^h  

^a MDS Inc   (Canada)

^b BRISTOL MYERS SQUIBB   (United States)

^c Trimeris Inc   (United States)

^d LINCO Diagnostic Services   (United States)

^e Jasper Clinic   (United States)

^f ELI LILLY AND COMPANY   (United States)

^g Walter Reed Army Medical Center   (United States)

^h MERCK RESEARCH LABORATORIES   (United States)

ⁱ GLAXOSMITHKLINE   (United States)

^j MILLENNIUM PHARMACEUTICALS INC   (United States)

^k PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^l GENENTECH INC   (United States)

^m UNIVERSITY OF LOUISVILLE   (United States)

ⁿ UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^o CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^p Molecular Staging Inc   (United States)

more..

Author keywords

Biomarkers; Nonclinical and clinical drug development; Quantitative method development and validation

Indexed keywords

BIOLOGICAL MARKER; HERCEPTEST; TRASTUZUMAB; XENOBIOTIC AGENT;

CHEMICAL ANALYSIS; CLINICAL RESEARCH; CONFERENCE PAPER; DECISION MAKING; DIAGNOSTIC ACCURACY; DRUG EFFICACY; DRUG NOMENCLATURE; DRUG SAFETY; HEALTH CARE COST; HUMAN; MEDICAL RESEARCH; NONHUMAN; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; QUALITY OF LIFE; UNITED STATES; VALIDATION PROCESS;

BIOLOGICAL ASSAY; BIOLOGICAL MARKERS; CHEMISTRY, PHARMACEUTICAL; CLINICAL TRIALS; REPRODUCIBILITY OF RESULTS;

EID: 20944433395     PISSN: 07248741     EISSN: None     Source Type: Journal    
DOI: 10.1007/s11095-005-2495-9     Document Type: Conference Paper

References (40)

1. J. A. DiMasi, R. W. Hansen, and H. G. Grabowski. The price of innovation: new estimates of drug development costs. J. Health Econ. 22:151-185 (2003).
2. G. Levy. Mechanism-based pharmacodynamics modeling. Clin. Pharmacol. Ther. 56:356-358 (1994).
3. C. C. Peck, W. H. Barr, L. Z. Benet, J. Collino, R. E. Desjardins, D. E. Furst, J. G. Harter, G. Levy, T. Ludden, and J. H. Rodman. Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development. Pharm. Sci. 81:600-610 (1992).
4. W. A. Colburn. Selecting and validating biologic markers for drug development. J. Clin. Pharmacol. 37:355-362 (1997).
5. P. R. Jadhav, M. U. Mehta, and J. V. S. Gobburu. How biomarkers can improve clinical drug development. Am. Pharm. Rev. 7:62-64 (2004).
6. E. Zerhouni. Medicine. The NIH Roadmap. Science 302:63-72 (2003). Available at http://nihroadmap.nih.gov.
7. F. D. A. March 2004 report. Innovation or stagnation: challenge and opportunity on the critical path. Available at http://www.fda.gov/oc/ initiatives/criticalpath/.
8. G. J. Downing. Biomarkers and Surrogate Endpoints: Clinical Research and Applications. Proceedings of the NIH-FDA Conference held on 15-16 April 1999. Elsevier, New York, 2000.
9. Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin. Pharmacol. Ther. 69:89-95 (2001).
10. R. R. Bowsher. Analytical validation of assays for novel biomarkers. Presentation at AAPS Workshop, Method Validation and Measurement of Biomarkers in Nonclinical and Clinical Samples in Drug Development, Salt Lake City, Utah, 2003.
11. J. A. Wagner. Early clinical development of pharmaceuticals for type 2 diabetes mellitus: from pre-clinical models to human investigation. J. Clin. Endocrinol. Metab. 87:5362-5366 (2002).
12. J. A. Wagner. Overview of biomarkers and surrogate endpoints in drug development. Dis. Markers 18:41-46 (2002).
13. J. Berger and J. A. Wagner. Physiological and therapeutic roles of peroxisome proliferator-activated receptors. Diabetes Technol. Ther. 4:163-174 (2002).
14. U. Krishnamurti and M. W. Steffes. Glycohemoglobin: a primary predictor of the development or reversal of complications of diabetes mellitus. Clin. Chem. 47:1157-1165 (2001).
15. D. A. Dillon. Molecular markers in the diagnosis and staging of breast cancer. Semin. Radiat. Oncol. 12:305-318 (2002).
16. R. Dates, M. Schmitt, and N. Harbeck. Advanced statistical methods for the definition of new staging models. Recent Results Cancer Res. 162:101-113 (2003).
17. B. N. Swanson. Delivery of high-quality biomarker assays. Dis. Markers 18:47-56 (2002).
18. I. C. H. Guidelines. Text on validation of analytical procedures. Q2A. International Conference on Harmonization, Geneva, Switzerland, 1994.
19. V. P. Shah, K. K. Midha, S. Dighe, I. J. McGilveray, J. P. Skelly, A. Yacobi, T. Layloff, C. T. Viswanathan, C. E. Cook, R. D. McDowall, K. A. Pittman, and S. Spector. Analytical methods validation: bioavailability, bioequivalence, and pharmacokinetic studies. Pharm. Res. 9:588-592 (1992).
20. V. P. Shah, K. K. Midha, J. W. A. Findlay, H. M. Hill, J. D. Hulse, I. J. McGilvary, G. McKay, K. J. Miller, R. N. Patnaik, M. L. Powell, A. Tonnelli, C. T. Viswanathan, and A. Yacobi. Bioanalytical method validation. A revisit with a decade of progress. Pharm. Res. 17:1551-1557 (2000).
21. Guidance for industry on bioanalytical method validation: availability. Federal Register 66:28526-28527 (2001).
22. FDA government document. Code of Federal Regulations. Title 21, Vol. 1. Good Laboratory Practice for Nonclinical Laboratory Studies. Revised April 1, 2001.
23. J. W. A. Findlay, W. C. Smith, J. W. Lee, G. D. Nordblom, I. Das, B. S. DeSilva, M. N. Khan, and R. R. Bowsher. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J. Pharm. Biomed. Anal. 21:1249-1273 (2000).
24. K. J. Miller, R. R. Bowsher, A. Celniker, J. Gibbons, S. Gupta, J. W. Lee, S. J. Swanson, W. C. Smith, and R. S. Weiner. Workshop on Bioanalytical Methods Validation for Macromolecules: summary report. Pharm. Res. 18:1373-1383 (2001).
25. B. DeSilva, W. Smith, R. Weiner, M. Kelley, J. Smolec, B. Lee, M. Khan, D. Tracey, H. Hill, and A. Celniker. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. 20:1885-1900 (2003).
26. W. C. Smith and G. S. Sittampalam. Conceptual and statistical issues in the validation of analytic dilution assays for pharmaceutical applications. J. Biopharm. Stat. 8:509-532 (1998).
27. J. W. Lee, W. C. Smith, G. D. Nordblom, and R. R. Bowsher. Validation of Assays for the Bioanalysis of Novel Biomarkers. In J. C. Bloom and R.A. Dean (eds.), Biomarkers in Clinical Drug Development. Marcel Dekker, New York, 2003, pp. 119-149.
28. A. R. Mire-Sluis, Y. C. Barrett, V. Devanarayan, E. Koren, H. Liu, M. Maia, T. Parish, G. Scott, G. Shankar, E. Shores, S. J. Swanson, G. Taniguchi, D. Wierda, and L. A. Zuckerman. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J. Immunol. Methods 289:1-16 (2004).
29. National Committee for Clinical Laboratory Standards (NCCLS). Document EP5-A: Evaluation of Precision Performance of Clinical Chemistry Devices: Approved Guideline (1999); Document EP6-P: Evaluation of the Linearity of Quantitative Analytical Method: Proposed Guideline (1986); Document EP7-P: Interference Testing in Clinical Chemistry: Proposed Guideline (1986); Document EP9-A: Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline (1995).
30. National Committee for Clinical Laboratory Standards (NCCLS). Document EP5-A: Evaluation of Precision Performance of Clinical Chemistry Devices: Approved Guideline (1999); Document EP6-P: Evaluation of the Linearity of Quantitative Analytical Method: Proposed Guideline (1986); Document EP7-P: Interference Testing in Clinical Chemistry: Proposed Guideline (1986); Document EP9-A: Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline (1995).
31. National Committee for Clinical Laboratory Standards (NCCLS). Document EP5-A: Evaluation of Precision Performance of Clinical Chemistry Devices: Approved Guideline (1999); Document EP6-P: Evaluation of the Linearity of Quantitative Analytical Method: Proposed Guideline (1986); Document EP7-P: Interference Testing in Clinical Chemistry: Proposed Guideline (1986); Document EP9-A: Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline (1995).
32. National Committee for Clinical Laboratory Standards (NCCLS). Document EP5-A: Evaluation of Precision Performance of Clinical Chemistry Devices: Approved Guideline (1999); Document EP6-P: Evaluation of the Linearity of Quantitative Analytical Method: Proposed Guideline (1986); Document EP7-P: Interference Testing in Clinical Chemistry: Proposed Guideline (1986); Document EP9-A: Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline (1995).
33. FDA government document. Code of Federal Regulations. Title 42, Vol. 3. Clinical Laboratory Improvement Amendment. Revised October 1, 2001.
34. J. O. Westgard, P. L. Barry, M. R. Hunt, and T. Grove. A multi-rule Shewhart chart for quality control in clinical chemistry. Clin. Chem. 27:493-501 (1981).
35. J. O. Westgard and G. G. Klee. Quality management. In C. Burtis (ed.), Fundamentals of Clinical Chemistry, 4th ed. WB Saunders, Philadelphia, 1996, pp. 211-223.
36. P. M. Bossuyt, J. B. Reitsma, D. E. Burns, C. A. Gatsonis, P. P. Glasziou, L. M. Irwig, D. Moher, D. Rennie, H. C. de Vet, and J. G. Lijmer. Standards for Reporting of Diagnostic Accuracy. The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Clin. Chem. 49:7-18 (2003).
37. DAKO HercepTest™ Facts, DAKO, Fort Collins, CO, USA, 2000.
38. B. Schweitzer, S. Roberts, B. Grimwade, W. Shao, M. Wang, Q. Fu, Q. Shu, I. Laroche, Z. Zhou, V. T. Tchernev, J. Christiansen, M. Velleca, and S. F. Kingsmore. Multiplexed protein profiling on microarrays by rolling-circle amplification. Nat. Biotechnol. 20:359-365 (2002).
39. W. Shao, Z. Zhou, I. Laroche, H. Lu, Q. Zong, D. D. Patel, S. Kingsmor, and S. P. Piccoli. Optimization of rolling-circle amplified protein microarrays for multiplexed protein profiling. J. Biomed. Biotechnol. 5:299-307 (2003).
40. S. F. Kingsmore and D. D. Patel. Multiplexed protein profiling on antibody-based microarrays by rolling circle amplification. Curr. Opin. Biotechnol. 14:74-81 (2003).