Regulatory guidance and validation of toxicologic biomarkers

Toxicologic Biomarkers

Volumn , Issue , 2006, Pages 187-200

  Goodsaid, Federico M ^a   Frueh, Felix W ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84886072189     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (32)

1. FDA whitepaper, 2004: Innovation or Stagnation, challenge and opportunity on the critical path to new medical products. http://www.fda.gov/oc/initia-tives/criticalpath/whitepaper.html [accessed September 4, 2004].
2. The Innovative Medicines Initiative (IMI) Strategic Research Agenda. Creating Biomedical R&D Leadership for Europe to Benefit Patients and Society. Draft document, European Commission, July 26, 2005. http://europa.eu.int/comm/ research/fp6/index_en.cfm?p=1 innomed.
3. Biomarkers Definition Working Group. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clin Pharmacol Ther 2001; 69:89-95.
4. Guidance for Industry: Pharmacogenomic Data Submissions, posted on March 22, 2005. http://www.fda.gov/cder/guidance/6400fnl.pdf.
5. Salerno RA, Lesko LJ. Pharmacogenomics in drug development and regulatory decision-making: the Genomic Data Submission (GDS) proposal. Pharmacoge-nomics 2004; 5:25-30.
6. Salerno RA, Lesko LJ. Pharmacogenomic data: FDA voluntary and required submission guidance. Pharmacogenomics 2004; 5:503-505.
7. Leighton JK, DeGeorge J, Jacobson-Kram D, MacGregor J, Mendrick D, Worobec A. Pharmacogenomic data submissions to the FDA: non-clinical case studies. Pharmacogenomics 2004; 5:507-511.
8. Ruano G, Collins JM, Dorner AJ, Wang S-J, Guerciolini R, Huang S-M. Phar-macogenomic data submissions to the FDA: clinical pharmacology case studies. Pharmacogenomics 2004; 5:513-517.
9. Trepicchio WL, Williams GA, Essayan D, et al. Pharmacogenomic data submissions to the FDA: clinical case studies. Pharmacogenomics 2004; 5:519-524.
10. Frueh FW, Huang SM, Lesko LJ. Regulatory acceptance of toxicogenomics data. Environ Health Perspect 2004; 112(August):A663-A664.
11. Lesko L, Woodcock J. Translation of pharmacogenomics and pharmacoge-netics: a regulatory perspective. Nat Rev Drug Discov 2004; 3:763-770.
12. Guideline on Pharmacogenetics Briefing Meetings (London, March 17, 2005. EMEA/CHMP/20227/2004). http://www.emea.eu.int/pdfs/human/pharma-cogenetics/2022704en.pdf.
13. Tong W, Cao X, Harris S, et al. ArrayTrack-Supporting Toxicogenomic Research at the FDA's National Center for Toxicological Research (NCTR). Environ Health Persp 2003; 111:1819-1826.
14. Cronin M, Ghosh K, Sistare F, Quackenbush J, Vilker V, O'Connell C. Universal RNA reference materials for gene expression. Clin Chem 2004; 50: 1464-1471.
15. MicroArray Quality Control (MAQC) project. 2006. http://www.fda.gov/nctr/science/centers/toxicoinformatics/maqc/.
16. External RNA Control Consortium Workshop: Specifications for Universal External RNA Spike-In Controls. National Institute of Standards and Technology. 2003. http://www.cstl.nist.gov/biotech/workshops/ERCC2003/.
17. Use of External RNA Spike-In Controls in Gene Expression Assays. 2005. http://www.nccls.org/Template.cfm?Section=Projects_in_Development8.
18. Workshop on Fluorescence Standards for Microarray Assays. 2002. http://www.cstl.nist.gov/biotech/fluormicroarray/FluorescentStdsForMicroarrays2002Notes.pdf.
19. Electronic Regulatory Submissions and Review. 2005. http://www.fda.gov/cder/regulatory/ersr/default.htm.
20. Thukral S, Nordone P, Hu R, et al. Prediction of nephrotoxicant action and identification of candidate toxicity-related biomarkers. Toxical Pathol, 2005; 33:343-355.
21. Castle A, Carver M, Mendrick D. Toxicogenomics: a new revolution in drug safety. Drug Discovery Today 2002; 7:728-736.
22. Ganter B, Tugendreich S, Pearson CI, et al. 2005. Development of a large-scale chemogenomics database to improve drug candidate selection and to understand mechanisms of chemical toxicity and action. J Biotechnol 2005; 119(3):219-244.
23. Fielden MR, Pearson C, Brennan R, Kolaja KL. Preclinical drug safety analysis by chemogenomic profiling in the liver. Am J Pharmacogenomics 2005; 5(3):161-171.
24. Thompson KL, Afshari CA, Amin RP, et al. Identification of platform-independent gene expression markers of cisplatin nephrotoxicity. Environ Health Perspect. 2004; 112:488-494.
25. Amin RP, Vickers AE, Sistare F, et al. Identification of putative gene based markers of renal toxicity. Environ Health Perspect 2004; 112:465-479.
26. Kramer JA, Pettit SD, Amin RP, et al. Overview on the application of transcription profiling using selected nephrotoxicants for toxicology assessment. Environ Health Perspect 2004; 112:460-446.
27. Davis JW II, Goodsaid FM, Bral CM, et al. Quantitative gene expression analysis in a nonhuman primate model of antibiotic-induced nephrotoxicity. Toxicol Appl Pharmacol 2004; 200:16-26.
28. Ichimura T, Bonventre JV, Bailly V, et al. Kidney injury molecule-1 (KIM-1), a putative epithelial cell adhesion molecule containing a novel immunoglobulin domain, is up-regulated in renal cells after injury. J Biol Chem 1998; 273: 4135-1142.
29. Han WK, Bailly V, Abichandani R, Thadhani R, Bonventre JV. Kidney Injury Molecule-1 (KIM-1): a novel biomarker for human renal proximal tubule injury. Kidney Int 2002; 62:237-244.
30. The Validation Process at ECVAM. 2005. http://ecvam.jrc.it/index.htm.
31. The ICCVAM Test Method Evaluation Process. 2005. http://iccvam.niehs.-nih.gov/about/overview.htm.
32. Corvi et al. Validation of toxicogenomics-based test Systems: ECVAM- ICC-VAM/NICEATM considerations for regulatory Use. EHP. Epub ahead of print. doi:10.1289/ehp.8247.