Preclinical predictors of clinical safety: Opportunities for improvement

Clinical Pharmacology and Therapeutics

Volumn 82, Issue 2, 2007, Pages 210-214

  Sistare, F D ^a   DeGeorge, J J ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

16ALPHA CYANOPREGNENOLONE; BIOLOGICAL MARKER; EFAVIRENZ; MIDAZOLAM; PEROXISOME PROLIFERATOR ACTIVATED RECEPTOR ALPHA; RIFAMPICIN; TOXIN;

DECISION MAKING; DRUG EFFICACY; DRUG INDUSTRY; DRUG SAFETY; EXPERIMENTAL MODEL; EXPLORATORY RESEARCH; GENETIC ENGINEERING; HUMAN; NONHUMAN; PREDICTOR VARIABLE; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT;

ANIMALS; CLINICAL TRIALS; DISEASE MODELS, ANIMAL; DRUG APPROVAL; DRUG EVALUATION, PRECLINICAL; DRUG TOXICITY; DRUGS, INVESTIGATIONAL; HUMANS;

EID: 34447568267     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/sj.clpt.6100243     Document Type: Review

References (27)

1. International Conference on Harmonization Guidance for Industry: M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, http://www.fda.gov/cder/guidance/1855fnl.pdf (July 1997).
2. Kola, I. & Landis, J. Can the pharmaceutical industry reduce attrition rates? Nat. Rev. Drug Discov. 3, 711-715 (2004).
3. Olson, H. et al. Concordance of the toxicity of pharmaceuticals in humans and in animals. Regul. Toxicol. Pharmacol. 32, 56-67 (2000).
4. Mutlib, A.E. et al. The species-dependent metabolism of efavirenz produces a nephrotoxic glutathione conjugate in rats. Toxicol. Appl. Pharmacol. 169, 102-113 (2000).
5. Donehower, L.A. et al. Mice deficient for p53 are developmentally normal but susceptible to spontaneous tumors. Nature 356, 215-221 (1992).
6. Saitoh, A. et al. Most tumors in transgenic mice with human c-Ha-ras gene contained somatically activated transgenes. Oncogene 5, 1195-1200 (1990).
7. Pritchard, J.B. et al. The role of transgenic mouse models in carcinogen identification. Environ. Health Perspect. 111, 444-454 (2003).
8. Gonzalez, F.J. & Yu, A.-M. Cytochrome P450 and xenobiotic receptor humanized mice. Annu. Rev. Pharmacol. Toxicol. 46, 41-64 (2006).
9. Ma, X. et al. The PREgnane X receptor gene-humanized mouse: a model for investigating drug-drug interactions mediated by cytochromes P450 3A. Drug Metab. Dispos. 35, 194-200 (2007).
10. Gonzalez, F.J., Peters, J.M. & Cattley, R.C. Mechanism of action of the nongenotoxic peroxisome proliferators: role of the peroxisome proliferator-activator receptor alpha. J. Natl. Cancer Inst. 90, 1702-1709 (1998).
11. Zhang, J. et al. Mechanisms and biomarkers of cardiovascular injury induced by phosphodiesterase inhibitor III SK&F 95654 in the spontaneously hypertensive rat. Toxicol. Pathol. 34, 152-163 (2006).
12. Stewart, J. & Turner, K.J. Inhibin B as a potential biomarker of testicular toxicity. Cancer Biomark 1, 75-91 (2005).
13. Cummins, B., Auckland, M.L. & Cummins, P. Cardiac-specific troponin-I radioimmunoassay in the diagnosis of acute myocardial infarction. Am. Heart J. 113, 1333-1344 (1987).
14. Antman, E. et al. Myocardial infarction redefined - a consensus document of the joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of myocardial infarction. J. Am. Coll. Cardiol. 36, 959-969 (2000).
15. Ichimura, T. 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. 273, 4135-4142 (1998).
16. Han, W. et al. Kidney injury molecule-1 (KIM-1): a novel biomarker for human renal proximal tubule injury. Kidney Int. 62, 237-244 (2002).
17. Amin, R.P. et al. Identification of putative gene based markers of renal toxicity. Environ. Health Perspect. 112, 465-479 (2004).
18. Sistare, F.D. & Vonderscher, J. Impact on drug development and regulatory review of the qualification of novel biomarkers of nephrotoxicity. Toxicologist, 444 (2007).
19. Woodcock, J. Combining research with clinical study, http://www.fda.gov/ cder/livertox/presentations2007/Woodcock2.pdf (24 January 2007).
20. Food and Drug Administration. Innovation or Stagnation? Challenge and Opportunity on the Critical Path to New Medical Products, http://www.fda.gov/oc/ initiatives/criticalpath/whitepaper.pdf (16 March 2004).
21. Food and Drug Administration. Guidance for Industry: Pharmacogenomic Data Submissions, http://www.fda.gov/cder/guidance/6400fnl.pdf (May 2005).
22. Wagner, J.A., Williams, S.A. & Webster, C.J. Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs. Clin. Pharmacol. Ther. 81, 104-107 (2007).
23. Wilson, C., Schulz, S. & Waldman, S.A. Biomarker development, commercialization, and regulation: individualization of medicine lost in translation. Clin. Pharmacol. Ther. 81, 153-155 (2007).
24. Food and Drug Administration. Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies, http://www.fda.gov/cder/guidance/7086fnl.pdf (January 2006).
25. Boyd, R.A. & Lalonde, R.L. Nontraditional approaches to first-in-human studies to increase efficiency of drug development: will microdose studies make a significant impact? Clin. Pharmacol. Ther. 81, 24-26 (2007).
26. Wu, A.H.B., et al. Evaluation of a point-of-care assay for cardiac markers for patients suspected of acute myocardial infarction. Clin. Chim. Acta 346, 211-219 (2004).
27. Zheng, G. et al. Multiplexed electrical detection of cancer markers with nanowire sensor arrays. Nat. Biotechnol. 23, 1294-1301 (2005).