937
Views
49
CrossRef citations to date
0
Altmetric
Reviews

Tissue-specific, non-invasive toxicity biomarkers: translation from preclinical safety assessment to clinical safety monitoring

&
Pages 1023-1038 | Published online: 17 Jul 2009

Bibliography

  • Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther 2001;69:89-95
  • Marrer E, Dieterle F. Biomarkers in oncology drug development: rescuers or troublemakers? Expert Opin Drug Metab Toxicol 2008;4:1391-402
  • CHMP/EMEA. Final Report on the Pilot Joint EMEA/FDA VXDS experience on qualification on nephrotoxicity biomarkers. 2008
  • Ozer J, Ratner M, Shaw M, et al. The current state of serum biomarkers of hepatotoxicity. Toxicology 2008;245:194-205
  • CDER/FDA. Guidance for industry: bioanalytical method validation. 2001
  • Lee JW, Devanarayan V, Barrett YC, et al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm Res 2006;23:312-28
  • DeSilva B, Smith W, Weiner R, et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res 2003;20:1885-900
  • Smolec J, DeSilva B, Smith W, et al. Bioanalytical method validation for macromolecules in support of pharmacokinetic studies. Pharm Res 2005;22:1425-31
  • Viswanathan CT, Bansal S, Booth B, et al. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. Pharm Res 2007;24:1962-73
  • Goodsaid F, Frueh F. Biomarker qualification pilot process at the US Food and Drug Administration. AAPS J 2007;9:E105-8
  • Wagner JA. Strategic approach to fit-for-purpose biomarkers in drug development. Annu Rev Pharmacol Toxicol 2008;48:631-51
  • CDER-CBER-CDRH/FDA. Guidance for industry: pharmacogenomic data submissions. 2005
  • Dieterle F, Marrer E, Suzuki E, et al. Monitoring kidney safety in drug development: emerging technologies and their implications. Curr Opin Drug Discov Dev 2008;11:60-71
  • Available from: PSTC, http://www.c-path.org/pstc.cfm.
  • CHMP/EMEA. Biomarkers qualification: guidance to applicants. 2008
  • Temple R. Hy's law: predicting serious hepatotoxicity. Pharmacoepidemiol Drug Saf 2006;15:241-3
  • Available from: http://ltbs.bg-medicine.com
  • Available from: http://www.fda.gov/oc/initiatives/criticalpath
  • Hunt CM, Papay JI, Edwards RI, et al. Monitoring liver safety in drug development: the GSK experience. Regul Toxicol Pharmacol 2007;49:90-100
  • Giannini EG, Testa R, Savarino V. Liver enzyme alteration: a guide for clinicians. CMAJ 2005;172:367-79
  • Murayama H, Ikemoto M, Nagata A. Marked elevation of serum mitochondrion-derived markers in mild models of non-alcoholic steatohepatitis in rats. J Gastroenterol Hepatol 2009;24:270-7
  • Clarke H, Egan DA, Heffernan M, et al. Alpha-glutathione s-transferase (alpha-GST) release, an early indicator of carbon tetrachloride hepatotoxicity in the rat. Hum Exp Toxicol 1997;16:154-7
  • Higuchi H, Adachi Y, Wada H, et al. Comparison of plasma alpha glutathione S-transferase concentrations during and after low-flow sevoflurane or isoflurane anaesthesia. Acta Anaesthesiol Scand 2001;45:1226-9
  • Kaplowitz N. Idiosyncratic drug hepatotoxicity. Nat Rev Drug Discov 2005;4:489-99
  • CDER-CBER/FDA. Guidance for industry: drug-induced liver injury: premarketing clinical evaluation. 2005
  • Chalasani N. Statins and hepatotoxicity: focus on patients with fatty liver. Hepatology 2005;41:690-5
  • Bosch JP. Renal reserve: a functional view of glomerular filtration rate. Semin Nephrol 1995;15:381-5
  • Hjalmarsson C, Ohlson M, Haraldsson B. Puromycin aminonucleoside damages the glomerular size barrier with minimal effects on charge density. Am J Physiol Renal Physiol 2001;281:F503-12
  • Izzedine H, Launay-Vacher V, Bourry E, et al. Drug-induced glomerulopathies. Expert Opin Drug Saf 2006;5:95-106
  • Russo LM, Sandoval RM, Campos SB, et al. Impaired tubular uptake explains albuminuria in early diabetic nephropathy. J Am Soc Nephrol 2009;20:489-94
  • Han WK, Bailly V, Abichandani R, et al. Kidney Injury Molecule-1 (KIM-1): a novel biomarker for human renal proximal tubule injury. Kidney Int 2002;62:237-44
  • Vaidya VS, Ramirez V, Ichimura T, et al. Urinary kidney injury molecule-1: a sensitive quantitative biomarker for early detection of kidney tubular injury. Am J Physiol Renal Physiol 2006;290:F517-29
  • Mishra J, Mori K, Ma Q, et al. Neutrophil gelatinase-associated lipocalin: a novel early urinary biomarker for cisplatin nephrotoxicity. Am J Nephrol 2004;24:307-15
  • Mishra J, Dent C, Tarabishi R, et al. Neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker for acute renal injury after cardiac surgery. Lancet 2005;365:1231-8
  • Bachorzewska-Gajewska H, Malyszko J, Sitniewska E, et al. NGAL (neutrophil gelatinase-associated lipocalin) and cystatin C: are they good predictors of contrast nephropathy after percutaneous coronary interventions in patients with stable angina and normal serum creatinine? Int J Cardiol 2008;127:290-1
  • Usuda K, Kono K, Dote T, et al. Urinary biomarkers monitoring for experimental fluoride nephrotoxicity. Arch Toxicol 1998;72:104-9
  • Branten AJ, Mulder TP, Peters WH, et al. Urinary excretion of glutathione S transferases alpha and pi in patients with proteinuria: reflection of the site of tubular injury. Nephron 2000;85:120-6
  • Vickers AE, Rose K, Fisher R, et al. Kidney slices of human and rat to characterize cisplatin-induced injury on cellular pathways and morphology. Toxicol Pathol 2004;32:577-90
  • Pai MP, Norenberg JP, Telepak RA, et al. Assessment of effective renal plasma flow, enzymuria, and cytokine release in healthy volunteers receiving a single dose of amphotericin B desoxycholate. Antimicrob Agents Chemother 2005;49:3784-8
  • Sundberg AG, Appelkvist EL, Backman L, Dallner G. Urinary pi-class glutathione transferase as an indicator of tubular damage in the human kidney. Nephron 1994;67:308-16
  • Naidu SG, Lee FT Jr. Contrast nephrotoxicity: predictive value of urinary enzyme markers in a rat model. Acad Radiol 1994;1:3-9
  • Liangos O, Perianayagam MC, Vaidya VS, et al. Urinary N-acetyl-beta-(D)-glucosaminidase activity and kidney injury molecule-1 level are associated with adverse outcomes in acute renal failure. J Am Soc Nephrol 2007;18:904-12
  • Roald AB, Aukland K, Tenstad O. Tubular absorption of filtered cystatin-C in the rat kidney. Exp Physiol 2004;89:701-7
  • Conti M, Moutereau S, Zater M, et al. Urinary cystatin C as a specific marker of tubular dysfunction. Clin Chem Lab Med 2006;44:288-91
  • Dharnidharka VR, Kwon C, Stevens G. Serum cystatin C is superior to serum creatinine as a marker of kidney function: a meta-analysis. Am J Kidney Dis 2002;40:221-6
  • Trof RJ, Di Maggio F, Leemreis J, Groeneveld AB. Biomarkers of acute renal injury and renal failure. Shock 2006;26:245-53
  • Elzinga LW, Rosen S, Bennett WM. Dissociation of glomerular filtration rate from tubulointerstitial fibrosis in experimental chronic cyclosporine nephropathy: role of sodium intake. J Am Soc Nephrol 1993;4:214-21
  • Reasor MJ, Kacew S. Drug-induced phospholipidosis: are there functional consequences? Exp Biol Med (Maywood) 2001;226:825-30
  • Reasor MJ, Hastings KL, Ulrich RG. Drug-induced phospholipidosis: issues and future directions. Expert Opin Drug Saf 2006;5:567-83
  • Halliwell WH. Cationic amphiphilic drug-induced phospholipidosis. Toxicol Pathol 1997;25:53-60
  • Ikeda K, Hirayama M, Hirota Y, et al. Drug-induced phospholipidosis is caused by blockade of mannose 6-phosphate receptor-mediated targeting of lysosomal enzymes. Biochem Biophys Res Commun 2008;377:268-74
  • Sawada H, Takami K, Asahi S. A toxicogenomic approach to drug-induced phospholipidosis: analysis of its induction mechanism and establishment of a novel in vitro screening system. Toxicol Sci 2005;83:282-92
  • Feldman S, Wang MY, Kaloyanides GJ. Aminoglycosides induce a phospholipidosis in the renal cortex of the rat: an early manifestation of nephrotoxicity. J Pharmacol Exp Ther 1982;220:514-20
  • Sundin DP, Sandoval R, Molitoris BA. Gentamicin inhibits renal protein and phospholipid metabolism in rats: implications involving intracellular trafficking. J Am Soc Nephrol 2001;12:114-23
  • Mortuza GB, Neville WA, Delaney J, et al. Characterisation of a potential biomarker of phospholipidosis from amiodarone-treated rats. Biochim Biophys Acta 2003;1631:136-46
  • Baronas ET, Lee JW, Alden C, Hsieh FY. Biomarkers to monitor drug-induced phospholipidosis. Toxicol Appl Pharmacol 2007;218:72-8
  • Delaney J, Neville WA, Swain A, et al. Phenylacetylglycine, a putative biomarker of phospholipidosis: its origins and relevance to phospholipid accumulation using amiodarone treated rats as a model. Biomarkers 2004;9:271-90
  • Yavuz T, Altuntas I, Delibas N, et al. Cardiotoxicity in rats induced by methidathion and ameliorating effect of vitamins E and C. Hum Exp Toxicol 2004;23:323-9
  • Urbanova D, Urban L, Carter A, et al. Cardiac troponins–biochemical markers of cardiac toxicity after cytostatic therapy. Neoplasma 2006;53:183-90
  • Bertinchant JP, Robert E, Polge A, et al. Comparison of the diagnostic value of cardiac troponin I and T determinations for detecting early myocardial damage and the relationship with histological findings after isoprenaline-induced cardiac injury in rats. Clin Chim Acta 2000;298:13-28
  • Polanczyk CA, Lee TH, Cook EF, et al. Cardiac troponin I as a predictor of major cardiac events in emergency department patients with acute chest pain. J Am Coll Cardiol 1998;32:8-14
  • Chew HC. Cardiac troponin T in acute coronary syndrome with renal insufficiency. Asian Cardiovasc Thorac Ann 2008;16:284-7
  • Okumura H, Iuchi K, Yoshida T, et al. Brain natriuretic peptide is a predictor of anthracycline-induced cardiotoxicity. Acta Haematol 2000;104:158-63
  • Koh E, Nakamura T, Takahashi H. Troponin-T and brain natriuretic peptide as predictors for adriamycin-induced cardiomyopathy in rats. Circ J 2004;68:163-7
  • Kropp S, Tountopoulou A, Schneider U, Lichtinghagen R. N-terminal fragment of B-type natriuretic peptide (NT-proBNP), a marker of cardiac safety during antipsychotic treatment. Ann Gen Psychiatry 2005;4:10
  • Sandri MT, Salvatici M, Cardinale D, et al. N-terminal pro-B-type natriuretic peptide after high-dose chemotherapy: a marker predictive of cardiac dysfunction? Clin Chem 2005;51:1405-10
  • Buzzard JJ, Loveland KL, O'Bryan MK, et al. Changes in circulating and testicular levels of inhibin A and B and activin A during postnatal development in the rat. Endocrinology 2004;145:3532-41
  • Blumenfeld Z. Preservation of fertility and ovarian function and minimalization of chemotherapy associated gonadotoxicity and premature ovarian failure: the role of inhibin-A and -B as markers. Mol Cell Endocrinol 2002;187:93-105
  • Cicognani A, Cacciari E, Pasini A, et al. Low serum inhibin B levels as a marker of testicular damage after treatment for a childhood malignancy. Eur J Pediatr 2000;159:103-7
  • Available from: http://www.hesiglobal.org
  • Kerns W, Schwartz L, Blanchard K, et al. Drug-induced vascular injury–a quest for biomarkers. Toxicol Appl Pharmacol 2005;203:62-87
  • Dagues N, Pawlowski V, Sobry C, et al. Investigation of the molecular mechanisms preceding PDE4 inhibitor-induced vasculopathy in rats: tissue inhibitor of metalloproteinase 1, a potential predictive biomarker. Toxicol Sci 2007;100:238-47
  • Losco PE, Evans EW, Barat SA, et al. The toxicity of SCH 351591, a novel phosphodiesterase-4 inhibitor, in Cynomolgus monkeys. Toxicol Pathol 2004;32:295-308
  • Bian H, Zhang J, Wu P, et al. Differential type 4 cAMP-specific phosphodiesterase (PDE4) expression and functional sensitivity to PDE4 inhibitors among rats, monkeys and humans. Biochem Pharmacol 2004;68:2229-36
  • Giembycz MA. An update and appraisal of the cilomilast Phase III clinical development programme for chronic obstructive pulmonary disease. Br J Clin Pharmacol 2006;62:138-52
  • Nagashima H, Maeda-Nakamura K, Iwashita K, Goto T. Induced secretion of tissue inhibitor of metalloproteinases-1 (TIMP-1) in vivo and in vitro by hepatotoxin rubratoxin B. Food Chem Toxicol 2006;44:1138-43
  • Sieber M, Hoffmann D, Adler M, et al. Comparative analysis of novel noninvasive renal biomarkers and metabonomic changes in a rat model of gentamicin nephrotoxicity. Toxicol Sci 2009;109:336-49
  • Ketteler M, Giachelli C. Novel insights into vascular calcification. Kidney Int Suppl 2006;105:S5-9
  • Cranenburg EC, Vermeer C, Koos R, et al. The circulating inactive form of matrix Gla Protein (ucMGP) as a biomarker for cardiovascular calcification. J Vasc Res 2008;45:427-36
  • Available from: http://www.azbio.org/images/BIOZONA%20Presentations/Biomarkers%20Mattes.pdf.
  • Brott D, Gould S, Jones H, et al. Biomarkers of drug-induced vascular injury. Toxicol Appl Pharmacol 2005;207:441-5
  • Le Moine O, Devaster JM, Deviere J, et al. Trypsin activity. A new marker of acute alcoholic pancreatitis. Dig Dis Sci 1994;39:2634-8
  • Neoptolemos JP, Kemppainen EA, Mayer JM, et al. Early prediction of severity in acute pancreatitis by urinary trypsinogen activation peptide: a multicentre study. Lancet 2000;355:1955-60
  • Wang Y, Naruse S, Kitagawa M, et al. Urinary excretion of trypsinogen activation peptide (TAP) in taurocholate-induced pancreatitis in rats. Pancreas 2001;22:24-7
  • CDER/FDA. Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. 2005
  • Campbell JA, Corrigall AV, Guy A, Kirsch RE. Immunohistologic localization of alpha, mu, and pi class glutathione S-transferases in human tissues. Cancer 1991;67:1608-13
  • Hidaka S, Kranzlin B, Gretz N, Witzgall R. Urinary clusterin levels in the rat correlate with the severity of tubular damage and may help to differentiate between glomerular and tubular injuries. Cell Tissue Res 2002;310:289-96
  • Aoyagi T, Hayakawa K, Miyaji K, et al. Cadmium nephrotoxicity and evacuation from the body in a rat modeled subchronic intoxication. Int J Urol 2003;10:332-8
  • Kinai E, Hanabusa H. Renal tubular toxicity associated with tenofovir assessed using urine-beta 2 microglobulin, percentage of tubular reabsorption of phosphate and alkaline phosphatase levels. AIDS 2005;19:2031-3
  • Tenner S, Fernandez-del Castillo C, Warshaw A, et al. Urinary trypsinogen activation peptide (TAP) predicts severity in patients with acute pancreatitis. Int J Pancreatol 1997;21:105-10
  • Reisler RB, Murphy RL, Redfield RR, Parker RA. Incidence of pancreatitis in HIV-1-infected individuals enrolled in 20 adult AIDS clinical trials group studies: lessons learned. J Acquir Immune Defic Syndr 2005;39:159-66
  • Bennett M, Dent CL, Ma Q, et al. Urine NGAL predicts severity of acute kidney injury after cardiac surgery: a prospective study. Clin J Am Soc Nephrol 2008;3:665-73

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.