Assessment of the impact of renal impairment on systemic exposure of new molecular entities: Evaluation of recent new drug applications

Clinical Pharmacology and Therapeutics

Volumn 85, Issue 3, 2009, Pages 305-311

  Zhang, Y ^a   Zhang, L ^a   Abraham, S ^a   Apparaju, S ^a   Wu, T C ^a   Strong, J M ^b   Xiao, S ^b   Atkinson Jr , A J ^a   Thummel, K E ^a   Leeder, J S ^a   Lee, C ^a   Burckart, G J ^a   Lesko, L J ^a   Huang, S M ^a  

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

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

Author keywords

[No Author keywords available]

Indexed keywords

ACAMPROSATE; ALFUZOSIN; ALISKIREN; APREPITANT; DARIFENACIN; DULOXETINE; EMTRICITABINE; ENTECAVIR; GEMIFLOXACIN; IBANDRONIC ACID; LANTHANUM; MEMANTINE; MIGLUSTAT; PALIPERIDONE; PREGABALIN; RANOLAZINE; ROSUVASTATIN; SITAGLIPTIN; SOLIFENACIN; TADALAFIL; TELBIVUDINE; TELITHROMYCIN; TINIDAZOLE; TROSPIUM CHLORIDE; VARDENAFIL; VARENICLINE;

AREA UNDER THE CURVE; ARTICLE; CREATININE BLOOD LEVEL; DRUG ABSORPTION; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG ELIMINATION; DRUG EXCRETION; DRUG METABOLISM; DRUG SCREENING; DRUG TRANSPORT; FOOD AND DRUG ADMINISTRATION; GLOMERULUS FILTRATION RATE; HEALTH SURVEY; HEMODIALYSIS; HUMAN; KIDNEY FAILURE; KIDNEY FUNCTION; MAXIMUM PLASMA CONCENTRATION; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE;

DRUGS, INVESTIGATIONAL; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; KIDNEY DISEASES; PRACTICE GUIDELINES AS TOPIC;

EID: 60349107936     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2008.208     Document Type: Article

References (25)

1. Coresh, J. et al. Prevalence of chronic kidney disease in the United States. JAMA 298, 2038-2047 (2007).
2. Matzke, G.R. & Frye, R.F. Drug administration in patients with renal insufficiency. Minimising renal and extrarenal toxicity. Drug Saf. 16, 205-231 (1997).
3. Dreisbach, A.W. & Lertora, J.J. The effect of chronic renal failure on hepatic drug metabolism and drug disposition. Semin. Dial. 16, 45-50 (2003).
4. Nolin, T.D., Naud, J., Leblond, F.A. & Pichette, V. Emerging evidence of the impact of kidney disease on drug metabolism and transport. Clin. Pharmacol. Ther. 83, 898-903 (2008).
5. Reidenberg, M.M. & Drayer, D.E. Drug metabolism and active drug metabolites in renal failure. J. Dial. 1, 313-318 (1977).
6. Sun, H., Frassetto, L. & Benet, L.Z. Effects of renal failure on drug transport and metabolism. Pharmacol. Ther. 109, 1-11 (2006).
7. Touchette, M.A. & Slaughter, R.L. The effect of renal failure on hepatic drug clearance. DICP 25, 1214-1224 (1991).
8. Yuan, R. & Venitz, J. Effect of chronic renal failure on the disposition of highly hepatically metabolized drugs. Int. J. Clin. Pharmacol. Ther. 38, 245-253 (2000).
9. Gibbons, J. et al. Phase I and pharmacokinetic study of imatinib mesylate in patients with advanced malignancies and varying degrees of renal dysfunction: a study by the National Cancer Institute Organ Dysfunction Working Group. J. Clin. Oncol. 26, 570-576 (2008).
10. Guévin, C., Michaud, J., Naud, J., Leblond, F.A. & Pichette, V. Down-regulation of hepatic cytochrome p450 in chronic renal failure: role of uremic mediators. Br. J. Pharmacol. 137, 1039-1046 (2002).
11. Leblond, F.A., Giroux, L., Villeneuve, J.P. & Pichette, V. Decreased in vivo metabolism of drugs in chronic renal failure. Drug Metab. Dispos. 28, 1317-1320 (2000).
12. Glassock, R.J. Uremic toxins: what are they? An integrated overview of pathobiology and classification. J. Ren. Nutr. 18, 2-6 (2008).
13. Niwa, T. Organic acids and the uremic syndrome: protein metabolite hypothesis in the progression of chronic renal failure. Semin. Nephrol. 16, 167-182 (1996).
14. Michaud, J. et al. Effects of serum from patients with chronic renal failure on rat hepatic cytochrome P450. Br. J. Pharmacol. 144, 1067-1077 (2005).
15. Hanada, K. et al. Effects of indoxylsulfate on the in vitro hepatic metabolism of various compounds using human liver microsomes and hepatocytes. Nephron Physiol. 103, 179-186 (2006).
16. Dowling, T.C. et al. Characterization of hepatic cytochrome p4503A activity in patients with end-stage renal disease. Clin. Pharmacol. Ther. 73, 427-434 (2003).
17. Kanfer, A., Stamatakis, G., Torlotin, J.C., Fredj, G., Kenouch, S. & Méry, J.P. Changes in erythromycin pharmacokinetics induced by renal failure. Clin. Nephrol. 27, 147-150 (1987).
18. Nolin, T.D., Appiah, K., Kendrick, S.A., Le, P., McMonagle, E. & Himmelfarb, J. Hemodialysis acutely improves hepatic CYP3A4 metabolic activity. J. Am. Soc. Nephrol. 17, 2363-2367 (2006).
19. US Food and Drug Administration Center for Drug Evaluation and Research. Guidance for Industry: Pharmacokinetics in Patients With Impaired Renal Function - Study Design, Data Analysis, and Impact on Dosing and Labeling 〈http://www.fda.gov/cder/guidance〉 (1998).
20. US Food and Drug Administration. Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting, 19 March 2008 〈http://www.fda. gov/ohrms/dockets/ac/cder08.html#PharmScience〉 (2008).
21. Ibrahim, S., Honig, P., Huang, S.M., Gillespie, W., Lesko, L.J. & Williams, R.L. Clinical pharmacology studies in patients with renal impairment: past experience and regulatory perspectives. J. Clin. Pharmacol. 40, 31-38 (2000).
22. US Food and Drug Administration Center for Drug Evaluation and Research. Drug Information in Drugs@FDA 〈http://www.accessdata.fda.gov/ scripts/cder/drugsatfda/index.cfm〉 (2008).
23. US Food and Drug Administration. The Preliminary Concept Paper: Pharmacokinetics in Patients With Impaired Renal Function - Study Design, Data Analysis, and Impact on Dosing and Labeling 〈http://www.fda.gov/ohrms/ dockets/ac/08/briefing/2008-4351b1-00-index.htm〉 (2008) 57-73.
24. De Martin, S., Orlando, R., Bertoli, M., Pegoraro, P. & Palatini, P. Differential effect of chronic renal failure on the pharmacokinetics of lidocaine in patients receiving and not receiving hemodialysis. Clin. Pharmacol. Ther. 80, 597-606 (2006).
25. Benet, L.Z., Cummins, C.L. & Wu, C.Y. Unmasking the dynamic interplay between efflux transporters and metabolic enzymes. Int. J. Pharm. 277, 3-9 (2004).