Drug development perspective on pharmacokinetic studies of new drugs in patients with renal impairment

Clinical Pharmacology and Therapeutics

Volumn 86, Issue 5, 2009, Pages 557-561

  Lalonde, R L ^a   Wagner, J A ^b  

^a PFIZER INC   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIINFECTIVE AGENT; CREATININE; NEW DRUG; PREGABALIN; TELITHROMYCIN;

CREATININE BLOOD LEVEL; CREATININE CLEARANCE; DECISION TREE; DRUG CLEARANCE; DRUG DEVELOPMENT; DRUG ELIMINATION; FOOD AND DRUG ADMINISTRATION; GLOMERULUS FILTRATION RATE; HUMAN; KIDNEY; KIDNEY FAILURE; KIDNEY FUNCTION; PHARMACOKINETICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; SHORT SURVEY;

CLINICAL TRIALS AS TOPIC; DECISION TREES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG DESIGN; DRUG DOSAGE CALCULATIONS; FEMALE; HUMANS; MALE; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; PRACTICE GUIDELINES AS TOPIC; RENAL INSUFFICIENCY; SEVERITY OF ILLNESS INDEX;

EID: 70350217334     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2009.182     Document Type: Short Survey

References (19)

1. Coresh, J. et al. Prevalence of chronic kidney disease in the United States. JAMA 298, 2038-2047 (2007). (Pubitemid 350074801)
2. US Food and Drug Administration. Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function-Study Design, Data Analysis, and Impact on Dosing and Labeling (1998).
3. European Medicines Agency. Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function-Study Design, Data Analysis, and Impact on Dosing and Labeling (2004).
4. Zhang, Y. et al. Assessment of the impact of renal impairment on systemic exposure of new molecular entities: evaluation of recent new drug applications. Clin. Pharmacol. Ther. 85, 305-311 (2009).
5. 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).
6. US Food and Drug Administration. March 2008 FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee (2008).
7. Shi, J. et al. Pharmacokinetics and safety of the ketolide telithromycin in patients with renal impairment. J. Clin. Pharmacol. 44, 234-244 (2004).
8. Cockcroft, D.W. & Gault, M.H. Prediction of creatinine clearance from serum creatinine. Nephron 16, 31-41 (1976).
9. Levey, A.S., Bosch, J.P., Lewis, J.B., Greene, T., Rogers, N. & Roth, D. A more accurate method to estimate glomerular fltration rate from serum creatinine: a new prediction equation. Modifcation of Diet in Renal Disease Study Group. Ann. Intern. Med. 130, 461-470 (1999).
10. Roubenof, R., Drew, H., Moyer, M., Petri, M., Whiting-O'Keefe, Q. & Hellmann, D.B. Oral cimetidine improves the accuracy and precision of creatinine clearance in lupus nephritis. Ann. Intern. Med. 113, 501-506 (1990).
11. Stevens, L.A., Coresh, J., Greene, T. & Levey, A.S. Assessing kidney function-measured and estimated glomerular fltration rate. N. Engl. J. Med. 354, 2473-2483 (2006).
12. National Kidney Foundation. Kidney disease outcome quality initiative, clinical practice guidelines for chronic kidney disease: evaluation, classifcation, and stratifcation. Part 5: evaluation of laboratory measurements for clinical assessment of kidney disease. Guideline 4: estimate of glomerular fltration rate (2002). Accessed 1 July 2009.
13. Levey, A.S. et al. A new equation to estimate glomerular fltration rate. Ann. Intern. Med. 150, 604-612 (2009).
14. Sarafdis, P.A. & Bakris, G.L. Does evidence support renin-angiotensin system blockade for slowing nephropathy progression in elderly persons? Ann. Intern. Med. 150, 731-733 (2009).
15. Wolowich, W.R., Raymo, L. & Rodriguez, J.C. Problems with the use of the modifed diet in renal disease formula to estimate renal function. Pharmacotherapy 25, 1283-1284; discussion 1284 (2005).
16. Bauer, L. Creatinine clearance versus glomerular fltration rate for the use of renal drug dosing in patients with kidney dysfunction. Pharmacotherapy 25, 1286-1287; discussion 1287 (2005).
17. Wargo, K.A., Eiland, E.H., Hamm, W., English, T.M. & Phillippe, H.M. Comparison of the modifcation of diet in renal disease and Cockcroft-Gault equations for antimicrobial dosage adjustments. Ann. Pharmacother. 40, 1248-1253 (2006).
18. Golik, M.V. & Lawrence, K.R. Comparison of dosing recommendations for antimicrobial drugs based on two methods for assessing kidney function: Cockcroft-Gault and modifcation of diet in renal disease. Pharmacotherapy 28, 1125-1132 (2008).
19. Alvey, C.W. et al. Clinical pharmacokinetics of pregabalin in healthy volunteers. Diabetes 53, A470 (2004).