A semiphysiological population model for prediction of the pharmacokinetics of drugs under liver and renal disease conditions

Drug Metabolism and Disposition

Volumn 39, Issue 7, 2011, Pages 1278-1287

  Strougo, Ashley ^a,b   Yassen, Ashraf ^a   Krauwinkel, Walter ^a   Danhof, Meindert ^b   Freijer, Jan ^a  

^a Astellas Pharma Global Development   (Netherlands)

^b LEIDEN UNIVERSITY   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

LIVER ENZYME; PLASMA PROTEIN; SOLIFENACIN;

ADULT; ARTICLE; BIOLOGICAL MODEL; BODY COMPOSITION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG EXCRETION; DRUG LIVER LEVEL; DRUG PROTEIN BINDING; DRUG TISSUE LEVEL; DRUG URINE LEVEL; FEMALE; GLOMERULUS FILTRATION; HUMAN; KIDNEY DYSFUNCTION; LIVER BLOOD FLOW; LIVER DISEASE; MALE; PHARMACOKINETICS; PHYSIOLOGY; POPULATION MODEL; PREDICTION; PRIORITY JOURNAL; SINGLE DRUG DOSE;

HUMANS; KIDNEY DISEASES; LIVER DISEASES; MODELS, BIOLOGICAL; PHARMACOKINETICS;

EID: 79959484646     PISSN: 00909556     EISSN: 1521009X     Source Type: Journal    
DOI: 10.1124/dmd.110.037838     Document Type: Article

References (33)

1. Boer P (1984) Estimated lean body mass as an index for normalization of body fluid volumes in humans. Am J Physiol 247:F632-F636.
2. Choukèr A, Martignoni A, Dugas M, Eisenmenger W, Schauer R, Kaufmann I, Schelling G, Löhe F, Jauch KW, Peter K, et al. (2004) Estimation of liver size for liver transplantation: the impact of age and gender. Liver Transpl 10:678-685. (Pubitemid 38628230)
3. Cockcroft DW and Gault MH (1976) Prediction of creatinine clearance from serum creatinine. Nephron 16:31-41.
4. Doroshyenko O and Fuhr U (2009) Clinical pharmacokinetics and pharmacodynamics of solifenacin. Clin Pharmacokinet 48:281-302.
5. Dreisbach AW (2009) The influence of chronic renal failure on drug metabolism and transport. Clin Pharmacol Ther 86:553-556.
6. Dreisbach AW and Lertora JJ (2003) The effect of chronic renal failure on hepatic drug metabolism and drug disposition. Semin Dial 16:45-50. (Pubitemid 37356766)
7. Edginton AN and Willmann S (2008) Physiology-based simulations of a pathological condition: prediction of pharmacokinetics in patients with liver cirrhosis. Clin Pharmacokinet 47:743-752.
8. Gibaldi M and McNamara PJ (1978) Apparent volumes of distribution and drug binding to plasma proteins and tissues. Eur J Clin Pharmacol 13:373-380.
9. Hallifax D, Foster JA, and Houston JB (2010) Prediction of human metabolic clearance from in vitro systems: retrospective analysis and prospective view. Pharm Res 27:2150-2161.
10. Haycock GB, Schwartz GJ, and Wisotsky DH (1978) Geometric method for measuring body surface area: a height-weight formula validated in infants, children, and adults. J Pediatr 93:62-66. (Pubitemid 8351870)
11. Himmelfarb J, Evanson J, Hakim RM, Freedman S, Shyr Y, and Ikizler TA (2002) Urea volume of distribution exceeds total body water in patients with acute renal failure. Kidney Int 61:317-323. (Pubitemid 34075159)
12. Janmahasatian S, Duffull SB, Ash S, Ward LC, Byrne NM, and Green B (2005) Quantification of lean bodyweight. Clin Pharmacokinet 44:1051-1065. (Pubitemid 41356391)
13. Johnson TN, Boussery K, Rowland-Yeo K, Tucker GT, and Rostami-Hodjegan A (2010) A semi-mechanistic model to predict the effects of liver cirrhosis on drug clearance. Clin Pharmacokinet 49:189-206.
14. Johnson TN, Rostami-Hodjegan A, and Tucker GT (2006) Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children. Clin Pharmacokinet 45:931-956. (Pubitemid 44299829)
15. Krauwinkel WJ, Smulders RA, Mulder H, Swart PJ, and Taekema-Roelvink ME (2005) Effect of age on the pharmacokinetics of solifenacin in men and women. Int J Clin Pharmacol Ther 43:227-238. (Pubitemid 40668446)
16. Kuipers M, Smulders R, Krauwinkel W, and Hoon T (2006) Open-label study of the safety and pharmacokinetics of solifenacin in subjects with hepatic impairment. J Pharmacol Sci 102:405-412. (Pubitemid 44954600)
17. Kuipers ME, Krauwinkel WJ, Mulder H, and Visser N (2004) Solifenacin demonstrates high absolute bioavailability in healthy men. Drugs R D 5:73-81. (Pubitemid 38607628)
18. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, and Roth D (1999) A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med 130:461-470. (Pubitemid 29135798)
19. Mehvar R (2005) Role of protein binding in pharmacokinetics. Am J Pharm Educ 69:1-8.
20. Michel MC, Yanagihara T, Minematsu T, Swart PJ, and Smulders RA (2004) Disposition and metabolism of solifenacin in humans. Br J Clin Pharmacol 59:647.
21. Nolin TD, Naud J, Leblond FA, and Pichette V (2008) Emerging evidence of the impact of kidney disease on drug metabolism and transport. Clin Pharmacol Ther 83:898-903. (Pubitemid 351704931)
22. Payne CK (2006) Solifenacin in overactive bladder syndrome. Drugs 66:175-190.
23. Post TM, Freijer JI, Ploeger BA, and Danhof M (2008) Extensions to the visual predictive check to facilitate model performance evaluation. J Pharmacokinet Pharmacodyn 35:185-202.
24. Proulx NL, Akbari A, Garg AX, Rostom A, Jaffey J, and Clark HD (2005) Measured creatinine clearance from timed urine collections substantially overestimates glomerular filtration rate in patients with liver cirrhosis: a systematic review and individual patient meta-analysis. Nephrol Dial Transplant 20:1617-1622. (Pubitemid 41418585)
25. Rowland M and Tozer TN (1995) Clinical Pharmacokinetics: Concepts and Applications. Lippincott Williams & Wilkins, Baltimore.
26. Schuppan D and Afdhal NH (2008) Liver cirrhosis. Lancet 371:838-851. (Pubitemid 351323895)
27. Simpson D and Wagstaff AJ (2005) Solifenacin in overactive bladder syndrome. Drugs Aging 22:1061-1069. (Pubitemid 41821442)
28. Smulders RA, Smith NN, Krauwinkel WJ, and Hoon TJ (2007) Pharmacokinetics, safety, and tolerability of solifenacin in patients with renal insufficiency. J Pharmacol Sci 103:67-74. (Pubitemid 46175596)
29. Vasson MP, Baguet JC, Arveiller MR, Bargnoux PJ, Giroud JP, and Raichvarg D (1993) Serum and urinary α-1 acid glycoprotein in chronic renal failure. Nephron 65:299-303. (Pubitemid 23268043)
30. Watson PE, Watson ID, and Batt RD (1980) Total body water volumes for adult males and females estimated from simple anthropometric measurements. Am J Clin Nutr 33:27-39. (Pubitemid 10141676)
31. Wu CY and Benet LZ (2005) Predicting drug disposition via application of BCS: transport/absorption/elimination interplay and development of a biopharmaceutics drug disposition classification system. Pharm Res 22:11-23.
32. Wynne HA, Cope LH, Mutch E, Rawlins MD, Woodhouse KW, and James OF (1989) The effect of age upon liver volume and apparent liver blood flow in healthy man. Hepatology 9:297-301. (Pubitemid 19063317)
33. Yang J, Jamei M, Yeo KR, Rostami-Hodjegan A, and Tucker GT (2007) Misuse of the well-stirred model of hepatic drug clearance. Drug Metab Dispos 35:501-502. (Pubitemid 46333921)