Customized in silico population mimics actual population in docetaxel population pharmacokinetic analysis

Journal of Pharmaceutical Sciences

Volumn 100, Issue 3, 2011, Pages 1156-1166

  Hudachek, Susan F ^a   Gustafson, Daniel L ^a  

^a Department of Environmental and Radiological Health Sciences   (United States)

Author keywords

Cancer chemotherapy; Pharmacokinetic pharmacodynamic models; Physiological model; Population pharmacokinetics; Simulations

Indexed keywords

DOCETAXEL; PLASMA PROTEIN;

AREA UNDER THE CURVE; ARTICLE; BLOOD VOLUME; BODY SIZE; COMPUTER MODEL; DRUG CLEARANCE; DRUG METABOLISM; LIVER FUNCTION; LIVER METABOLISM; MICHAELIS CONSTANT; MONTE CARLO METHOD; PHYSIOLOGICAL PROCESS; PLASMA CONCENTRATION-TIME CURVE; POPULATION; VIRTUAL REALITY;

EID: 79251577704     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22322     Document Type: Article

References (34)

1. Sheiner LB, Rosenberg B, Marathe VV. 1977. Estimation of population characteristics of pharmacokinetic parameters from routine clinical data. J Pharmacokinet Biopharm 5(5):445-479.
2. Sheiner LB, Ludden TM. 1992. Population pharmacokinetics/dynamics. Annu Rev Pharmacol Toxicol 32:185-209.
3. Vozeh S, Steimer JL, Rowland M, Morselli P, Mentre F, Balant LP, Aarons L. 1996. The use of population pharmacokinetics in drug development. Clin Pharmacokinet 30(2):81-93.
4. Sun H, Fadiran EO, Jones CD, Lesko L, Huang SM, Higgins K, Hu C, Machado S, Maldonado S, Williams R, Hossain M, Ette EI. 1999. Population pharmacokinetics. A regulatory perspective. Clin Pharmacokinet 37(1):41-58.
5. Aarons L, Balant LP, Mentre F, Morselli PL, Rowland M, Steimer JL, Vozeh S. 1996. Practical experience and issues in designing and performing population pharmacokinetic/pharmacodynamic studies. Eur J Clin Pharmacol 49(4):251-254.
6. Kowalski KG, Hutmacher MM. 2001. Design evaluation for a population pharmacokinetic study using clinical trial simulations: A case study. Stat Med 20(1):75-91.
7. Ogungbenro K, Aarons L. 2008. How many subjects are necessary for population pharmacokinetic experiments? Confidence interval approach. Eur J Clin Pharmacol 64(7):705-713.
8. Ribbing J, Jonsson EN. 2004. Power, selection bias and predictive performance of the population pharmacokinetic covariate model. J Pharmacokinet Pharmacodyn 31(2):109-134.
9. Bradshaw-Pierce EL, Eckhardt SG, Gustafson DL. 2007. A physiologically based pharmacokinetic model of docetaxel disposition: From mouse to man. Clin Cancer Res 13(9):2768-2776.
10. Strother RM, Sweeney C. 2008. Lessons learned from development of docetaxel. Expert Opin Drug Metab Toxicol 4(7):1007-1019.
11. Price PS, Conolly RB, Chaisson CF, Gross EA, Young JS, Mathis ET, Tedder DR. 2003. Modeling interindividual variation in physiological factors used in PBPK models of humans. Crit Rev Toxicol 33(5):469-503.
12. Bruno R, Vivier N, Vergniol JC, De Phillips SL, Montay G, Sheiner LB. 1996. A population pharmacokinetic model for docetaxel (Taxotere): Model building and validation. J Pharmacokinet Biopharm 24(2):153-172.
13. Clarke SJ, Rivory LP. 1999. Clinical pharmacokinetics of docetaxel. Clin Pharmacokinet 36(2):99-114.
14. Witta SE, Gustafson DL, Pierson AS, Menter A, Holden SN, Basche M, Persky M, O'Bryant CL, Zeng C, Baron A, Long ME, Gibbs A, Kelly K, Bunn PA Jr, Chan DC, Pallansch P, Eckhardt SG. 2004. A phase I and pharmacokinetic study of exisulind and docetaxel in patients with advanced solid tumors. Clin Cancer Res 10(21):7229-7237.
15. Puisset F, Alexandre J, Treluyer JM, Raoul V, Roche H, Goldwasser F, Chatelut E. 2007. Clinical pharmacodynamic factors in docetaxel toxicity. Br J Cancer 97(3):290-296.
16. Minami H, Kawada K, Sasaki Y, Tahara M, Igarashi T, Itoh K, Fujii H, Saeki T, Ozawa K, Sato H. 2009. Population pharmacokinetics of docetaxel in patients with hepatic dysfunction treated in an oncology practice. Cancer Sci 100(1):144-149.
17. Hooker AC, Ten Tije AJ, Carducci MA, Weber J, Garrett-Mayer E, Gelderblom H, McGuire WP, Verweij J, Karlsson MO, Baker SD. 2008. Population pharmacokinetic model for docetaxel in patients with varying degrees of liver function: Incorporating cytochrome P4503A activity measurements. Clin Pharmacol Ther 84(1):111-118.
18. Tham LS, Holford NH, Hor SY, Tan T, Wang L, Lim RC, Lee HS, Lee SC, Goh BC. 2007. Lack of association of single-nucleotide polymorphisms in pregnane X receptor, hepatic nuclear factor 4alpha, and constitutive androstane receptor with docetaxel pharmacokinetics. Clin Cancer Res 13(23):7126-7132.
19. Bosch TM, Huitema AD, Doodeman VD, Jansen R, Witteveen E, Smit WM, Jansen RL, van Herpen CM, Soesan M, Beijnen JH, Schellens JH. 2006. Pharmacogenetic screening of CYP3A and ABCB1 in relation to population pharmacokinetics of docetaxel. Clin Cancer Res 12(19):5786-5793.
20. Puisset F, Chatelut E, Dalenc F, Busi F, Cresteil T, Azema J, Poublanc M, Hennebelle I, Lafont T, Chevreau C, Roche H. 2004. Dexamethasone as a probe for docetaxel clearance. Cancer Chemother Pharmacol 54(3):265-272.
21. French AJ, Datta SN, Allman R, Matthews PN. 2004. Investigation of sequential mitomycin C and photodynamic therapy in a mitomycin-resistant bladder cancer cell-line model. BJU Int 93(1):156-161.
22. Goh BC, Lee SC, Wang LZ, Fan L, Guo JY, Lamba J, Schuetz E, Lim R, Lim HL, Ong AB, Lee HS. 2002. Explaining interindividual variability of docetaxel pharmacokinetics and pharmacodynamics in Asians through phenotyping and genotyping strategies. J Clin Oncol 20(17):3683-3690.
23. Launay-Iliadis MC, Bruno R, Cosson V, Vergniol JC, Oulid-Aissa D, Marty M, Clavel M, Aapro M, Le Bail N, Iliadis A. 1995. Population pharmacokinetics of docetaxel during phase I studies using nonlinear mixed-effect modeling and nonparametric maximum-likelihood estimation. Cancer Chemother Pharmacol 37(1-2):47-54.
24. Shou M, Martinet M, Korzekwa KR, Krausz KW, Gonzalez FJ, Gelboin HV. 1998. Role of human cytochrome P450 3A4 and 3A5 in the metabolism of taxotere and its derivatives: Enzyme specificity, interindividual distribution and metabolic contribution in human liver. Pharmacogenetics 8(5):391-401.
25. Baker SD, Sparreboom A, Verweij J. 2006. Clinical pharmacokinetics of docetaxel: Recent developments. Clin Pharmacokinet 45(3):235-252.
26. Urien S, Barre J, Morin C, Paccaly A, Montay G, Tillement JP. 1996. Docetaxel serum protein binding with high affinity to alpha 1-acid glycoprotein. Invest New Drugs 14(2):147-151.
27. Baker SD, van Schaik RH, Rivory LP, Ten Tije AJ, Dinh K, Graveland WJ, Schenk PW, Charles KA, Clarke SJ, Carducci MA, McGuire WP, Dawkins F, Gelderblom H, Verweij J, Sparreboom A. 2004. Factors affecting cytochrome P-450 3A activity in cancer patients. Clin Cancer Res 10(24):8341-8350.
28. Osteen RT, Klebanoff G. 1971. Early plasma protein recovery after total volume plasmapheresis in baboons. Surgery 69(2):276-283.
29. Wraight EP. 1974. Capillary permeability to protein as a factor in the control of plasma volume. J Physiol 237(1):39-47.
30. Manning RD Jr, Guyton AC. 1983. Effects of hypoproteinemia on fluid volumes and arterial pressure. Am J Physiol 245(2):H284-293.
31. Chinard FP, Lauson HD, Eder HA, Greif RL. 1954. Plasma volume changes following the administration of albumin to patients with the nephrotic syndrome. J Clin Invest 33(4):629-635.
32. Koomans HA, Geers AB, Kortlandt W, Dorhout Mees EJ. 1985. Albumin infused in nephrotics: Where does it go? Neth J Med 28(4):148-152.
33. Whittaker PG, Lind T. 1993. The intravascular mass of albumin during human pregnancy: A serial study in normal and diabetic women. Br J Obstet Gynaecol 100(6):587-592.
34. Morris MD. 1991. Factorial sampling plans for preliminary computational experiments. Technometrics 33(2):161-174.