265
Views
35
CrossRef citations to date
0
Altmetric
Original Articles

Comparison of Model-Based Tests and Selection Strategies to Detect Genetic Polymorphisms Influencing Pharmacokinetic Parameters

, &
Pages 1084-1102 | Received 26 Jul 2007, Accepted 28 Nov 2007, Published online: 20 Nov 2008

REFERENCES

  • Akaike , H. ( 1974 ). A new look at the statistical model identification . IEEE Trans. Automat. Contr. 19 : 716 – 723 .
  • Beal , S. L. ( 2005 ). Conditioning on certain random events associated with statistical variability in PK/PD . J. Pharmacokinet. Pharmacodyn. 32 : 213 – 243 .
  • Benjamini , Y. , Hochberg , Y. ( 1995 ). Controlling the false discovery rate: a practical and powerful approach to multiple testing . J. Roy. Stat. Soc. B Met. 57 : 289 – 300 .
  • Bodor , M. , Kelly , E. J. , Ho , R. J. ( 2005 ). Characterization of the human MDR1 gene . AAPS J. 7 : E1 – E5 .
  • Bozdogan , H. ( 1987 ). Model selection and Akaike's information criteria (AIC): The general theory and its analytical extensions . Psychometrika 52 : 345 – 370 .
  • Brendel , K. , Legrand , M. , Taburet , A. M. , Baron , G. , Goujard , C. , Mentre , F. ( 2005 ). Population pharmacokinetic analysis of indinavir in HIV-infected patient treated with a stable antiretroviral therapy . Fundam. Clin. Pharmacol. 19 : 373 – 383 .
  • Burnham , K. P. , Anderson , D. R. ( 2002 ). Model Selection and Multimodel. A Practical Information – Theoric Approach . New York : Springer-Verlag .
  • Comets , E. , Mentré , F. ( 2001 ). Evaluation of tests based on individual vs population modelling to compare dissolution curves . J. Biopharm. Stat. 11 : 107 – 123 .
  • Comets , E. , Verstuyft , C. , Lavielle , M. , Jaillon , P. , Becquemont , L. , Mentré , F. ( 2007 ). Modelling the influence of MDR1 polymorphism on digoxin pharmacokinetic parameters . Eur. J. Pharmacol. 63 : 437 – 449 .
  • Csajka , C. , Marzolini , C. , Fattinger , K. , Decosterd , L. A. , Telenti , A. , Biollaz , J. , Buclin , T. ( 2004 ). Population pharmacokinetics of indinavir in patients infected with human immunodeficiency virus . Antimicrob. Agents Chemother. 48 : 3226 – 3232 .
  • Fellay , J. , Marzolini , C. , Meaden , E. , Back , D. , Buclin , T. , Chave , J. ( 2002 ). Response to antiretroviral treatment in HIV-1-infected individuals with allelic variants of the multidrug resistance transporter gene MDR1: A pharmacogenetic study . Lancet 359 : 30 – 36 .
  • Gabrielsson , J. , Weiner , D. ( 1999 ). Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications . Stockholm : Apotekarsocieteten .
  • Girard , P. , Mentré , F. ( 2005 ). A comparison of estimation methods in nonlinear mixed effects models using a blind analysis . PAGE 14 :Abstr 834 .
  • Goujard , C. , Legrand , M. , Panhard , X. , Diquet , B. , Duval , X. , Peytavin , G. , Vincent , I. , Katlama , C. , Leport , C. , Bonnet , B. , Salmon-Ceron , D. , Mentre , F. , Taburet , A. M. ( 2005 ). High variability of indinavir and nelfinavir pharmacokinetics in HIV-infected patients with a sustained virological response on highly active antiretroviral therapy . Clin. Pharmacokinet. 44 : 1267 – 1278 .
  • Henningsson , A. , Marsh , S. , Loos , W. J. , Karlsson , M. O. , Garsa , A. , Mross , K. , Mielke , S. , Vigano , L. , Locatelli , A. , Verweij , J. , Sparreboom , A. , McLeod , H. L. ( 2005 ). Association of CYP2C8, CYP3A4, CYP3A5, and ABCB1 polymorphisms with the pharmacokinetics of paclitaxel . Clin. Cancer Res. 11 : 8097 – 8104 .
  • Innocentia , F. , Liua , W. , Chenb , P. , Desaia , A. A. , Dasb , S. , Rataina , M. J. (2005). Haplotypes of variants in the UDP-glucuronosyltransferase 1A9 and 1A1 genes. Pharmacogenet. Genomics 15:295–301.
  • Inomata , S. , Nagashima , A. , Itagaki , F. , Homma , M. , Nishimura , M. , Osaka , Y. , Okuyama , K. , Tanaka , E. , Nakamura , T. , Kohda , Y. , Naito , S. , Miyabe , M. , Toyooka , H. ( 2005 ). CYP2C19 genotype affects diazepam pharmacokinetics and emergence from general anesthesia . Clin. Pharmacol. Ther. 78 : 647 – 655 .
  • Kappelhoff , B. S. , Huitema , A. D. , Sankatsing , S. U. , Meenhorst , P. L. , Van Gorp , E. C. , Mulder , J. W. , Prins , J. M. , Beijnen , J. H. ( 2005 ). Population pharmacokinetics of indinavir alone and in combination with ritonavir in HIV-1-infected patients . Br. J. Clin. Pharmacol. 60 : 276 – 286 .
  • Kerbusch , T. , Wählby , U. , Milligan , P. , Karlsson , M. ( 2003 ). Population pharmacokinetic modelling of darifenacin and its hydroxylated metabolite using pooled data, incorporating saturable first pass metabolism, CYP2D6 genotype and formulation-dependant bio availability . Br. J. Clin. Pharmacol. 56 : 639 – 652 .
  • Licinio , J. , Wong , M. L. ( 2002 ). Pharmacogenomics: The Search for Individualized Therapy . Weinheim : Wiley-VCH .
  • Machin , D. , Campbell , M. , Fayers , P. , Pinol , A. ( 1997 ). Sample Size Tables for Clinical Studies . Oxford : Blackwell Science .
  • Mamiya , K. , Hadama , A. , Yukawa , E. , Ieiri , I. , Otsubo , K. , Ninomiya , H. , Tashiro , N. , Higuchi , S. ( 2000 ). CYP2C9 polymorphism effect on phenobarbiton kinetics in Japanese patients with epilepsy: Analysis by population phamacokinetics . Eur. J. Clin. Pharmacol. 55 : 821 – 825 .
  • Marzolini , C. , Paus , E. , Buclin , T. , Kim , R. B. ( 2003 ). Polymorphisms in Human MDR1 (P-glycoprotein): Recent advances and clinical relevance . Clin. Pharmacol. Ther. 75 : 13 – 33 .
  • Meerum , T. J. , Malingre , M. , Beijnen , J. , Ten , B. , Huinink , W. , Rosing , H. , et al. . ( 1999 ). Co-administration of cyclosporine A enables oral therapy with paclitaxel . Clin. Cancer Res. 5 : 3379 – 3384 .
  • Mentré , F. , Duval , X. , Rey , E. , Peytavin , G. , Auleley , S. , Legrand , M. , Biour , M. , Bouxin , A. , Goujard , C. , Taburet , A. , Katlama , C. , Diquet , B. , Lascoux , C. , Tréluyer , J. M. , Salmon-Céron , D. ( 2005 ). Prospective Trial to Evaluate How Therapeutic Drug Monitoring of Protease Inhibitors Increases Virologic Success and Tolerance of HAART (COPHAR 2-ANRS 111 Trial). 12th Conference on Retroviruses and Opportunistic Infections. Boston .
  • Min , D. I. , Ellingrod , V. L. , Marsh , S. , McLeod , H. ( 2004 ). CYP3A5 polymorphism and the ethnic differences in cyclosporine pharmacokinetics in healthy subjects . Ther. Drug Monit. 26 : 524 – 528 .
  • Panhard , X. , Mentré , F. ( 2005 ). Evaluation by simulation of tests based on non-linear mixed-effects models in pharmacokinetic interaction and bioequivalence cross-over trials . Stat. Med. 24 : 1509 – 1524 .
  • R Development Core Team ( 2006 ). R: A Language and Environment for Statistical Computing . Vienna, Austria : R Foundation for Statistical Computing .
  • Raftery , A. E. ( 1995 ). Bayesian model selection in social research (with discussion) . Sociol. Methodol. 111 – 195 .
  • Retout , S. , Comets , E. , Samson , A. , Mentre , F. ( 2007 ). Design in nonlinear mixed effects models: Optimization using the Fedorov–Wynn algorithm and power of the Wald test for binary covariates . Stat. Med. 26 : 5162 – 5179 .
  • Retout , S. , Mentre , F. ( 2003 ). Optimization of individual and population designs using Splus . J. Pharmacokinet. Pharmacodyn. 30 : 417 – 443 .
  • Roe , D. J. ( 1997 ). Comparison of population pharmacokinetic modeling methods using simulated data: results from the Population Modeling Workgroup . Stat. Med. 16 : 1241–1257; discussion 1257 – 1262 .
  • Sakaeda , T. , Nakamura , T. , Okumura , K. (2002). MDR1 genotype-related pharmacokinetics and pharmacodynamics. Biol. Pharm. Bull. 25:1391–1400.
  • Samson , A. , Lavielle , M. , Mentré , F. ( 2007 ). The SAEM algorithm for group comparison test in longitudinal data analysis based in nonlinear mixed-effects model . Stat. Med. 26 : 4860 – 4875 .
  • Schwartz , G. ( 1978 ). Estimating the dimension of a model . Ann. Stat. 6 : 461 – 464 .
  • Sheiner , L. , Beal , S. ( 1998 ). NONMEM Version 5.1 . San Francisco : University of California , NONMEM Project Group .
  • Sugiura , N. ( 1978 ). Further analysis of the data by Akaike's information criterion and the finite corrections . Communication in Statistics. Theory and Methods 7 : 13 – 26 .
  • Taguchi , M. , Fujiki , A. , Iwamoto , J. , Inoue , H. , Tahara , K. , Saigusa , K. , Horiuchi , I. , Oshima , Y. , Hashimoto , Y. ( 2006 ). Nonlinear mixed effects model analysis of the pharmacokinetics of routinely administered bepridil in japanese patients with arrhythmias . Biol. Pharm. Bull. 29 : 517 – 521 .
  • Verstuyft , C. , Marcellin , R. , Morand-Joubert , L. , Launay , O. , Brendel , K. , Mentré , F. , Peytavin , G. , Gérard , L. , Becquemont , L. , Aboulker , J. P. ( 2005 ). Absence of association between MDR1 genetic polymorphisms, indinavir pharmacokinetics and response to HAART . AIDS 19 : 2127 – 2131 .
  • Wählby , U. , Jonsson , E. N. , Karlsson , M. O. ( 2001 ). Assessment of actual significance levels for covariate effects in NONMEM . J. Pharmacokinet. Pharmacodyn. 28 : 231 – 252 .
  • Wang , Y. ( 2007 ). Derivation of various NONMEM estimation methods . J. Pharmacokinet. Pharmacodyn. 34 : 575 – 593 .
  • Yamaguchi , H. , Hishinuma , T. , Endo , N. , Tsukamoto , H. , Kishikawa , Y. , Sato , M. , Murai , Y. , Hiratsuka , M. , Ito , K. , Okamura , C. , Yaegashi , N. , Suzuki , N. , Tomioka , Y. , Goto , J. ( 2006 ). Genetic variation in ABCB1 influences paclitaxel pharmacokinetics in Japanese patients with ovarian cancer . Int. J. Gynecol. Cancer 16 : 979 – 985 .

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.