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Optimal Design for Model Discrimination and Parameter Estimation for Itraconazole Population Pharmacokinetics in Cystic Fibrosis Patients

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Abstract

Optimal sampling times are found for a study in which one of the primary purposes is to develop a model of the pharmacokinetics of itraconazole in patients with cystic fibrosis for both capsule and solution doses. The optimal design is expected to produce reliable estimates of population parameters for two different structural PK models. Data collected at these sampling times are also expected to provide the researchers with sufficient information to reasonably discriminate between the two competing structural models

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References

  1. R.B. Moss (2002) ArticleTitleAllergic bronchopulmonary aspergillosis Clin. Rev. Allergy Immunol 23 87–104 Occurrence Handle12162109 Occurrence Handle1:CAS:528:DC%2BD38XmsF2ls7c%3D

    PubMed  CAS  Google Scholar 

  2. M. Skov N. Hoiby C. Koch (2002) ArticleTitleItraconazole treatment of allergic bronchopulmonary aspergillosis in patients with cystic fibrosis Allergy 57 723–728 Occurrence Handle10.1034/j.1398-9995.2002.23583.x Occurrence Handle12121192 Occurrence Handle1:CAS:528:DC%2BD38Xms1SgtLw%3D

    Article  PubMed  CAS  Google Scholar 

  3. D.A. Stevens J.Y. Lee H.J. Schwartz D. Jerome A. Catanzaro (2000) ArticleTitleA randomized trial of itraconazole in allergic bronchopulmonary aspergillosis N. Engl. J. Med 342 756–762 Occurrence Handle10.1056/NEJM200003163421102 Occurrence Handle10717010 Occurrence Handle1:CAS:528:DC%2BD3cXit1Smu7g%3D

    Article  PubMed  CAS  Google Scholar 

  4. A. Hedman Y. Adan-Abdi G. Alvan B. Strandvik A. Arvidsson (1988) ArticleTitleInfluence of the glomerular filtration rate on renal clearance of ceftazidime in cystic fibrosis Clin. Pharmacokinet 15 57–65 Occurrence Handle3042246 Occurrence Handle1:STN:280:BieB1MrmtFQ%3D

    PubMed  CAS  Google Scholar 

  5. W.J. Jusko L.L. Mosovich L.M. Gerbracht M.E. Matter S.J. Yaffe (1975) ArticleTitleEnhanced renal excretion of dicloxacillin in patients with cystic fibrosis Pediatrics 56 1038–1044 Occurrence Handle1196754 Occurrence Handle1:CAS:528:DyaE28Xotl2ltw%3D%3D

    PubMed  CAS  Google Scholar 

  6. E. Finkelstein K. Hall (1979) ArticleTitleAminoglycosides clearance in patients with cystic fibrosis J. Pediatr 94 163–164 Occurrence Handle758407 Occurrence Handle1:STN:280:CSaD28bkslY%3D

    PubMed  CAS  Google Scholar 

  7. M.D. Reed (1997) ArticleTitleThe pathophysiology and treatment of cystic fibrosis J. Pediatr. Pharm. Pract 2 285–308

    Google Scholar 

  8. M. Spino (1991) ArticleTitlePharmacokinetics of drugs in cystic fibrosis Clin. Rev. Allergy 9 169–210 Occurrence Handle1884324 Occurrence Handle1:STN:280:By6A2Mnks1Q%3D

    PubMed  CAS  Google Scholar 

  9. J. Heykants A. Van Peer V. Vande Velde P. Van Rooy W. Meuldermans K. Lavrijsen (1989) ArticleTitleThe clinical pharmacokinetics of itraconazole: an overview Mycoses 32 67–87 Occurrence Handle2561187

    PubMed  Google Scholar 

  10. C. Koks R. Sparidans G. Lucassen K. Crommentuyn J. Beijnen (2002) ArticleTitleSelective high performance liquid chromatography assay for itraconazole and hydroxyitraconazole in plasma from human immunodeficiency virus-infected patients J. Chromatogr. B 767 103–110 Occurrence Handle1:CAS:528:DC%2BD38XhsFahsLo%3D

    CAS  Google Scholar 

  11. J.S. Hostetler J. Heykants K. Clemons R. Woestenborghs L.H. Hanson D.A. Stevens (1993) ArticleTitleDiscrepancies in bioassay and chromatography determination explained by metabolism of itraconazole to hydroxyitraconazole: studies of interpatient variations in concentrations Antimicrob. Agents Chemother 37 2224–2227 Occurrence Handle8257148 Occurrence Handle1:CAS:528:DyaK2cXit12rsw%3D%3D

    PubMed  CAS  Google Scholar 

  12. J. Cutsem ParticleVan (1989) ArticleTitleThe in-vitro antifungal spectrum of itraconazole Mycoses 32 7–13 Occurrence Handle2561189

    PubMed  Google Scholar 

  13. S. Jaruratanasirikul A. Kleepkaew (1997) ArticleTitleInfluence of an acidic beverage (coca-cola) on the absorption of itraconazole Eur. J. Clin. Pharmacol 52 235–237 Occurrence Handle10.1007/s002280050280 Occurrence Handle9218932 Occurrence Handle1:CAS:528:DyaK2sXktF2itL8%3D

    Article  PubMed  CAS  Google Scholar 

  14. J.A. Barone J. Koh R.H. Bierman J.L. Colaizzi K. Swanson M. Gaffar B.L. Moskovitz W. Mechlinski V. Vande Velde (1993) ArticleTitleFood interaction and steady-state pharmacokinetics of itraconazole capsules in healthy male volunteers Antirnicrob. Agents Chemother 37 778–784 Occurrence Handle1:CAS:528:DyaK3sXksVShu7s%3D

    CAS  Google Scholar 

  15. V. Vande Velde A. Van Peer J. Heykants R. Woestenborghs P. Van Rooy K. De Beule G. Cauwenbergh (1996) ArticleTitleEffect of food on the pharmacokinetics of a new hydroxypropyl, β-cyclodextrin formulation of itraconazole Pharmacotherapy 16 424–428 Occurrence Handle1:STN:280:BymA3snnsVI%3D

    CAS  Google Scholar 

  16. S. Grant S. Clissold (1989) ArticleTitleItraconazole: a review of its pharmacodynamics and pharmacokinetic properties and therapeutic use in superficial and systemic mycoses Drugs 37 310–344 Occurrence Handle2540949 Occurrence Handle1:STN:280:BiaB3s7ltFc%3D

    PubMed  CAS  Google Scholar 

  17. K. Beule ParticleDe J. Gestel ParticleVan (2001) ArticleTitlePharmacology of itraconazole Drugs 61 27–37 Occurrence Handle11219548

    PubMed  Google Scholar 

  18. T. Zimmerman R. Yeates H. Laufen G. Pfaff A. Wildfeuer (1994) ArticleTitleInfluence of concomitant food intake on the oral absorption of two triazole antifungal agents, itraconazole and iuconazole Eur. J. Clin. Pharmacol 46 147–150

    Google Scholar 

  19. A. Van Peer R. Woestenborghs J. Heykants R. Gasparini G. Gauwenbergh (1989) ArticleTitleThe effects of food and dose on the oral systemic availability of itraconazole in healthy subjects Eur. J. Clin. Pharmacol 36 423–426 Occurrence Handle2544431 Occurrence Handle1:CAS:528:DyaL1MXktFOisro%3D

    PubMed  CAS  Google Scholar 

  20. J.A. Barone B.L. Moskovitz J. Guarnieri A. Hassell J.L. Colaizzi R.H. Bierman L. Jessen (1998) ArticleTitleEnhanced bioavailability of itraconazole in hydroxypropyl-β-cyclodextrin solution versus capsules in healthy volunteers Antimicrob. Agents Chemother 42 1862–1865 Occurrence Handle9661037 Occurrence Handle1:CAS:528:DyaK1cXktlKqu74%3D

    PubMed  CAS  Google Scholar 

  21. T.C. Hardin J.R. Graybill R.J. Fetchick R. Woestenborghs M.G. Rinaldi J. Kuhn (1988) ArticleTitlePharmacokinetics of itraconazole following oral administration to normal volunteers Antimicrob. Agents Chemother 32 1310–1313 Occurrence Handle2848442 Occurrence Handle1:CAS:528:DyaL1cXlvVaqtbY%3D

    PubMed  CAS  Google Scholar 

  22. S. Retout F. Mentré (2003) ArticleTitleFurther developments of the fisher information matrix in nonlinear mixed effects models with evaluation in population pharmacokinetics J. Biopharm. Stat 13 209–227 Occurrence Handle10.1081/BIP-120019267 Occurrence Handle12729390

    Article  PubMed  Google Scholar 

  23. A.C. Atkinson A.N. Donev (1992) Optimum Experimental Designs Oxford University Press Oxford

    Google Scholar 

  24. S. Retout F. Mentré R. Bruno (2002) ArticleTitleFisher information matrix for non-linear mixedeffects models: evaluation and application for optimal design of enoxaparin population pharmacokinetics Stat. Med 21 2623–2639 Occurrence Handle10.1002/sim.1041 Occurrence Handle12228881

    Article  PubMed  Google Scholar 

  25. N.R. Draper W.G. Hunter (1966) ArticleTitleDesign of experiments for parameter estimation in multiresponse situations Biometrika 53 525–533

    Google Scholar 

  26. A.C. Atkinson V.V. Fedorov (1975) ArticleTitleThe design of experiments for discriminating between two rival models Biometrika 62 57–70

    Google Scholar 

  27. T. H. Waterhouse, J. A. Eccleston, and S. B. Duffull. On optimal design for discrimination and estimation. Research Report 106, Centre for Statistics, The University of Queensland (2004).

  28. A. C. Atkinson and D. R. Cox. Planning experiments for discriminating between models. J. R. Stat. Soc. Ser. B 36:321–348 (1974). With discussion by H. P. Wynn, D. M. Titterington, P. J. Laycock, D. V. Lindley, D. H. Hill, Agnes M. Herzberg, P. A. Tukey, A. O’Hagan, V. V. Fedorov, J. Dickey, J. Kiefer and C. A. B. Smith.

  29. C.H.W. Koks A.D.R. Huitema E.D.M. Kroon T. Chuenyam R.W. Sparidans J.M.A. Lange J.H. Beijnen (2003) ArticleTitlePopulation pharmacokinetics of itraconazole in thai hiv-1-infected persons Ther. Drug Monit 25 229–233 Occurrence Handle10.1097/00007691-200304000-00014 Occurrence Handle12657919 Occurrence Handle1:CAS:528:DC%2BD3sXitlKitLk%3D

    Article  PubMed  CAS  Google Scholar 

  30. Janssen Pharmaceutica Products, L.P. Sporanox® (itraconazole) oral solution (2002). URL http://www.fda.gov/cder/foi/label/2002/20657s7lbl.pdf.

  31. Janssen Pharmaceutica Products, L.P. Sporanox® (itraconazole) injection (2002). URL http://www.fda.gov/cder/foi/label/2002/20966s61bl.pdf.

  32. J.A. Barone B.L. Moskovitz J. Guarnieri A. Hassel J.L. Colaizzi R.H. Bierman L. Jessen (1998) ArticleTitleFood interactions and steady-state pharmacokinetics of itraconazole oral solution in healthy volunteers Pharmacotherapy 18 295–301 Occurrence Handle9545149 Occurrence Handle1:CAS:528:DyaK1cXkt1Kjtbs%3D

    PubMed  CAS  Google Scholar 

  33. A. Corana M. Marchesi C. Martini S. Ridella (1987) ArticleTitleMinimizing multimodal functions of continuous variables with the “simulated annealing” algorithm ACM Trans. Math. Softw 13 262–280 Occurrence Handle10.1145/29380.29864

    Article  Google Scholar 

  34. W.L. Goffe G.D. Ferrier J. Rogers (1994) ArticleTitleGlobal optimization of statistical functions with simulated annealing J. Econ 60 65–99

    Google Scholar 

  35. A.C. Atkinson B. Bogacka (2002) ArticleTitleCompound and other optimum designs for systems of nonlinear differential equations arising in chemical kinetics Chemometr. Intell. Lab 61 17–33 Occurrence Handle1:CAS:528:DC%2BD38XhsVagtLw%3D

    CAS  Google Scholar 

  36. I. Gueorguieva. D-optimal Design for Multivariate Response: Prospective Planning of a Beta-blocker Study in Rat Involving Cassette Dosing. Poster Presented at PAGE 2003.

  37. A. Hooker. Simultaneous Population D-optimal Designs of Pharmacokinetic-Pharmacodynmic Experiments. Poster Presented at PAGE 2003.

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Authors and Affiliations

  1. School of Physical Sciences, The University of Queensland, Brisbane, Australia

    Timothy H. Waterhouse & John A. Eccleston

  2. School of Pharmacy, The University of Queensland, Brisbane, Australia

    Stefanie Redmann & Stephen B. Duffull

  3. Department of Mathematics, The University of Queensland, Brisbane, QLD 4072, Australia

    Timothy H. Waterhouse

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  1. Timothy H. Waterhouse
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  2. Stefanie Redmann
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  3. Stephen B. Duffull
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  4. John A. Eccleston
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Correspondence to Timothy H. Waterhouse.

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Waterhouse, T.H., Redmann, S., Duffull, S.B. et al. Optimal Design for Model Discrimination and Parameter Estimation for Itraconazole Population Pharmacokinetics in Cystic Fibrosis Patients. J Pharmacokinet Pharmacodyn 32, 521–545 (2005). https://doi.org/10.1007/s10928-005-0026-2

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  • DOI: https://doi.org/10.1007/s10928-005-0026-2

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