Population pharmacokinetics III: Design, analysis, and application of population pharmacokinetic studies

Annals of Pharmacotherapy

Volumn 38, Issue 12, 2004, Pages 2136-2144

  Ette, Ene I ^a   Williams, Paul J ^b,c   Lane, James R ^d  

^a VERTEX PHARMACEUTICALS   (United States)

^b UNIVERSITY OF THE PACIFIC   (United States)

^c Trials by Design   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Population phamnacokinetics; Study design

Indexed keywords

FLUCYTOSINE;

BIOEQUIVALENCE; DATA ANALYSIS; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; DRUG DOSE; DRUG SCREENING; HUMAN; INFORMATION PROCESSING; METHODOLOGY; MODEL; NONHUMAN; PHARMACOLOGICAL PARAMETERS; PRIORITY JOURNAL; REVIEW; SIMULATION; VALIDATION PROCESS;

HUMANS; MODELS, BIOLOGICAL; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS;

EID: 12844270487     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1E260     Document Type: Review

References (58)

1. Ette EI, Williams PJ. Population pharmacokinetics. I: background, concepts, and models. Ann Pharmacother 2004;38:1702-6. DOI 10.1345/aph.1D374
2. Ette EI, Williams PJ. Population pharmacokinetics. II: estimation methods. Ann Pharmacother 2004;38:1907-15. DOI 10.1345/aph.1E259
3. Ette EI, Williams P, Fadiran E, Ajayi FO, Onyiah LC. The process of knowledge discovery from large pharmacokinetic data sets. J Clin Pharmacol 2001;41:25-34.
4. Ette EI, Williams PJ, Kim YH, Lane JR, Liu MJ, Capparelli EV. Model appropriateness and PPK modeling. J Clin Pharmacol 2003;43:610-23.
5. Ette EI, Sun H, Ludden TM. Design of population pharmacokinetic studies. Proc Am Stat Assoc 1994;487-92.
6. Jones CD, Sun H, Ette EI. Designing cross-sectional pharmacokinetic studies: implications for pediatric and animal studies. Clin Res Regul Affairs 1996;13:133-65.
7. Fadiran EO, Jones CD, Ette EI. Designing population pharmacokinetic studies: performance of mixed designs. Eur J Drug Metab Pharmacokinet 2000;25:231-9.
8. Guidance for industry: population pharmacokinetics. Rockville, MD: Food and Drug Administration, Department of Health and Human Services, 1999.
9. Grasela TH, Antal EJ, Fiedler-Kelley J, Foit DJ, Barth B, Knuth DW, et al. An automated drug concentration screening and quality assurance program for clinical trials. Drug Info J 1999;33:273-9.
10. Ette EI. Statistical graphics in pharmacokinetics and pharmacodynamics: a tutorial. Ann Pharmacother 1998;32:818-28. DOI 10.1345/aph.17304
11. Ette EI, Ludden TM. Population pharmacokinetic modeling: the importance of informative graphics. Pharm Res 1995;12:1845-55.
12. Sheiner LB. Ludden TM. Population pharmacokinetics. Annu Rev Pharmacol Toxicol 1992;32:185-209.
13. Karlsson MO, Sheiner LB. The importance of modeling interoccasion variability in population pharmacokinetic analyses. J Pharmacokinet Biopharm 1993;21:735-50.
14. Sidhu JS, Ashton M, Huong NV, Hai TN, Karlsson MO, Sy ND, et al. Artemisinin population pharmacokinetics in children and adults with uncomplicated falciparum malaria. Br J Clin Pharmacol 1998;45:347-54.
15. Sun H, Fadiran EO, Jones CD, Lesko L, Huang SM, Higgins K, et al. Population pharmacokinetics: a regulatory perspective. Clin Pharmacokinet 1999;37:41-58.
16. Al-Banna MK, Kelman AW, Whiting B. Experimental design and efficient parameter estimation in population pharmacokinetics. J Pharmacokinet Biopharm 1990;18:347-60.
17. Bonate PL. Clinical trial simulation in drug development. Pharm Res 2000;17:252-6.
18. Hale M, Gillespie WR, Gupta SK, Tuk B, Holford NH. Clinical trial simulation: streamlining your drug development process. Appl Clin Trials 1996;5:35-40.
19. Johnson NE, Wade JR, Karlsson MO. Comparison of some practical sampling strategies for population pharmacokinetic studies. J Pharmacokinet Biopharm 1996;24:245-72.
20. Kowalski KG, Hutmacher MM. Design evaluation for a population pharmacokinetic study using clinical trial simulations: a case study. Stat Med 2001;20:75-91.
21. Ette EI, Godfrey CJ, Ogenstad S, Williams PJ. Analysis of simulated trials. In: Kimko HC, Duffil S, eds. Clinical trial simulations. New York: Marcel Dekker, 2002:131-51.
22. Ette EI, Kelman AW, Howie CA, Whiting B. Analysis of animal pharmacokinetic data: performance of the one point per animal design. J Pharmacokinet Biopharm 1995;23:551-66.
23. Rubin DB. Multiple imputation after 18+ years. J Am Stat Assoc 1996;91:473-89.
24. Rubin DB. Inference and missing data. Biometrika 1976;63:581-2.
25. Ette EI, Kelman AW, Howie CA, Whiting B. Efficient experimental design and estimation of population pharmacokinetic parameters in preclinical animal studies. Pharm Res 1995;12:729-37.
26. Miller RG. The jackknife: a review. Biometrika 1974;61:1-15.
27. Hinkley DV. Jackknife confidence limits using Student t approximations. Biometrika 1977;64:21-8.
28. Efron B, Gong G. A leisurely look at the bootstrap, the jackknife and cross validation. Am Statistician 1983;37:36-48.
29. Ette EI. Population model stability and performance. J Clin Pharmacol 1997;37:486-95.
30. Box GEP. Robustness in the strategy of scientific model building. In: Laurer RL, Wilkinson GN, eds. Robustness in statistics. New York: Academic Press, 1979:201-36.
31. Hirsch RP. Validation samples. Biometrics 1991;47:1193-4.
32. Ette EI. Comparing non-hierarchical models: application to nonlinear mixed effects modeling. Comput Biol Med 1996;26:505-12.
33. Ette EI, Onyiah LC. Estimating inestimable standard errors in population pharmacokinetic studies: the bootstrap with winsorization. Eur J Drug Metab Pharmacokinet 2002;27:213-24.
34. Williams PJ, Ette EI. Determination of model appropriateness. In: Kimko HC, Duffil S, eds. Clinical trial simulations. New York: Marcel Dekker, 2002:73-104.
35. Gelman A. Meng XL, Stern H. Posterior predictive assessment of model fitness via realized discrepancies. Statistica Sinica 1996;6:733-807.
36. Dufull SB, Chabaud S, Nony P, Girard P, Aarons L. A pharmacokinetic simulation model for ivabradine in healthy volunteers. Eur J Pharm Sci 2000;10:285-95.
37. Dufull SB, Aarons L. Development of a sequential linked pharmacokinetic and pharmacodynamic simulation model for ivabradine in healthy volunteers. Eur J Pharm Sci 2000;10:275-84.
38. Yano H, Beal SL, Sheiner LB. Evaluating pharmacokinetic/pharmacodynamic models using the posterior predictive check. J Pharmacokinet Pharmacodynam 2001;28:171-91.
39. Mentre F, Ebelen ME. Validation of population pharmacokinetic- pharmacodynamic analyses: review of proposed approaches. In: Balant LP, Aarons L, eds. The population approach: measuring and managing variability in response concentration and dose (COST B1). Brussels: Office for Official Publications of the European Communities, 1997:146-60.
40. Williams PJ, Lane JR, Capparelli EC, Kim YH, Coleman RB. Direct comparison of three methods for predicting digoxin concentrations. Pharmacotherapy 1996;16:1085-92.
41. Vozeh S, Maitre PO, Stanski DR. Evaluation of population (NONMEM) pharmacokinetic parameter estimates. J Pharmacokinet Biopharm 1990;18:161-73.
42. Bruno R, Vivler N, Vergniol JC, De Phillips SL, Montay G, Sheiner LB. A population pharmacokinetic model for docetaxel (taxotere): model building and validation. J Pharmacokinet Biopharm 1996;24:153-72.
43. Steimer JL, Vozeh S, Racine-Poon A, Holford N, O'Neil R. The population approach: rationale, methods, and applications in clinical pharmacology and drug development. In: Welling PG, Balant LP, eds. Pharmacokinetics of drugs (handbook of experimental pharmacology). Berlin-Heidelberg: Springer-Verlag, 1994;110:404-51.
44. Samara E, Granne R. Role of pharmacokinetics in drug development: a pharmaceutical industry perspective. Clin Pharmacokinet 1997;32:294-312.
45. Whiting B, Kelman AW, Grevel J. Population pharmacokinetics: theory and clinical application. Clin Pharmacokinet 1986;11:387-401.
46. Olsen SC, Bockbrader H, Boyd RA, Cook J, Koup JR, Lalonde RL, et al. Impact of population pharmacokinetic-pharmacodynamic analyses on the drug development process. Clin Pharmacokinet 2000;38:449-59.
47. Ette EI, Miller R, Gillespie WR, Huang SM, Lesko L, Williams R. The population approach: FDA experience. In: Aarons L, Balant LP, Danhof M, Gex-Fabry M, Gundert-Remy VA, Karlsson MO, et al., eds. The population approach: measuring and managing variability in response, concentration and dose. Brussels: Commission of the European Communities, European Cooperation in the Field of Scientific and Technical Research, 1997:271-5.
48. Peck CC. Population approach in pharmacokinetics and pharmacodynamics: FDA view. In: Rowland M, Aarons L, eds. New strategies in drug development and clinical evaluation: the population approach. Luxembourg: Commission of the European Communities, 1992:157-68.
49. Hossain M, Wright E, Baweja R, Ludden TM, Miller R. Nonlinear mixed effects modeling of single dose and multiple dose data for an immediate release (IR) and controlled release (CR) dosage form of alpazolam. Pharm Res 1997;14:309-15.
50. Holford NHG, Ambros RJ, Stoeckel K. Models for describing absorption rate and estimating extent of bioavailability: application to cefetamet pivoxil. J Pharmacokinet Biopharm 1992;20:421-42.
51. Kaniwa N, Aoyagi N, Ogata H, Ishi M. Application of the NONMEM method to the evaluation of the bioavailability of drug products. J Pharm Sci 1990;79:1116-20.
52. Graves DA, Chang I. Application of NONMEM to routine bioavailability data. J Pharmacokinet Biopharm 1990;2:145-60.
53. Karlsson MO, Sheiner LB. Estimating bioavailability when clearance varies with time. Clin Pharmacol Ther 1994;55:623-37.
54. Pentikis HS, Henderson JD, Tran NL, Ludden TM. Bioequivalence: individual and population compartmental modeling compared to the noncompartmental approach. Pharm Res 1996;13:1116-21.
55. Park K, Verotta D, Blaschke TF, Sheiner LB. A semiparametric method for describing noisy population pharmacokinetic data. J Pharmacokinet Biopharm 1997;25:615-42.
56. Cockroft D, Gault M. Creatinine clearance from serum creatinine. Nephron 1976;16:31-41.
57. Devine BJ. Gentamicin therapy. Drug Intell Clin Pharm 1974;8:650-5.
58. Gilbert DN, Moellering RC, Eliopoulos GM, Sande MA. The Sanford guide to antimicrobial therapy. 34th ed. Hyde Park, VT: Antimicrobial Therapy, 1995:112.