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Study Design Publications

  • Designing population pharmacokinetic studies for efficient parameter estimation.
    • Ette EI, Roy A. Designing population pharmacokinetic studies for efficient parameter estimation. In: Pharmacometrics: the Science of Quantitative Pharmacology. Ette EI, Williams PJ (eds). Hoboken: John Wiley & Sons, 2007, pp 303 – 344.
  • A Pragmatic Approach to the Design of Population Pharmacokinetic Studies.
    • Roy A, Ette EI. A Pragmatic Approach to the Design of Population Pharmacokinetic Studies. AAPS Journal 2005 7(2): E408-420
  • Designing population pharmacokinetic studies: performance of mixed designs.
    • Fadiran EO, Jones CD, Ette EI. Designing population pharmacokinetic studies: performance of mixed designs. Eur J Drug Metab Pharmacokinet 2000; 25: 231 – 239.
  • Designing cross-sectional pharmacokinetic studies: implications for pediatric and animal studies.
    • Jones CD, Sun H, Ette EI. Designing cross-sectional pharmacokinetic studies: implications for pediatric and animal studies. Clin Res Regul Affairs 1996; 13 (3&4): 133-165.
  • Design of population pharmacokinetic studies.
    • Ette EI, Sun H, Ludden TM. Design of population pharmacokinetic studies. Proc Am Stat Assoc (Biopharmaceutics Section) 1994; pp 487 - 492.
  • Interpretation of simulation studies for efficient estimation of population pharmacokinetic parameters.
    • Ette EI, Kelman AW, Howie CA, Whiting B. Interpretation of simulation studies for efficient estimation of population pharmacokinetic parameters. Ann Pharmacother 1993; 27: 1034 - 1039 and Correction 27: 1548.
  • Designs for first time-in-human studies in non-oncology indications.
    • Chu H-M, Zha J, Roy A, Ette EI. Designs for first time-in-human studies in non-oncology indications. In: Pharmacometrics: the Science of Quantitative Pharmacology. Ette EI, Williams PJ (eds). Hoboken: John Wiley & Sons, 2007, pp 761 – 780.
  • Ignorability and parameter estimation in longitudinal pharmacokinetic studies.
    • Ette EI, Sun H, Ludden TM. Ignorability and parameter estimation in longitudinal pharmacokinetic studies. J Clin Pharmacol 1998; 38: 221 - 226.
  • Balanced designs in longitudinal population pharmacokinetic studies.
    • Ette EI, Sun H, Ludden TM. Balanced designs in longitudinal population pharmacokinetic studies. J Clin Pharmacol 1998; 38: 417 - 423.
  • On error in the recording of sampling times and parameter estimation from repeated measures pharmacokinetic data.
    • Sun H, Ette EI, Ludden TM. On error in the recording of sampling times and parameter estimation from repeated measures pharmacokinetic data. J Pharmacokinet Biopharm; 1996: 24 (6): 635 - 648.
  • Analysis of animal pharmacokinetic data: performance of the one point per animal design.
    • 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 (6): 551 -566.
  • Efficient experimental design and estimation of population pharmacokinetic parameters in preclinical animal studies.
    • 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 (5); 729 - 737.
  • Animal Pharmacokinetics: An application of the population approach.
    • Ette EI, Kelman AW, Howie CA, Whiting B. Animal Pharmacokinetics: An application of the population approach. Clin Research Regul Affairs 1994; 11 (3): 243 - 255.
  • Inter-animal variability and parameter estimation in preclinical animal pharmacokinetic studies.
    • Ette EI, Kelman AW, Howie CA, Whiting B. Inter-animal variability and parameter estimation in preclinical animal pharmacokinetic studies. Clin Research Regul Affairs 1994; 11 (2): 121 - 139.
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