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Clinical Research and Regulatory Affairs Volume 13, 1996 - Issue 3-4
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Research Article

Designing Cross-Sectional Population Pharmacokinetic Studies: Implications for Pediatric and Animal Studies

C. D. Jones office of Clinical Pharmacology & Biopharmaceutics Center for Drug Evaluation and Research Food and Drug Administration, 5600 Fishers Lane, Rm. 13 B 17, HFD-855, Rockville, MD, 20857, USA
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H. Sun office of Clinical Pharmacology & Biopharmaceutics Center for Drug Evaluation and Research Food and Drug Administration, 5600 Fishers Lane, Rm. 13 B 17, HFD-855, Rockville, MD, 20857, USA
&
E. I. Ette office of Clinical Pharmacology & Biopharmaceutics Center for Drug Evaluation and Research Food and Drug Administration, 5600 Fishers Lane, Rm. 13 B 17, HFD-855, Rockville, MD, 20857, USA
Pages 133-165 | Published online: 28 Sep 2008

Citations (13)

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Read on this site (1)

Ene I. Ette, Varun Garg & Angrew Jayaraj. (2005) A Rational Approach to Drug Development: The Confirmatory Phase. Clinical Research and Regulatory Affairs 22:3-4, pages 103-118.
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Articles from other publishers (12)

C. Bon, P. L. Toutain, D. Concordet, R. Gehring, T. Martin-Jimenez, J. Smith, L. Pelligand, M. Martinez, T. Whittem, J. E. Riviere & J. P. Mochel. (2018) Mathematical modeling and simulation in animal health. Part III: Using nonlinear mixed-effects to characterize and quantify variability in drug pharmacokinetics. Journal of Veterinary Pharmacology and Therapeutics 41:2, pages 171-183.
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C. C. Llanos-Paez, C. E. Staatz, R. Lawson & S. Hennig. (2017) A Population Pharmacokinetic Model of Gentamicin in Pediatric Oncology Patients To Facilitate Personalized Dosing. Antimicrobial Agents and Chemotherapy 61:8.
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Peter L. BonatePeter L. Bonate. 2011. Pharmacokinetic-Pharmacodynamic Modeling and Simulation. Pharmacokinetic-Pharmacodynamic Modeling and Simulation 303 358 .
Robert J. Bauer, Serge Guzy & Chee Ng. (2007) A survey of population analysis methods and software for complex pharmacokinetic and pharmacodynamic models with examples. The AAPS Journal 9:1, pages E60-E83.
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Mamoru Narukawa & Akifumi Yafune. (2005) A Note on Population Pharmacokinetic Studies With a Single Sampling Design. Therapeutic Drug Monitoring 27:2, pages 111-115.
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Hui-May Chu & Ene I. Ette. (2005) A random sampling approach for robust estimation of tissue-to-plasma ratio from extremely sparse data. The AAPS Journal 7:1, pages E249-E258.
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Ene I Ette, Paul J Williams & James R Lane. (2004) Population Pharmacokinetics III: Design, Analysis, and Application of Population Pharmacokinetic Studies. Annals of Pharmacotherapy 38:12, pages 2136-2144.
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Ene I Ette & Paul J Williams. (2004) Population Pharmacokinetics II: Estimation Methods. Annals of Pharmacotherapy 38:11, pages 1907-1915.
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Ene I. Ette & Leonard C. Onyiah. (2002) Estimating inestimable standard errors in population pharmacokinetic studies: The bootstrap with winsorization. European Journal of Drug Metabolism and Pharmacokinetics 27:3, pages 213-224.
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Paul J. Williams & Ene I. Ette. (2000) The Role of Population Pharmacokinetics in Drug Development in Light of the Food and Drug Administration??s ???Guidance for Industry: Population Pharmacokinetics???. Clinical Pharmacokinetics 39:6, pages 385-395.
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E. O. Fadiran, C. D. Jones & E. I. Ette. (2000) Designing population pharmacokinetic studies: Performance of mixed designs. European Journal of Drug Metabolism and Pharmacokinetics 25:3-4, pages 231-239.
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Ene I. Ette, He Sun & Thomas M. Ludden. (2013) Balanced Designs in Longitudinal Population Pharmacokinetic Studies. The Journal of Clinical Pharmacology 38:5, pages 417-423.
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