Rowland, M, Tozer, TN. Clinical Pharmacokinetics: Concepts and Applications. Philadeliphia, PA: Lea %26 Febiger; 2010.
Shargel, L, Yu, A. Applied Biopharmaceutics and Pharmacokinetics. New York: McGraw‐Hill; 1999.
Paalzow, LK. Torsten Teorell, the father of pharmacokinetics. Ups Med J 1995, 100:41–46.
Hall, SD, Thummel, KE, Watkins, PB, Lown, KS, Benet, LZ, Paine, MF, Mayo, RR, Turgeon, DK, Bailey, DG, Fontana, RJ, et al. Molecular and physical mechanisms of first‐pass extraction. Drug Metab Dispos 2002, 27: 161–166.
Kararli, TT. Gastrointestinal absorption of drugs. Ther Drug Carrier Syst 1989, 6:39–86.
Amidon, GE, Lennernas, H, Shan, VP, Crison, JR. A theoretical basis for a biopharmaceutical classification system: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 1995, 12: 413–420.
Himmelstein, KJ, Lutz, RJ. A review of the applications of physiologically based pharmacokinetic modeling. J Pharmacokinet Biopharm 1979, 7:127–145.
Oie, S, Tozer, TN. Effect of altered plasma protein binding on apparent volume of distribution. J Pharm Sci 1979, 68:1203–1205.
Tse, FLS, Ballard, F, Skinn, J. Estimating the fraction reabsorbed in drugs undergoing enterohepatic recycling. J Pharmacokinet Biopharm 1982, 10:455–461.
Berezhkovsky, LM. On the influence of protein binding on pharmacological activity of drugs. J Pharm Sci 2010, 99:2153–2165.
Zini, R, Riant, P, Barre, J, Tillement, JP. Disease‐induced variations in plasma protein levels: implications for drug dosage regimens (part 1). Clin Pharmacokinet 1990, 19:147–159.
Aggeler, PM, O`Reilly, RA, Leong, L, Kowitz, PE. Potentiation of anticoagulant effect of warfarin by phenylbutazone. New Engl J Med 1967, 276:496–501.
Benet, LZ, Hoener, B‐A. Changes in plasma protein binding have little clinical relevance. Clin Pharmacol Ther 2002, 71:115–121.
Testa, B, Kramer, S. The Biochemistry of Drug Metabolism: Principles, Redox Reactions, and Hydrolyses. New York: John Wiley %26 Sons, Inc; 2010.
Lin, JH, Lu, AYH. Role of pharmacokinetics and metabolism in drug discovery and development. Pharmacol Rev 1997, 49:403–449.
Jann, MW, Lam, YWF, Gray, EC, Chang, W‐H. Reversible metabolism of drugs. Drug Metabol Drug Interact 1994, 11:1–24.
Atkinson, AJ, Stec, GP, Lertora, JJL, Ruo, TI, Thenot, JP. Impact of active metabolites on monitoring plasma concentrations of therapeutic drugs. Ther Drug Monit 2010, 2:19–27.
Bonate, PL, Arthaud, L, Stuhler, J, Yerino, P, Press, RJ, Rose, JQ. The distribution, metabolism, and elimination of clofarabine in rats. Drug Metab Dispos 2005, 33: 739–748.
Bonate, PL, Cunningham, C, Gaynon, P, Jeha, S, Lam, GN, Razzouk, B, Steinherz, P, Weitman, S. Population pharmacokinetics of clofarabine and its metabolite, 6‐keto‐clofarabine, in adult and pediatric patients with cancer. Cancer Chemother Pharmacol (epub; June 26, 2010).
International Transporter Consortium, Giacomini, KM, Huang, S‐M, Tweedie, D, Benet, LZ, Brouwer, X Chu, A, Dhalin, R, Evers, V, Fischer, KM, et al. Membrane transporters in drug development. Nat Rev Drug Dis 2010, 9: 215–236.
Lin, JH. How significant is the role of p‐glycoprotein in drug absorption and brain uptake? Drugs Today 2004, 40:5–22.
Wilkinson, GR, Shand, DG. A physiological approach to hepatic drug clearance. Clin Pharmacol Therap 1975, 18:377–390.
Bekersky, I. Renal excretion. J Clin Pharmacol 1987, 27:447–449.
Rowland, M, Benet, LZ, Graham, GG. Clearance concepts in pharmacokinetics. J Pharmacokinet Biopharm 1973, 1:123–136.
Gibaldi, M, Levy, G, Weintraub, H. Drug distribution and pharmacologic effects. Clin Pharmacol Therap 1971, 12:734–742.
United States Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products ‐ General Considerations; 2000.
Muir, KT, Gomeni, R. %22Non‐compartmental analysis.%22 In: Bonate, PL, Howard, DR, eds. Pharmacokinetics in Drug Development: Clinical Study Design and Analysis. Arlington, VA: AAPS Press; 2004, 235–265.
Pharsight Corporation. WinNonlin Reference Guide, Version 3.2. Mountain View, CA: Pharsight Corporation; 2002.
Purves, RD. Optimum numerical integration methods for area‐under‐the‐curve (AUC) and area‐under‐the‐moment‐curve (AUMC). J Pharmacokinet Biopharm 1992, 20:211–226.
Gough, K, Hutchison, M, Keene, O, Byrom, B, Ellis, S, Lacey, L, McKellar, J. Assessment of dose proportionality: report from the Statisticians in the Pharmaceutical Industry/Pharmacokinetics UK Joint Working Party. Drug Inf J 1995, 29:1039–1048.
Lacey, LF, O`Keene, ON, Pritchard, JF, Bye, A. Common noncompartmental pharmacokinetic variables: are they normally and log‐normally distributed? J Biopharm Stat 1997, 7:171–178.
Cobelli, C, Foster, DM. Compartmental models: theory and practice using the SAAM II software system. Adv Exp Med Biol 1998, 445:79–101.
Zierler, K. A critique of compartmental analysis. Ann Rev Biophys Bioeng 1981, 10:531–562.
Sheiner, LB, Beal, SL. Evaluation of methods for estimating population pharmacokinetics parameters. I. Michaelis‐Menten model: routine clinical pharmacokinetic data. J Pharmacokinet Biopharm 1980, 8: 553–571.
Sheiner, LB, Beal, SL. Evaluation of methods for estimating population pharmacokinetic parameters. II. Biexponential model and experimental pharmacokinetic data. J Pharmacokinet Biopharm 1981, 9:635–651.
Sheiner, LB, Beal, SL. Evaluation of methods for estimating population pharmacokinetic parameters. III. Monoexponential model: routine clinical pharmacokinetic data. J Pharmacokinet Biopharm 1983, 11:303–319.
Boeckmann, AJ, Sheiner, LB, Beal, SL. NONMEM Users Guide (1989–2006). Ellicott City, MD: ICON Development Solutions; 2006.
Bonate, PL. %22Pharmacokinetic‐Pharmacodynamic Modeling and Simulation%22. New York: Springer; 2006.
Holford, NHG, Kimko, HC, Monteleone, JPR, Peck, CC. Simulation of clinical trials. Ann Rev Pharmacol Toxicol 2000, 40:209–234.
Kimko, HC, Reele, SSB, Holford, NHG, Peck, CC. Prediction of the outcome of a phase 3 clinical trial of an antipsychotic agent (quetiapine fumarate) by simulation with a population pharmacokinetic and pharmacodynamic model. Clin Pharmacol Ther 2000, 68:568–577.
Kimko, HC, Duffull, SB, eds. Simulation for Designing Clinical Trials: A Pharmacokinetic‐Pharmacodynamic Modeling Perspective. New York: Marcel Dekker; 2001.
Lalonde, R, Kowalski, KG, Hutmacher, MM, Ewy, W, Nichols, DJ, Milligan, PA, Corrigan, BW, Lockwood, PA, Marshall, SA, Benincosa, LJ, et al. Model‐based drug development. Clin Pharmacol Ther 2007, 82:21–32.
Sheiner, LB, Steimer, JL. Pharmacokinetic/ pharmacodynamic modeling in drug development. Ann Rev Pharmacol Toxicol 2000, 40:67–95.
Holford, NHG, Sheiner, LB. Understanding the dose‐effect relationship: clinical application of of pharmacokinetic‐pharmacodynamic models. Clin Pharmacokinet 1981, 6:429–453.
Jusko, WJ, Ko, HC. Physiologic indirect response models characterize diverse types of pharmacodynamic effects. Clin Pharmacol Ther 1994, 56:406–419.
Mager, DE, Wyska, E, Jusko, WJ. Diversity of mechanism‐based pharmacodynamic models. Drug Metab Dispos 2003, 31:510–519.
Bonate, PL, Craig, A, Gaynon, P, Gandhi, V, Jeha, S, Kadota, R, Lam, GN, Plunkett, W, Razzouk, B, Rytting, M, et al. Population pharmacokinetics of clofarabine, a second‐generation nucleoside analog, in pediatric patients with acute leukemia. J Clin Pharmacol 2004, 44:1309–1322.
Gobburu, JVS, Lesko, LJ. Quantitative disease, drug, and trial models. Ann Rev Pharmacol Toxicol 2008, 49:291–301.
McDonald, CJ, Mazzuca, SA, McCabe, GP. How much of the placebo ‘effect’ is really statistical regression? Stat Med 1983, 2:417–427.
Bhattaram, AV, Siddiqui, O, Kapcala, LP, Gobburu, JVS. Endpoints and analyses to discern disease‐modifying drug‐effects in early Parkinson`s disease. AAPS J 2009, 11:456–464.
Wang, Y, Sung, C, Dartois, C, Ramchandani, R, Booth, BP, Rock, E, Gobburu, J. Elucidation of relationship between tumor size and survival in non‐small‐cell lung cancer patients can aid early decision making in clinical drug development. Clin Pharmacol Ther 2009, 86:167–174.
Mathijssen, RHJ, van Alphen, RJ, Verweij, J, Loos, WJ, Nooter, K, Stoter, G, Sparreboom, A. Clinical pharmacokinetics and metabolism of irinotecan (CPT‐11). Clin Cancer Res 2001, 7:2182–2194.
Xie, R, Mathijssen, RHJ, Sparreboom, A, Verweij, J, Karlsson, MO. Clinical pharmacokinetics of irinotecan its metabolite in relation with diarrhea. Clin Pharmacol Ther 2002, 72:265–272.
O`Dwyer, PJ, Catalano, RB. Uridine diphosphate glucuronyltransferase (UGT) 1A1 and irinotecan: practical pharmacogenomics arrives in cancer therapy. J Clin Oncol 2006, 28:4534–4538.
United States Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research. Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function ‐ Study Design, Data Analysis, and Impact on Dosing and Labeling; 1998.
United States Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research. Guidance for Industry: Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Labelling; 2003.
United States Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research. Guidance for Industry: Guideline for the Study of Drugs Likely to be Used in the Elderly; 1989.
Kimko, HC, Peck, CC. Clinical trial simulations: applications and trends. New York: Springer; 2011.