Application of PBPK modelling in drug discovery and development at Pfizer

References

• Agoram B, Woltosz WS, Bolger MB. (2001). Predicting the impact of physiological and biochemical processes on oral drug bioavailability. Adv Drug Deliv Rev 50 Suppl 1:S41–S67.
   PubMed Web of Science ®Google Scholar
• Allan G, Davis J, Dickins M, Gardner I, Jenkins T, Jones H, Webster R, Westgate H. (2008). Pre-clinical pharmacokinetics of UK-453,061, a novel non-nucleoside reverse transcriptase inhibitor (NNRTI), and use of in silico physiologically based prediction tools to predict the oral pharmacokinetics of UK-453,061 in man. Xenobiotica 38:620–640.
   PubMed Web of Science ®Google Scholar
• Almond LM, Yang J, Jamei M, Tucker GT, Rostami-Hodjegan A. (2009). Towards a quantitative framework for the prediction of DDIs arising from cytochrome P450 induction. Curr Drug Metab 10:420–432.
   PubMed Web of Science ®Google Scholar
• Andersen ME. (1995). Development of physiologically based pharmacokinetic and physiologically based pharmacodynamic models for applications in toxicology and risk assessment. Toxicol Lett 79:35–44.
   PubMed Web of Science ®Google Scholar
• Baxter LT, Zhu H, Mackensen DG, Jain RK. (1994). Physiologically based pharmacokinetic model for specific and nonspecific monoclonal antibodies and fragments in normal tissues and human tumor xenografts in nude mice. Cancer Res 54:1517–1528.
   PubMed Web of Science ®Google Scholar
• Berezhkovskiy LM. (2004). Determination of volume of distribution at steady state with complete consideration of the kinetics of protein and tissue binding in linear pharmacokinetics. J Pharm Sci 93:364–374.
   PubMed Web of Science ®Google Scholar
• Björkman S, Wada DR, Berling BM, Benoni G. (2001). Prediction of the disposition of midazolam in surgical patients by a physiologically based pharmacokinetic model. J Pharm Sci 90:1226–1241.
   PubMed Web of Science ®Google Scholar
• Bouzom F, Walther B. (2008). Pharmacokinetic predictions in children by using the physiologically based pharmacokinetic modelling. Fundam Clin Pharmacol 22:579–587.
   PubMed Web of Science ®Google Scholar
• Boxenbaum H. (1984). Interspecies pharmacokinetic scaling and the evolutionary-comparative paradigm. Drug Metab Rev 15:1071–1121.
   PubMed Web of Science ®Google Scholar
• Brightman FA, Leahy DE, Searle GE, Thomas S. (2005a). Application of a generic physiologically-based pharmacokinetic model to the estimation of xenobiotic levels in human plasma. Drug Metab Dispos 34:94–101.
   PubMed Web of Science ®Google Scholar
• Brightman FA, Leahy DE, Searle GE, Thomas S. (2005b). Application of a generic physiologically-based pharmacokinetic model to the estimation of xenobiotic levels in rat plasma. Drug Metab Dispos 34:84–93.
   PubMed Web of Science ®Google Scholar
• Bungay PJ, Tweedy S, Howe DC, Gibson, KR, Jones HM, Mount NM. (2011). Pre-clinical and clinical pharmacokinetics of pf-02413873, a non-steroidal progesterone receptor antagonist. Drug Metab Dispos 39:1396–1405.
   PubMed Web of Science ®Google Scholar
• Davda JP, Jain M, Batra SK, Gwilt PR, Robinson DH. (2008). A physiologically based pharmacokinetic (PBPK) model to characterize and predict the disposition of monoclonal antibody CC49 and its single chain Fv constructs. Int Immunopharmacol 8:401–413.
   PubMed Web of Science ®Google Scholar
• De Buck SS, Sinha VK, Fenu LA, Gilissen RA, Mackie CE, Nijsen MJ. (2007). The prediction of drug metabolism, tissue distribution, and bioavailability of 50 structurally diverse compounds in rat using mechanism-based absorption, distribution, and metabolism prediction tools. Drug Metab Dispos 35:649–659.
   PubMed Web of Science ®Google Scholar
• De Buck SS, Sinha VK, Fenu LA, Nijsen MJ, Mackie CE, Gilissen RA. (2007). Prediction of human pharmacokinetics using physiologically based modeling: A retrospective analysis of 26 clinically tested drugs. Drug Metab Dispos 35:1766–1780.
   PubMed Web of Science ®Google Scholar
• Edginton AN, Schmitt W, Willmann S. (2006). Development and evaluation of a generic physiologically based pharmacokinetic model for children. Clin Pharmacokinet 45:1013–1034.
   PubMed Web of Science ®Google Scholar
• Edginton AN, Theil FP, Schmitt W, Willmann S. (2008). Whole body physiologically-based pharmacokinetic models: Their use in clinical drug development. Expert Opin Drug Metab Toxicol 4:1143–1152.
   PubMed Web of Science ®Google Scholar
• Edginton AN, Willmann S. (2008). Physiology-based simulations of a pathological condition: Prediction of pharmacokinetics in patients with liver cirrhosis. Clin Pharmacokinet 47:743–752.
   PubMed Web of Science ®Google Scholar
• Endres CJ, Endres MG, Unadkat JD. (2009). Interplay of drug metabolism and transport: A real phenomenon or an artifact of the site of measurement? Mol Pharm 6:1756–1765.
   PubMedGoogle Scholar
• Fang L, Sun D. (2008). Predictive physiologically based pharmacokinetic model for antibody-directed enzyme prodrug therapy. Drug Metab Dispos 36:1153–1165.
   PubMed Web of Science ®Google Scholar
• Ferl GZ, Wu AM, DiStefano JJ 3rd. (2005). A predictive model of therapeutic monoclonal antibody dynamics and regulation by the neonatal Fc receptor (FcRn). Ann Biomed Eng 33:1640–1652.
   PubMed Web of Science ®Google Scholar
• Gao M, Nettles RE, Belema M, Snyder LB, Nguyen VN, Fridell RA, Serrano-Wu MH, Langley DR, Sun JH, O’Boyle DR 2nd, Lemm JA, Wang C, Knipe JO, Chien C, Colonno RJ, Grasela DM, Meanwell NA, Hamann LG. (2010). Chemical genetics strategy identifies an HCV NS5A inhibitor with a potent clinical effect. Nature 465:96–100.
   PubMed Web of Science ®Google Scholar
• Garg A, Balthasar JP. (2007). Physiologically-based pharmacokinetic (PBPK) model to predict IgG tissue kinetics in wild-type and FcRn-knockout mice. J Pharmacokinet Pharmacodyn 34:687–709.
   PubMed Web of Science ®Google Scholar
• Germani M, Crivori P, Rocchetti M, Burton PS, Wilson AG, Smith ME, Poggesi I. (2007). Evaluation of a basic physiologically based pharmacokinetic model for simulating the first-time-in-animal study. Eur J Pharm Sci 31:190–201.
   PubMed Web of Science ®Google Scholar
• Giacomini KM, Huang SM, Tweedie DJ, Benet LZ, Brouwer KL, Chu X, Dahlin A, Evers R, Fischer V, Hillgren KM, Hoffmaster KA, Ishikawa T, Keppler D, Kim RB, Lee CA, Niemi M, Polli JW, Sugiyama Y, Swaan PW, Ware JA, Wright SH, Yee SW, Zamek-Gliszczynski MJ, Zhang L; International Transporter Consortium. (2010). Membrane transporters in drug development. Nat Rev Drug Discov 9:215–236.
   PubMed Web of Science ®Google Scholar
• Guest EJ, Rowland-Yeo K, Rostami-Hodjegan A, Tucker GT, Houston JB, Galetin A. (2011). Assessment of algorithms for predicting drug-drug interactions via inhibition mechanisms: Comparison of dynamic and static models. Br J Clin Pharmacol 71:72–87.
   PubMed Web of Science ®Google Scholar
• Heiskanen T, Heiskanen T, Kairemo K. (2009). Development of a PBPK model for monoclonal antibodies and simulation of human and mice PBPK of a radiolabelled monoclonal antibody. Curr Pharm Des 15:988–1007.
   PubMed Web of Science ®Google Scholar
• Hosea NA, Collard WT, Cole S, Maurer TS, Fang RX, Jones H, Kakar SM, Nakai Y, Smith BJ, Webster R, Beaumont K. (2009). Prediction of human pharmacokinetics from preclinical information: Comparative accuracy of quantitative prediction approaches. J Clin Pharmacol 49:513–533.
   PubMed Web of Science ®Google Scholar
• Houston JB. (1994). Utility of in vitro drug metabolism data in predicting in vivo metabolic clearance. Biochem Pharmacol 47:1469–1479.
   PubMed Web of Science ®Google Scholar
• Houston JB, Carlile DJ. (1997). Prediction of hepatic clearance from microsomes, hepatocytes, and liver slices. Drug Metab Rev 29:891–922.
   PubMed Web of Science ®Google Scholar
• Howgate EM, Rowland Yeo K, Proctor NJ, Tucker GT, Rostami-Hodjegan A. (2006). Prediction of in vivo drug clearance from in vitro data. I: Impact of inter-individual variability. Xenobiotica 36:473–497.
   PubMed Web of Science ®Google Scholar
• Hunt CA, Ropella GE, Yan L, Hung DY, Roberts MS. (2006). Physiologically based synthetic models of hepatic disposition. J Pharmacokinet Pharmacodyn 33:737–772.
   PubMed Web of Science ®Google Scholar
• Inoue S, Howgate EM, Rowland-Yeo K, Shimada T, Yamazaki H, Tucker GT, Rostami-Hodjegan A. (2006). Prediction of in vivo drug clearance from in vitro data. II: Potential inter-ethnic differences. Xenobiotica 36:499–513.
   PubMed Web of Science ®Google Scholar
• Ito K, Houston JB. (2004). Comparison of the use of liver models for predicting drug clearance using in vitro kinetic data from hepatic microsomes and isolated hepatocytes. Pharm Res 21:785–792.
   PubMed Web of Science ®Google Scholar
• Iwatsubo T, Hirota N, Ooie T, Suzuki H, Shimada N, Chiba K, Ishizaki T, Green CE, Tyson CA, Sugiyama Y. (1997). Prediction of in vivo drug metabolism in the human liver from in vitro metabolism data. Pharmacol Ther 73:147–171.
   PubMed Web of Science ®Google Scholar
• Jamei M, Dickinson GL, Rostami-Hodjegan A. (2009). A framework for assessing inter-individual variability in pharmacokinetics using virtual human populations and integrating general knowledge of physical chemistry, biology, anatomy, physiology and genetics: A tale of ‘bottom-up’ vs ‘top-down’ recognition of covariates. Drug Metab Pharmacokinet 24:53–75.
   PubMed Web of Science ®Google Scholar
• Jamei M, Turner D, Yang J, Neuhoff S, Polak S, Rostami-Hodjegan A, Tucker G. (2009). Population-based mechanistic prediction of oral drug absorption. AAPS J 11:225–237.
   PubMed Web of Science ®Google Scholar
• Johnson TN, Boussery K, Rowland-Yeo K, Tucker GT, Rostami-Hodjegan A. (2010). A semi-mechanistic model to predict the effects of liver cirrhosis on drug clearance. Clin Pharmacokinet 49:189–206.
   PubMed Web of Science ®Google Scholar
• Johnson TN, Rostami-Hodjegan A, Tucker GT. (2006). Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children. Clin Pharmacokinet 45:931–956.
   PubMed Web of Science ®Google Scholar
• Jones BC, Middleton DS, Youdim K. (2009). Cytochrome P450 metabolism and inhibition: Analysis for drug discovery. Prog Med Chem 47:239–263.
   PubMedGoogle Scholar
• Jones HM, Gardner IB, Collard WT, Stanley PJ, Oxley P, Hosea NA, Plowchalk D, Gernhardt S, Lin J, Dickins M, Rahavendran SR, Jones BC, Watson KJ, Pertinez H, Kumar V, Cole S. (2011). Simulation of human intravenous and oral pharmacokinetics of 21 diverse compounds using physiologically based pharmacokinetic modelling. Clin Pharmacokinet 50:331–347.
   PubMed Web of Science ®Google Scholar
• Jones HM, Gardner IB, Watson KJ. (2009). Modelling and PBPK simulation in drug discovery. AAPS J 11:155–166.
   PubMed Web of Science ®Google Scholar
• Jones HM, Houston JB. (2004). Substrate depletion approach for determining in vitro metabolic clearance: Time dependencies in hepatocyte and microsomal incubations. Drug Metab Dispos 32:973–982.
   PubMed Web of Science ®Google Scholar
• Jones HM, Parrott N, Jorga K, Lavé T. (2006). A novel strategy for physiologically based predictions of human pharmacokinetics. Clin Pharmacokinet 45:511–542.
   PubMed Web of Science ®Google Scholar
• Jones HM, Parrott N, Ohlenbusch G, Lavé T. (2006). Predicting pharmacokinetic food effects using biorelevant solubility media and physiologically based modelling. Clin Pharmacokinet 45:1213–1226.
   PubMed Web of Science ®Google Scholar
• Kletting P, Bunjes D, Reske SN, Glatting G. (2009). Improving anti-CD45 antibody radioimmunotherapy using a physiologically based pharmacokinetic model. J Nucl Med 50:296–302.
   PubMed Web of Science ®Google Scholar
• Kletting P, Kull T, Bunjes D, Mahren B, Luster M, Reske SN, Glatting G. (2010). Radioimmunotherapy with anti-CD66 antibody: Improving the biodistribution using a physiologically based pharmacokinetic model. J Nucl Med 51:484–491.
   PubMed Web of Science ®Google Scholar
• Kovacevic I, Parojcic J, Homsek I, Tubic-Grozdanis M, Langguth P. (2009). Justification of biowaiver for carbamazepine, a low soluble high permeable compound, in solid dosage forms based on IVIVC and gastrointestinal simulation. Mol Pharm 6:40–47.
   PubMed Web of Science ®Google Scholar
• Krishnan K, Andersen ME. (1994). Physiologically based pharmacokinetic modeling in toxicology. In: Hayes WA. (ed). Principles and methods of toxicology. NY: Raven Press.
   Google Scholar
• Lavé T, Chapman K, Goldsmith P, Rowland M. (2009). Human clearance prediction: Shifting the paradigm. Expert Opin Drug Metab Toxicol 5:1039–1048.
   PubMed Web of Science ®Google Scholar
• Lavé T, Coassolo P, Reigner B. (1999). Prediction of hepatic metabolic clearance based on interspecies allometric scaling techniques and in vitro-in vivo correlations. Clin Pharmacokinet 36:211–231.
   PubMed Web of Science ®Google Scholar
• Lavé T, Dupin S, Schmitt C, Valles B, Ubeaud G, Chou RC, Jaeck D, Coassolo P. (1997). The use of human hepatocytes to select compounds based on their expected hepatic extraction ratios in humans. Pharm Res 14:152–155.
   PubMed Web of Science ®Google Scholar
• Liu X, Smith BJ, Chen C, Callegari E, Becker SL, Chen X, Cianfrogna J, Doran AC, Doran SD, Gibbs JP, Hosea N, Liu J, Nelson FR, Szewc MA, Van Deusen J. (2005). Use of a physiologically based pharmacokinetic model to study the time to reach brain equilibrium: An experimental analysis of the role of blood-brain barrier permeability, plasma protein binding, and brain tissue binding. J Pharmacol Exp Ther 313:1254–1262.
   PubMed Web of Science ®Google Scholar
• Löbenberg R, Krämer J, Shah VP, Amidon GL, Dressman JB. (2000). Dissolution testing as a prognostic tool for oral drug absorption: Dissolution behavior of glibenclamide. Pharm Res 17:439–444.
   PubMed Web of Science ®Google Scholar
• Lukacova V, Woltosz WS, Bolger MB. (2009). Prediction of modified release pharmacokinetics and pharmacodynamics from in vitro, immediate release, and intravenous data. AAPS J 11:323–334.
   PubMed Web of Science ®Google Scholar
• Mahmood I. (1998). Interspecies scaling of renally secreted drugs. Life Sci 63:2365–2371.
   PubMed Web of Science ®Google Scholar
• Malhotra B, Guan Z, Wood N, Gandelman K. (2008). Pharmacokinetic profile of fesoterodine. Int J Clin Pharmacol Ther 46:556–563.
   PubMed Web of Science ®Google Scholar
• Malhotra B, Sachse R, Wood N. (2009). Evaluation of drug-drug interactions with fesoterodine. Eur J Clin Pharmacol 65:551–560.
   PubMed Web of Science ®Google Scholar
• McCarley KD, Bunge AL. (2001). Pharmacokinetic models of dermal absorption. J Pharm Sci 90:1699–1719.
   PubMed Web of Science ®Google Scholar
• Modok S, Hyde P, Mellor HR, Roose T, Callaghan R. (2006). Diffusivity and distribution of vinblastine in three-dimensional tumour tissue: Experimental and mathematical modelling. Eur J Cancer 42:2404–2413.
   PubMed Web of Science ®Google Scholar
• Nestorov I. (2003). Whole body pharmacokinetic models. Clin Pharmacokinet 42:883–908.
   PubMed Web of Science ®Google Scholar
• Obach RS. (1999). Prediction of human clearance of twenty-nine drugs from hepatic microsomal intrinsic clearance data: An examination of in vitro half-life approach and nonspecific binding to microsomes. Drug Metab Dispos 27:1350–1359.
   PubMed Web of Science ®Google Scholar
• Okumu A, DiMaso M, Löbenberg R. (2009). Computer simulations using GastroPlus to justify a biowaiver for etoricoxib solid oral drug products. Eur J Pharm Biopharm 72:91–98.
   PubMed Web of Science ®Google Scholar
• Paine SW, Parker AJ, Gardiner P, Webborn PJ, Riley RJ. (2008). Prediction of the pharmacokinetics of atorvastatin, cerivastatin, and indomethacin using kinetic models applied to isolated rat hepatocytes. Drug Metab Dispos 36:1365–1374.
   PubMed Web of Science ®Google Scholar
• Parrott N, Jones H, Paquereau N, Lavé T. (2005). Application of full physiological models for pharmaceutical drug candidate selection and extrapolation of pharmacokinetics to man. Basic Clin Pharmacol Toxicol 96:193–199.
   PubMed Web of Science ®Google Scholar
• Parrott N, Paquereau N, Coassolo P, Lavé T. (2005). An evaluation of the utility of physiologically based models of pharmacokinetics in early drug discovery. J Pharm Sci 94:2327–2343.
   PubMed Web of Science ®Google Scholar
• Peng B, Andrews J, Nestorov I, Brennan B, Nicklin P, Rowland M. (2001). Tissue distribution and physiologically based pharmacokinetics of antisense phosphorothioate oligonucleotide ISIS 1082 in rat. Antisense Nucleic Acid Drug Dev 11:15–27.
   PubMedGoogle Scholar
• Peters SA. (2008). Evaluation of a generic physiologically based pharmacokinetic model for lineshape analysis. Clin Pharmacokinet 47:261–275.
   PubMed Web of Science ®Google Scholar
• Poirier A, Cascais AC, Funk C, Lavé T. (2009). Prediction of pharmacokinetic profile of valsartan in humans based on in vitro uptake-transport data. Chem Biodivers 6:1975–1987.
   PubMed Web of Science ®Google Scholar
• Poulin P, Jones RD, Jones HM, Gibson CR, Rowland M, Chien JY, Ring BJ, Adkison KK, Ku MS, He H, Vuppugalla R, Marathe P, Fischer V, Dutta S, Sinha VK, Bjornsson T, Lave T, Yates JW. (2011). Phrma cpcdc initiative on predictive models of human pharmacokinetics, part 5: Prediction of plasma concentration-time profiles in human by using the physiologically-based pharmacokinetic modeling approach. J Pharm Sci Epub ahead of print: 10.1002/jps.22550.
   Web of Science ®Google Scholar
• Poulin P, Schoenlein K, Theil FP. (2001). Prediction of adipose tissue: Plasma partition coefficients for structurally unrelated drugs. J Pharm Sci 90:436–447.
   PubMed Web of Science ®Google Scholar
• Poulin P, Theil FP. (2000). A priori prediction of tissue:Plasma partition coefficients of drugs to facilitate the use of physiologically-based pharmacokinetic models in drug discovery. J Pharm Sci 89:16–35.
   PubMed Web of Science ®Google Scholar
• Poulin P, Theil FP. (2002). Prediction of pharmacokinetics prior to in vivo studies. 1. Mechanism-based prediction of volume of distribution. J Pharm Sci 91:129–156.
   PubMed Web of Science ®Google Scholar
• Price PS, Conolly RB, Chaisson CF, Gross EA, Young JS, Mathis ET, Tedder DR. (2003). Modeling interindividual variation in physiological factors used in PBPK models of humans. Crit Rev Toxicol 33:469–503.
   PubMed Web of Science ®Google Scholar
• Proctor NJ, Tucker GT, Rostami-Hodjegan A. (2004). Predicting drug clearance from recombinantly expressed CYPs: Intersystem extrapolation factors. Xenobiotica 34:151–178.
   PubMed Web of Science ®Google Scholar
• Rodgers T, Leahy D, Rowland M. (2005). Physiologically based pharmacokinetic modeling 1: Predicting the tissue distribution of moderate-to-strong bases. J Pharm Sci 94:1259–1276.
   PubMed Web of Science ®Google Scholar
• Rodgers T, Rowland M. (2006). Physiologically based pharmacokinetic modelling 2: Predicting the tissue distribution of acids, very weak bases, neutrals and zwitterions. J Pharm Sci 95:1238–1257.
   PubMed Web of Science ®Google Scholar
• Rodgers T, Rowland M. (2007). Mechanistic approaches to volume of distribution predictions: Understanding the processes. Pharm Res 24:918–933.
   PubMed Web of Science ®Google Scholar
• Rostami-Hodjegan A, Tucker G. (2004). In silico simulations to assess the in vivo consequences of in vitro metabolic drug-drug interactions. Drug Discovery Today: Technologies 1:441–448.
   PubMedGoogle Scholar
• Rostami-Hodjegan A, Tucker GT. (2007). Simulation and prediction of in vivo drug metabolism in human populations from in vitro data. Nat Rev Drug Discov 6:140–148.
   PubMed Web of Science ®Google Scholar
• Rowland M, Balant L, Peck C. (2004). Physiologically based pharmacokinetics in drug development and regulatory science: A workshop report (Georgetown University, Washington, DC, May 29-30, 2002). AAPS PharmSci 6:E6.
   PubMedGoogle Scholar
• Rowland M, Peck C, Tucker G. (2011). Physiologically-based pharmacokinetics in drug development and regulatory science. Annu Rev Pharmacol Toxicol 51:45–73.
   PubMed Web of Science ®Google Scholar
• Rowland Yeo K, Jamei M, Yang J, Tucker GT, Rostami-Hodjegan A. (2010). Physiologically based mechanistic modelling to predict complex drug-drug interactions involving simultaneous competitive and time-dependent enzyme inhibition by parent compound and its metabolite in both liver and gut - the effect of diltiazem on the time-course of exposure to triazolam. Eur J Pharm Sci 39:298–309.
   PubMed Web of Science ®Google Scholar
• Smith DA, Obach RS. (2009). Metabolites in safety testing (MIST): Considerations of mechanisms of toxicity with dose, abundance, and duration of treatment. Chem Res Toxicol 22:267–279.
   PubMed Web of Science ®Google Scholar
• Sugano K. (2009). Introduction to computational oral absorption simulation. Expert Opin Drug Metab Toxicol 5:259–293.
   PubMed Web of Science ®Google Scholar
• Tanaka C, Kawai R, Rowland M. (2000). Dose-dependent pharmacokinetics of cyclosporin A in rats: Events in tissues. Drug Metab Dispos 28:582–589.
   PubMed Web of Science ®Google Scholar
• Theil FP, Guentert TW, Haddad S, Poulin P. (2003). Utility of physiologically based pharmacokinetic models to drug development and rational drug discovery candidate selection. Toxicol Lett 138:29–49.
   PubMed Web of Science ®Google Scholar
• Tubic-Grozdanis M, Bolger MB, Langguth P. (2008). Application of gastrointestinal simulation for extensions for biowaivers of highly permeable compounds. AAPS J 10:213–226.
   PubMed Web of Science ®Google Scholar
• Urva SR, Yang VC, Balthasar JP. (2010). Physiologically based pharmacokinetic model for T84.66: A monoclonal anti-CEA antibody. J Pharm Sci 99:1582–1600.
   PubMed Web of Science ®Google Scholar
• Watanabe T, Kusuhara H, Maeda K, Shitara Y, Sugiyama Y. (2009). Physiologically based pharmacokinetic modeling to predict transporter-mediated clearance and distribution of pravastatin in humans. J Pharmacol Exp Ther 328:652–662.
   PubMed Web of Science ®Google Scholar
• Weiss M, Krejcie TC, Avram MJ. (2007). Circulatory transport and capillary-tissue exchange as determinants of the distribution kinetics of inulin and antipyrine in dog. J Pharm Sci 96:913–926.
   PubMed Web of Science ®Google Scholar
• Willmann S, Höhn K, Edginton A, Sevestre M, Solodenko J, Weiss W, Lippert J, Schmitt W. (2007). Development of a physiology-based whole-body population model for assessing the influence of individual variability on the pharmacokinetics of drugs. J Pharmacokinet Pharmacodyn 34:401–431.
   PubMed Web of Science ®Google Scholar
• Willmann S, Schmitt W, Keldenich J, Dressman JB. (2003). A physiologic model for simulating gastrointestinal flow and drug absorption in rats. Pharm Res 20:1766–1771.
   PubMed Web of Science ®Google Scholar
• Willmann S, Schmitt W, Keldenich J, Lippert J, Dressman JB. (2004). A physiological model for the estimation of the fraction dose absorbed in humans. J Med Chem 47:4022–4031.
   PubMed Web of Science ®Google Scholar
• Yamazaki S, Skaptason J, Romero D, Vekich S, Jones HM, Tan W, Wilner KD, Koudriakova T. (2011). Prediction of oral pharmacokinetics of cMet kinase inhibitors in humans: Physiologically based pharmacokinetic model versus traditional one-compartment model. Drug Metab Dispos 39:383–393.
   PubMed Web of Science ®Google Scholar
• Yu LX, Amidon GL. (1999). A compartmental absorption and transit model for estimating oral drug absorption. Int J Pharm 186:119–125.
   PubMed Web of Science ®Google Scholar
• Zhang L, Zhang YD, Strong JM, Reynolds KS, Huang SM. (2008). A regulatory viewpoint on transporter-based drug interactions. Xenobiotica 38:709–724.
   PubMed Web of Science ®Google Scholar
• Zhao P, Zhang L, Grillo JA, Liu Q, Bullock JM, Moon YJ, Song P, Brar SS, Madabushi R, Wu TC, Booth BP, Rahman NA, Reynolds KS, Gil Berglund E, Lesko LJ, Huang SM. (2011). Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review. Clin Pharmacol Ther 89:259–267.
   PubMed Web of Science ®Google Scholar
• Zuegge J, Schneider G, Coassolo P, Lavé T. (2001). Prediction of hepatic metabolic clearance: Comparison and assessment of prediction models. Clin Pharmacokinet 40:553–563.
   PubMed Web of Science ®Google Scholar