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Additional Suggested Reading

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This appendix details the references that were relevant to the development and validation of GastroPlus, but were not cited directly in this version of the GastroPlus Scientific Principles Guide.

  1. Abazari, A., Elliott, J.A., et al. (2009). “A biomechanical triphasic approach to the transport of nondilute solutions in articular cartilage.” Biophys. J. 97(12): 3054-64.

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  3. Abugayyas, L. and Balthasar, J.P. (2012). “Application of knockout mouse models to investigate the influence of FcℽR on the tissue distribution and elimination of 8C2, a murine IgG1 monoclonal antibody.” Int. J. Pharm. 439(1-2): 8-16.

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  5. Austin, R.P., Barton, P., et al. (2002). “The influence of nonspecific microsomal binding on apparent intrinsic clearance, and its prediction from physicochemical properties.” Drug Metab. Dispos. 30(12): 1497-503.

  6. Austin, R.P., Barton, P., et al. (2005). “The binding of drugs to hepatocytes and its relationship to physicochemical properties.” Drug Metab. Dispos. 33(3): 419-25.

  7. Barnett, C.H. (1958). “Measurement and interpretation of synovial fluid viscosities.” Ann. Rheum. Dis. 17(2): 229-33.

  8. Bautista, C.A., Varela, C.R., et al. (1991). “Measurement of colonic transit time in children.” J. Pediatr. Gastroenterol. Nutr. 13(1): 42-5.

  9. Baxter, L.T., Zhu, H., et al. (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.

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  11. Bigaard, J., Frederiksen, K., et al. (2004). “Body fat and fat-free mass and all-cause mortality.” Obes. Res. 12(7): 1042-9.

  12. Brace, R.A. (1995). “Progress toward understanding the regulation of amniotic fluid volume: water and solute fluxes in and through the fetal membranes.” Placenta 16(1): 1-18.

  13. Brightman, F.A., Leahy, D.E., et al. (2006). “Application of a generic physiologically based pharmacokinetic model to the estimation of xenobiotic levels in human plasma.” Drug Metab. Dispos. 34(1): 94-101.

  14. Brightman, F.A., Leahy, D.E., et al. (2006). “Application of a generic physiologically based pharmacokinetic model to the estimation of xenobiotic levels in rat plasma.” Drug Metab. Dispos. 34(1): 84-93.

  15. Casteleyn, C., Rekecki, A., Van Der Aa, A., Simoens, P., and Van Den Broeck, W. (2010). "Surface area assessment of the murine intestinal tract as a prerequisite for oral dose translation from mouse to man." Laboratory Animals. 44(3): 176-183.

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  17. Chen, Y. and Balthasar, J.P. (2012). “Evaluation of a catenary PBPK model for predicting the in vivo disposition of mAbs engineered for high-affinity binding to FcRn.” AAPS. J. 14(4): 850-859.

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  20. Cubitt, H.E., Houston, J.B., et al. (2011). “Prediction of human drug clearance by multiple metabolic pathways: integration of hepatic and intestinal microsomal and cytosolic data.” Drug Metab. Dispos. 39(5): 864-73.

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  23. De Zwart, L.L., Haenen, H.E.M.G., et al. (2002). “Pharmacokinetics of ingested xenobiotics in children: A comparison with adults.” RIVM report 623860011/2002.

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  25. DeSesso, J.M. and Williams, A.L. (2008). “Contrasting the Gastrointestinal Tracts of Mammals: Factors that Influence Absorption”. Annual Reports in Medicinal Chemistry.

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  29. Dumas-Campagna, J., Tardif, R., et al. (2014). “Ethanol toxicokinetics resulting from inhalation exposure in human volunteers and toxicokinetic modeling.” Inhal. Toxicol. 26(2): 59-69.

  30. Ellis, K.J. (1997). “Body composition of a young, multiethnic, male population.” Am. J. Clin. Nutr. 66(6): 1323-31.

  31. Ellis, K.J. (2000). “Human body composition: in vivo methods.” Physiol. Rev. 80(2): 649-80.

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  35. FDA/CDER (1997). “Guidance for Industry: Extended Release Oral Dosage Forms: Development, Evaluation and Application of In Vitro / In Vivo Correlations.”

  36. FDA/CDER (2010). “Guidance for Industry: Pharmacokinetics in patients with impaired renal function - Study design, data analysis, and impact on dosing and labeling.”

  37. Foord, R.D. (1976). “Cefuroxime: human pharmacokinetics.” Antimicrob. Agents Chemother. 9(5): 741-7.

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  39. Garg, A. and Balthasar, J.P. (2007). “Physiologically-based pharmacokinetic (PBPK) model to predict IgG tissue kinetics in wild-type and FcRn-knockout mice.” J. Pharmacokinet. Pharmacodyn. 34(5): 687-709.

  40. Garg, A. and Balthasar, J.P. (2009). “Investigation of the influence of FcRn on the distribution of IgG to the brain.” AAPS J. 11(3): 553-557.

  41. Gerwin, N., Hops, C., et al. (2006). “Intra-articular drug delivery in osteoarthritis.” Adv. Drug Deliv. Rev. 58(2): 226-42.

  42. Gibbs, J.P., Yang, J.S., et al. (1998). “Comparison of human liver and small intestinal glutathione S-transferase-catalyzed busulfan conjugation in vitro.” Drug Metab. Dispos. 26(1): 52-5.

  43. Gohel, M. (2005). “Simplified mathematical approach for back calculation in Wagner- Nelson method.” http://Pharmainfo.net . Published Online. 3(2). (PDF) Simplified Mathematical Approach for Back Calculation in Wagner-Nelson Method (researchgate.net).

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  45. Gutiérrez, C., Marco, A., et al. (2002). “Total and segmental colonic transit time and anorectal manometry in children with chronic idiopathic constipation.” J. Pediatr. Gastroenterol. Nutr. 35(1): 31-8.

  46. Hadler, N.M. (1980). “Synovial fluids facilitate small solute diffusivity.” Ann. Rheum. Dis. 39(6): 580-5.

  47. Hallifax, D. and Houston, J.B. (2006). “Binding of drugs to hepatic microsomes: comment and assessment of current prediction methodology with recommendation for improvement.” Drug Metab. Dispos. 34(4): 724-6.

  48. Hatton, G.B., Yadav, V, Basit, A.W. (2015). “Animal Farm: Considerations in Animal Gastrointestinal Physiology and Relevance to Drug Delivery in Humans.” Journal of Pharmaceutical Sciences, U.S. National Library of Medicine. 104(9): 2747-76.

  49. Hayduk, W. and Laudie, H. (1974). “Prediction of diffusion coefficients for nonelectrolytes in dilute aqueous solutions.” AIChE J. 20(3): 611-615.

  50. Heikkinen, A.T., Friedlein, A., et al. (2012). “Mass spectrometry-based quantification of CYP enzymes to establish in vitro/in vivo scaling factors for intestinal and hepatic metabolism in beagle dog.” Pharm. Res. 29(7): 1832-42.

  51. Heikkinen, A.T., Friedlein, A., et al. (2015). “Quantitative ADME proteomics - CYP and UGT enzymes in the beagle dog liver and intestine.” Pharm. Res. 32: 74-90.

  52. Herrera-Ruiz, D., Wang, Q., et al. (2001). “Spatial expression patterns of peptide transporters in the human and rat gastrointestinal tracts, Caco-2 in vitro cell culture model, and multiple human tissues.” AAPS Pharm. Sci. 3(1): E9.

  53. Hewitt, K.M. and Stringer, M.D. (2008). “Correlation between the surface area of synovial membrane and the surface area of articular cartilage in synovial joints of the mouse and human.” Surg. Radiol. Anat. 30(8): 645-51.

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