Pharmacokinetics and pharmacodynamics of peptide and protein drugs

Pharmaceutical Biotechnology: Fundamentals and Applications, Third Edition

Volumn , Issue , 2016, Pages 95-123

  Meibohm, Bernd ^a   Braeckman, Rene ^b  

^a UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

^b Reliance Clinical Research Services   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 39149115174     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (143)

1. Agoram B, Heatherington AC, Gastonguay MR (2006). Development and evaluation of a population pharmacokinetic-pharmacodynamic model of darbepoetin alfa in patients with nonmyeloid malignancies undergoing multicycle chemotherapy. Aaps J 8(3):E552-63.
2. Allon M, Kleinman K, Walczyk M, et al. (2002). Pharmacokinetics and pharmacodynamics of darbepoetin alfa and epoetin in patients undergoing dialysis. Clin Pharmacol Ther 72(5):546-55.
3. Andersen S, Lambrecht L, Swan S, et al. (1999). Disposition of recombinant human interleukin-10 in subjects with various degrees of renal function. J Clin Pharmacol 39(10):1015-20.
4. Anderson PM, Sorenson MA (1994). Effects of route and formulation on clinical pharmacokinetics of interleukin-2. Clin Pharmacokinet 27(1):19-31.
5. Bartocci A, Mastrogiannis DS, Migliorati G, Stockert RJ, Wolkoff AW, Stanley ER (1987). Macrophages specifically regulate the concentration of their own growth factor in the circulation. Proc Natl Acad Sci USA 84(17):6179-83.
6. Bauer RJ, Gibbons JA, Bell DP, Luo ZP, Young JD (1994). Nonlinear pharmacokinetics of recombinant human macrophage colony-stimulating factor (M-CSF) in rats. J Pharmacol Exp Ther 268(1):152-8.
7. 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(6):1517-28.
8. Benincosa LJ, Chow FS, Tobia LP, Kwok DC, Davis CB, Jusko WJ (2000). Pharmacokinetics and pharmacodynamics of a humanized monoclonal antibody to factor IX in cynomolgus monkeys. J Pharmacol Exp Ther 292(2):810-6.
9. Bennett HP, McMartin C (1978). Peptide hormones and their analogues: Distribution, clearance from the circulation, and inactivation in vivo. Pharmacol Rev 30(3):247-92.
10. Boxenbaum H (1982). Interspecies scaling, allometry, physiological time, and the ground plan of pharmacokinetics. J Pharmacokinet Biopharm 10(2):201-27.
11. Braeckman RA (2000). Pharmacokinetics and pharmacodynamics of protein therapeutics. In: Reid RE, ed. Peptide and Protein Drug Analysis. New York:Marcel Dekker, 633-69.
12. Breimer DD, Danhof M (1997). Relevance of the application of pharmacokinetic-pharmacodynamic modelling concepts in drug development. The "wooden shoe" paradigm. Clin Pharmacokinet 32(4):259-67.
13. Bressolle F, Audran M, Gareau R, Pham TN, Gomeni R (1997). Comparison of a direct and indirect population pharmacodynamic model: Application to recombinant human erythropoietin in athletes. J Pharmacokinet Biopharm 25(3):263-75.
14. Bu G, Williams S, Strickland DK, Schwartz AL (1992). Low density lipoprotein receptor-related protein/alpha 2- macroglobulin receptor is an hepatic receptor for tissue-type plasminogen activator. Proc Natl Acad Sci USA 89(16):7427-31.
15. Burwen SJ, Jones AL (1990). Hepatocellular processing of endocytosed proteins. J Electron Microsc Tech 14(2):140-51.
16. Caliceti P, Veronese FM (2003). Pharmacokinetic and biodistribution properties of poly(ethylene glycol)-protein conjugates. Adv Drug Deliv Rev 55(10):1261-77.
17. Carone FA, Peterson DR (1980). Hydrolysis and transport of small peptides by the proximal tubule. Am J Physiol 238(3):F151-8.
18. Carone FA, Peterson DR, Flouret G (1982). Renal tubular processing of small peptide hormones. J Lab Clin Med 100(1):1-14.
19. Chanson P, Timsit J, Harris AG (1993). Clinical pharmacokinetics of octreotide. Therapeutic applications in patients with pituitary tumours. Clin Pharmacokinet 25(5):375-91.
20. Chen SA, Sawchuk RJ, Brundage RC, et al. (2000). Plasma and lymph pharmacokinetics of recombinant human interleukin-2 and polyethylene glycol-modified interleukin-2 in pig. J Pharmacol Exp Ther 2000; 293(1):248-59.
21. Chiang J, Gloff CA, Yoshizawa CN, Williams GJ (1993). Pharmacokinetics of recombinant human interferonbeta ser in healthy volunteers and its effect on serum neopterin. Pharm Res 10(4):567-72.
22. Chow FS, Benincosa LJ, Sheth SB, et al. (2002). Pharmacokinetic and pharmacodynamic modeling of humanized anti-factor IX antibody (SB 249417) in humans. Clin Pharmacol Ther 71(4):235-45.
23. Colburn W (1991). Peptide, peptoid, and protein pharmacokinetics/ pharmacodynamics. In: Garzone P, Colburn W, Mokotoff M, eds. Peptides, Peptoids, and Proteins, Vol. 3. Cincinnati, OH, Harvey: Whitney Books, 94-115.
24. Cumming DA (1991). Glycosylation of recombinant protein therapeutics: Control and functional implications. Glycobiology 1(2):115-30.
25. Daniel H, Herget M (1997). Cellular and molecular mechanisms of renal peptide transport. Am J Physiol 273(1 Pt 2):F1-8.
26. Dayneka NL, Garg V, Jusko WJ (1993). Comparison of four basic models of indirect pharmacodynamic responses. J Pharmacokinet Bioharm 21(4):457-78.
27. Dedrick RL (1973). Animal scale-up. J Pharmacokinet Biopharm 1(5):435-61.
28. Deen WM, Lazzara MJ, Myers BD (2001). Structural determinants of glomerular permeability. Am J Physiol Renal Physiol 281(4):F579-96.
29. Derendorf H, Meibohm B (1999). Modeling of pharmacokinetic/ pharmacodynamic (PK/PD) relationships:Concepts and perspectives. Pharm Res 16(2):176-85.
30. Edwards A, Daniels BS, Deen WM (1999). Ultrastructural model for size selectivity in glomerular filtration. Am J Physiol 276(6 Pt 2):F892-902.
31. Eppler SM, Combs DL, Henry TD, et al. (2002). A targetmediated model to describe the pharmacokinetics and hemodynamic effects of recombinant human vascular endothelial growth factor in humans. Clin Pharmacol Ther 72(1):20-32.
32. Fasano A (1998). Novel approaches for oral delivery of macromolecules. J Pharm Sci 87(11):1351-6.
33. Ferraiolo B, Mohler M (1992). Goals and analytical methodologies for protein distribution studies. In: Ferraiolo B, Mohler M, Gloff CA, eds. Protein Pharmacokinetics and Metabolism. New York: Plenum Press.
34. Flessner MF, Lofthouse J, Zakariael R (1997). In vivo diffusion of immunoglobulin G in muscle: Effects of binding, solute exclusion, and lymphatic removal. Am J Physiol 273(6 Pt 2):H2783-93.
35. Graham ML (2003). Pegaspargase: A review of clinical studies. Adv Drug Deliv Rev 55(10):1293-302.
36. Handelsman DJ, Swerdloff RS (1986). Pharmacokinetics of gonadotropin-releasing hormone and its analogs. Endocr Rev 7(1):95-105.
37. Herbst RS, Langer CJ (2002). Epidermal growth factor receptors as a target for cancer treatment: The emerging role of IMC-C225 in the treatment of lung and head and neck cancers. Semin Oncol 29(1 Suppl 4):27-36.
38. Holford NH, Sheiner LB (1982). Kinetics of pharmacologic response. Pharmacol Ther 16(2):143-66.
39. Hooper S (1991). Pharmacokinetics and pharmacodynamics of intravenous regular human insulin. In: Garzone P, Colburn W, Mokotoff M, eds. Petides, Peptoids, and Proteins, Vol. 3. Cincinnati, OH: Harvey Whitney Books, 128-37.
40. Inui K, Terada T, Masuda S, Saito H (2000). Physiological and pharmacological implications of peptide transporters, PEPT1 and PEPT2. Nephrol Dial Transplant 15(Suppl 6):11-3.
41. Ismair MG, Stieger B, Cattori V, et al. (2001). Hepatic uptake of cholecystokinin octapeptide by organic aniontransporting polypeptides OATP4 and OATP8 of rat and human liver. Gastroenterology 121(5):1185-90.
42. Jin F, Krzyzanski W (2004). Pharmacokinetic model of target-mediated disposition of thrombopoietin. AAPS Pharm Sci 6(1):E9.
43. Johnson V, Maack T (1977). Renal extraction, filtration, absorption, and catabolism of growth hormone. Am J Physiol 233(3):F185-96.
44. Kageyama S, Yamamoto, H, Nakazawa H, et al. (2002). Pharmacokinetics and pharmacodynamics of AJW200, a humanized monoclonal antibody to von Willebrand factor, in monkeys. Arterioscler Thromb Vasc Biol 22(1):187-92.
45. Kaufman JS, Reda DJ, Fye CL, et al. (1998). Subcutaneous compared with intravenous epoetin in patients receiving hemodialysis: Department of Veterans Affairs Cooperative Study Group on Erythropoietin in Hemodialysis Patients. N Engl J Med 339(9):578-83.
46. Khor SP, McCarthy K, DuPont M, Murray K, Timony G (2000). Pharmacokinetics, pharmacodynamics, allometry, and dose selection of rPSGL-Ig for phase I trial. J Pharmacol Exp Ther 293(2):618-24.
47. Kim DC, Sugiyama Y, Satoh H, Fuwa T, Iga T, Hanano M (1988). Kinetic analysis of in vivo receptor-dependent binding of human epidermal growth factor by rat tissues. J Pharm Sci 77(3):200-7.
48. Kobayashi H, et al. (2002). Rapid accumulation and internalization of radiolabeled herceptin in an inflammatory breast cancer xenograft with vasculogenic mimicry predicted by the contrast-enhanced dynamic MRI with the macromolecular contrast agent G6- (1B4M-Gd)(256). Cancer Res 62(3):860-6.
49. Kompella U, Lee V (1991). Pharmacokinetics of peptide and protein drugs. In: Lee V, ed. Peptide and Protein Drug Delivery. New York: Marcel Dekker, 391-484.
50. Krogsgaard Thomsen M, Friis C, Sehested Hansen B, et al. (1994). Studies on the renal kinetics of growth hormone (GH) and on the GH receptor and related effects in animals. J Pediatr Endocrinol 7(2):93-105.
51. Kuwabara T, Uchimura T, Kobayashi H, Kobayashi S, Sugiyama Y (1995). Receptor-mediated clearance of G-CSF derivative nartograstim in bone marrow of rats. Am J Physiol 269(1 Pt 1):E1-9.
52. Lee H, Kimko HC, Rogge M, Wang D, Nestorov I, Peck CC (2003). Population pharmacokinetic and pharmacodynamicmodeling of etanercept using logistic regression analysis. Clin Pharmacol Ther 73(4):348-65.
53. Lee HJ (2002). Protein drug oral delivery: The recent progress. Arch Pharm Res 25(5):572-84.
54. Lesko LJ (2007). Paving the critical path: How can clinical pharmacology help achieve the vision? Clin Pharmacol Ther 81(2):170-7.
55. Lesko LJ, Rowland M, Peck CC, Blaschke TF (2000). Optimizing the science of drug development:Opportunities for better candidate selection and accelerated evaluation in humans. J Clin Pharmacol 40(8):803-14.
56. Levy G (1986). Kinetics of drug action: An overview. J Allergy Clin Immunol 78(4 Pt 2):754-61.
57. Levy G (1994). Mechanism-based pharmacodynamic modeling. Clin Pharmacol Ther 56(4):356-8.
58. Maack T, Park C, Camargo M (1985). Renal filtration, transport and metabolism of proteins. In: Seldin D, Giebisch G, ed. The Kidney. New York: Raven Press, 1773-1803.
59. Macdougall IC, Gray SJ, Elston O et al. (1999). Pharmacokinetics of novel erythropoiesis stimulating protein compared with epoetin alfa in dialysis patients. J Am Soc Nephrol 10(11):2392-5.
60. Machado SG, Miller R, Hu C (1999). A regulatory perspective on pharmacokinetic/pharmacodynamic modelling. Stat Method Med Res 8(3):217-45.
61. Mager DE (2006). Target-mediated drug disposition and dynamics. Biochem Pharmacol 72(1):1-10.
62. Mager DE, Wyska E, Jusko WJ, (2003). Diversity of mechanism-based pharmacodynamic models. Drug Metab Dispos 31(5):510-8.
63. Mahato RI, Narang AS, Thoma L, Miller DD (2003). Emerging trends in oral delivery of peptide and protein drugs. Crit Rev Ther Drug Carrier Syst 20 (2-3):153-214.
64. Mahmood I (2002). Interspecies scaling: Predicting oral clearance in humans. Am J Ther 9(1):35-42.
65. Mahmood I, Balian JD (1999). The pharmacokinetic principles behind scaling from preclinical results to phase I protocols. Clin Pharmacokinet 36(1):1-11.
66. Marks DL, Gores GJ, LaRusso NF (1995). Hepatic processing of peptides. In: Taylor MD, Amidon GL, eds. Peptidebased Drug Design: Controlling Transport and Metabolism. Washington, DC: American Chemical Society, 221-48.
67. McMartin C (1992). Pharmacokinetics of peptides and proteins: Opportunities and challenges. Advances in Drug Research 22:39-106.
68. Meibohm B (2004). Pharmacokinetics of protein- and nucleotide- based drugs. In: Mahato RI, ed. Biomaterials for Delivery and Targeting of Proteins and Nucleic Acids. Boca Raton, FL: CRC Press, 275-94.
69. Meibohm B, Derendorf H (1994). Pharmacokinetics and pharmacodynamics of biotech drugs. In: Kayser O, Muller R, eds. Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications. Weinheim:Wiley, 141-66.
70. Meibohm B, Derendorf H (1997). Basic concepts of pharmacokinetic/ pharmacodynamic (PK/PD) modelling. Int J Clin Pharmacol Ther 35(10):401-13.
71. Meibohm B, Derendorf H (2002). Pharmacokinetic/pharmacodynamic studies in drug product development. J Pharm Sci 91(1):18-31.
72. Meibohm B, Derendorf H (2003). Pharmacokinetics and pharmacodynamics of biotech drugs. In: Muller R, Kayser O, eds. Applications of Pharmaceutical Biotechnology. Weinheim: Wiley-VCH.
73. Meijer D, Ziegler K (1993). Biological Barriers to Protein Delivery. New York: Plenum Press.
74. Mohler M, Cook J, Lewis D, et al. (1993). Altered pharmacokinetics of recombinant human deoxyribonuclease in rats due to the presence of a binding protein. Drug Metab Dispos 21(1):71-5.
75. Molineux G (2003). Pegylation: Engineering improved biopharmaceuticals for oncology. Pharmacotherapy 23(8 Pt 2):3S-8S.
76. Montero-Julian FA, Klein B, Gautherot E, Brailly H (1995). Pharmacokinetic study of anti-interleukin-6 (IL-6) therapy with monoclonal antibodies: Enhancement of IL-6 clearance by cocktails of anti-IL-6 antibodies. Blood 85(4):917-24.
77. Mordenti J, Chen SA, Moore JA, Ferraiolo BL, Green JD (1991). Interspecies scaling of clearance and volume of distribution data for five therapeutic proteins. Pharm Res 8(11):1351-9.
78. Mould DR, Davis CB, Minthorn EA, et al. (1999). Apopulation pharmacokinetic-pharmacodynamic analysis of single doses of clenoliximab in patients with rheumatoid arthritis. Clin Pharmacol Ther 66(3):246-57.
79. Nagaraja NV, Pechstein B, Erb K, et al. (2003). Pharmacokinetic/pharmacodynamic modeling of luteinizing hormone (LH) suppression and LH surge delay by cetrorelix after single and multiple doses in healthy premenopausal women. J Clin Pharmacol 43(3):243-51.
80. Nagaraja NV, Pechstein B, Erb K (2000). Pharmacokinetic and pharmacodynamic modeling of cetrorelix, an LH-RH antagonist, after subcutaneous administration in healthy premenopausal women. Clin Pharmacol Ther 68(6):617-25.
81. Nagle T, Berg C, Nassr R, Pang K (2003). The further evolution of biotech. Nat Rev Drug Discov 2(1):75-9.
82. Nielsen S, Nielsen JT, Christensen EI (1987). Luminal and basolateral uptake of insulin in isolated, perfused, proximal tubules. Am J Physiol 253(5 Pt 2):F857-67.
83. Pauletti GM, Gangwar S, Siahaan TJ, Jeffrey A, Borchardt RT (1997). Improvement of oral peptide bioavailability:Peptidomimetics and prodrug strategies. Adv Drug Deliv Rev 27(2-3):235-56.
84. Pechstein B, Nagaraja NV Hermann R, Romeis P, Locher M, Derendorf H (2000). Pharmacokinetic-pharmacodynamic modeling of testosterone and luteinizing hormone suppression by cetrorelix in healthy volunteers. J Clin Pharmacol 40(3):266-74.
85. Peck CC, et al. (1994). Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development. J Clin Pharmacol 34(2):111-9.
86. Perez-Ruixo JJ, Kimko HC, Chow AT, Piotrovsky V, Krzyzanski W, Jusko WJ (2005). Population cell life span models for effects of drugs following indirect mechanisms of action. J Pharmacokinet Pharmacodyn 32(5-6):767-93.
87. Periti P, Mazzei T, Mini E (2002). Clinical pharmacokinetics of depot leuprorelin. Clin Pharmacokinet 41(7):485-504.
88. Perrier D, Mayersohn M (1982). Noncompartmental determination of the steady-state volume of distribution for any mode of administration. J Pharm Sci 71(3):372-3.
89. Piscitelli SC, Reiss WG, Figg WD, Petros WP (1997). Pharmacokinetic studies with recombinant cytokines. Scientific issues and practical considerations. Clin Pharmacokinet 32(5):368-81.
90. Porter CJ, Charman SA (2000). Lymphatic transport of proteins after subcutaneous administration. J Pharm Sci 89(3):297-310.
91. Rabkin R, Ryan MP, Duckworth WC (1984). The renal metabolism of insulin. Diabetologia 27(3):351-7.
92. Racine-Poon A, Botta L, Chang TW, et al. (1997). Efficacy, pharmacodynamics, and pharmacokinetics of CGP 51901, an anti- immunoglobulin E chimeric monoclonal antibody, in patients with seasonal allergic rhinitis. Clin Pharmacol Ther 62(6):675-90.
93. Radwanski E, Chakraborty A, Van Wart S, et al. (1998). Pharmacokinetics and leukocyte responses of recombinant human interleukin-10. Pharm Res 15(12):1895-901.
94. Ramakrishnan R, Cheung WK, Wacholtz MC, Minton N, Jusko WJ (2004). Pharmacokinetic and pharmacodynamic modeling of recombinant human erythropoietin after single and multiple doses in healthy volunteers. J Clin Pharmacol 44(9):991-1002.
95. Reddy ST, Berk DA, Jain RK, Swartz MA (2006). A sensitive in vivo model for quantifying interstitial convective transport of injected macromolecules and nanoparticles. J Appl Physiol 101(4):1162-9.
96. Rosenblum MG, Unger BW, Gutterman JU, Hersh EM, David GS, Frincke JM (1985). Modification of human leukocyte interferon pharmacology with a monoclonal antibody. Cancer Res 45(6):2421-4.
97. Roskos LK, Lum P, Lockbaum P, Schwab G, Yang BB (2006). Pharmacokinetic/pharmacodynamic modeling of pegfilgrastim in healthy subjects. J Clin Pharmacol 46(7):747-57.
98. Schomburg A, Kirchner H, Atzpodien J (1993). Renal, metabolic, and hemodynamic side-effects of interleukin-2 and/or interferon alpha: Evidence of a risk/ benefit advantage of subcutaneous therapy. J Cancer Res Clin Oncol 119(12):745-55.
99. Sharma A, Jusko W (1998). Characteristics of indirect pharmacodynamic models and applications to clinical drug responses. Br J Clin Pharmacol 45:229-39.
100. Sheiner LB, Stanski DR, Vozeh S, Miller RD, Ham J (1979). Simultaneous modeling of pharmacokinetics and pharmacodynamics: Application to d-tubocurarine. Clin Pharmacol Ther 25(3):358-71.
101. Sheiner LB, Steimer JL (2000). Pharmacokinetic/pharmacodynamic modeling in drug development. Annu Rev Pharmacol Toxicol 40:67-95.
102. Shen WC (2003). Oral peptide and protein delivery:Unfulfilled promises? Drug Discov Today 8(14):607-8.
103. Smedsrod B, Einarsson M (1990). Clearance of tissue plasminogen activator by mannose and galactose receptors in the liver. Thromb Haemost 63(1):60-6.
104. Straughn AB (1982). Model-independent steady-state volume of distribution. J Pharm Sci 71(5):597-8.
105. Straughn AB (2006). Limitations of noncompartmental pharmacokinetic analysis of biotech drugs. In: Meibohm B, ed. Pharmacokinetics and Pharmacodynamics of Biotech Drugs. Weinheim:Wiley, 181-8.
106. Strickland DK, Kounnas MZ, Argraves WS (1995). LDL receptor-related protein: A multiligand receptor for lipoprotein and proteinase catabolism. Faseb J 9(10):890-8.
107. Sugiyama Y, HananoM (1989). Receptor-mediated transport of peptide hormones and its importance in the overall hormone disposition in the body. PharmRes 6(3):192-202.
108. Sun YN, Jusko WJ (1999). Role of baseline parameters in determining indirect pharmacodynamic responses. J Pharm Sci 88(10):987-90.
109. Sun YN, Lee HJ, Almon RR, Jusko WJ (1999). A pharmacokinetic/ pharmacodynamic model for recombinant human growth hormone effects on induction of insulin-like growth factor I in monkeys. J Pharmacol Exp Ther 289(3):1523-32.
110. Supersaxo A, Hein W Gallati H, Steffen H (1988). Recombinant human interferon alpha-2a: Delivery to lymphoid tissue by selected modes of application. Pharm Res 5(8):472-6.
111. Supersaxo A, Hein WR, Steffen H (1990). Effect of molecular weight on the lymphatic absorption of water-soluble compounds following subcutaneous administration. Pharm Res 7(2):167-9.
112. Tabrizi M, Roskos LK (2006). Exposure-reponse relationships for therapeutic biologics. In: Meibohm B, ed. Pharmacokinetics and Pharmacodynamics of Biotech Drugs. Weinheim: Wiley, 295-330.
113. Takagi A, Masuda H, Takakura Y, Hashida M (1995). Disposition characteristics of recombinant human interleukin-11 after a bolus intravenous administration in mice. J Pharmacol Exp Ther 275(2):537-43.
114. Taki Y, Sakane T, Nadai T, et al. (1998). First-pass metabolism of peptide drugs in rat perfused liver. J Pharm Pharmacol 50(9):1013-8.
115. Tang L, Meibohm B (2006). Pharmacokinetics of peptides and proteins. In: Meibohm B, ed. Pharmacokinetics and Pharmacodynamics of Biotech Drugs. Weinheim:Wiley, 17-44.
116. Tang L, Persky AM, Hochhaus G, Meibohm B (2004). Pharmacokinetic aspects of biotechnology products. J Pharm Sci 93(9):2184-204.
117. Tanswell P, Modi N, Combs D, Danays T (2002). Pharmacokinetics and pharmacodynamics of tenecteplase in fibrinolytic therapy of acute myocardial infarction. Clin Pharmacokinet 41(15):1229-45.
118. Tokuda Y, et al. (1999). Dose escalation and pharmacokinetic studyof ahumanized anti-HER2monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer. Br J Cancer 81(8):1419-25.
119. Toon S (1996). The relevance of pharmacokinetics in the development of biotechnology products. Eur J Drug Metab Pharmacokinet 21(2):93-103.
120. Veng-Pedersen P, GillespieW (1984). Mean residence time in peripheral tissue: A linear disposition parameter useful for evaluating a drug's tissue distribution. J Pharmacokinet Biopharm 12(5):535-43.
121. Veronese FM, P. Caliceti (2006). Custom-tailored pharmacokinetics and pharmacodynamics via chemical modifications of biotech drugs. In: Meibohm B, ed. Pharmacokinetics and Pharmacodynamics of Boptech Drugs. Weinheim: Wiley, 271-94.
122. Walsh S, Shah A, Mond J (2003). Improved pharmacokinetics and reduced antibody reactivity of lysostaphin conjugated to polyethylene glycol. Antimicrob Agents Chemother 47(2):554-8.
123. Wills R (1991). A kinetic/dynamic perspective of a peptide and protein: GRF and rHuIFN-alpha-2a. In: Garzone P, Colburn W, Mokotoff M, eds. Petides, Peptoids, and Proteins, Vol. 3. Cincinnati, OH: Harvey Whitney Books, 117-27.
124. Wills RJ, Ferraiolo BL (1992). The role of pharmacokinetics in the development of biotechnologically derived agents. Clin Pharmacokinet 23(6):406-14.
125. Woodworth JR, Howey DC, Bowsher RR (1994). Establishment of time-action profiles for regular andNPHinsulin using pharmacodynamic modeling. Diabetes Care 17(1):64-9.
126. Working P, Cossum P (1991). Clinical and preclinical studies with recombinant human proteins: Effect of antibody production. In: Garzone P, Colburn W, Mokotoff M, eds. Peptides, Peptoids, and Proteins, Vol. 3. Cincinnati, OH: Harvey Whitney Books, 158-68.
127. Working PK (1992). Potential effects of antibody induction by protein drugs. In: Ferraiolo BL, Mohler MA, Gloff CA, eds. Portein Pharmacokinetics and Metabolism. New York: Plenum Press, 73-92.
128. Yang BB (2006). Integration of pharmacokinetics and pharmacodynamics into the drug development of pegfilgrastim, a pegylated protein. In: Meibohm B, ed. Pharmacokinetics and Pharmacodynamics of Biotech Drugs. Weinheim: Wiley, 373-94.
129. Zamboni WC (2003). Pharmacokinetics of pegfilgrastim. Pharmacotherapy 23(8 Pt 2):9S-14S.
130. Zia-Amirhosseini P, Minthorn E Benincosa LJ, et al. (1999). Pharmacokinetics and pharmacodynamics of SB-240563, a humanized monoclonal antibody directed to human interleukin-5, in monkeys. J Pharmacol Exp Ther 291(3):1060-7.
131. Ziegler K, Polzin G, Frimmer M (1988). Hepatocellular uptake of cyclosporin A by simple diffusion. Biochim Biophys Acta 938(1):44-50.
132. Zito SW (1997). Pharmaceutical biotechnology: A programmed text. Lancaster, PA: Technomic Pub. Co.
133. Atkinson A, Abernethy D, Daniels C, Dedrick R, Markey S (2006). Principles of Clinical Pharmacology. San Diego, CA: Academic Press.
134. Bjornsson TD (1997). Practical uses of individual pharmacokinetic parameters in drug development and clinical practice: Examples and simulations. Eur J Drug Metab Pharmacokinet 22(1):1-14.
135. Bonate PL (2006). Pharmacokinetic-Pharmacodynamic Modeling and Simulation. New York: Springer.
136. Derendorf H, Meibohm B (1999). Modeling of pharmacokinetic/pharmacodynamic (PK/PD) relationships:Concepts and perspectives. Pharm Res 16(2):176-85.
137. Gibaldi M, Perrier D (1982). Pharmacokinetics. New York:Marcel Dekker.
138. Holford NH, Sheiner LB (1982). Kinetics of pharmacologic response. Pharmacol Ther 16(2):143-66.
139. Rowland M, Tozer T (1993). Clinical Pharmacokinetics:Concepts and Applications. Media, PA: Williams & Wilkins.
140. Baumann A (2006). Early development of therapeutic biologics - pharmacokinetics. Curr Drug Metab 7, 15-21.
141. Ferraiolo BL, Mohler MA, Gloff CA (1992). Protein Pharmacokinetics and Metabolism. New York:Plenum Press.
142. Meibohm B (2006). Pharmacokinetics and Pharmacodynamics of Biotech Drugs. Weinheim:Wiley.
143. Tang L, Persky AM, Hochhaus G, Meibohm B (2004). Pharmacokinetic aspects of biotechnology products. J Pharm Sci 93(9):2184-204.