Disposition and interaction of biotherapeutics in pediatric populations

Current Drug Metabolism

Volumn 13, Issue 7, 2012, Pages 882-900

  Yanni, Souzan ^a  

^a DMPK Consultants Inc   (United States)

Author keywords

ADME; Biotherapeutics; DDI; Drug clearance; Drug disposition; Monoclonal antibodies; Pediatric populations; Pharmacokinetics; Small molecules

Indexed keywords

ALBUMIN; ALEMTUZUMAB; BASILIXIMAB; BEVACIZUMAB; BUPRENORPHINE; CAFFEINE; CETUXIMAB; CIPROFLOXACIN; CYCLOSPORIN; DACLIZUMAB; FENTANYL; FETAL ALBUMIN; GEMTUZUMAB; GENTAMICIN; HUMAN GROWTH HORMONE; INFLIXIMAB; ISEPAMICIN; LIDOCAINE; MIDAZOLAM; MORPHINE; NATALIZUMAB; OROSOMUCOID; PARACETAMOL; PEPTIDE DERIVATIVE; PROTEIN DERIVATIVE; ROPIVACAINE; SERUM ALBUMIN; SERUM GLOBULIN; THEOPHYLLINE; UNCLASSIFIED DRUG; UNINDEXED DRUG; VORICONAZOLE;

ACCURACY; ACUTE GRANULOCYTIC LEUKEMIA; ACUTE LYMPHOBLASTIC LEUKEMIA; AGE; AREA UNDER THE CURVE; ARTICLE; BODY WEIGHT; CHRONIC LYMPHATIC LEUKEMIA; CROHN DISEASE; DISTRIBUTION VOLUME; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISPOSITION; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG ELIMINATION; DRUG EXCRETION; DRUG EXPOSURE; DRUG HALF LIFE; DRUG METABOLISM; DRUG SAFETY; HUMAN; PERINATAL PERIOD; RECOMMENDED DRUG DOSE; ULCERATIVE COLITIS;

AGE FACTORS; BIOLOGICAL AGENTS; BIOLOGICAL THERAPY; CHILD; DRUG INTERACTIONS; HUMANS; METABOLIC NETWORKS AND PATHWAYS; PHARMACEUTICAL PREPARATIONS;

EID: 84865785880     PISSN: 13892002     EISSN: 18755453     Source Type: Journal    
DOI: 10.2174/138920012802138624     Document Type: Article

References (167)

1. rd edn, chapter 3. 2005. Lippincott Williams & Wilkins, Philadelphia, pp 20-31.
2. Björkman, S. Prediction of Drug Disposition in Infants and Children by Means of Physiologically Based Pharmacokinetic (PBPK) Modelling: Theophylline and Midazolam as Model Drugs. Br. J. Clin. Pharmacol., 2004, 59, 691-704.
3. Benedetti, M.S.; Whomsley, R.; and Baltes, L.E. Differences in absorption, distribution, metabolism and excretion of xenobiotics between the paediatric and adult Populations. Expert Opin. Drug Metab. Toxicol., 2005, 1, 447-471.
4. Kennedy, M.J. Hormonal regulation of hepatic drug metabolizing enzyme activity during adolescence. Clin. Pharmacol. Ther., 2008, 84, 662-673.
5. Lacroix, D.; Sonnier, M.; Moncion, A.; Cheron, G.; Cresteil, T. Expression of CYP3A in the human liver. Evidence that the shift between CYP3A7 and CYP3A4 occurs immediately after birth. Eur. J. Biochem., 1997, 247, 625-634.
6. Hines, R.N.; McCarver, D.G. The ontogeny of human drugmetabolizing enzymes: Phase 1 oxidative enzymes. J. Pharmacol. Exp. Ther., 2002, 300, 355-360.
7. Johnson, T.N. and Thomson, M. Intestinal metabolism and transport of drugs in children: the effects of age and disease. J. Pediatr. Gastroenterol. Nutr., 2008, 47, 3-10.
8. Chen, H.L.; Liu, Y.J.; Feng, C.H.; Wu, C.Y.; Shyu, M.K.; Yuan, R.H.; Chang, M.H. Expression of hepatocyte transporters and nuclear receptors in children with early and late-stage biliary atresia. Pediatr. Res., 2008, 63, 15-21.
9. Gao, B.; Pierre, M.V.; Stieger, B.; Meier, P.J. Differential expression of bile salt and organic anion transporters in developing rat liver. J. Hepatol., 2004, 41, 201-208.
10. Chen, N.; Aleksa, K.; Woodland, C.; Rieder, M.; Koren, G. Ontogeny of drug elimination by the human kidney. Pediatr. Nephrol., 2006, 21,160-168.
11. Yanni, S.B. and Allegaert, K. Drug metabolism and interaction in pediatric patients. Encyclopedia of Drug Metabolism, 2011, V6 Wiley & Sons: New York.
12. Johnson, T.N. The development of drug metabolizing enzymes and their influence on the susceptibility to adverse drug reactions in children. Toxicology, 2003, 192, 37-48.
13. Björkman, S. Prediction of cytochrome P450-mediated hepatic drug clearance in neonates, infants and children: how accurate are available scaling methods? Clin. Pharmacokinet., 2006, 45, 1-11.
14. Anderson, B.J.; Holford, N.H. Mechanism-based concepts of size and maturity in pharmacokinetics. Annu. Rev. Pharmacol. Toxicol., 2008, 48, 303-332.
15. Anderson, G.D. and Lynn, A.M. Optimizing pediatric dosing: A developmental pharmacologic approach. Pharmacotherapy, 2009, 29, 680-690.
16. Alcorn, J.; McNamara, P.J. Ontogeny of hepatic and renal systemic clearance pathways in infants: part II. Clin. Pharmacokine., 2002, 41, 1077-1094.
17. Johnson, T.N.; Rostami-Hodjegan, A.; Tucker, G.T. Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children. Clin. Pharmacokinet., 2006, 45, 931-956.
18. Yanni, S.B.; Annaert, P.P.; Augustijns, P.; Ibrahim, J.G.; Benjamin, D.K.; and Thakker, D.R. In vitro hepatic metabolism explains higher clearance of voriconazole in children versus adults: role of CYP2C19 and FMO. Drug Metab. Dispos., 2010, 38, 45-51.
19. Rostami-Hodjegan, A. and Tucker, G.T. Simulation and prediction of in vivo drug metabolism in human populations from in vitro data. Nat. Rev. Drug Discov., 2007, 6, 140-148.
20. Karlsson, M.O.; Lutsar, I.,; and Milligan, P.A. Population pharmacokinetic analysis of voriconazole plasma concentration data from pediatric studies. Antimicrob. Agents Chemother., 2009, 53, 935-944.
21. Johnson, T.N.; Rostami-Hodjegan, A.; Tucker, G.T. Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children. Clin. Pharmacokinet., 2006, 45, 931-956.
22. Kearns, G.L.; Abdel-Rahman, S.M.; Alander, S.W.; Blowey, D.L.; Leeder, J.S., Kaufman, R.E. Developmental pharmacology: drug disposition, action, and therapy in infants and children. N. Engl. J. Med., 2003, 349, 1157-1167.
23. Edginton, A.N.; Schmitt, W.; Voith, B.; Willmann, S. A mechanistic approach for the scaling of clearance in children. Clin. Pharmacokinet., 2006, 45,683-704.
24. Hines, R.N. The ontogeny of drug metabolism enzymes and implications for adverse drug events. Pharmacol. Ther., 2008, 118, 250-267.
25. Yanni, S.B.; Psmith, B.; Benjamin, D.K. Jr.; Augustijns, P.F.; Thakker, D.R.; and Annaert, P.P. Higher clearance of micafungin in neonates compared to adults: role of age-dependent micafungin serum binding. Biopharm. Drug Dispos., 2011, 32, 222-232.
26. Alcorn, J.; McNamara, P.J. Using ontogeny information to build predictive models for drug elimination. Drug Discov. Today, 2008, 13, 507-512.
27. Filler, G.; Bendrick-Peart, J.; Christians, U. Pharmacokinetics of mycophenolate mofetil and sirolimus in children. Ther. Drug Monit., 2008, 30, 138-142.
28. Bory, C.; Baltassat, P.; Porthault, M.; Bethenod, M.; Frederich, A.; Aranda, J.V. Metabolism of theophylline to caffeine in premature newborn infants. J. Pediatr., 1979, 94, 988-993.
29. Coughtrie, M.W.H.; Burche, B.; Leakey, J.E.A.; Hume, R. The inadequacy of perinatal glucuronidation: immunoblot analysis of the developmental expression of individual UDP-glucuronosyltransferase isoenzymes in rat and human liver microsomes. Mol. Pharmacol., 1988, 34, 729-735.
30. Leakey, J.E.A.; Hume, R.; Burchell, B. Development of multiple activities of UDP glucuronyltransferase in human liver. Biochemical J., 1987, 243, 859-861.
31. Gawronska-Szklarz, B.; Svensson, J.O.; Widen, J.; Rane, A. Differential hepatic glucuronidation of (-) and (+)-morphine in the rat and the human fetus. Advances in Glucuronide Conjugation. Lancaster, UK, 1985, 335-340.
32. Pacifici, G.M.; Säwe, J.; Kager, L.; Rane, A. Morphine glucuronidation in human fetal and adult liver. Eur. J. Clin. Pharmacol.,1982, 22, 553-558.
33. Coffman BL, Rios GR, King D, TephlY TR. Human UGT2B7 catalyzes morphine glucuronidation. Drug Metab. Dispos., 1997, 25, 1-4.
34. Weiss CV, Blaska AJ, Weston JK: Chloramphenicol in the newborn infant-a physiological explanation of its toxicity when given in excessive doses. N. Eng. J. Med., 1960, 262, 787-792.
35. Choonara, I.A.; Mckay, P.; Hain, R.; Rane, A. Morphine metabolism in children. Br. J. Clin. Pharmacol., 1989, 28, 599-604.
36. Court, M.H.; Duan, S.X.; von Moltke, L.L.; Greenblatt, D.J.; Patten, C.J.; Miners, J.O.; Mackenzie, P.I. Interindividual variability in acetaminophen glucuronidation by human liver microsomes: identification of relevant acetaminophen UDPglucuronosyltransferase isoforms. J. Pharmacol. Exp. Ther., 2001, 299, 998-1006.
37. Anderson, B.J.; Allegaert, K.; Holford, N.H. Population clinical pharmacology of children: modelling covariate effects. Eur. J. Pediatr., 2006, 165, 819-829.
38. Allegaert, K.; de Hoon, J.; Verbesselt, R.; Vanhole, C.; Devlieger, H. Intra-and interindividual variability of glucuronidation of paracetamol during repeated administration of propacetamol in neonates. Acta Pediatr., 2005, 94, 1273-1279.
39. Cortez, M.A.; Scrideli, C.A.; Yunes. J.A.; Valera, E.T.; Toledo, S.R.; Pavoni-Ferreira, P.C.; Lee, M.L.; Petrilli, A.S.; Brandalise, S.R.; Tone, L.G. Pediatr. Blood Cancer, 2009, 53, 996-1004.
40. Shitara, Y.; Sugiyama, Y. Review Pharmacokinetic and pharmacodynamic alterations of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors: drug-drug interactions and interindividual differences in transporter and metabolic enzyme functions. Pharmacol. Ther., 2006, 112, 71-105.
41. Chandra, P. and Brouwer, K.L. The complexities of hepatic drug transport: current knowledge and emerging concepts. Pharmaceut. Res., 2004, 21, 719-735.
42. Fanta, S.; Jonsson, S.; Backman, J.T.; Karlsson, M.O.; Hoppu, K. Developmental pharmacokinetics of ciclosporin: a population pharmacokinetic study in pediatric renal transplant candidates. Br. J. Clin. Pharmacol., 2007, 64, 772-784.
43. Krishna, R.; Krishnaswami, S.; Kittner, B.; Sankoh, A.J.; Jensen, B.K. The utility of mixed-effects covariate analysis in rapid selection of doses in pediatric subjects: a case study with fexofenadine hydrochloride. Biopharmaceut. Drug Dispos., 2004, 25, 373-387.
44. Sweet, D.H; Bush, K.T.; Nigam, S.K. The organic anion transporter family: from physiology to ontogeny and the clinic. Am. J. Physiol. Renal Physiol., 2001, 281, F197-F205.
45. Hayton, W.L. Maturation and growth of renal function: dosing renally cleared drugs in children. AAPS. Pharmceut. Sci., 2000, 2, 1-7.
46. Murry, D.J.; Crom, W.R.; Reddick, W.E.; Bhargava, R.; Evans, W.E. Liver volume as a determinant of drug clearance in children and adolescents. Drug Metab. Dispos., 1995, 23, 1110-1116.
47. Noda, T.; Todini, T.; Watanabe, Y.; Yamamoto, S. Liver volume in children measures by computer tomography. Pediatr. Radiol., 1997, 27, 250-252.
48. Zaya, M.J.; Hines, R.N.; Stevens, J.C. Epirubicin glucuronidation and UGT2B7 developmental expression. Drug Metab. Dispos., 2006, 34, 2097-2101.
49. McNamara, P.J.; Alcorn, J. Protein binding predictions in infants. Pharmaceut. Sci., 2002, 4, E4.
50. Nau, H.; Luck, W.; Kuhnz, W. Decreased serum protein binding of diazepam and its major metabolite in the neonate during the first postnatal week relate to increased free fatty acid levels. Br. J. Clin. Pharmacol., 1984, 17, 92-98.
51. Yanni, S.B. Mechanism underlying altered antifungal drug disposition in children. PhD Thesis, 2010 June 9.
52. FDA. Guidance for Industry General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products http://www.fda.gov/ downloads/Drugs/GuidanceCompliance Regulatory Information/Guidances/ucm072114. pdf (accessed on 1 December 2010).
53. Lobo, E.D.; Hansen, R.J.; Balthasar, J.P. Antibody pharmacokinetics and pharmacodynamics. J. Pharm. Sci., 2004, 93, 2645-2668.
54. Tang, L.; Persky, A.M.; Hochhaus, G.; Meibohm, B. Pharmacokinetic aspects of biotechnology products. J. Pharm. Sci., 2004, 93, 2184-2204.
55. Shi, R.; Derendorf, H. Pediatric Dosing and Body Size in Biotherapeutics Pharmaceutics, 2010, 2, 389-418.
56. Reilly, R.M.; Sandhu, J.; Alvarez-Diez, T.M.; Gallinger, S.; Kirsh, J.; Stern, H. Problems of delivery of monoclonal antibodies. Pharmaceutical and pharmacokinetic solutions. Clin. Pharmacokinet., 1995,28, 126-142.
57. Zito, S.W., Pharmaceutical Biotechnology: A Programmed Text; Technomic Pub.Co.: Lancaster, PA, USA, 1997; pp. 184-186.
58. Tan, A.C.; Russel, F.G.; Thien, T.; Benraad, T.J. Atrial natriuretic peptide. An overview of clinical pharmacology and pharmacokinet-ics. Clin. Pharmacokinet. 1993, 24, 28-45.
59. Eppler, S.M.; Combs, D.L.; Henry, T.D.; Lopez, J.J.; Ellis, S.G.; Yi, J.H.; Annex, B.H.; McCluskey, E.R.; Zioncheck, T.F. A target-mediated model to describe the pharmacokinetics and hemody-namic effects of recombinant human vascular endothelial growth factor in humans. Clin. Pharmacol. Ther., 2002, 72, 20-32.
60. Piscitelli, S.C.; Reiss, W.G.; Figg, W.D.; Petros, W.P. Pharmacoki-netic studies with recombinant cytokines. Scientific issues and practical considerations. Clin. Pharmacokinet., 1997, 32, 368-381.
61. Soy, D.; Aweeka, F.T.; Church, J.A.; Cunningham, C.K.; Palumbo, P.; Kosel, B.W.; Sheiner, L.B. Population pharmacokinetics of en-fuvirtide in pediatric patients with human immunodeficiency virus: searching for exposure-response relationships. Clin. Pharmacol. Ther., 2003, 74, 569-580.
62. Toon, S. The relevance of pharmacokinetics in the development of biotechnology products. Eur. J. Drug. Metab. Pharmacokinet., 1996,21, 93-103.
63. Colburn, W. Peptide, Peptoid, and Protein Pharmacokinetics/ Pharmacodynamics; Harvey Whitney Books: Cincinnati, OH, USA, 1991; Volume 3, pp. 94-115.
64. Authier, F.; Danielsen, G.M.; Kouach, M.; Briand, G.; Chauvet, G. Identification of insulin domains important for binding to and degradation by endosomal acidic insulinase. Endocrinology, 2001, 142, 276-289.
65. Smedsrod, B.; Einarsson, M. Clearance of tissue plasminogen activator by mannose and galactose receptors in the liver. Thromb. Haemost., 1990, 63, 60-66.
66. Johnson, V.; Maack, T. Renal extraction, filtration, absorption, and catabolism of growth hormone. Am. J. Physiol., 1977, 233, F185-F196.
67. Rabkin, R.; Ryan, M.P.; Duckworth, W.C. The renal metabolism of insulin. Diabetologia, 1984, 27, 351-357.
68. Takagi, A.; Masuda, H.; Takakura, Y.; Hashida, M. Disposition characteristics of recombinant human interleukin-11 after a bolus intravenous administration in mice. J. Pharmacol. Exp. Ther., 1995, 275, 537-543.
69. Carone, F.A.; Peterson, D.R. Hydrolysis and transport of small peptides by the proximal tubule. Am. J. Physiol., 1980, 238, F151-F158.
70. Nielsen, S.; Nielsen, J.T.; Christensen, E.I. Luminal and basolateral uptake of insulin in isolated, perfused, proximal tubules. Am. J. Physiol., 1987, 253, F857-F867.
71. Authier, F.; Posner, B.I.; Bergeron, J.J. Endosomal proteolysis of internalized proteins. FEBS Lett., 1996, 389, 55-60.
72. Meibohm, B.; Derendorf, H. Pharmacokinetics and Pharmacody-namics of Biotech Drugs; Wiley-VCH: Weinheim, Germany, 2003; pp. 35-36.
73. Racine-Poon, A.; Botta, L.; Chang, T.W.; Davis, F.M.; Gygax, D.; Liou, R.S.; Rohane, P.; Staehelin, T.; van Steijn, A.M.; Frank, W. Efficacy, pharmacodynamics, and pharmacokinetics of CGP 51901, an anti-immunoglobulin E chimeric monoclonal antibody, in patients with seasonal allergic rhinitis. Clin. Pharmacol. Ther., 1997, 62, 675-690.
74. Schulman, E.S. Development of a monoclonal anti-immunoglobulin E antibody (omalizumab) for the treatment of al-lergic respiratory disorders. Am. J. Respir. Crit. Care Med., 2001, 164, S6-11.
75. Angiolillo, A.L.; Yu, A.L.; Reaman, G.; Ingle, A.M.; Secola, R.; Adamson, P.C. A phase II study of Campath-1H in children with relapsed or refractory acute lymphoblastic leukemia: a Children's Oncology Group report. Pediatr. Blood Cancer, 2009, 53, 978-983.
76. Mould, D.R.; Baumann, A.; Kuhlmann, J.; Keating, M.J.; Weit-man, S.; Hillmen, P.; Brettman, L.R.; Reif, S.; Bonate, P.L. Popula-tion pharmacokinetics-pharmacodynamics of alemtuzumab (Cam-path) in patients with chronic lymphocytic leukaemia and its link to treatment response. Br. J. Clin. Pharmacol., 2007, 64, 278-291.
77. Hale, G.; Rebello, P.; Brettman, L.R.; Fegan, C.; Kennedy, B.; Kimby, E.; Leach, M.; Lundin, J.; Mellstedt, H.; Moreton, P.; Raw-stron, A.C.; Waldmann, H.; Osterborg, A.; Hillmen, P. Blood con-centrations of alemtuzumab and antiglobulin responses in patients with chronic lymphocytic leukemia following intravenous or sub-cutaneous routes of administration. Blood, 2004, 104, 948-955.
78. Kovarik, J.M.; Offner, G.; Broyer, M.; Niaudet, P.; Loirat, C.; Mentser, M.; Lemire, J.; Crocker, J.F.; Cochat, P.; Clark, G.; Ger-beau, C.; Chodoff, L.; Korn, A.; Hall, M. A rational dosing algo-rithm for basiliximab (Simulect) in pediatric renal transplantation based on pharmacokineticdynamic evaluations. Transplantation, 2002, 74, 966-971.
79. Kovarik, J.M.; Gridelli, B.G.; Martin, S.; Rodeck, B.; Melter, M.; Dunn, S.P.; Merion, R.M.; Tzakis, A.G.; Alonso, E.; Bucuvalas, J.; Sharp, H.; Gerbeau, C.; Chodoff, L.; Korn, A.; Hall, M. Basilixi-mab in pediatric liver transplantation: A pharmacokinetic-derived dosing algorithm. Pediatr. Transplant., 2002, 6, 224-230.
80. Hocker, B.; Kovarik, J.M.; Daniel, V.; Opelz, G.; Fehrenbach, H.; Holder, M.; Hoppe, B.; Hoyer, P.; Jungraithmayr, T.C.; Kopf-Shakib, S.; Laube, G.F.; Muller-Wiefel, D.E.; Offner, G.; Plank, C.; Schroder, M.; Weber, L.T.; Zimmerhackl, L.B.; Tonshoff, B. Pharmacokinetics and immunodynamics of basiliximab in pediatric renal transplant recipients on mycophenolate mofetil comedication. Transplantation, 2008, 86, 1234-1240.
81. Kovarik, J.M.; Pescovitz, M.D.; Sollinger, H.W.; Kaplan, B.; Leg-endre, C.; Salmela, K.; Book, B.K.; Gerbeau, C.; Girault, D.; Som-berg, K. Differential influence of azathioprine and mycophenolate mofetil on the disposition of basiliximab in renal transplant pa-tients. Clin. Transplant., 2001, 15, 123-130.
82. Glade Bender, J.L.; Adamson, P.C.; Reid, J.M.; Xu, L.; Baruchel, S.; Shaked, Y.; Kerbel, R.S.; Cooney-Qualter, E.M.; Stempak, D.; Chen, H.X.; Nelson, M.D.; Krailo, M.D.; Ingle, A.M.; Blaney, S.M.; Kandel, J.J.; Yamashiro, D.J. Phase I trial and pharmacoki-netic study of bevacizumab in pediatric patients with refractory solid tumors: A Children's Oncology Group Study. J. Clin. Oncol., 2008, 26, 399-405.
83. Gordon, M.S.; Margolin, K.; Talpaz, M.; Sledge, G.W., Jr.; Holm-gren, E.; Benjamin, R.; Stalter, S.; Shak, S.; Adelman, D. Phase I safety and pharmacokinetic study of recombinant human antivascu-lar endothelial growth factor in patients with advanced cancer. J. Clin. Oncol., 2001, 19, 843-850.
84. Lu, J.F.; Bruno, R.; Eppler, S.; Novotny, W.; Lum, B.; Gaudreault, J. Clinical pharmacokinetics of bevacizumab in patients with solid tumors. Cancer Chemother. Pharmacol., 2008, 62, 779-786.
85. Trippett, T.M.; Herzog, C.; Whitlock, J.A.; Wolff, J.; Kuttesch, J.; Bagatell, R.; Hunger, S.P.; Boklan, J.; Smith, A.A.; Arceci, R.J.; Katzenstein, H.M.; Harbison, C.; Zhou, X.; Lu, H.; Langer, C.; Weber, M.; Gore, L. Phase I and pharmacokinetic study of cetuxi-mab and irinotecan in children with refractory solid tumors: A study of the pediatric oncology experimental therapeutic investiga-tors' consortium. J. Clin. Oncol., 2009, 27, 5102-5108.
86. Tan, A.R.; Moore, D.F.; Hidalgo, M.; Doroshow, J.H.; Poplin, E.A.; Goodin, S.; Mauro, D.; Rubin, E.H. Pharmacokinetics of cetuximab after administration of escalating single dosing and weekly fixed dosing in patients with solid tumors. Clin. Cancer Res., 2006, 12, 6517-6522.
87. Pescovitz, M.D.; Knechtle, S.; Alexander, S.R.; Colombani, P.; Nevins, T.; Nieforth, K.; Bouw, M.R. Safety and pharmacokinetics of daclizumab in pediatric renal transplant recipients. Pediatr. Transplant., 2008, 12, 447-455.
88. Buckwalter, M.; Dowell, J.A.; Korth-Bradley, J.; Gorovits, B.; Mayer, P.R. Pharmacokinetics of gemtuzumab ozogamicin as a single-agent treatment of pediatric patients with refractory or re-lapsed acute myeloid leukemia. J. Clin. Pharmacol., 2004, 44, 873-880.
89. Dowell, J.A.; Korth-Bradley, J.; Liu, H.; King, S.P.; Berger, M.S. Pharmacokinetics of gemtuzumab ozogamicin, an antibody-targeted chemotherapy agent for the treatment of patients with acute myeloid leukemia in first relapse. J. Clin. Pharmacol., 2001, 41, 1206-1214.
90. Burns, J.C.; Best, B.M.; Mejias, A.; Mahony, L.; Fixler, D.E.; Jafri, H.S.; Melish, M.E.; Jackson, M.A.; Asmar, B.I.; Lang, D.J.; Connor, J.D.; Capparelli, E.V.; Keen, M.L.; Mamun, K.; Keenan, G.F.; Ramilo, O. Infliximab treatment of intravenous immunoglobulin-resistant Kawasaki disease. J. Pediatr., 2008, 153, 833-838.
91. Ruperto, N.; Lovell, D.J.; Cuttica, R.; Wilkinson, N.; Woo, P.; Espada, G.; Wouters, C.; Silverman, E.D.; Balogh, Z.; Henrickson, M.; Apaz, M.T.; Baildam, E.; Fasth, A.; Gerloni, V.; Lahdenne, P.; Prieur, A.M.; Ravelli, A.; Saurenmann, R.K.; Gamir, M.L.; Wulffraat, N.; Marodi, L.; Petty, R.E.; Joos, R.; Zulian, F.; McCurdy, D.; Myones, B.L.; Nagy, K.; Reuman, P.; Szer, I.; Travers, S.; Beutler, A.; Keenan, G.; Clark, J.; Visvanathan, S.; Fasanmade, A.; Raychaudhuri, A.; Mendelsohn, A.; Martini, A.; Giannini, E.H. Paediatric Rheumatology International Trials Organisation; Pediatric Rheumatology Collaborative Study Group. A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum., 2007, 56, 3096-3106.
92. Ternant, D.; Mulleman, D.; Degenne, D.; Willot, S.; Guillaumin, J.M.; Watier, H.; Goupille, P.; Paintaud, G. An enzyme-linked im-munosorbent assay for therapeutic drug monitoring of infliximab. Ther. Drug Monit., 2006, 28, 169-174.
93. Sleight, B.S.; Chan, K.W.; Braun, T.M.; Serrano, A.; Gilman, A.L. Infliximab for GVHD therapyin children. Bone Marrow Trans-plant., 2007, 40, 473-480.
94. Hyams, J.S.; Wilson, D.C.; Thomas, A.; Heuschkel, R.; Mitton, S.; Mitchell, B.; Daniels, R.; Libonati, M.A.; Zanker, S.; Kugathasan, S. Natalizumab therapy for moderate to severe Crohn disease in adolescents. J. Pediatr. Gastroenterol. Nutr., 2007, 44, 185-191.
95. Walvoord, E.C.; de la Pena, A.; Park, S.; Silverman, B.; Cuttler, L.; Rose, S.R.; Cutler, G.; Drop, S.; Chipman, J.J. Inhaled growth hormone (GH) compared with subcutaneous GH in children with GH deficiency: pharmacokinetics, pharmacodynamics, and safety. J. Clin. Endocrinol. Metab., 2009, 94, 2052-2059.
96. Peter, F.; Savoy, C.; Ji, H.J.; Juhasz, M.; Bidlingmaier, M.; Saenger, P. Pharmacokinetic and pharmacodynamic profile of a new sustained-release GH formulation, LB03002, in children with GH deficiency. Eur. J. Endocrinol., 2009, 160, 349-355.
97. Houdijk, E.C.; Herdes, E.; Delemarre-Van de Waal, H.A. Pharma-cokinetics and pharmacodynamics of recombinant human growth hormone by subcutaneous jet-or needle injection in patients with growth hormone deficiency. Acta, Paediatr., 1997, 86, 1301-1307.
98. Danne, T.; Datz, N.; Endahl, L.; Haahr, H.; Nestoris, C.; Wester-gaard, L.; Fjording, M.S.; Kordonouri, O. Insulin detemir is charac-terized by a more reproducible pharmacokinetic profile than insulin glargine in children and adolescents with type 1 diabetes: results from a randomized, double-blind, controlled trial. Pediatr. Diabe-tes, 2008, 9, 554-560.
99. Danne, T. Flexibility of rapid-acting insulin analogues in children and adolescents with diabetes mellitus. Clin. Ther., 2007, 29 (Suppl. D), S145-S152.
100. Mortensen, H.B.; Lindholm, A.; Olsen, B.S.; Hylleberg, B. Rapid appearance and onset of action of insulin aspart in paediatric sub-jects with type 1 diabetes. Eur. J. Pediatr., 2000, 159, 483-488.
101. Danne, T.; Becker, R.H.; Heise, T.; Bittner, C.; Frick, A.D.; Rave, K. Pharmacokinetics, prandial glucose control, and safety of insulin glulisine in children and adolescents with type 1 diabetes. Diabetes Care, 2005, 28, 2100-2105.
102. Freeman, B.B., 3rd; Hinds, P.; Iacono, L.C.; Razzouk, B.I.; Burghen, E.; Stewart, C.F. Pharmacokinetics and pharmacodynam ics of intravenous epoetin alfa in children with cancer. Pediatr. Blood Cancer, 2006, 47, 572-579.
103. Lim, V.S.; DeGowin, R.L.; Zavala, D.; Kirchner, P.T.; Abels, R.; Perry, P.; Fangman, J. Recombinant human erythropoietin treat-ment in pre-dialysis patients. A double-blind placebocontrolled trial. Ann. Intern. Med., 1989, 110, 108-114.
104. Widness, J.A.; Veng-Pedersen, P.; Peters, C.; Pereira, L.M.; Schmidt, R.L.; Lowe, L.S. Erythropoietin pharmacokinetics in premature infants: developmental, nonlinearity, and treatment effects. J. Appl. Physiol., 1996, 80, 140-148.
105. Ohls, R.K.; Veerman, M.W.; Christensen, R.D., Pharmacokinetics and effectiveness of recombinant erythropoietin administered to preterm infants by continuous infusion in total parenteral nutrition solution. J. Pediatr., 1996, 128, 518-523.
106. Knebel, W.; Palmen, M.; Dowell, J.A.; Gastonguay, M. Population pharmacokinetic modeling of epoetin delta in pediatric patients with chronic kidney disease. J. Clin. Pharmacol., 2008, 48, 837-848.
107. Smith, W.B.; Dowell, J.A.; Pratt, R.D. Pharmacokinetics and pharmacodynamics of epoetin delta in two studies in healthy volun-teers and two studies in patients with chronic kidney disease. Clin. Ther., 2007, 29, 1368-1380.
108. Lerner, G.; Kale, A.S.; Warady, B.A.; Jabs, K.; Bunchman, T.E.; Heatherington, A.; Olson, K.; Messer-Mann, L.; Maroni, B.J. Pharmacokinetics of darbepoetin alfa in pediatric patients with chronic kidney disease. Pediatr. Nephrol., 2002, 17, 933-937.
109. Macdougall, I.C.; Gray, S.J.; Elston, O.; Breen, C.; Jenkins, B.; Browne, J.; Egrie, J. Pharmacokinetics of novel erythropoiesis stimulating protein compared with epoetin alfa indialysis patients. J. Am. Soc. Nephrol., 1999, 10, 2392-2395.
110. Evans, J.H.; Brocklebank, J.T.; Bowmer, C.J.; Ng, P.C. Pharma-cokinetics of recombinant human erythropoietin in children with renal failure. Nephrol. Dial. Transplant., 1991, 6, 709-714.
111. Ateshkadi, A.; Johnson, C.A.; Oxton, L.L.; Hammond, T.G.; Bo-henek, W.S.; Zimmerman, S.W. Pharmacokinetics of intraperito-neal, intravenous, and subcutaneous recombinant human erythro-poietin in patients on continuous ambulatory peritoneal dialysis. Am. J. Kidney Dis., 1993, 21, 635-642.
112. Macdougall, I.C.; Roberts, D.E.; Coles, G.A.; Williams, J.D. Clini-cal pharmacokinetics of epoetin (recombinant human erythro-poietin). Clin. Pharmacokinet., 1991, 20, 99-113.
113. Blumer, J.; Berg, S.; Adamson, P.C.; Loew, T.; Rossi, G.; Hastings, C. Pharmacokinetic evaluation of darbepoetin alfa for the treatment of pediatric patients with chemotherapy-induced anemia. Pediatr. Blood Cancer, 2007, 49, 687-693.
114. De Palo, T.; Giordano, M.; Palumbo, F.; Bellantuono, R.; Messina, G.; Colella, V.; Caringella, A.D. Clinical experience with darbe-poietin alfa (NESP) in children undergoing hemodialysis. Pediatr. Nephrol., 2004, 19, 337-340.
115. Wells, R.J.; Weck, P.K.; Baehner, R.L.; Krivit, W.; Raney, R.B.; Ortega, J.A.; Bernstein, I.O.; Lampkin, B.; Whisnant, J.K.; Sather, H.N. Interferon-alpha n1 in children with recurrent acute lympho-cytic leukemia: a phase I study of pharmacokinetics and tolerance. J. Interferon Res., 1988, 8, 309-318.
116. Knost, J.A.; Sherwin, S.A.; Abrams, P.G.; Ochs, J.J.; Foon, K.A.; Williams, R.; Tuttle, R.; Oldham, R.K. The treatment of cancer pa-tients with human lymphoblastoid interferon. A comparison of two routes of administration. Cancer Immunol. Immunother., 1983, 15, 144-148.
117. Schwarz, K.B.; Mohan, P.; Narkewicz, M.R.; Molleston, J.P.; Nash, S.R.; Hu, S.; Wang, K.; Gries, J.M. Safety, efficacy and pharmacokinetics of peginterferon alpha2a (40 kd) in children with chronic hepatitis C. J. Pediatr. Gastroenterol. Nutr., 2006, 43, 499-505.
118. Zeuzem, S.; Feinman, S.V.; Rasenack, J.; Heathcote, E.J.; Lai, M.Y.; Gane, E.; O'Grady, J.; Reichen, J.; Diago, M.; Lin, A.; Hoffman, J.; Brunda, M.J. Peginterferon alfa-2a in patients with chronic hepatitis C. N. Engl. J. Med., 2000, 343, 1666-1672.
119. Wirth, S.; Ribes-Koninckx, C.; Calzado, M.A.; Bortolotti, F.; Zan-can, L.; Jara, P.; Shelton, M.; Kerkar, N.; Galoppo, M.; Pedreira, A.; Rodriguez-Baez, N.; Ciocca, M.; Lachaux, A.; Lacaille, F.; Lang, T.; Kullmer, U.; Huber, W.D.; Gonzalez, T.; Pollack, H.; Alonso, E.; Broue, P.; Ramakrishna, J.; Neigut, D.; Valle-Segarra, A.D.; Hunter, B.; Goodman, Z.; Xu, C.R.; Zheng, H.; Noviello, S.; Sniukiene, V.; Brass, C.; Albrecht, J.K. High sustained virologic response rates in children with chronic hepatitis C receiving peginterferon alfa-2b plus ribavirin. J. Hepatol., 2010, 52, 501-507.
120. Villar, A.; Aronis, S.; Morfini, M.; Santagostino, E.; Auerswald, G.; Thomsen, H.F.; Erhardtsen, E.; Giangrande, P.L. Pharmacokinetics of activated recombinant coagulation factor VII (NovoSeven) in children vs. adults with haemophilia A. Haemophilia, 2004, 10, 352-359.
121. Klitgaard, T.; Nielsen, T.G. Overview of the human pharmacokinetics of recombinant activated factor VII. Br. J. Clin. Pharmacol., 2008, 65, 3-11.
122. Tarantino, M.D.; Collins, P.W.; Hay, C.R.; Shapiro, A.D.; Gruppo, R.A.; Berntorp, E.; Bray, G.L.; Tonetta, S.A.; Schroth, P.C.; Retzios, A.D.; Rogy, S.S.; Sensel, M.G.; Ewenstein, B.M. Clinical evaluation of an advanced category antihaemophilic factor prepared using a plasma/albumin-free method: Pharmacokinetics, efficacy, and safety in previously treated patients with haemophilia A. Haemophilia, 2004, 10, 428-437.
123. Gale, R.F.; Hird, M.F.; Colvin, B.T. Management of a premature infant with moderate haemophilia A using recombinant factor VIII. Haemophilia, 1998, 4, 850-853.
124. Carlsson, M.; Berntorp, E.; Björkman, S.; Lethagen, S.; Ljung, R. Improved cost-effectiveness by pharmacokinetic dosing of factor VIII in prophylactic treatment of haemophilia A. Haemophilia, 2007, 3, 96-101.
125. Bjorkman, S.; Folkesson, A.; Berntorp, E. In vivo recovery of factor VIII and factor IX: intra-and interindividual variance in a clinical setting. Haemophilia, 2007, 13, 2-8.
126. Lee, J.I.; Zhang, L.; Men, A.Y.; Kenna, L.A.; Huang, S.M. CYPmediated therapeutic protein-drug interactions: clinical findings, proposed mechanisms and regulatory implications. Clin. Pharmacokinet., 2010, 495, 295-310
127. Seitz, K.; Zhou, H. Pharmacokinetic drug-drug interaction potentials for therapeutic monoclonal antibodies: reality check. J. Clin. Pharmacol., 2007, 47,1104-1118
128. Mahmood, I.; Green, M.D. Drug interaction studies of therapeutic proteins ormonoclonal antibodies. J. Clin. Pharmacol., 2007, 47, 1540-1554.
129. Zhou, H.; Davis, H.M. Risk-based strategy for the assessment of pharmacokinetic drug-drug interactions for therapeutic monoclonal antibodies. Drug Discov. Today, 2009, 14, 891-898.
130. Huang, S.M.; Zhao, H.; Lee, J.I.; Reynolds, K.; Zhang, L.; Temple, R.; Lesko, L.J. Therapeutic protein-drug interactions and implications for drug development. Clin. Pharmacol. Ther., 2010, 87, 497-503.
131. Zhou H and Mary Ann Mascelli MA. Mechanisms of Monoclonal Antibody-Drug Interactions. Annu. Rev. Pharmacol. Toxicol., 2011, 51, 359-372.
132. Morgan, E.T. Regulation of cytochromes P450 during inflammation and infection. Drug Metab. Rev., 1997, 29, 1129-1188.
133. Prandota, J. Important role of proinflammatory cytokines/other endogenous substances in druginduced hepatotoxicity: depression of drug metabolism during infections/inflammation states, and genetic polymorphisms of drug-metabolizing enzymes/cytokinesmay markedly contribute to this pathology. Am. J. Ther., 2005, 12, 254-261.
134. Morgan, E.T. Impact of infectious and inflammatory disease on cytochrome P450-mediated drug metabolism and pharmacokinetics. Clin. Pharmacol. Ther., 2009, 85, 434-438.
135. Morgan, E.T.; Goralski, K.B.; Piquette-Miller, M.; Renton, K.W.; Robertson, G.R.; Chaluvadi, M.R.; Charles, K.A.; Clarke, S.J.; Kacevska, M.; Liddle, C.; Richardson, T.A.; Sharma, R.; Sinal, C.J. Regulation of drug-metabolizing enzymes and transporters in infection, inflammation, and cancer. Drug Metab. Dispos., 2008, 36, 205-216.
136. Le Vee, L.M.; Lecureur, V.; Stieger, B.; Fardel, O. Regulation of drug transporter expression in human hepatocytes exposed to the proinflammatory cytokines tumor necrosis factor-α or interleukin6. Drug Metab. Dispos., 2009, 37, 685-693.
137. Aitken, A.E.; Richardson, T.A.; Morgan, E.T. Regulation of drugmetabolizing enzymes and transporters in inflammation. Annu. Rev. Pharmacol. Toxicol., 2006, 46,123-149.
138. Kato, R.; Nakamura, Y.; Chiesara, E. Enhanced phenobarbital induction of liver microsomal drug metabolizing enzymes in mice infected with murine hepatitus virus. Biochem. Pharmacol., 1963, 12, 365-370.
139. Chang, K.C.; Lauer, B.A.; Bell, T.D.; Chai, H. Altered theophylline pharmacokinetics during acute respiratory viral illness. Lancet, 1978, 311,1132-1133.
140. Kraemer, M.J.; Furukawa, C.T.; Koup, J.R.; Shapiro; G.G.; Pierson; W.E.; Bierman, C.W. Altered theophylline clearance during an influenza B outbreak. Pediatrics, 1982, 69, 476-480.
141. Singh, G.; Renton, K.W. Interferon-mediated depression of cyto-chrome P-450-dependent drug biotransformation. Mol. Pharmacol., 1981, 20, 681-684.
142. Renton, K.W. Depression of hepatic cytochrome P-450-dependent mixed function oxidases during infection with encephalomyocardi-tis virus. Biochem. Pharmacol., 1981, 30, 2333-2336.
143. Meredith, C.G.; Christian, C.D.; Johnson, R.F.; Troxell, R.; Davis, G.L.; Schenker, S. Effects of influenza virus vaccine on hepatic drug metabolism. Clin. Pharmacol. Ther., 1985, 37, 396-401.
144. Chow, H.H.; Tang, Y.; Li, P.; Brookshier, G.; Liang, B.; Watson, R. The effect of chronic retrovirus infection and immune dysfunc-tion on the P-450-mediated activation of acetaminophen in mouse liver microsomes. Biopharm. Drug Dispos., 1998, 19, 9-15
145. Jones, A.E.; Brown, K.C.; Werner, R.E.; Gotzkowsky, K.; Gaedigk, A.; Blake, M.; Hein, D.W.; van der Horst, C.; Kashuba, A.D. Variability in drug metabolizing enzyme activity in HIV-infected patients. Eur. J. Clin. Pharmacol., 2010, 66, 475-485.
146. Chen, Y.L.; Le Vraux, V.; Leneveu, A.; Dreyfus, F.; Stheneur, A.; Florentin, I.; De Sousa, M.; Giroud, J.P.; Flouvat, B.; Chauvelot-Moachon, L. Acute-phase response, interleukin-6, and alteration of cyclosporine pharmacokinetics. Clin. Pharmacol. Ther., 1994, 55, 649-660.
147. Sakamoto, K.; Arakawa, H.; Mita, S.; Ishiko, T.; Ikei, S.; Egami, H.; Hisano, S.; Ogawa, M. Elevation of circulating interleukin 6 af-ter surgery: factors influencing the serum level. Cytokine., 1994, 6, 181-186.
148. Gidal, B.E.; Reiss, W.G.; Liao, J.S.; Pitterle, M.E. Changes in
149. Mayo, P.R.; Skeith, K.; Russell, A.S.; Jamali, F. Decreased dromo-tropic response to verapamil despite pronounced increased drug concentration in rheumatoid arthritis. Br. J. Clin. Pharmacol., 2000, 50, 605-613.
150. Schneider, R.E.; Babb, J.; Bishop, H.; Mitchard, M.; Hoare, A.M. Plasma levels of propranolol in treated patients with celiac disease and patients with Crohn's disease. Br. Med. J., 1976, 2, 794-795.
151. Balthasar, J.P. An academic view of therapeutic protein drug-drug interactions. Presented at AAPS Workshop Ther. Protein Drug In-teract., 2010, May 15-16, San Francisco.
152. Maini, R.N.; Breedveld, F.C.; Kalden, J.R.; Smolen, J.S.; Davis, D.; Macfarlane, J.D.; Antoni. C.; Leeb, B.; Elliott, M.J.; Woody, J.N.; Schaible, T.F.; Feldmann, M. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor α monoclonal antibody combined with low-dose weekly methotrexate in rheuma-toid arthritis. Arthritis Rheum., 1998, 41, 1552-1563.
153. Baert, F.; Noman, M.; Vermeire, S.; Van Assche, G.; D'Haens, G.; Carbonez, A.; Rutgeertsm P. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N. Eng. J. Med., 2003, 348, 601-608.
154. Humira, T.M. [package insert]. Chicago, IL: Abbott Laboratories; 2002
155. Xu, Z.; Vu, T.; Lee, H.; Hu, C.; Ling, J.; Yan, H.; Baker, D.; Beut-ler, A.; Pendley, C.; Wagner, C.; Davis, H.M.; Zhou, H. Population pharmacokinetics of golimumab, an anti-tumor necrosis factor-α human monoclonal antibody, in patients with psoriatic arthritis. J. Clin. Pharmacol., 2009, 49, 1056-1070.
156. Aikawa, N.E.; Freire de Carvalho, F.J.; Silva, C.A.A.; Bonfa, E. Immunogenicity of anti-TNF-α agents in autoimmune diseases. Clin. Rev. Allergy Immuno., 2010, 38, 82-89.
157. Bunescu, A.; Seideman, P.; Lenkei, R.; Levin, K.; Egberg, N. En-hanced Fcγreceptor I, αMβ2 integrin receptor expression by mono-cytes and neutrophils in rheumatoid arthritis: interaction with plate-lets. J. Rheumatol., 2004, 31, 2347-2355.
158. Kovarik, J.M.; Pescovitz, M.D.; Sollinger, H.W.; Kaplan, B.; Leg-endre, C.; Girault, D.; Somberg, K. Differential influence of azathioprine and mycophenolate mofetil on the disposition of basiliximab in renal transplant patients. Clin. Transplant., 2001, 15, 123-130.
159. Kimball, J.A.; Pescovitz, M.D.; Book, B.K.; Norman, D.J. Reduced human IgG anti-ATGAM antibody formation in renal transplant re-cipients receiving mycophenolate mofetil. Transplantation, 1995, 60, 1379-1383.
160. Smith, K.G.C.; Isbel, N.M.; Catton, M.G.; Leydon, J.A.; Becker, G.J.; Walker, R.G. Suppression of the humoral immune response by mycophenolate mofetil. Nephrol. Dial. Transplant., 1998, 13, 160-164.
161. Junghans, R.P.; Anderson, C.L. The protection receptor for IgG catabolism is the β2-microglobulincontaining neonatal intestinal transport receptor. Proc. Natl. Acad. Sci. USA, 1996, 93, 5512-5516.
162. Ganjoo, K.N.; An, C.S.; Robertson, M.J.; Gordon, L.I.; Sen, J.A.; Weisenbach, J.; Li, S.; Weller, E.A.; Orazi. A.; Horning, S.J. Ri-tuximab, bevacizumab and CHOP (RA-CHOP) in untreated diffuse large B-cell lymphoma: safety, biomarker and pharmacokinetic analysis. Leukemia Lymphoma., 2006, 47, 998-1005.
163. Barni, S.; Petrelli, F.; Cabiddu, M.; Cazzaniga, M.E.; Cremonesi, M. From the trastuzumab era to new target therapies: beyond revo-lution. Ann. Onco., 2007, 18(Suppl. 6): vi1-4.
164. Hansen, R.J.; Balthasar, J.P. Effects of intravenous immunoglobu-lin on platelet count and antiplatelet antibody disposition in a rat model of immune thrombocytopenia. Blood, 2002, 100, 2087-2093.
165. Rosh, J.R.; Lerer T.; Markowitz, J.; Goli, S.R.; Mamula, P.; Noe, J.D.; Pfefferkorn, M.D.; Kelleher, K.T.; Griffiths, A.M.; Kugathasan, S.; Keljo, D.; Oliva-Hemker, M.; Crandall, W.; Car-valho, R.S.; Mack, D.R.; Hyams, J.S. Retrospective Evaluation of the Safety and Effect of Adalimumab Therapy (RESEAT) in Pedi-atric Crohn's Disease. Am. J. Gastroenterol., 2009, 104, 3042-3049.
166. Rosh, J.R.; Gross, T.; Mamula, P.; Anne, G.; Hyams, J. Hepa-tosplenic T-cell lymphoma in adolescents and young adults with Crohn's disease: a cautionary tale? Inflamm. Bowel Dis., 2007, 13,1024-1030.
167. Mackey, A.; Green, L.; Leptak, C. et al. Hepatosplenic T cell lym-phoma associated with infl iximab use in young patients treated for inflamatory bowel disease: update. J. Pediatr. Gastro. Nut., 2009, 48, 386-387.