메뉴 건너뛰기




Volumn 29, Issue 2, 2012, Pages 490-499

Subcutaneous absorption of monoclonal antibodies: Role of dose, site of injection, and injection volume on rituximab pharmacokinetics in rats

Author keywords

Lymphatic absorption; Pharmacokinetic modeling; Saturable absorption; Therapeutic proteins

Indexed keywords

MONOCLONAL ANTIBODY; RITUXIMAB; ANTINEOPLASTIC AGENT;

EID: 84858229014     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-011-0578-3     Document Type: Article
Times cited : (85)

References (49)
  • 1
    • 3843133934 scopus 로고    scopus 로고
    • The clinical pharmacology of therapeutic monoclonal antibodies
    • Roskos LK, Davis CG, Schwab GM. The clinical pharmacology of therapeutic monoclonal antibodies. Drug Develop Res. 2004;61:108-20.
    • (2004) Drug Develop Res , vol.61 , pp. 108-120
    • Roskos, L.K.1    Davis, C.G.2    Schwab, G.M.3
  • 2
    • 72949106918 scopus 로고    scopus 로고
    • Pharmacokinetics of biotech drugs: Peptides, proteins and monoclonal antibodies
    • Lin JH. Pharmacokinetics of biotech drugs: peptides, proteins and monoclonal antibodies. Curr Drug Metab. 2009;10:661-91.
    • (2009) Curr Drug Metab , vol.10 , pp. 661-691
    • Lin, J.H.1
  • 4
    • 32444438731 scopus 로고    scopus 로고
    • Elimination mechanisms of therapeutic monoclonal antibodies
    • Tabrizi MA, Tseng CM, Roskos LK. Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov Today. 2006;11:81-8.
    • (2006) Drug Discov Today , vol.11 , pp. 81-88
    • Tabrizi, M.A.1    Tseng, C.M.2    Roskos, L.K.3
  • 5
    • 24144455629 scopus 로고    scopus 로고
    • Pharmacokinetics and concentration-effect relationships of therapeutic monoclonal antibodies and fusion proteins
    • Ternantand D, Paintaud G. Pharmacokinetics and concentration-effect relationships of therapeutic monoclonal antibodies and fusion proteins. Expert Opin Biol Th. 2005;5:S37-47.
    • (2005) Expert Opin Biol Th , vol.5
    • Ternantand, D.1    Paintaud, G.2
  • 6
    • 65549100701 scopus 로고    scopus 로고
    • Tumor burden influences exposure and response to rituximab: Pharmacokinetic-pharmacodynamic modeling using a syngeneic bioluminescent murine model expressing human CD20
    • Dayde D, Ternant D, Ohresser M, Lerondel S, Pesnel S, Watier H, et al. Tumor burden influences exposure and response to rituximab: pharmacokinetic- pharmacodynamic modeling using a syngeneic bioluminescent murine model expressing human CD20. Blood. 2009;113:3765-72.
    • (2009) Blood , vol.113 , pp. 3765-3772
    • Dayde, D.1    Ternant, D.2    Ohresser, M.3    Lerondel, S.4    Pesnel, S.5    Watier, H.6
  • 7
    • 76649094549 scopus 로고    scopus 로고
    • Physiologically based pharmacokinetic model for T84.66: A monoclonal anti-CEA antibody
    • Urva SR, Yang VC, Balthasar JP. Physiologically based pharmacokinetic model for T84.66: A monoclonal anti-CEA antibody. J Pharmaceut Sci. 2010;99:1582-600.
    • (2010) J Pharmaceut Sci , vol.99 , pp. 1582-1600
    • Urva, S.R.1    Yang, V.C.2    Balthasar, J.P.3
  • 8
    • 4344634877 scopus 로고    scopus 로고
    • Pharmacokinetic aspects of biotechnology products
    • Tang L, Persky AM, Hochhaus G, Meibohm B. Pharmacokinetic aspects of biotechnology products. J Pharm Sci. 2004;93:2184-204.
    • (2004) J Pharm Sci , vol.93 , pp. 2184-2204
    • Tang, L.1    Persky, A.M.2    Hochhaus, G.3    Meibohm, B.4
  • 9
    • 0034020054 scopus 로고    scopus 로고
    • Lymphatic transport of proteins after subcutaneous administration
    • Porter CJ, Charman SA. Lymphatic transport of proteins after subcutaneous administration. J Pharm Sci. 2000;89:297-310.
    • (2000) J Pharm Sci , vol.89 , pp. 297-310
    • Porter, C.J.1    Charman, S.A.2
  • 10
    • 77956388219 scopus 로고    scopus 로고
    • Population pharmacokinetics of therapeutic monoclonal antibodies
    • Dirks NL, Meibohm B. Population pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010;49:633-59.
    • (2010) Clin Pharmacokinet , vol.49 , pp. 633-659
    • Dirks, N.L.1    Meibohm, B.2
  • 11
    • 33750603988 scopus 로고    scopus 로고
    • The absorption of darbepoetin alfa occurs predominantly via the lymphatics following subcutaneous administration to sheep
    • McLennan DN, Porter CJ, Edwards GA, Heatherington AC, Martin SW, Charman SA. The absorption of darbepoetin alfa occurs predominantly via the lymphatics following subcutaneous administration to sheep. Pharm Res. 2006;23:2060-6.
    • (2006) Pharm Res , vol.23 , pp. 2060-2066
    • McLennan, D.N.1    Porter, C.J.2    Edwards, G.A.3    Heatherington, A.C.4    Martin, S.W.5    Charman, S.A.6
  • 12
    • 0035940080 scopus 로고    scopus 로고
    • Lymphatic transport of proteins after s.c. injection: Implications of animal model selection
    • Porter CJ, Edwards GA, Charman SA. Lymphatic transport of proteins after s.c. injection: implications of animal model selection. Adv Drug Deliv Rev. 2001;50:157-71.
    • (2001) Adv Drug Deliv Rev , vol.50 , pp. 157-171
    • Porter, C.J.1    Edwards, G.A.2    Charman, S.A.3
  • 13
    • 0034749977 scopus 로고    scopus 로고
    • Lymphatic absorption is a significant contributor to the subcutaneous bioavailability of insulin in a sheep model
    • Charman SA, McLennan DN, Edwards GA, Porter CJ. Lymphatic absorption is a significant contributor to the subcutaneous bioavailability of insulin in a sheep model. Pharm Res. 2001;18:1620-6.
    • (2001) Pharm Res , vol.18 , pp. 1620-1626
    • Charman, S.A.1    McLennan, D.N.2    Edwards, G.A.3    Porter, C.J.4
  • 14
    • 36348992581 scopus 로고    scopus 로고
    • Lymphatic absorption of subcutaneously administered proteins: Influence of different injection sites on the absorption of darbepoetin alfa using a sheep model
    • Kota J, Machavaram KK, McLennan DN, Edwards GA, Porter CJ, Charman SA. Lymphatic absorption of subcutaneously administered proteins: influence of different injection sites on the absorption of darbepoetin alfa using a sheep model. Drug Metab Dispos. 2007;35:2211-7.
    • (2007) Drug Metab Dispos , vol.35 , pp. 2211-2217
    • Kota, J.1    Machavaram, K.K.2    McLennan, D.N.3    Edwards, G.A.4    Porter, C.J.5    Charman, S.A.6
  • 15
  • 16
    • 0033540056 scopus 로고    scopus 로고
    • Ghrelin is a growth-hormone-releasing acylated peptide from stomach
    • Kojima M, Hosoda H, Date Y, Nakazato M, Matsuo H, Kangawa K. Ghrelin is a growth-hormone-releasing acylated peptide from stomach. Nature. 1999;402:656-60.
    • (1999) Nature , vol.402 , pp. 656-660
    • Kojima, M.1    Hosoda, H.2    Date, Y.3    Nakazato, M.4    Matsuo, H.5    Kangawa, K.6
  • 17
    • 0022543845 scopus 로고
    • The lymphatic route. 1 Albumin and hyaluronidase modify the normal distribution of interferon in lymph and plasma
    • Bocci V, Muscettola M, Grasso G, Magyar Z, Naldini A, Szabo G. The lymphatic route. 1) Albumin and hyaluronidase modify the normal distribution of interferon in lymph and plasma. Experientia. 1986;42:432-3.
    • (1986) Experientia , vol.42 , pp. 432-433
    • Bocci, V.1    Muscettola, M.2    Grasso, G.3    Magyar, Z.4    Naldini, A.5    Szabo, G.6
  • 18
    • 0025955645 scopus 로고
    • The effect of subcutaneous injection site on absorption of human growth hormone: Abdomen versus thigh
    • Oxf
    • Beshyah SA, Anyaoku V, Niththyananthan R, Sharp P, Johnston DG. The effect of subcutaneous injection site on absorption of human growth hormone: abdomen versus thigh. Clin Endocrinol (Oxf). 1991;35:409-12.
    • (1991) Clin Endocrinol , vol.35 , pp. 409-412
    • Beshyah, S.A.1    Anyaoku, V.2    Niththyananthan, R.3    Sharp, P.4    Johnston, D.G.5
  • 20
    • 0029958430 scopus 로고    scopus 로고
    • Injection site effects on the pharmacokinetics and glucodynamics of insulin lispro and regular insulin
    • Ter Braak E, Woodworth J, Bianchi R, Cerimele B, Erkelens D, Thijssen J, et al. Injection site effects on the pharmacokinetics and glucodynamics of insulin lispro and regular insulin. Diabetes Care. 1996;19:1437-40.
    • (1996) Diabetes Care , vol.19 , pp. 1437-1440
    • Ter Braak, E.1    Woodworth, J.2    Bianchi, R.3    Cerimele, B.4    Erkelens, D.5    Thijssen, J.6
  • 21
    • 0031047342 scopus 로고    scopus 로고
    • Lymphatic uptake and biodistribution of liposomes after subcutaneous injection I. Influence of the anatomical site of injection
    • Oussoren C, Zuidema J, Crommelin DJA, Storm G. Lymphatic uptake and biodistribution of liposomes after subcutaneous injection I. Influence of the anatomical site of injection. J Liposome Res. 1997;7:85-99.
    • (1997) J Liposome Res , vol.7 , pp. 85-99
    • Oussoren, C.1    Zuidema, J.2    Crommelin, D.J.A.3    Storm, G.4
  • 22
    • 0023735020 scopus 로고
    • Enzymatic barriers to peptide and protein absorption
    • Lee VH. Enzymatic barriers to peptide and protein absorption. Crit Rev Ther Drug Carrier Syst. 1988;5:69-97.
    • (1988) Crit Rev Ther Drug Carrier Syst , vol.5 , pp. 69-97
    • Lee, V.H.1
  • 23
    • 0018385518 scopus 로고
    • Evidence that protease inhibitors reduce the degradation of parathyroid hormone and calcitonin injected subcutaneously
    • Parsons JA, Rafferty B, Stevenson RW, Zanelli JM. Evidence that protease inhibitors reduce the degradation of parathyroid hormone and calcitonin injected subcutaneously. Br J Pharmacol. 1979;66:25-32.
    • (1979) Br J Pharmacol , vol.66 , pp. 25-32
    • Parsons, J.A.1    Rafferty, B.2    Stevenson, R.W.3    Zanelli, J.M.4
  • 25
    • 0028057250 scopus 로고
    • Depletion of B cells in vivo by a chimeric mouse human monoclonal antibody to CD20
    • Reff ME, Carner K, Chambers KS, Chinn PC, Leonard JE, Raab R, et al. Depletion of B cells in vivo by a chimeric mouse human monoclonal antibody to CD20. Blood. 1994;83:435-45.
    • (1994) Blood , vol.83 , pp. 435-445
    • Reff, M.E.1    Carner, K.2    Chambers, K.S.3    Chinn, P.C.4    Leonard, J.E.5    Raab, R.6
  • 26
    • 0037251878 scopus 로고    scopus 로고
    • Rituximab: A review of its use in non-Hodgkin's lymphoma and chronic lymphocytic leukaemia
    • Plosker GL, Figgitt DP. Rituximab: a review of its use in non-Hodgkin's lymphoma and chronic lymphocytic leukaemia. Drugs. 2003;63:803-43.
    • (2003) Drugs , vol.63 , pp. 803-843
    • Plosker, G.L.1    Figgitt, D.P.2
  • 27
    • 0031810433 scopus 로고    scopus 로고
    • Subcutaneous bioavailability of a PRIMATIZED IgG1 anti-human CD4 monoclonal antibody is dose dependent in transgenic mice bearing human CD4
    • Davis CB, Bugelski PJ. Subcutaneous bioavailability of a PRIMATIZED IgG1 anti-human CD4 monoclonal antibody is dose dependent in transgenic mice bearing human CD4. Drug Deliv. 1998;5:95-100.
    • (1998) Drug Deliv , vol.5 , pp. 95-100
    • Davis, C.B.1    Bugelski, P.J.2
  • 28
    • 3142564395 scopus 로고    scopus 로고
    • Three new assays for rituximab based on its immunological activity or antigenic properties: Analyses of sera and plasmas of RTX-treated patients with chronic lymphocytic leukemia and other B cell lymphomas
    • Beum PV, Kennedy AD, Taylor RP. Three new assays for rituximab based on its immunological activity or antigenic properties: analyses of sera and plasmas of RTX-treated patients with chronic lymphocytic leukemia and other B cell lymphomas. J Immunol Methods. 2004;289:97-109.
    • (2004) J Immunol Methods , vol.289 , pp. 97-109
    • Beum, P.V.1    Kennedy, A.D.2    Taylor, R.P.3
  • 30
    • 10744230729 scopus 로고    scopus 로고
    • Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules
    • DeSilva B, Smith W, Weiner R, Kelley M, Smolec J, Lee B, et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res. 2003;20:1885-900.
    • (2003) Pharm Res , vol.20 , pp. 1885-1900
    • DeSilva, B.1    Smith, W.2    Weiner, R.3    Kelley, M.4    Smolec, J.5    Lee, B.6
  • 31
    • 34447345725 scopus 로고    scopus 로고
    • Appropriate calibration curve fitting in ligand binding assays
    • Findlay JW, Dillard RF. Appropriate calibration curve fitting in ligand binding assays. AAPS J. 2007;9:E260-7.
    • (2007) AAPS J , vol.9
    • Findlay, J.W.1    Dillard, R.F.2
  • 32
    • 0842343448 scopus 로고    scopus 로고
    • Visualizing the site and dynamics of IgG salvage by the MHC class I-related receptor, FcRn
    • Ober RJ, Martinez C, Vaccaro C, Zhou J, Ward ES. Visualizing the site and dynamics of IgG salvage by the MHC class I-related receptor, FcRn. J Immunol. 2004;172:2021-9.
    • (2004) J Immunol , vol.172 , pp. 2021-2029
    • Ober, R.J.1    Martinez, C.2    Vaccaro, C.3    Zhou, J.4    Ward, E.S.5
  • 33
    • 34748877223 scopus 로고    scopus 로고
    • Physiologically-based pharmacokinetic (PBPK) model to predict IgG tissue kinetics in wild-type and FcRn-knockout mice
    • Garg A, Balthasar JP. Physiologically-based pharmacokinetic (PBPK) model to predict IgG tissue kinetics in wild-type and FcRn-knockout mice. J Pharmacokinet Pharmacodyn. 2007;34:687-709.
    • (2007) J Pharmacokinet Pharmacodyn , vol.34 , pp. 687-709
    • Garg, A.1    Balthasar, J.P.2
  • 34
    • 0035940071 scopus 로고    scopus 로고
    • The physiology of the lymphatic system
    • Swartz MA. The physiology of the lymphatic system. Adv Drug Deliv Rev. 2001;50:3-20.
    • (2001) Adv Drug Deliv Rev , vol.50 , pp. 3-20
    • Swartz, M.A.1
  • 36
  • 39
    • 0029731813 scopus 로고    scopus 로고
    • Fc receptors and their interactions with immunoglobulins
    • Raghavan M, Bjorkman PJ. Fc receptors and their interactions with immunoglobulins. Annu Rev Cell Dev Biol. 1996;12:181-220.
    • (1996) Annu Rev Cell Dev Biol , vol.12 , pp. 181-220
    • Raghavan, M.1    Bjorkman, P.J.2
  • 40
    • 0029927482 scopus 로고    scopus 로고
    • Abnormally short serum half-lives of IgG in beta 2-microglobulin- deficient mice
    • Ghetie V, Hubbard JG, Kim JK, Tsen MF, Lee Y, Ward ES. Abnormally short serum half-lives of IgG in beta 2-microglobulin-deficient mice. Eur J Immunol. 1996;26:690-6.
    • (1996) Eur J Immunol , vol.26 , pp. 690-696
    • Ghetie, V.1    Hubbard, J.G.2    Kim, J.K.3    Tsen, M.F.4    Lee, Y.5    Ward, E.S.6
  • 41
    • 0029891262 scopus 로고    scopus 로고
    • The protection receptor for IgG catabolism is the beta2-microglobulin- containing neonatal intestinal transport receptor
    • Junghans RP, Anderson CL. The protection receptor for IgG catabolism is the beta2-microglobulin-containing neonatal intestinal transport receptor. Proc Natl Acad Sci U S A. 1996;93:5512-6.
    • (1996) Proc Natl Acad Sci U S A , vol.93 , pp. 5512-5516
    • Junghans, R.P.1    Anderson, C.L.2
  • 42
    • 54249138516 scopus 로고    scopus 로고
    • Monoclonal antibody pharmacokinetics and pharmacodynamics
    • Wang W, Wang EQ, Balthasar JP. Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther. 2008;84:548-58.
    • (2008) Clin Pharmacol Ther , vol.84 , pp. 548-558
    • Wang, W.1    Wang, E.Q.2    Balthasar, J.P.3
  • 43
    • 0032741975 scopus 로고    scopus 로고
    • Bidirectional FcRn-dependent IgG transport in a polarized human intestinal epithelial cell line
    • Dickinson BL, Badizadegan K, Wu Z, Ahouse JC, Zhu X, Simister NE, et al. Bidirectional FcRn-dependent IgG transport in a polarized human intestinal epithelial cell line. J Clin Invest. 1999;104:903-11.
    • (1999) J Clin Invest , vol.104 , pp. 903-911
    • Dickinson, B.L.1    Badizadegan, K.2    Wu, Z.3    Ahouse, J.C.4    Zhu, X.5    Simister, N.E.6
  • 44
    • 0035113258 scopus 로고    scopus 로고
    • Expression of functionally active FcRn and the differentiated bidirectional transport of IgG in human placental endothelial cells
    • Antohe F, Radulescu L, Gafencu A, Ghetie V, Simionescu M. Expression of functionally active FcRn and the differentiated bidirectional transport of IgG in human placental endothelial cells. Hum Immunol. 2001;62:93-105.
    • (2001) Hum Immunol , vol.62 , pp. 93-105
    • Antohe, F.1    Radulescu, L.2    Gafencu, A.3    Ghetie, V.4    Simionescu, M.5
  • 45
    • 0038621933 scopus 로고    scopus 로고
    • Pharmacokinetic/pharmacodynamic modeling of the effects of intravenous immunoglobulin on the disposition of antiplatelet antibodies in a rat model of immune thrombocytopenia
    • Hansen RJ, Balthasar JP. Pharmacokinetic/pharmacodynamic modeling of the effects of intravenous immunoglobulin on the disposition of antiplatelet antibodies in a rat model of immune thrombocytopenia. J Pharm Sci. 2003;92:1206-15.
    • (2003) J Pharm Sci , vol.92 , pp. 1206-1215
    • Hansen, R.J.1    Balthasar, J.P.2
  • 46
    • 25144510899 scopus 로고    scopus 로고
    • Quasi-equilibrium pharmacokinetic model for drugs exhibiting target-mediated drug disposition
    • Mager DE, Krzyzanski W. Quasi-equilibrium pharmacokinetic model for drugs exhibiting target-mediated drug disposition. Pharm Res. 2005;22:1589-96.
    • (2005) Pharm Res , vol.22 , pp. 1589-1596
    • Mager, D.E.1    Krzyzanski, W.2
  • 47
    • 0035210960 scopus 로고    scopus 로고
    • Differences in promiscuity for antibody-FcRn interactions across species: Implications for therapeutic antibodies
    • Ober RJ, Radu CG, Ghetie V, Ward ES. Differences in promiscuity for antibody-FcRn interactions across species: implications for therapeutic antibodies. Int Immunol. 2001;13:1551-9.
    • (2001) Int Immunol , vol.13 , pp. 1551-1559
    • Ober, R.J.1    Radu, C.G.2    Ghetie, V.3    Ward, E.S.4
  • 49
    • 77649211091 scopus 로고    scopus 로고
    • Subcutaneous bioavailability of golimumab at 3 different injection sites in healthy subjects
    • Xu Z, Wang Q, Zhuang Y, Frederick B, Yan H, Bouman-Thio E, et al. Subcutaneous bioavailability of golimumab at 3 different injection sites in healthy subjects. J Clin Pharmacol. 2010;50:276-84.
    • (2010) J Clin Pharmacol , vol.50 , pp. 276-284
    • Xu, Z.1    Wang, Q.2    Zhuang, Y.3    Frederick, B.4    Yan, H.5    Bouman-Thio, E.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.