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Volumn 37, Issue 2, 2016, Pages 51-65

Projecting human pharmacokinetics of monoclonal antibodies from nonclinical data: Comparative evaluation of prediction approaches in early drug development

Author keywords

allometry scaling; monoclonal antibody; pharmacokinetics; species invariant time method; target mediated drug disposition

Indexed keywords

MONOCLONAL ANTIBODY;

EID: 84962343549     PISSN: 01422782     EISSN: 1099081X     Source Type: Journal    
DOI: 10.1002/bdd.1952     Document Type: Review
Times cited : (57)

References (81)
  • 1
    • 84860896956 scopus 로고    scopus 로고
    • Marketed therapeutic antibodies compendium
    • Reichert JM,. Marketed therapeutic antibodies compendium. MAbs 2012; 4 (3): 413-415.
    • (2012) MAbs , vol.4 , Issue.3 , pp. 413-415
    • Reichert, J.M.1
  • 2
    • 84856120429 scopus 로고    scopus 로고
    • Monoclonal antibodies: What are the pharmacokinetic and pharmacodynamic considerations for drug development?
    • Deng R, Jin F, Prabhu S, Iver S,. Monoclonal antibodies: what are the pharmacokinetic and pharmacodynamic considerations for drug development? Expert Opin Drug Metab Toxicol 2012; 8 (2): 141-160.
    • (2012) Expert Opin Drug Metab Toxicol , vol.8 , Issue.2 , pp. 141-160
    • Deng, R.1    Jin, F.2    Prabhu, S.3    Iver, S.4
  • 4
    • 69949109408 scopus 로고    scopus 로고
    • Pharmacokinetic allometric scaling of antibodies: Application to the first-in-human dose estimation
    • Mahmood I,. Pharmacokinetic allometric scaling of antibodies: application to the first-in-human dose estimation. J Pharm Sci 2009; 98 (10): 3850-3861.
    • (2009) J Pharm Sci , vol.98 , Issue.10 , pp. 3850-3861
    • Mahmood, I.1
  • 5
    • 84863221758 scopus 로고    scopus 로고
    • Prediction of human plasma concentration-time profiles of monoclonal antibodies from monkey data by species-invariant time method
    • Oitate M, Nakayama S, Ito T, Kurihara A, Okudaira N, Izumi T,. Prediction of human plasma concentration-time profiles of monoclonal antibodies from monkey data by species-invariant time method. Drug Metab Pharmacokinet 2012; 27 (3): 354-359.
    • (2012) Drug Metab Pharmacokinet , vol.27 , Issue.3 , pp. 354-359
    • Oitate, M.1    Nakayama, S.2    Ito, T.3    Kurihara, A.4    Okudaira, N.5    Izumi, T.6
  • 6
    • 15244357228 scopus 로고    scopus 로고
    • Mixed-effects modelling of the interspecies pharmacokinetic scaling of pegylated human erythropoietin
    • Jolling K, Perez Ruixo JJ, Hemeryck A, Vermuelen A, Greway T,. Mixed-effects modelling of the interspecies pharmacokinetic scaling of pegylated human erythropoietin. Eur J Pharm Sci 2005; 24 (5): 465-475.
    • (2005) Eur J Pharm Sci , vol.24 , Issue.5 , pp. 465-475
    • Jolling, K.1    Perez Ruixo, J.J.2    Hemeryck, A.3    Vermuelen, A.4    Greway, T.5
  • 7
    • 84861480783 scopus 로고    scopus 로고
    • Towards a platform PBPK model to characterize the plasma and tissue disposition of monoclonal antibodies in preclinical species and human
    • Shah DK, Betts AM,. Towards a platform PBPK model to characterize the plasma and tissue disposition of monoclonal antibodies in preclinical species and human. J Pharmacokinet Pharmacodyn 2012; 39 (1): 67-86.
    • (2012) J Pharmacokinet Pharmacodyn , vol.39 , Issue.1 , pp. 67-86
    • Shah, D.K.1    Betts, A.M.2
  • 8
    • 71449090902 scopus 로고    scopus 로고
    • Interspecies scaling of therapeutic monoclonal antibodies: Initial look
    • Ling J, Zhou H, Jiao Q, Davis HM,. Interspecies scaling of therapeutic monoclonal antibodies: initial look. J Clin Pharmacol 2009; 49 (12): 1382-1402.
    • (2009) J Clin Pharmacol , vol.49 , Issue.12 , pp. 1382-1402
    • Ling, J.1    Zhou, H.2    Jiao, Q.3    Davis, H.M.4
  • 9
    • 77955297665 scopus 로고    scopus 로고
    • Prediction of human clearance of therapeutic proteins: Simple allometric scaling method revisited
    • Wang W, Prueksaritanont T,. Prediction of human clearance of therapeutic proteins: simple allometric scaling method revisited. Biopharm Drug Dispos 2010; 31 (4): 253-263.
    • (2010) Biopharm Drug Dispos , vol.31 , Issue.4 , pp. 253-263
    • Wang, W.1    Prueksaritanont, T.2
  • 10
    • 78651400009 scopus 로고    scopus 로고
    • Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data: What have we learned?
    • Deng R, Iyer S, Theil FP, Mortensen DL, Fielder PJ, Prabhu S,. Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data: what have we learned? MAbs 2011; 3 (1): 61-66.
    • (2011) MAbs , vol.3 , Issue.1 , pp. 61-66
    • Deng, R.1    Iyer, S.2    Theil, F.P.3    Mortensen, D.L.4    Fielder, P.J.5    Prabhu, S.6
  • 11
    • 78751499845 scopus 로고    scopus 로고
    • Quantitative prediction of human pharmacokinetics for monoclonal antibodies: Retrospective analysis of monkey as a single species for first-in-human prediction
    • Dong JQ, Salinger DH, Endres CJ, et al., Quantitative prediction of human pharmacokinetics for monoclonal antibodies: retrospective analysis of monkey as a single species for first-in-human prediction. Clin Pharmacokinet 2011; 50 (2): 131-142.
    • (2011) Clin Pharmacokinet , vol.50 , Issue.2 , pp. 131-142
    • Dong, J.Q.1    Salinger, D.H.2    Endres, C.J.3
  • 12
    • 80052599925 scopus 로고    scopus 로고
    • Prediction of human pharmacokinetics of therapeutic monoclonal antibodies from simple allometry of monkey data
    • Oitate M, Masubuchi N, Ito T, et al., Prediction of human pharmacokinetics of therapeutic monoclonal antibodies from simple allometry of monkey data. Drug Metab Pharmacokinet 2011; 26 (4): 423-430.
    • (2011) Drug Metab Pharmacokinet , vol.26 , Issue.4 , pp. 423-430
    • Oitate, M.1    Masubuchi, N.2    Ito, T.3
  • 13
    • 77949739818 scopus 로고    scopus 로고
    • The application of target information and preclinical pharmacokinetic/pharmacodynamic modeling in predicting clinical doses of a Dickkopf-1 antibody for osteoporosis
    • Betts AM, Clark TH, Yang J, et al., The application of target information and preclinical pharmacokinetic/pharmacodynamic modeling in predicting clinical doses of a Dickkopf-1 antibody for osteoporosis. J Pharmacol Exp Ther 2010; 333 (1): 2-13.
    • (2010) J Pharmacol Exp Ther , vol.333 , Issue.1 , pp. 2-13
    • Betts, A.M.1    Clark, T.H.2    Yang, J.3
  • 14
    • 84861555037 scopus 로고    scopus 로고
    • A model-based approach to predicting the human pharmacokinetics of a monoclonal antibody exhibiting target-mediated drug disposition
    • Luu KT, Bergquist S, Chen E, Hu-Lowe D, Kraynove E,. A model-based approach to predicting the human pharmacokinetics of a monoclonal antibody exhibiting target-mediated drug disposition. J Pharmacol Exp Ther 2012; 341 (3): 702-708.
    • (2012) J Pharmacol Exp Ther , vol.341 , Issue.3 , pp. 702-708
    • Luu, K.T.1    Bergquist, S.2    Chen, E.3    Hu-Lowe, D.4    Kraynove, E.5
  • 15
    • 0016756272 scopus 로고
    • Continuous cultures of fused cells secreting antibody of predefined specificity
    • Kohler G, Milstein C,. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 1975; 256 (5517): 495-497.
    • (1975) Nature , vol.256 , Issue.5517 , pp. 495-497
    • Kohler, G.1    Milstein, C.2
  • 16
    • 77953658260 scopus 로고    scopus 로고
    • The immunogenicity of humanized and fully human antibodies: Residual immunogenicity resides in the CDR regions
    • Harding FA, Stickler MM, Razo J, DuBridge RB,. The immunogenicity of humanized and fully human antibodies: residual immunogenicity resides in the CDR regions. MAbs 2010; 2 (3): 256-265.
    • (2010) MAbs , vol.2 , Issue.3 , pp. 256-265
    • Harding, F.A.1    Stickler, M.M.2    Razo, J.3    DuBridge, R.B.4
  • 17
    • 8644234910 scopus 로고    scopus 로고
    • Antibody pharmacokinetics and pharmacodynamics
    • Lobo ED, Hansen RJ, Balthasar JP,. Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci 2004; 93 (11): 2645-2668.
    • (2004) J Pharm Sci , vol.93 , Issue.11 , pp. 2645-2668
    • Lobo, E.D.1    Hansen, R.J.2    Balthasar, J.P.3
  • 18
    • 84868201883 scopus 로고    scopus 로고
    • Application of pharmacokinetics-pharmacodynamics/clinical response modeling and simulation for biologics drug development
    • Zhao L, Shang EY, Sahajwalla CG,. Application of pharmacokinetics-pharmacodynamics/clinical response modeling and simulation for biologics drug development. J Pharm Sci 2012; 101 (12): 4367-4382.
    • (2012) J Pharm Sci , vol.101 , Issue.12 , pp. 4367-4382
    • Zhao, L.1    Shang, E.Y.2    Sahajwalla, C.G.3
  • 19
    • 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 (10): 633-659.
    • (2010) Clin Pharmacokinet , vol.49 , Issue.10 , pp. 633-659
    • Dirks, N.L.1    Meibohm, B.2
  • 21
    • 0030993535 scopus 로고    scopus 로고
    • Finally! the Brambell receptor (FcRB). Mediator of transmission of immunity and protection from catabolism for IgG
    • Junghans RP,. Finally! The Brambell receptor (FcRB). Mediator of transmission of immunity and protection from catabolism for IgG. Immunol Res 1997; 16 (1): 29-57.
    • (1997) Immunol Res , vol.16 , Issue.1 , pp. 29-57
    • Junghans, R.P.1
  • 22
    • 0000146003 scopus 로고
    • A theoretical model of gamma-globulin catabolism
    • Brambell F, Hemmings W, Morris I,. A theoretical model of gamma-globulin catabolism. Nature 1964; 203: 1352-1355.
    • (1964) Nature , vol.203 , pp. 1352-1355
    • Brambell, F.1    Hemmings, W.2    Morris, I.3
  • 23
    • 34548229364 scopus 로고    scopus 로고
    • FcRn: The neonatal Fc receptor comes of age
    • Roopenian DC, Akilesh S,. FcRn: the neonatal Fc receptor comes of age. Nat Rev Immunol 2007; 7 (9): 715-725.
    • (2007) Nat Rev Immunol , vol.7 , Issue.9 , pp. 715-725
    • Roopenian, D.C.1    Akilesh, S.2
  • 24
    • 7844225540 scopus 로고    scopus 로고
    • Association of serum Rituximab (IDEC-C2B8) concentration and anti-tumor response in the treatment of recurrent low-grade or follicular non-Hodgkin's lymphoma
    • Berinstein NL, Grillo-Lopez AJ, White CA, et al., Association of serum Rituximab (IDEC-C2B8) concentration and anti-tumor response in the treatment of recurrent low-grade or follicular non-Hodgkin's lymphoma. Ann Oncol 1998; 9 (9): 995-1001.
    • (1998) Ann Oncol , vol.9 , Issue.9 , pp. 995-1001
    • Berinstein, N.L.1    Grillo-Lopez, A.J.2    White, C.A.3
  • 25
    • 18944386328 scopus 로고    scopus 로고
    • The origin of allometric scaling laws in biology from genomes to ecosystems: Towards a quantitative unifying theory of biological structure and organization
    • West GB, Brown JH,. The origin of allometric scaling laws in biology from genomes to ecosystems: towards a quantitative unifying theory of biological structure and organization. J Exp Biol 2005; 208 (9): 1575-1592.
    • (2005) J Exp Biol , vol.208 , Issue.9 , pp. 1575-1592
    • West, G.B.1    Brown, J.H.2
  • 26
    • 0021703938 scopus 로고
    • Interspecies pharmacokinetic scaling and the evolutionary-comparative paradigm
    • Boxenbaum H,. Interspecies pharmacokinetic scaling and the evolutionary-comparative paradigm. Drug Metab Rev 1984; 15 (5-6): 1071-1121.
    • (1984) Drug Metab Rev , vol.15 , Issue.56 , pp. 1071-1121
    • Boxenbaum, H.1
  • 27
    • 0021010984 scopus 로고
    • Interspecies pharmacokinetic scaling and the Dedrick plots
    • Boxenbaum H, Ronfeld R,. Interspecies pharmacokinetic scaling and the Dedrick plots. Am J Physiol 1983; 245 (6): R768-R775.
    • (1983) Am J Physiol , vol.245 , Issue.6 , pp. R768-R775
    • Boxenbaum, H.1    Ronfeld, R.2
  • 28
    • 0026063359 scopus 로고
    • Interspecies scaling of clearance and volume of distribution data for five therapeutic proteins
    • Mordenti J, Chen SA, Moore JA, Ferraiolo BL, Green JD,. Interspecies scaling of clearance and volume of distribution data for five therapeutic proteins. Pharm Res 1991; 8 (11): 1351-1359.
    • (1991) Pharm Res , vol.8 , Issue.11 , pp. 1351-1359
    • Mordenti, J.1    Chen, S.A.2    Moore, J.A.3    Ferraiolo, B.L.4    Green, J.D.5
  • 29
    • 0347755132 scopus 로고    scopus 로고
    • Interspecies scaling of protein drugs: Prediction of clearance from animals to humans
    • Mahmood I,. Interspecies scaling of protein drugs: prediction of clearance from animals to humans. J Pharm Sci 2004; 93 (1): 177-185.
    • (2004) J Pharm Sci , vol.93 , Issue.1 , pp. 177-185
    • Mahmood, I.1
  • 30
    • 0032962265 scopus 로고    scopus 로고
    • Preclinical pharmacokinetics, interspecies scaling, and tissue distribution of a humanized monoclonal antibody against vascular endothelial growth factor
    • Lin YS, Nguyen C, Menoza JL, et al., Preclinical pharmacokinetics, interspecies scaling, and tissue distribution of a humanized monoclonal antibody against vascular endothelial growth factor. J Pharmacol Exp Ther 1999; 288 (1): 371-378.
    • (1999) J Pharmacol Exp Ther , vol.288 , Issue.1 , pp. 371-378
    • Lin, Y.S.1    Nguyen, C.2    Menoza, J.L.3
  • 31
    • 33747104543 scopus 로고    scopus 로고
    • Preclinical pharmacokinetics, pharmacodynamics, and activity of a humanized anti-CD40 antibody (SGN-40) in rodents and non-human primates
    • Kelley SK, Gelzleichter T, Xie D, et al., Preclinical pharmacokinetics, pharmacodynamics, and activity of a humanized anti-CD40 antibody (SGN-40) in rodents and non-human primates. Br J Pharmacol 2006; 148 (8): 1116-1123.
    • (2006) Br J Pharmacol , vol.148 , Issue.8 , pp. 1116-1123
    • Kelley, S.K.1    Gelzleichter, T.2    Xie, D.3
  • 32
    • 39149100941 scopus 로고    scopus 로고
    • Preclinical pharmacokinetics, interspecies scaling, and tissue distribution of humanized monoclonal anti-IL-13 antibodies with different IL-13 neutralization mechanisms
    • Vugmeyster Y, Szklut P, Tchistiakova L, Abraham W, Kasaian M, Xu X,. Preclinical pharmacokinetics, interspecies scaling, and tissue distribution of humanized monoclonal anti-IL-13 antibodies with different IL-13 neutralization mechanisms. Int Immunopharmacol 2008; 8 (3): 477-483.
    • (2008) Int Immunopharmacol , vol.8 , Issue.3 , pp. 477-483
    • Vugmeyster, Y.1    Szklut, P.2    Tchistiakova, L.3    Abraham, W.4    Kasaian, M.5    Xu, X.6
  • 33
    • 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 (12): 1551-1559.
    • (2001) Int Immunol , vol.13 , Issue.12 , pp. 1551-1559
    • Ober, R.J.1    Radu, C.G.2    Ghetie, V.3    Ward, E.S.4
  • 34
    • 33845364560 scopus 로고    scopus 로고
    • Enhanced half-life of genetically engineered human IgG1 antibodies in a humanized FcRn mouse model: Potential application in humorally mediated autoimmune disease
    • Petkova SB, Akilesh S, Sproule TJ, et al., Enhanced half-life of genetically engineered human IgG1 antibodies in a humanized FcRn mouse model: potential application in humorally mediated autoimmune disease. Int Immunol 2006; 18 (12): 1759-1769.
    • (2006) Int Immunol , vol.18 , Issue.12 , pp. 1759-1769
    • Petkova, S.B.1    Akilesh, S.2    Sproule, T.J.3
  • 36
    • 33747631571 scopus 로고    scopus 로고
    • Properties of human IgG1s engineered for enhanced binding to the neonatal Fc receptor (FcRn)
    • Dall'Acqua WF, Kiener PA, Wu H,. Properties of human IgG1s engineered for enhanced binding to the neonatal Fc receptor (FcRn). J Biol Chem 2006; 281 (33): 23514-23524.
    • (2006) J Biol Chem , vol.281 , Issue.33 , pp. 23514-23524
    • Dall'Acqua, W.F.1    Kiener, P.A.2    Wu, H.3
  • 37
    • 0036839457 scopus 로고    scopus 로고
    • Increasing the affinity of a human IgG1 for the neonatal Fc receptor: Biological consequences
    • Dall'Acqua WF, Woods RM, Ward ES, et al., Increasing the affinity of a human IgG1 for the neonatal Fc receptor: biological consequences. J Immunol 2002; 169 (9): 5171-5180.
    • (2002) J Immunol , vol.169 , Issue.9 , pp. 5171-5180
    • Dall'Acqua, W.F.1    Woods, R.M.2    Ward, E.S.3
  • 38
    • 77951156788 scopus 로고    scopus 로고
    • Cross-species binding analyses of mouse and human neonatal Fc receptor show dramatic differences in immunoglobulin G and albumin binding
    • Andersen JT, Daba MB, Berntzen G, Michaelsen TE, Sandlie I,. Cross-species binding analyses of mouse and human neonatal Fc receptor show dramatic differences in immunoglobulin G and albumin binding. J Biol Chem 2010; 285 (7): 4826-4836.
    • (2010) J Biol Chem , vol.285 , Issue.7 , pp. 4826-4836
    • Andersen, J.T.1    Daba, M.B.2    Berntzen, G.3    Michaelsen, T.E.4    Sandlie, I.5
  • 39
    • 67649207267 scopus 로고    scopus 로고
    • Engineering human IgG1 affinity to human neonatal Fc receptor: Impact of affinity improvement on pharmacokinetics in primates
    • Yeung YA, Leabman MK, Marvin JS, et al., Engineering human IgG1 affinity to human neonatal Fc receptor: impact of affinity improvement on pharmacokinetics in primates. J Immunol 2009; 182 (12): 7663-7671.
    • (2009) J Immunol , vol.182 , Issue.12 , pp. 7663-7671
    • Yeung, Y.A.1    Leabman, M.K.2    Marvin, J.S.3
  • 40
    • 84891627700 scopus 로고    scopus 로고
    • Humanized FcRn mouse models for evaluating pharmacokinetics of human IgG antibodies
    • Proetzel G, Roopenian DC,. Humanized FcRn mouse models for evaluating pharmacokinetics of human IgG antibodies. Methods 2014; 65 (1): 148-153.
    • (2014) Methods , vol.65 , Issue.1 , pp. 148-153
    • Proetzel, G.1    Roopenian, D.C.2
  • 42
    • 0029918773 scopus 로고    scopus 로고
    • Interspecies scaling: Predicting pharmacokinetic parameters of antiepileptic drugs in humans from animals with special emphasis on clearance
    • Mahmood I, Balian JD,. Interspecies scaling: predicting pharmacokinetic parameters of antiepileptic drugs in humans from animals with special emphasis on clearance. J Pharm Sci 1996; 85 (4): 411-414.
    • (1996) J Pharm Sci , vol.85 , Issue.4 , pp. 411-414
    • Mahmood, I.1    Balian, J.D.2
  • 43
    • 0027275566 scopus 로고
    • Physiological parameters in laboratory animals and humans
    • Davies B, Morris T,. Physiological parameters in laboratory animals and humans. Pharm Res 1993; 10 (7): 1093-1095.
    • (1993) Pharm Res , vol.10 , Issue.7 , pp. 1093-1095
    • Davies, B.1    Morris, T.2
  • 44
    • 23944496599 scopus 로고    scopus 로고
    • A mathematical description of the functionality of correction factors used in allometry for predicting human drug clearance
    • Tang H, Mayersohn M,. A mathematical description of the functionality of correction factors used in allometry for predicting human drug clearance. Drug Metab Dispos 2005; 33 (9): 1294-1296.
    • (2005) Drug Metab Dispos , vol.33 , Issue.9 , pp. 1294-1296
    • Tang, H.1    Mayersohn, M.2
  • 46
    • 0028268634 scopus 로고
    • Physiologically based pharmacokinetic model for specific and nonspecific monoclonal antibodies and fragments in normal tissues and human tumor xenografts in nude mice
    • Baxter LT, Zhu H, Mackensen DG, Jain RK,. Physiologically based pharmacokinetic model for specific and nonspecific monoclonal antibodies and fragments in normal tissues and human tumor xenografts in nude mice. Cancer Res 1994; 54 (6): 1517-1528.
    • (1994) Cancer Res , vol.54 , Issue.6 , pp. 1517-1528
    • Baxter, L.T.1    Zhu, H.2    MacKensen, D.G.3    Jain, R.K.4
  • 47
    • 0028885668 scopus 로고
    • Biodistribution of monoclonal antibodies: Scale-up from mouse to human using a physiologically based pharmacokinetic model
    • Baxter LT, Zhu H, Mackensne DG, Butler WF, Jain RK,. Biodistribution of monoclonal antibodies: scale-up from mouse to human using a physiologically based pharmacokinetic model. Cancer Res 1995; 55 (20): 4611-4622.
    • (1995) Cancer Res , vol.55 , Issue.20 , pp. 4611-4622
    • Baxter, L.T.1    Zhu, H.2    MacKensne, D.G.3    Butler, W.F.4    Jain, R.K.5
  • 48
    • 38949185331 scopus 로고    scopus 로고
    • A physiologically based pharmacokinetic (PBPK) model to characterize and predict the disposition of monoclonal antibody CC49 and its single chain Fv constructs
    • Davda JP, Jain M, Batra SK, Gwilt PR, Robinson DH,. A physiologically based pharmacokinetic (PBPK) model to characterize and predict the disposition of monoclonal antibody CC49 and its single chain Fv constructs. Int Immunopharmacol 2008; 8 (3): 401-413.
    • (2008) Int Immunopharmacol , vol.8 , Issue.3 , pp. 401-413
    • Davda, J.P.1    Jain, M.2    Batra, S.K.3    Gwilt, P.R.4    Robinson, D.H.5
  • 49
    • 29144457336 scopus 로고    scopus 로고
    • A predictive model of therapeutic monoclonal antibody dynamics and regulation by the neonatal Fc receptor (FcRn)
    • Ferl GZ, Wu AM, DiStefano JJ 3rd.,. A predictive model of therapeutic monoclonal antibody dynamics and regulation by the neonatal Fc receptor (FcRn). Ann Biomed Eng 2005; 33 (11): 1640-1652.
    • (2005) Ann Biomed Eng , vol.33 , Issue.11 , pp. 1640-1652
    • Ferl, G.Z.1    Wu, A.M.2    DiStefano, J.J.3
  • 50
    • 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 (5): 687-709.
    • (2007) J Pharmacokinet Pharmacodyn , vol.34 , Issue.5 , pp. 687-709
    • Garg, A.1    Balthasar, J.P.2
  • 51
    • 77950265888 scopus 로고    scopus 로고
    • Pharmacokinetics of humanized monoclonal anti-tumor necrosis factor-{alpha} antibody and its neonatal Fc receptor variants in mice and cynomolgus monkeys
    • Deng R, Loyet KM, Lien S, et al., Pharmacokinetics of humanized monoclonal anti-tumor necrosis factor-{alpha} antibody and its neonatal Fc receptor variants in mice and cynomolgus monkeys. Drug Metab Dispos 2010; 38 (4): 600-605.
    • (2010) Drug Metab Dispos , vol.38 , Issue.4 , pp. 600-605
    • Deng, R.1    Loyet, K.M.2    Lien, S.3
  • 52
    • 84869147336 scopus 로고    scopus 로고
    • Evaluation of a catenary PBPK model for predicting the in vivo disposition of mAbs engineered for high-affinity binding to FcRn
    • Chen Y, Balthasar JP,. Evaluation of a catenary PBPK model for predicting the in vivo disposition of mAbs engineered for high-affinity binding to FcRn. AAPS J 2012; 14 (4): 850-859.
    • (2012) AAPS J , vol.14 , Issue.4 , pp. 850-859
    • Chen, Y.1    Balthasar, J.P.2
  • 53
    • 33644830115 scopus 로고    scopus 로고
    • Analysis of a family of antibodies with different half-lives in mice fails to find a correlation between affinity for FcRn and serum half-life
    • Gurbaxani B, De la Cruz LL, Chintalacharuvuv K, Morrison SL,. Analysis of a family of antibodies with different half-lives in mice fails to find a correlation between affinity for FcRn and serum half-life. Mol Immunol 2006; 43 (9): 1462-1473.
    • (2006) Mol Immunol , vol.43 , Issue.9 , pp. 1462-1473
    • Gurbaxani, B.1    De La Cruz, L.L.2    Chintalacharuvuv, K.3    Morrison, S.L.4
  • 54
    • 84881107497 scopus 로고    scopus 로고
    • Are endosomal trafficking parameters better targets for improving mAb pharmacokinetics than FcRn binding affinity?
    • Gurbaxani B, Dostalek M, Gardner I,. Are endosomal trafficking parameters better targets for improving mAb pharmacokinetics than FcRn binding affinity? Mol Immunol 2013; 56 (4): 660-674.
    • (2013) Mol Immunol , vol.56 , Issue.4 , pp. 660-674
    • Gurbaxani, B.1    Dostalek, M.2    Gardner, I.3
  • 55
    • 84863275336 scopus 로고    scopus 로고
    • Influence of improved FcRn binding on the subcutaneous bioavailability of monoclonal antibodies in cynomolgus monkeys
    • Datta-Mannan A, Witcher DR, Lu J, Wroblewski VJ,. Influence of improved FcRn binding on the subcutaneous bioavailability of monoclonal antibodies in cynomolgus monkeys. MAbs 2012; 4 (2): 267-273.
    • (2012) MAbs , vol.4 , Issue.2 , pp. 267-273
    • Datta-Mannan, A.1    Witcher, D.R.2    Lu, J.3    Wroblewski, V.J.4
  • 56
    • 84862634533 scopus 로고    scopus 로고
    • Best practice in the use of physiologically based pharmacokinetic modeling and simulation to address clinical pharmacology regulatory questions
    • Zhao P, Rowland M, Huang SM,. Best practice in the use of physiologically based pharmacokinetic modeling and simulation to address clinical pharmacology regulatory questions. Clin Pharmacol Ther 2012; 92 (1): 17-20.
    • (2012) Clin Pharmacol Ther , vol.92 , Issue.1 , pp. 17-20
    • Zhao, P.1    Rowland, M.2    Huang, S.M.3
  • 57
    • 0027998106 scopus 로고
    • Pharmacologic target-mediated drug disposition
    • Levy G,. Pharmacologic target-mediated drug disposition. Clin Pharmacol Ther 1994; 56 (3): 248-252.
    • (1994) Clin Pharmacol Ther , vol.56 , Issue.3 , pp. 248-252
    • Levy, G.1
  • 58
    • 0021237725 scopus 로고
    • Pharmacokinetics of repeated single oral doses of enalapril maleate (MK-421) in normal volunteers
    • Till AE, Gomez HJ, Hichens M, et al., Pharmacokinetics of repeated single oral doses of enalapril maleate (MK-421) in normal volunteers. Biopharm Drug Dispos 1984; 5 (3): 273-280.
    • (1984) Biopharm Drug Dispos , vol.5 , Issue.3 , pp. 273-280
    • Till, A.E.1    Gomez, H.J.2    Hichens, M.3
  • 59
    • 0345167205 scopus 로고    scopus 로고
    • Simultaneous modeling of abciximab plasma concentrations and ex vivo pharmacodynamics in patients undergoing coronary angioplasty
    • Mager DE, Mascelli MA, Kleiman NS, Fitzgerald DJ, Abernethy DR,. Simultaneous modeling of abciximab plasma concentrations and ex vivo pharmacodynamics in patients undergoing coronary angioplasty. J Pharmacol Exp Ther 2003; 307 (3): 969-976.
    • (2003) J Pharmacol Exp Ther , vol.307 , Issue.3 , pp. 969-976
    • Mager, D.E.1    Mascelli, M.A.2    Kleiman, N.S.3    Fitzgerald, D.J.4    Abernethy, D.R.5
  • 60
    • 0036137093 scopus 로고    scopus 로고
    • Pharmacokinetics of murine anti-human CD3 antibodies in man are determined by the disappearance of target antigen
    • Meijer RT, Koopmans RP, ten Berge IJ, Schellekens PT,. Pharmacokinetics of murine anti-human CD3 antibodies in man are determined by the disappearance of target antigen. J Pharmacol Exp Ther 2002; 300 (1): 346-353.
    • (2002) J Pharmacol Exp Ther , vol.300 , Issue.1 , pp. 346-353
    • Meijer, R.T.1    Koopmans, R.P.2    Ten Berge, I.J.3    Schellekens, P.T.4
  • 61
    • 47949113939 scopus 로고    scopus 로고
    • Integrated cellular bone homeostasis model for denosumab pharmacodynamics in multiple myeloma patients
    • Marathe A, Peterson MC, Mager DE,. Integrated cellular bone homeostasis model for denosumab pharmacodynamics in multiple myeloma patients. J Pharmacol Exp Ther 2008; 326 (2): 555-562.
    • (2008) J Pharmacol Exp Ther , vol.326 , Issue.2 , pp. 555-562
    • Marathe, A.1    Peterson, M.C.2    Mager, D.E.3
  • 62
    • 33747876762 scopus 로고    scopus 로고
    • Effect of target dynamics on pharmacokinetics of a novel therapeutic antibody against the epidermal growth factor receptor: Implications for the mechanisms of action
    • Lammerts van Bueren JJ, Bleeker WK, Bogh HO, et al., Effect of target dynamics on pharmacokinetics of a novel therapeutic antibody against the epidermal growth factor receptor: implications for the mechanisms of action. Cancer Res 2006; 66 (15): 7630-7638.
    • (2006) Cancer Res , vol.66 , Issue.15 , pp. 7630-7638
    • Lammerts Van Bueren, J.J.1    Bleeker, W.K.2    Bogh, H.O.3
  • 63
    • 84889798743 scopus 로고    scopus 로고
    • Lessons for the clinic from rituximab pharmacokinetics and pharmacodynamics
    • Golay J, Semenzato G, Rambaldi A, et al., Lessons for the clinic from rituximab pharmacokinetics and pharmacodynamics. MAbs 2013; 5 (6): 826-837.
    • (2013) MAbs , vol.5 , Issue.6 , pp. 826-837
    • Golay, J.1    Semenzato, G.2    Rambaldi, A.3
  • 64
    • 0035730322 scopus 로고    scopus 로고
    • General pharmacokinetic model for drugs exhibiting target-mediated drug disposition
    • Mager DE, Jusko WJ,. General pharmacokinetic model for drugs exhibiting target-mediated drug disposition. J Pharmacokinet Pharmacodyn 2001; 28 (6): 507-532.
    • (2001) J Pharmacokinet Pharmacodyn , vol.28 , Issue.6 , pp. 507-532
    • Mager, D.E.1    Jusko, W.J.2
  • 65
    • 77949272760 scopus 로고    scopus 로고
    • Selection between Michaelis-Menten and target-mediated drug disposition pharmacokinetic models
    • Yan X, Mager DE, Krzyzanski W,. Selection between Michaelis-Menten and target-mediated drug disposition pharmacokinetic models. J Pharmacokinet Pharmacodyn 2010; 37 (1): 25-47.
    • (2010) J Pharmacokinet Pharmacodyn , vol.37 , Issue.1 , pp. 25-47
    • Yan, X.1    Mager, D.E.2    Krzyzanski, W.3
  • 66
    • 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 (10): 1589-1596.
    • (2005) Pharm Res , vol.22 , Issue.10 , pp. 1589-1596
    • Mager, D.E.1    Krzyzanski, W.2
  • 67
    • 67650729799 scopus 로고    scopus 로고
    • Target-mediated drug disposition model: Approximations, identifiability of model parameters and applications to the population pharmacokinetic-pharmacodynamic modeling of biologics
    • Gibiansky L, Gibiansky E,. Target-mediated drug disposition model: approximations, identifiability of model parameters and applications to the population pharmacokinetic-pharmacodynamic modeling of biologics. Expert Opin Drug Metab Toxicol 2009; 5 (7): 803-812.
    • (2009) Expert Opin Drug Metab Toxicol , vol.5 , Issue.7 , pp. 803-812
    • Gibiansky, L.1    Gibiansky, E.2
  • 68
    • 57749111624 scopus 로고    scopus 로고
    • Approximations of the target-mediated drug disposition model and identifiability of model parameters
    • Gibiansky L, Gibiansky E, Kakkar T, Ma P,. Approximations of the target-mediated drug disposition model and identifiability of model parameters. J Pharmacokinet Pharmacodyn 2008; 35 (5): 573-591.
    • (2008) J Pharmacokinet Pharmacodyn , vol.35 , Issue.5 , pp. 573-591
    • Gibiansky, L.1    Gibiansky, E.2    Kakkar, T.3    Ma, P.4
  • 69
    • 67649312041 scopus 로고    scopus 로고
    • Scaling pharmacodynamics from in vitro and preclinical animal studies to humans
    • Mager DE, Woo S, Jusko WJ,. Scaling pharmacodynamics from in vitro and preclinical animal studies to humans. Drug Metab Pharmacokinet 2009; 24 (1): 16-24.
    • (2009) Drug Metab Pharmacokinet , vol.24 , Issue.1 , pp. 16-24
    • Mager, D.E.1    Woo, S.2    Jusko, W.J.3
  • 70
    • 0742304308 scopus 로고    scopus 로고
    • Integrated pharmacokinetic-pharmacodynamic modeling and allometric scaling for optimizing the dosage regimen of the monoclonal ior EGF/r3 antibody
    • Duconge J, Castillo R, Crombet T, et al., Integrated pharmacokinetic-pharmacodynamic modeling and allometric scaling for optimizing the dosage regimen of the monoclonal ior EGF/r3 antibody. Eur J Pharm Sci 2004; 21 (2-3): 261-270.
    • (2004) Eur J Pharm Sci , vol.21 , Issue.23 , pp. 261-270
    • Duconge, J.1    Castillo, R.2    Crombet, T.3
  • 71
    • 77953287466 scopus 로고    scopus 로고
    • Interspecies scaling of receptor-mediated pharmacokinetics and pharmacodynamics of type I interferons
    • Kagan L, Abraham AK, Harrold JM, Mager DE,. Interspecies scaling of receptor-mediated pharmacokinetics and pharmacodynamics of type I interferons. Pharm Res 2010; 27 (5): 920-932.
    • (2010) Pharm Res , vol.27 , Issue.5 , pp. 920-932
    • Kagan, L.1    Abraham, A.K.2    Harrold, J.M.3    Mager, D.E.4
  • 72
    • 84863073460 scopus 로고    scopus 로고
    • Subcutaneous bioavailability of therapeutic antibodies as a function of FcRn binding affinity in mice
    • Deng R, Meng YG, Hoyte K, et al., Subcutaneous bioavailability of therapeutic antibodies as a function of FcRn binding affinity in mice. MAbs 2012; 4 (1): 101-109.
    • (2012) MAbs , vol.4 , Issue.1 , pp. 101-109
    • Deng, R.1    Meng, Y.G.2    Hoyte, K.3
  • 73
    • 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 (5): 548-558.
    • (2008) Clin Pharmacol Ther , vol.84 , Issue.5 , pp. 548-558
    • Wang, W.1    Wang, E.Q.2    Balthasar, J.P.3
  • 74
    • 84858229014 scopus 로고    scopus 로고
    • Subcutaneous absorption of monoclonal antibodies: Role of dose, site of injection, and injection volume on rituximab pharmacokinetics in rats
    • Kagan L, Turner MR, Balu-Iyer SV, Mager DE,. Subcutaneous absorption of monoclonal antibodies: role of dose, site of injection, and injection volume on rituximab pharmacokinetics in rats. Pharm Res 2012; 29 (2): 490-499.
    • (2012) Pharm Res , vol.29 , Issue.2 , pp. 490-499
    • Kagan, L.1    Turner, M.R.2    Balu-Iyer, S.V.3    Mager, D.E.4
  • 75
    • 84863230445 scopus 로고    scopus 로고
    • Minipig as a potential translatable model for monoclonal antibody pharmacokinetics after intravenous and subcutaneous administration
    • Zheng Y, Tesar DB, Benincosa L, et al., Minipig as a potential translatable model for monoclonal antibody pharmacokinetics after intravenous and subcutaneous administration. MAbs 2012; 4 (2): 243-255.
    • (2012) MAbs , vol.4 , Issue.2 , pp. 243-255
    • Zheng, Y.1    Tesar, D.B.2    Benincosa, L.3
  • 76
    • 84884911158 scopus 로고    scopus 로고
    • Modeling approach to investigate the effect of neonatal Fc receptor binding affinity and anti-therapeutic antibody on the pharmacokinetic of humanized monoclonal anti-tumor necrosis factor-alpha IgG antibody in cynomolgus monkey
    • Ng CM, Loyet KM, Iyer S, Fielder PJ, Deng R,. Modeling approach to investigate the effect of neonatal Fc receptor binding affinity and anti-therapeutic antibody on the pharmacokinetic of humanized monoclonal anti-tumor necrosis factor-alpha IgG antibody in cynomolgus monkey. Eur J Pharm Sci 2014; 51: 51-58.
    • (2014) Eur J Pharm Sci , vol.51 , pp. 51-58
    • Ng, C.M.1    Loyet, K.M.2    Iyer, S.3    Fielder, P.J.4    Deng, R.5
  • 77
    • 84898623954 scopus 로고    scopus 로고
    • A comprehensive review of the pharmacokinetics of approved therapeutic monoclonal antibodies in Japan: Are Japanese phase I studies still needed?
    • Chiba K, Yoshitsuga H, Kyosaka Y, et al., A comprehensive review of the pharmacokinetics of approved therapeutic monoclonal antibodies in Japan: Are Japanese phase I studies still needed? J Clin Pharmacol 2014; 54 (5): 483-494.
    • (2014) J Clin Pharmacol , vol.54 , Issue.5 , pp. 483-494
    • Chiba, K.1    Yoshitsuga, H.2    Kyosaka, Y.3
  • 78
    • 85015349331 scopus 로고    scopus 로고
    • Prediction of the pharmacokinetics, pharmacodynamics, and efficacy of a monoclonal antibody, using a physiologically based pharmacokinetic FcRn model
    • Chetty M, Li L, Rose R, et al., Prediction of the pharmacokinetics, pharmacodynamics, and efficacy of a monoclonal antibody, using a physiologically based pharmacokinetic FcRn model. Front Immunol 2014; 5: 670.
    • (2014) Front Immunol , vol.5 , pp. 670
    • Chetty, M.1    Li, L.2    Rose, R.3
  • 79
    • 79960091033 scopus 로고    scopus 로고
    • Highly specific off-target binding identified and eliminated during the humanization of an antibody against FGF receptor 4
    • Bumbaca D, Wong A, Drake E, et al., Highly specific off-target binding identified and eliminated during the humanization of an antibody against FGF receptor 4. MAbs 2011; 3 (4): 376-386.
    • (2011) MAbs , vol.3 , Issue.4 , pp. 376-386
    • Bumbaca, D.1    Wong, A.2    Drake, E.3
  • 80
    • 79959872712 scopus 로고    scopus 로고
    • Complex pharmacokinetics of a humanized antibody against human amyloid beta peptide, anti-abeta Ab2, in nonclinical species
    • Vugmeyster Y, Szklut P, Wensel D, et al., Complex pharmacokinetics of a humanized antibody against human amyloid beta peptide, anti-abeta Ab2, in nonclinical species. Pharm Res 2011; 28 (7): 1696-1706.
    • (2011) Pharm Res , vol.28 , Issue.7 , pp. 1696-1706
    • Vugmeyster, Y.1    Szklut, P.2    Wensel, D.3
  • 81
    • 84866736720 scopus 로고    scopus 로고
    • Anti-neuropilin-1 (MNRP1685A): Unexpected pharmacokinetic differences across species, from preclinical models to humans
    • Xin Y, Bai S, Damico-Beyer LA, et al., Anti-neuropilin-1 (MNRP1685A): unexpected pharmacokinetic differences across species, from preclinical models to humans. Pharm Res 2012; 29 (9): 2512-2521.
    • (2012) Pharm Res , vol.29 , Issue.9 , pp. 2512-2521
    • Xin, Y.1    Bai, S.2    Damico-Beyer, L.A.3


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