메뉴 건너뛰기




Volumn 102, Issue 7, 2013, Pages 2380-2394

Allometry of factor VIII and informed scaling of next-generation therapeutic proteins

Author keywords

Allometry; Clearance; Pharamcokinetics; Protein delivery; Proteins; Simulations

Indexed keywords

BLOOD CLOTTING FACTOR 8;

EID: 84879016740     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23566     Document Type: Article
Times cited : (7)

References (89)
  • 1
    • 0019974098 scopus 로고
    • Interspecies scaling, allometry, physiological time, and the ground plan of pharmacokinetics
    • Boxenbaum H. 1982. Interspecies scaling, allometry, physiological time, and the ground plan of pharmacokinetics. J Pharmacokinet Biopharm 10(2):201-227.
    • (1982) J Pharmacokinet Biopharm , vol.10 , Issue.2 , pp. 201-227
    • Boxenbaum, H.1
  • 2
    • 0032921527 scopus 로고    scopus 로고
    • Prediction of hepatic metabolic clearance based on interspecies allometric scaling techniques and in vitro-in vivo correlations
    • Lave T, Coassolo P, Reigner B. 1999. Prediction of hepatic metabolic clearance based on interspecies allometric scaling techniques and in vitro-in vivo correlations. Clin Pharmacokinet 36(3):211-231.
    • (1999) Clin Pharmacokinet , vol.36 , Issue.3 , pp. 211-231
    • Lave, T.1    Coassolo, P.2    Reigner, B.3
  • 3
    • 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. 1991. Interspecies scaling of clearance and volume of distribution data for five therapeutic proteins. Pharm Res 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
  • 4
    • 0347755132 scopus 로고    scopus 로고
    • Interspecies scaling of protein drugs: Prediction of clearance from animals to humans
    • Mahmood I. 2004. Interspecies scaling of protein drugs: Prediction of clearance from animals to humans. J Pharm Sci 93(1):177-185.
    • (2004) J Pharm Sci , vol.93 , Issue.1 , pp. 177-185
    • Mahmood, I.1
  • 5
    • 77955297665 scopus 로고    scopus 로고
    • Prediction of human clearance of therapeutic proteins: Simple allometric scaling method revisited
    • Wang W, Prueksaritanont T. 2010. Prediction of human clearance of therapeutic proteins: Simple allometric scaling method revisited. Biopharm Drug Dispos 31(4):253-263.
    • (2010) Biopharm Drug Dispos , vol.31 , Issue.4 , pp. 253-263
    • Wang, W.1    Prueksaritanont, T.2
  • 6
    • 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, Gibbs JP, Hsu CP, Stouch BJ, Hurh E, Gibbs MA. 2011. Quantitative prediction of human pharmacokinetics for monoclonal antibodies: Retrospective analysis of monkey as a single species for first-in-human prediction. Clin Pharmcokinet 50(2):131-142.
    • (2011) Clin Pharmcokinet , vol.50 , Issue.2 , pp. 131-142
    • Dong, J.Q.1    Salinger, D.H.2    Endres, C.J.3    Gibbs, J.P.4    Hsu, C.P.5    Stouch, B.J.6    Hurh, E.7    Gibbs, M.A.8
  • 10
    • 20444503381 scopus 로고    scopus 로고
    • Factor VIII efficient and specific non-covalent binding to PEGylated liposomes enables prolongation of its circulation time and haemostatic efficacy
    • Baru M, Carmel-Goren L, Barenholz Y, Dayan I, Ostropolets S, Slepoy I, Gvirtzer N, Fukson V, Spira J. 2005. Factor VIII efficient and specific non-covalent binding to PEGylated liposomes enables prolongation of its circulation time and haemostatic efficacy. Thromb Haemost 93(6):1061-1068.
    • (2005) Thromb Haemost , vol.93 , Issue.6 , pp. 1061-1068
    • Baru, M.1    Carmel-Goren, L.2    Barenholz, Y.3    Dayan, I.4    Ostropolets, S.5    Slepoy, I.6    Gvirtzer, N.7    Fukson, V.8    Spira, J.9
  • 11
    • 77955962214 scopus 로고    scopus 로고
    • Phosphatidylinositol containing lipidic particles reduces immunogenicity and catabolism of factor VIII in hemophilia a mice
    • Peng A, Straubinger RM, Balu-Iyer SV. 2010. Phosphatidylinositol containing lipidic particles reduces immunogenicity and catabolism of factor VIII in hemophilia a mice. AAPS J 12(3):473-481.
    • (2010) AAPS J , vol.12 , Issue.3 , pp. 473-481
    • Peng, A.1    Straubinger, R.M.2    Balu-Iyer, S.V.3
  • 12
    • 59849090731 scopus 로고    scopus 로고
    • Combining mutations of charged residues at the A2 domain interface enhances factor VIII stability over single point mutations
    • Wakabayashi H, Griffiths AE, Fay PJ. 2009. Combining mutations of charged residues at the A2 domain interface enhances factor VIII stability over single point mutations. J Thromb Haemost 7(3):438-444.
    • (2009) J Thromb Haemost , vol.7 , Issue.3 , pp. 438-444
    • Wakabayashi, H.1    Griffiths, A.E.2    Fay, P.J.3
  • 13
    • 0030664471 scopus 로고    scopus 로고
    • Characterization of a genetically engineered inactivation-resistant coagulation factor VIIIa
    • Pipe SW, Kaufman RJ. 1997. Characterization of a genetically engineered inactivation-resistant coagulation factor VIIIa. Proc Natl Acad Sci USA 94(22):11851-11856.
    • (1997) Proc Natl Acad Sci USA , vol.94 , Issue.22 , pp. 11851-11856
    • Pipe, S.W.1    Kaufman, R.J.2
  • 17
    • 69949089085 scopus 로고    scopus 로고
    • Pharmacokinetic allometric scaling of coagulation factors and tissue-type plasminogen activators
    • Mahmood I. 2009. Pharmacokinetic allometric scaling of coagulation factors and tissue-type plasminogen activators. Haemophilia 15(5):1109-1117.
    • (2009) Haemophilia , vol.15 , Issue.5 , pp. 1109-1117
    • Mahmood, I.1
  • 18
    • 3042648079 scopus 로고    scopus 로고
    • Prediction of human pharmacokinetic profile in animal scale up based on normalizing time course profiles
    • Wajima T, Yano Y, Fukumura K, Oguma T. 2004. Prediction of human pharmacokinetic profile in animal scale up based on normalizing time course profiles. J Pharm Sci 93(7):1890-1900.
    • (2004) J Pharm Sci , vol.93 , Issue.7 , pp. 1890-1900
    • Wajima, T.1    Yano, Y.2    Fukumura, K.3    Oguma, T.4
  • 19
    • 0023028352 scopus 로고
    • NONLIN84/PCNONLIN: Software for the statistical analysis of nonlinear models
    • Weiner DL. 1986. NONLIN84/PCNONLIN: Software for the statistical analysis of nonlinear models. Methods Find Exp Clin Pharmacol 8(10):625-628.
    • (1986) Methods Find Exp Clin Pharmacol , vol.8 , Issue.10 , pp. 625-628
    • Weiner, D.L.1
  • 22
    • 70349229281 scopus 로고    scopus 로고
    • Pharmacokinetics and dose requirements of factor VIII over the age range 3-74 years: A population analysis based on 50 patients with long-term prophylactic treatment for haemophilia A
    • Bjorkman S, Folkesson A, Jonsson S. 2009. Pharmacokinetics and dose requirements of factor VIII over the age range 3-74 years: A population analysis based on 50 patients with long-term prophylactic treatment for haemophilia A. Eur J Clin Pharmacol 65(10):989-998.
    • (2009) Eur J Clin Pharmacol , vol.65 , Issue.10 , pp. 989-998
    • Bjorkman, S.1    Folkesson, A.2    Jonsson, S.3
  • 26
  • 27
    • 0024412249 scopus 로고
    • The pharmacology of a new pasteurized antihemophilic factor concentrate derived from human blood plasma
    • Rousell RH, Kasper CK, Schwartz RS. 1989. The pharmacology of a new pasteurized antihemophilic factor concentrate derived from human blood plasma. Transfusion 29(3):208-212.
    • (1989) Transfusion , vol.29 , Issue.3 , pp. 208-212
    • Rousell, R.H.1    Kasper, C.K.2    Schwartz, R.S.3
  • 29
    • 0025164545 scopus 로고
    • Initial clinical experience with a new pasteurized monoclonal antibody purified factor VIIIC
    • Smith KJ, Lusher JM, Cohen AR, Salzman P. 1990. Initial clinical experience with a new pasteurized monoclonal antibody purified factor VIIIC. Semin Hematol 27(2 Suppl 2):25-29.
    • (1990) Semin Hematol , vol.27 , Issue.2 SUPPL 2 , pp. 25-29
    • Smith, K.J.1    Lusher, J.M.2    Cohen, A.R.3    Salzman, P.4
  • 30
    • 0025755874 scopus 로고
    • The pharmacokinetics of recombinant factor VIII. The rFactor VIII Clinical Trial Group
    • discussion 36.
    • Harrison JF, Bloom AL, Abildgaard CF. 1991. The pharmacokinetics of recombinant factor VIII. The rFactor VIII Clinical Trial Group. Semin Hematol 28(2 Suppl 1 ):29-35; discussion 36.
    • (1991) Semin Hematol , vol.28 , Issue.2 SUPPL 1 , pp. 29-35
    • Harrison, J.F.1    Bloom, A.L.2    Abildgaard, C.F.3
  • 32
    • 0025822381 scopus 로고
    • Comparative evaluation of the pharmacokinetics of three monoclonal factor VIII concentrates
    • Morfini M, Mannucci PM, Longo G, Cinotti S, Messori A. 1991. Comparative evaluation of the pharmacokinetics of three monoclonal factor VIII concentrates. Thromb Res 61(3):285-290.
    • (1991) Thromb Res , vol.61 , Issue.3 , pp. 285-290
    • Morfini, M.1    Mannucci, P.M.2    Longo, G.3    Cinotti, S.4    Messori, A.5
  • 33
    • 0026609355 scopus 로고
    • Pharmacokinetics of factor VIII in humans. Obtaining clinically relevant data from comparative studies
    • Bjorkman S, Carlsson M, Berntorp E, Stenberg P. 1992. Pharmacokinetics of factor VIII in humans. Obtaining clinically relevant data from comparative studies. Clin Pharmacokinet 22(5):385-395.
    • (1992) Clin Pharmacokinet , vol.22 , Issue.5 , pp. 385-395
    • Bjorkman, S.1    Carlsson, M.2    Berntorp, E.3    Stenberg, P.4
  • 35
    • 0026706388 scopus 로고
    • Pharmacokinetic properties of recombinant factor VIII compared with a monoclonally purified concentrate (Hemofil M). The Recombinate Study Group
    • Morfini M, Longo G, Messori A, Lee M, White G, Mannucci P. 1992. Pharmacokinetic properties of recombinant factor VIII compared with a monoclonally purified concentrate (Hemofil M). The Recombinate Study Group. Thromb Haemost 68(4):433-435.
    • (1992) Thromb Haemost , vol.68 , Issue.4 , pp. 433-435
    • Morfini, M.1    Longo, G.2    Messori, A.3    Lee, M.4    White, G.5    Mannucci, P.6
  • 36
    • 0028125930 scopus 로고
    • Development and small-scale production of a severely heated factor VIII concentrate
    • Knevelman A, de Wit HJ, Potstra P, vd Does JA. 1994. Development and small-scale production of a severely heated factor VIII concentrate. Vox Sanguinis 66(2):89-95.
    • (1994) Vox Sanguinis , vol.66 , Issue.2 , pp. 89-95
    • Knevelman, A.1    de Wit, H.J.2    Potstra, P.3    Vd Does, J.A.4
  • 37
    • 0029443612 scopus 로고
    • A pharmacokinetic study of an ion-exchange solvent-detergent-treated high-purity factor VIII concentrate. Haemophilia Directors for Scotland and Northern Ireland
    • Ludlam CA, Lowe GD, Mayne EE. 1995. A pharmacokinetic study of an ion-exchange solvent-detergent-treated high-purity factor VIII concentrate. Haemophilia Directors for Scotland and Northern Ireland. Transfus Med 5(4):289-292.
    • (1995) Transfus Med , vol.5 , Issue.4 , pp. 289-292
    • Ludlam, C.A.1    Lowe, G.D.2    Mayne, E.E.3
  • 39
    • 0030855794 scopus 로고    scopus 로고
    • Second generation, B-domain deleted recombinant factor VIII
    • Berntorp E. 1997. Second generation, B-domain deleted recombinant factor VIII. Thromb Haemost 78(1):256-260.
    • (1997) Thromb Haemost , vol.78 , Issue.1 , pp. 256-260
    • Berntorp, E.1
  • 40
    • 0030940593 scopus 로고    scopus 로고
    • Improved cost-effectiveness by pharmacokinetic dosing of factor VIII in prophylactic treatment of haemophilia A
    • Carlsson M, Berntorp E, Björkman S, Lethagen S, Ljung R. 1997. Improved cost-effectiveness by pharmacokinetic dosing of factor VIII in prophylactic treatment of haemophilia A. Haemophilia 3(2):96-101.
    • (1997) Haemophilia , vol.3 , Issue.2 , pp. 96-101
    • Carlsson, M.1    Berntorp, E.2    Björkman, S.3    Lethagen, S.4    Ljung, R.5
  • 42
    • 0030972289 scopus 로고    scopus 로고
    • Comparative study of four different pharmacokinetic computer programs: Case study of a factor VIII preparation
    • Pascual B, Montoro JB. 1997. Comparative study of four different pharmacokinetic computer programs: Case study of a factor VIII preparation. Eur J Clin Pharmacol 52(1):59-64.
    • (1997) Eur J Clin Pharmacol , vol.52 , Issue.1 , pp. 59-64
    • Pascual, B.1    Montoro, J.B.2
  • 43
    • 0032908392 scopus 로고    scopus 로고
    • Intranasal DDAVP induced increases in plasma von Willebrand factor alter the pharmacokinetics of high-purity factor VIII concentrates in severe haemophilia A patients
    • Deitcher SR, Tuller J, Johnson JA. 1999. Intranasal DDAVP induced increases in plasma von Willebrand factor alter the pharmacokinetics of high-purity factor VIII concentrates in severe haemophilia A patients. Haemophilia 5(2):88-95.
    • (1999) Haemophilia , vol.5 , Issue.2 , pp. 88-95
    • Deitcher, S.R.1    Tuller, J.2    Johnson, J.A.3
  • 45
    • 0032878362 scopus 로고    scopus 로고
    • Pharmacokinetics and acute tolerance of a double virus inactivated plasma derived factor VIII concentrate
    • Saez A, Bosh N, Boadas N, Arguello A, Horvat D, Dinapoli G, Lisciani R. 1999. Pharmacokinetics and acute tolerance of a double virus inactivated plasma derived factor VIII concentrate. Haemophilia 5(4):260-265.
    • (1999) Haemophilia , vol.5 , Issue.4 , pp. 260-265
    • Saez, A.1    Bosh, N.2    Boadas, N.3    Arguello, A.4    Horvat, D.5    Dinapoli, G.6    Lisciani, R.7
  • 46
    • 0034045817 scopus 로고    scopus 로고
    • Sucrose formulated recombinant human antihemophilic factor VIII is safe and efficacious for treatment of hemophilia A in home therapy-International Kogenate-FS Study Group
    • Abshire TC, Brackmann HH, Scharrer I, Hoots K, Gazengel C, Powell JS, Gorina E, Kellermann E, Vosburgh E. 2000. Sucrose formulated recombinant human antihemophilic factor VIII is safe and efficacious for treatment of hemophilia A in home therapy-International Kogenate-FS Study Group. Thromb Haemost 83(6):811-816.
    • (2000) Thromb Haemost , vol.83 , Issue.6 , pp. 811-816
    • Abshire, T.C.1    Brackmann, H.H.2    Scharrer, I.3    Hoots, K.4    Gazengel, C.5    Powell, J.S.6    Gorina, E.7    Kellermann, E.8    Vosburgh, E.9
  • 47
    • 0034024658 scopus 로고    scopus 로고
    • Safety and efficacy of solvent/detergent-treated antihaemophilic factor with an added 80 degrees C terminal dry heat treatment in patients with haemophilia A
    • Powell JS, Bush M, Harrison J, Abildgaard C, Vosburgh E, Thompson AR, Hurst D. 2000. Safety and efficacy of solvent/detergent-treated antihaemophilic factor with an added 80 degrees C terminal dry heat treatment in patients with haemophilia A. Haemophilia 6(3):140-149.
    • (2000) Haemophilia , vol.6 , Issue.3 , pp. 140-149
    • Powell, J.S.1    Bush, M.2    Harrison, J.3    Abildgaard, C.4    Vosburgh, E.5    Thompson, A.R.6    Hurst, D.7
  • 48
    • 0034220228 scopus 로고    scopus 로고
    • Pharmacokinetics, prophylactic effects, and safety of a new recombinant FVIII formulated with sucrose (BAY 14-2222) in Japanese patients with hemophilia A
    • Shirahata A, Fukutake K, Takamatsu J, Shima M, Yoshioka A. 2000. Pharmacokinetics, prophylactic effects, and safety of a new recombinant FVIII formulated with sucrose (BAY 14-2222) in Japanese patients with hemophilia A. Int J Hematol 72(1):101-107.
    • (2000) Int J Hematol , vol.72 , Issue.1 , pp. 101-107
    • Shirahata, A.1    Fukutake, K.2    Takamatsu, J.3    Shima, M.4    Yoshioka, A.5
  • 49
    • 0034964673 scopus 로고    scopus 로고
    • Clinical evaluation of B-domain deleted recombinant factor VIII in previously treated patients
    • Courter SG, Bedrosian CL. 2001. Clinical evaluation of B-domain deleted recombinant factor VIII in previously treated patients. Semin Hematol 38(2 Suppl 4 ):44-51.
    • (2001) Semin Hematol , vol.38 , Issue.2 SUPPL 4 , pp. 44-51
    • Courter, S.G.1    Bedrosian, C.L.2
  • 51
    • 0036257628 scopus 로고    scopus 로고
    • European data of a clinical trial with a sucrose formulated recombinant factor VIII in previously treated haemophilia A patients
    • Rothschild C, Scharrer I, Brackmann HH, Stieltjes N, Vicariot M, Torchet MF, Effenberger W. 2002. European data of a clinical trial with a sucrose formulated recombinant factor VIII in previously treated haemophilia A patients. Haemophilia 8 Suppl 2:10-14.
    • (2002) Haemophilia , vol.8 , Issue.SUPPL 2 , pp. 10-14
    • Rothschild, C.1    Scharrer, I.2    Brackmann, H.H.3    Stieltjes, N.4    Vicariot, M.5    Torchet, M.F.6    Effenberger, W.7
  • 52
    • 0036565867 scopus 로고    scopus 로고
    • Antithrombotic effects of controlled inhibition of factor VIII with a partially inhibitory human monoclonal antibody in a murine vena cava thrombosis model
    • Singh I, Smith A, Vanzieleghem B, Collen D, Burnand K, Saint-Remy JM, Jacquemin M. 2002. Antithrombotic effects of controlled inhibition of factor VIII with a partially inhibitory human monoclonal antibody in a murine vena cava thrombosis model. Blood 99(9):3235-3240.
    • (2002) Blood , vol.99 , Issue.9 , pp. 3235-3240
    • Singh, I.1    Smith, A.2    Vanzieleghem, B.3    Collen, D.4    Burnand, K.5    Saint-Remy, J.M.6    Jacquemin, M.7
  • 53
    • 0037764676 scopus 로고    scopus 로고
    • Pharmacokinetics of factor VIII and factor IX
    • discussion 100.
    • Morfini M. 2003. Pharmacokinetics of factor VIII and factor IX. Haemophilia 9 Suppl 1:94-99; discussion 100.
    • (2003) Haemophilia , vol.9 , Issue.SUPPL 1 , pp. 94-99
    • Morfini, M.1
  • 54
    • 2542605872 scopus 로고    scopus 로고
    • A multicenter pharmacokinetic study of the B-domain deleted recombinant factor VIII concentrate using different assays and standards
    • Morfini M, Cinotti S, Bellatreccia A, Paladino E, Gringeri A, Mannucci PM, ReFacto ASG. 2003. A multicenter pharmacokinetic study of the B-domain deleted recombinant factor VIII concentrate using different assays and standards. J Thromb Haemost 1(11):2283-2289.
    • (2003) J Thromb Haemost , vol.1 , Issue.11 , pp. 2283-2289
    • Morfini, M.1    Cinotti, S.2    Bellatreccia, A.3    Paladino, E.4    Gringeri, A.5    Mannucci, P.M.6    ReFacto, A.S.G.7
  • 56
    • 4844222953 scopus 로고    scopus 로고
    • Clinical efficacy, safety and pharmacokinetic properties of the factor VIII concentrate Haemoctin SDH in previously treated patients with severe haemophilia A
    • Wolf DM, Rokicka-Milewska R, Lopaciuk S, Skotnicki AB, Klukowska A, Laguna P, Windyga J, Kotitschke R, Struff WG. 2004. Clinical efficacy, safety and pharmacokinetic properties of the factor VIII concentrate Haemoctin SDH in previously treated patients with severe haemophilia A. Haemophilia 10(5):438-448.
    • (2004) Haemophilia , vol.10 , Issue.5 , pp. 438-448
    • Wolf, D.M.1    Rokicka-Milewska, R.2    Lopaciuk, S.3    Skotnicki, A.B.4    Klukowska, A.5    Laguna, P.6    Windyga, J.7    Kotitschke, R.8    Struff, W.G.9
  • 57
    • 16344370554 scopus 로고    scopus 로고
    • B-domain deleted recombinant factor VIII preparations are bioequivalent to a monoclonal antibody purified plasma-derived factor VIII concentrate: A randomized, three-way crossover study
    • Kessler CM, Gill JC, White GC, 2nd, Shapiro A, Arkin S, Roth DA, Meng X, Lusher JM. 2005. B-domain deleted recombinant factor VIII preparations are bioequivalent to a monoclonal antibody purified plasma-derived factor VIII concentrate: A randomized, three-way crossover study. Haemophilia 11(2):84-91.
    • (2005) Haemophilia , vol.11 , Issue.2 , pp. 84-91
    • Kessler, C.M.1    Gill, J.C.2    White 2nd, G.C.3    Shapiro, A.4    Arkin, S.5    Roth, D.A.6    Meng, X.7    Lusher, J.M.8
  • 58
    • 30044450968 scopus 로고    scopus 로고
    • Octocog alfa, plasma/albumin-free method
    • discussion 2621-2612.
    • McCormack PL, Plosker GL. 2005. Octocog alfa, plasma/albumin-free method. Drugs 65(18):2613-2620; discussion 2621-2612.
    • (2005) Drugs , vol.65 , Issue.18 , pp. 2613-2620
    • McCormack, P.L.1    Plosker, G.L.2
  • 59
    • 33847171380 scopus 로고    scopus 로고
    • A limited sampling strategy for estimating individual pharmacokinetic parameters of coagulation factor VIII in patients with hemophilia A
    • Bolon-Larger M, Chamouard V, Bressolle F, Boulieu R. 2007. A limited sampling strategy for estimating individual pharmacokinetic parameters of coagulation factor VIII in patients with hemophilia A. Ther Drug Monit 29(1):20-26.
    • (2007) Ther Drug Monit , vol.29 , Issue.1 , pp. 20-26
    • Bolon-Larger, M.1    Chamouard, V.2    Bressolle, F.3    Boulieu, R.4
  • 61
    • 42949112991 scopus 로고    scopus 로고
    • Pharmacokinetics, efficacy and safety of IMMUNATE solvent/detergent (IMMUNATE S/D) in previously treated patients with severe hemophilia A: Results of a prospective, multicenter, open-label phase III study
    • Nemes L, Lissitchkov T, Dobaczewski G, Klukowska A, Komrska V, Zimmermann R, Auerswald G, Engl W, Abbuhl B, Pavlova BG, Ehrlich HJ. 2008. Pharmacokinetics, efficacy and safety of IMMUNATE solvent/detergent (IMMUNATE S/D) in previously treated patients with severe hemophilia A: Results of a prospective, multicenter, open-label phase III study. Acta Haematol 119(2):89-97.
    • (2008) Acta Haematol , vol.119 , Issue.2 , pp. 89-97
    • Nemes, L.1    Lissitchkov, T.2    Dobaczewski, G.3    Klukowska, A.4    Komrska, V.5    Zimmermann, R.6    Auerswald, G.7    Engl, W.8    Abbuhl, B.9    Pavlova, B.G.10    Ehrlich, H.J.11
  • 62
    • 38349083504 scopus 로고    scopus 로고
    • Safety and pharmacokinetics of a recombinant factor VIII with pegylated liposomes in severe hemophilia A
    • Powell JS, Nugent DJ, Harrison JA, Soni A, Luk A, Stass H, Gorina E. 2008. Safety and pharmacokinetics of a recombinant factor VIII with pegylated liposomes in severe hemophilia A. J Thromb Haemost 6(2):277-283.
    • (2008) J Thromb Haemost , vol.6 , Issue.2 , pp. 277-283
    • Powell, J.S.1    Nugent, D.J.2    Harrison, J.A.3    Soni, A.4    Luk, A.5    Stass, H.6    Gorina, E.7
  • 63
    • 69949106861 scopus 로고    scopus 로고
    • Enhancement of haemostatic efficacy of plasma-derived FVIII by formulation with PEGylated liposomes
    • Dayan I, Robinson M, Baru M. 2009. Enhancement of haemostatic efficacy of plasma-derived FVIII by formulation with PEGylated liposomes. Haemophilia 15(5):1006-1013.
    • (2009) Haemophilia , vol.15 , Issue.5 , pp. 1006-1013
    • Dayan, I.1    Robinson, M.2    Baru, M.3
  • 64
    • 65449189117 scopus 로고    scopus 로고
    • Stability, efficacy, and safety of continuously infused sucrose-formulated recombinant factor VIII (rFVIII-FS) during surgery in patients with severe haemophilia
    • Martinowitz U, Luboshitz J, Bashari D, Ravid B, Gorina E, Regan L, Stass H, Lubetsky A. 2009. Stability, efficacy, and safety of continuously infused sucrose-formulated recombinant factor VIII (rFVIII-FS) during surgery in patients with severe haemophilia. Haemophilia 15(3):676-685.
    • (2009) Haemophilia , vol.15 , Issue.3 , pp. 676-685
    • Martinowitz, U.1    Luboshitz, J.2    Bashari, D.3    Ravid, B.4    Gorina, E.5    Regan, L.6    Stass, H.7    Lubetsky, A.8
  • 66
    • 67649855138 scopus 로고    scopus 로고
    • Clinical evaluation of moroctocog alfa (AF-CC), a new generation of B-domain deleted recombinant factor VIII (BDDrFVIII) for treatment of haemophilia A: Demonstration of safety, efficacy, and pharmacokinetic equivalence to full-length recombinant factor VIII
    • Recht M, Nemes L, Matysiak M, Manco-Johnson M, Lusher J, Smith M, Mannucci P, Hay C, Abshire T, O'Brien A, Hayward B, Udata C, Roth DA, Arkin S. 2009. Clinical evaluation of moroctocog alfa (AF-CC), a new generation of B-domain deleted recombinant factor VIII (BDDrFVIII) for treatment of haemophilia A: Demonstration of safety, efficacy, and pharmacokinetic equivalence to full-length recombinant factor VIII. Haemophilia 15(4):869-880.
    • (2009) Haemophilia , vol.15 , Issue.4 , pp. 869-880
    • Recht, M.1    Nemes, L.2    Matysiak, M.3    Manco-Johnson, M.4    Lusher, J.5    Smith, M.6    Mannucci, P.7    Hay, C.8    Abshire, T.9    O'Brien, A.10    Hayward, B.11    Udata, C.12    Roth, D.A.13    Arkin, S.14
  • 67
    • 65449137867 scopus 로고    scopus 로고
    • Performance of recalibrated ReFacto laboratory standard in the measurement of FVIII plasma concentration via the chromogenic and one-stage assays after infusion of recalibrated ReFacto (B-domain deleted recombinant factor VIII)
    • Santoro C, Iorio A, Ferrante F, Pallotta A, Pignoloni P, Biondo F, Agnelli G, Mazzucconi MG. 2009. Performance of recalibrated ReFacto laboratory standard in the measurement of FVIII plasma concentration via the chromogenic and one-stage assays after infusion of recalibrated ReFacto (B-domain deleted recombinant factor VIII). Haemophilia 15(3):779-787.
    • (2009) Haemophilia , vol.15 , Issue.3 , pp. 779-787
    • Santoro, C.1    Iorio, A.2    Ferrante, F.3    Pallotta, A.4    Pignoloni, P.5    Biondo, F.6    Agnelli, G.7    Mazzucconi, M.G.8
  • 68
    • 65549169628 scopus 로고    scopus 로고
    • Integrated analysis of safety and efficacy of a plasma- and albumin-free recombinant factor VIII (rAHF-PFM) from six clinical studies in patients with hemophilia A
    • Shapiro A, Gruppo R, Pabinger I, Collins PW, Hay CR, Schroth P, Casey K, Patrone L, Ehrlich H, Ewenstein BM. 2009. Integrated analysis of safety and efficacy of a plasma- and albumin-free recombinant factor VIII (rAHF-PFM) from six clinical studies in patients with hemophilia A. Expert Opin Biol Ther 9(3):273-283.
    • (2009) Expert Opin Biol Ther , vol.9 , Issue.3 , pp. 273-283
    • Shapiro, A.1    Gruppo, R.2    Pabinger, I.3    Collins, P.W.4    Hay, C.R.5    Schroth, P.6    Casey, K.7    Patrone, L.8    Ehrlich, H.9    Ewenstein, B.M.10
  • 72
    • 84857936508 scopus 로고    scopus 로고
    • Bioequivalence between two serum-free recombinant factor VIII preparations (N8 and ADVATE(R))-an open-label, sequential dosing pharmacokinetic study in patients with severe haemophilia A
    • Martinowitz U, Bjerre J, Brand B, Klamroth R, Misgav M, Morfini M, Santagostino E, Tiede A, Viuff D. 2011. Bioequivalence between two serum-free recombinant factor VIII preparations (N8 and ADVATE(R))-an open-label, sequential dosing pharmacokinetic study in patients with severe haemophilia A. Haemophilia 17(6):854-859.
    • (2011) Haemophilia , vol.17 , Issue.6 , pp. 854-859
    • Martinowitz, U.1    Bjerre, J.2    Brand, B.3    Klamroth, R.4    Misgav, M.5    Morfini, M.6    Santagostino, E.7    Tiede, A.8    Viuff, D.9
  • 73
    • 84355162247 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamics of a new recombinant FVIII (N8) in haemophilia A mice
    • Elm T, Karpf DM, Ovlisen K, Pelzer H, Ezban M, Kjalke M, Tranholm M. 2012. Pharmacokinetics and pharmacodynamics of a new recombinant FVIII (N8) in haemophilia A mice. Haemophilia 18(1):139-145.
    • (2012) Haemophilia , vol.18 , Issue.1 , pp. 139-145
    • Elm, T.1    Karpf, D.M.2    Ovlisen, K.3    Pelzer, H.4    Ezban, M.5    Kjalke, M.6    Tranholm, M.7
  • 74
    • 84863193826 scopus 로고    scopus 로고
    • Intravascular recovery of VWF and FVIII following intraperitoneal injection and differences from intravenous and subcutaneous injection in mice
    • Shi Q, Kuether EL, Schroeder JA, Fahs SA, Montgomery RR. 2012. Intravascular recovery of VWF and FVIII following intraperitoneal injection and differences from intravenous and subcutaneous injection in mice. Haemophilia 18(4):639-646.
    • (2012) Haemophilia , vol.18 , Issue.4 , pp. 639-646
    • Shi, Q.1    Kuether, E.L.2    Schroeder, J.A.3    Fahs, S.A.4    Montgomery, R.R.5
  • 75
    • 84879029262 scopus 로고    scopus 로고
    • Baxter Healthcare Corporation. Dose-response study of recomb ant factor VIII manufactured prote -free (rAHF-PFM) patients with hemophilia A. Clinicaltrialsgov. Bethesda, Maryland: National Library of Medicine (US) [cited December 7, 2012].
    • Baxter Healthcare Corporation. 2000. Dose-response study of recombinant factor VIII manufactured protein-free (rAHF-PFM) in patients with hemophilia A. Clinicaltrialsgov. Bethesda, Maryland: National Library of Medicine (US) [cited December 7, 2012].
    • (2000)
  • 76
    • 84879014780 scopus 로고    scopus 로고
    • Baxter Healthcare Corporation. Pharmacok etic study of ADVATE reconstituted 2 mL sterile water for jection. Clinicaltrialsgov. Bethesda, Maryland: National Library of Medicine (US) [cited December 7, 2012].
    • Baxter Healthcare Corporation. 2000. Pharmacokinetic study of ADVATE reconstituted in 2 mL sterile water for injection. Clinicaltrialsgov. Bethesda, Maryland: National Library of Medicine (US) [cited December 7, 2012].
    • (2000)
  • 77
    • 2542628723 scopus 로고    scopus 로고
    • The factor VIII assay problem: Neither rhyme nor reason
    • Lollar P. 2003. The factor VIII assay problem: Neither rhyme nor reason. J Thromb Haemost 1(11):2275-2279.
    • (2003) J Thromb Haemost , vol.1 , Issue.11 , pp. 2275-2279
    • Lollar, P.1
  • 78
    • 0023033053 scopus 로고
    • Man versus beast: Pharmacokinetic scaling in mammals
    • Mordenti J. 1986. Man versus beast: Pharmacokinetic scaling in mammals. J Pharm Sci 75(11):1028-1040.
    • (1986) J Pharm Sci , vol.75 , Issue.11 , pp. 1028-1040
    • Mordenti, J.1
  • 79
    • 0018198995 scopus 로고
    • Survival of 125iodine-labeled Factor VIII in normals and patients with classic hemophilia. Observations on the heterogeneity of human Factor VIII
    • Over J, Sixma JJ, Bruine MH, Trieschnigg MC, Vlooswijk RA, Beeser-Visser NH, Bouma BN. 1978. Survival of 125iodine-labeled Factor VIII in normals and patients with classic hemophilia. Observations on the heterogeneity of human Factor VIII. J Clin Invest 62(2):223-234.
    • (1978) J Clin Invest , vol.62 , Issue.2 , pp. 223-234
    • Over, J.1    Sixma, J.J.2    Bruine, M.H.3    Trieschnigg, M.C.4    Vlooswijk, R.A.5    Beeser-Visser, N.H.6    Bouma, B.N.7
  • 80
    • 79951472629 scopus 로고    scopus 로고
    • Implications of coagulation factor VIII and IX pharmacokinetics in the prophylactic treatment of haemophilia
    • Collins PW, Fischer K, Morfini M, Blanchette VS, Bjorkman S. 2011. Implications of coagulation factor VIII and IX pharmacokinetics in the prophylactic treatment of haemophilia. Haemophilia 17(1):2-10.
    • (2011) Haemophilia , vol.17 , Issue.1 , pp. 2-10
    • Collins, P.W.1    Fischer, K.2    Morfini, M.3    Blanchette, V.S.4    Bjorkman, S.5
  • 84
    • 0003720769 scopus 로고
    • Cambridge [Eng.]University press. Cambridge, England. xv
    • Thompson DAW. 1917. On growth and form. Cambridge [Eng.]University press. Cambridge, England. xv, 793 p.
    • (1917) On growth and form , pp. 793
    • Thompson, D.A.W.1
  • 85
    • 33344457255 scopus 로고    scopus 로고
    • A global examination of allometric scaling for predicting human drug clearance and the prediction of large vertical allometry
    • Tang H, Mayersohn M. 2006. A global examination of allometric scaling for predicting human drug clearance and the prediction of large vertical allometry. J Pharm Sci 95(8):1783-1799.
    • (2006) J Pharm Sci , vol.95 , Issue.8 , pp. 1783-1799
    • Tang, H.1    Mayersohn, M.2
  • 87
    • 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. 2011. Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data: What have we learned? mAbs 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
  • 88
    • 0037384789 scopus 로고    scopus 로고
    • Darbepoetin alfa has a longer circulating half-life and greater in vivo potency than recombinant human erythropoietin
    • Egrie JC, Dwyer E, Browne JK, Hitz A, Lykos MA. 2003. Darbepoetin alfa has a longer circulating half-life and greater in vivo potency than recombinant human erythropoietin. Exp Hematol 31(4):290-299.
    • (2003) Exp Hematol , vol.31 , Issue.4 , pp. 290-299
    • Egrie, J.C.1    Dwyer, E.2    Browne, J.K.3    Hitz, A.4    Lykos, M.A.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.