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Volumn 93, Issue 9, 2004, Pages 2184-2204

Pharmacokinetic aspects of biotechnology products

Author keywords

Biotechnology; Disposition; Macromolecule drug delivery; Peptides; Pharmacokinetics; PK PD models; Proteins

Indexed keywords

ABARELIX; ADALIMUMAB; AGALSIDASE BETA; ALEFACEPT; ALEMTUZUMAB; ALTEPLASE; ASPARAGINASE; BASILIXIMAB; CETRORELIX; CYCLOSPORIN A; DACLIZUMAB; DENILEUKIN DIFTITOX; DESMOPRESSIN; DROTRECOGIN; EPTIFIBATIDE; ETANERCEPT; GANIRELIX; GLUCAGON; GOSERELIN; INFLIXIMAB; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; PROTEIN BASED DRUG; RECOMBINANT ALPHA2A INTERFERON; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT FOLLITROPIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; RECOMBINANT INTERLEUKIN 2; SYNTHETIC PEPTIDE; UNCLASSIFIED DRUG; UNINDEXED DRUG;

EID: 4344634877     PISSN: 00223549     EISSN: None     Source Type: Journal    
DOI: 10.1002/jps.20125     Document Type: Short Survey
Times cited : (273)

References (146)
  • 2
    • 0041954285 scopus 로고    scopus 로고
    • Today's alliances for tomorrow's medicines
    • DeLamarter J, Fumero S. 2002. Today's alliances for tomorrow's medicines. Drug Discov World 3, Fall:9-14.
    • (2002) Drug Discov World 3 , vol.FALL , pp. 9-14
    • DeLamarter, J.1    Fumero, S.2
  • 3
    • 0036144662 scopus 로고    scopus 로고
    • Pharmacokinetic pharmacodynamic studies in drug product development
    • Meibohm B, Derendorf H. 2002. Pharmacokinetic/pharmacodynamic studies in drug product development. J Pharm Sci 91:18-31.
    • (2002) J Pharm Sci , vol.91 , pp. 18-31
    • Meibohm, B.1    Derendorf, H.2
  • 4
    • 4344707565 scopus 로고    scopus 로고
    • Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research
    • CDER/FDA. 2003. Exposure response relationships: Guidance for industry. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research.
    • (2003) Exposure Response Relationships: Guidance for Industry
  • 5
    • 0006994027 scopus 로고
    • London: European Agency for the Evaluation of Medicinal Products
    • International Conference on Harmonization. 1994. ICH E4-Dose-response information to support drug registration. London: European Agency for the Evaluation of Medicinal Products.
    • (1994) ICH E4-Dose-Response Information to Support Drug Registration
  • 7
    • 0035043324 scopus 로고    scopus 로고
    • Pharmacokinetics of phosphorothioate antisense oligodeoxynucleotides
    • Geary RS, Yu RZ, Levin AA. 2001. Pharmacokinetics of phosphorothioate antisense oligodeoxynucleotides. Curr Opin Investig Drugs 2:562-573.
    • (2001) Curr Opin Investig Drugs , vol.2 , pp. 562-573
    • Geary, R.S.1    Yu, R.Z.2    Levin, A.A.3
  • 8
    • 0032697942 scopus 로고    scopus 로고
    • A review of the issues in the pharmacokinetics and toxicology of phosphorothioate antisense oligonucleotides
    • Levin AA. 1999. A review of the issues in the pharmacokinetics and toxicology of phosphorothioate antisense oligonucleotides. Biochim Biophys Acta 1489:69-84.
    • (1999) Biochim Biophys Acta , vol.1489 , pp. 69-84
    • Levin, A.A.1
  • 9
    • 0034469255 scopus 로고    scopus 로고
    • Bioanalytical method validation - A revisit with a decade of progress
    • Shah VP, Midha KK, Findlay JW, et al. 2000. Bioanalytical method validation - A revisit with a decade of progress. Pharm Res 17:1551-1557.
    • (2000) Pharm Res , vol.17 , pp. 1551-1557
    • Shah, V.P.1    Midha, K.K.2    Findlay, J.W.3
  • 10
    • 84988175795 scopus 로고
    • Analytical method validation: Bioavailability, bioequivalence, and pharmacokinetic studies
    • Shah V, Midha K, Dighe S, et al. 1992. Analytical method validation: Bioavailability, bioequivalence, and pharmacokinetic studies. J Pharmaceut Sci 81:309-312.
    • (1992) J Pharmaceut Sci , vol.81 , pp. 309-312
    • Shah, V.1    Midha, K.2    Dighe, S.3
  • 11
    • 0005905707 scopus 로고    scopus 로고
    • Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research
    • CDER/FDA. 2001. Bioanalytical method validation: Guidance for industry. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research.
    • (2001) Bioanalytical Method Validation: Guidance for Industry
  • 13
    • 0034840942 scopus 로고    scopus 로고
    • Progress in the use of biological assays during the development of biotechnology products
    • Mire-Sluis AR. 2001. Progress in the use of biological assays during the development of biotechnology products. Pharm Res 18:1239-1246.
    • (2001) Pharm Res , vol.18 , pp. 1239-1246
    • Mire-Sluis, A.R.1
  • 14
    • 0032604318 scopus 로고    scopus 로고
    • Bioassays for the characterisation and control of therapeutic cytokines; determination of potency
    • Thorpe R, Wadhwa M, Page C, Mire-Sluis A. 1999. Bioassays for the characterisation and control of therapeutic cytokines; Determination of potency. Dev Biol Stand 97:61-71.
    • (1999) Dev Biol Stand , vol.97 , pp. 61-71
    • Thorpe, R.1    Wadhwa, M.2    Page, C.3    Mire-Sluis, A.4
  • 15
    • 0034463924 scopus 로고    scopus 로고
    • Definition and measurement of follicle stimulating hormone
    • Rose MP, Gaines Das RE, Balen AH. 2000. Definition and measurement of follicle stimulating hormone. Endocr Rev 21:5-22.
    • (2000) Endocr Rev , vol.21 , pp. 5-22
    • Rose, M.P.1    Gaines Das, R.E.2    Balen, A.H.3
  • 16
    • 0036498813 scopus 로고    scopus 로고
    • Biological assays for interferons
    • Meager A. 2002. Biological assays for interferons. J Immunol Methods 261:21-36.
    • (2002) J Immunol Methods , vol.261 , pp. 21-36
    • Meager, A.1
  • 17
    • 0032610381 scopus 로고    scopus 로고
    • Kinase receptor activation (KIRA): A rapid and accurate alternative to endpoint bioassays
    • Sadick MD. 1999. Kinase receptor activation (KIRA): A rapid and accurate alternative to endpoint bioassays. Dev Biol Stand 97:121-133.
    • (1999) Dev Biol Stand , vol.97 , pp. 121-133
    • Sadick, M.D.1
  • 18
    • 0036633640 scopus 로고    scopus 로고
    • Optical biosensors in drug discovery
    • Cooper MA. 2002. Optical biosensors in drug discovery. Nat Rev Drug Discov 1:515-528.
    • (2002) Nat Rev Drug Discov , vol.1 , pp. 515-528
    • Cooper, M.A.1
  • 19
    • 0031244374 scopus 로고    scopus 로고
    • Biomolecular interaction analysis: Affinity biosensor technologies for functional analysis of proteins
    • Malmqvist M, Karlsson R. 1997. Biomolecular interaction analysis: Affinity biosensor technologies for functional analysis of proteins. Curr Opin Chem Biol 1:378-383.
    • (1997) Curr Opin Chem Biol , vol.1 , pp. 378-383
    • Malmqvist, M.1    Karlsson, R.2
  • 20
    • 0030980940 scopus 로고    scopus 로고
    • Pharmacokinetic studies with recombinant cytokines. Scientific issues and practical considerations
    • Piscitelli SC, Reiss WG, Figg WD, Petros WP. 1997. Pharmacokinetic studies with recombinant cytokines. Scientific issues and practical considerations. Clin Pharmacokinet 32:368-381.
    • (1997) Clin Pharmacokinet , vol.32 , pp. 368-381
    • Piscitelli, S.C.1    Reiss, W.G.2    Figg, W.D.3    Petros, W.P.4
  • 21
    • 0036914779 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamics of tenecteplase in fibrinolytic therapy of acute myocardial infarction
    • Tanswell P, Modi N, Combs D, Danays T. 2002. Pharmacokinetics and pharmacodynamics of tenecteplase in fibrinolytic therapy of acute myocardial infarction. Clin Pharmacokinet 41:1229-1245.
    • (2002) Clin Pharmacokinet , vol.41 , pp. 1229-1245
    • Tanswell, P.1    Modi, N.2    Combs, D.3    Danays, T.4
  • 23
    • 0035433756 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamics of epoetin alfa once weekly and three times weekly
    • Cheung W, Minton N, Gunawardena K. 2001. Pharmacokinetics and pharmacodynamics of epoetin alfa once weekly and three times weekly. Eur J Clin Pharmacol 57:411-418.
    • (2001) Eur J Clin Pharmacol , vol.57 , pp. 411-418
    • Cheung, W.1    Minton, N.2    Gunawardena, K.3
  • 24
    • 0026541509 scopus 로고
    • Pharmacokinetics of peptides and proteins: Opportunities and challenges
    • McMartin C. 1992. Pharmacokinetics of peptides and proteins: Opportunities and challenges. Adv Drug Res 22:39-106.
    • (1992) Adv Drug Res , vol.22 , pp. 39-106
    • McMartin, C.1
  • 25
    • 0030017103 scopus 로고    scopus 로고
    • The relevance of pharmacokinetics in the development of biotechnology products
    • Toon S. 1996. The relevance of pharmacokinetics in the development of biotechnology products. Eur J Drug Metab Pharmacokinet 21:93-103.
    • (1996) Eur J Drug Metab Pharmacokinet , vol.21 , pp. 93-103
    • Toon, S.1
  • 26
    • 0026488120 scopus 로고
    • The role of pharmacokinetics in the development of biotechnologically derived agents
    • Wills RJ, Ferraiolo BL. 1992. The role of pharmacokinetics in the development of biotechnologically derived agents. Clin Pharmacokinet 23:406-414.
    • (1992) Clin Pharmacokinet , vol.23 , pp. 406-414
    • Wills, R.J.1    Ferraiolo, B.L.2
  • 27
    • 0027725134 scopus 로고
    • Preparation and characterization of a recombinant DNA-derived ovine growth hormone variant internally labelled with sulphur-35
    • Wallis M, Gwilliam DJ, Wallis OC. 1993. Preparation and characterization of a recombinant DNA-derived ovine growth hormone variant internally labelled with sulphur-35. J Mol Endocrinol 11:351-359.
    • (1993) J Mol Endocrinol , vol.11 , pp. 351-359
    • Wallis, M.1    Gwilliam, D.J.2    Wallis, O.C.3
  • 29
    • 0029149502 scopus 로고
    • A comparison of mass balance, pharmacokinetics and disposition of [14C(U)]- and [125I]recombinant human interleukin-2 in cynomolgus monkeys
    • Nadeau RW, Satoh H, Scheide S, Growl R, Conroy R, Garland WA, Liberato DJ. 1995. A comparison of mass balance, pharmacokinetics and disposition of [14C(U)]- and [125I]recombinant human interleukin-2 in cynomolgus monkeys. Drug Metab Dispos 23:904-909.
    • (1995) Drug Metab Dispos , vol.23 , pp. 904-909
    • Nadeau, R.W.1    Satoh, H.2    Scheide, S.3    Growl, R.4    Conroy, R.5    Garland, W.A.6    Liberato, D.J.7
  • 30
    • 4344693624 scopus 로고
    • Novel derivatization approaches in the analysis of peptides in biological fluids by high performance liquid chromatography
    • Garzone P, Colburn W, Mokotoff M, editors. Cincinnati, OH: Harvey Whitney Books
    • Rodes G, Boppana V. 1991. Novel derivatization approaches in the analysis of peptides in biological fluids by high performance liquid chromatography. In: Garzone P, Colburn W, Mokotoff M, editors. Petides, peptoids, and proteins. Vol. 3. Cincinnati, OH: Harvey Whitney Books, pp 73-79.
    • (1991) Petides, Peptoids, and Proteins , vol.3 , pp. 73-79
    • Rodes, G.1    Boppana, V.2
  • 31
    • 0029096691 scopus 로고
    • Metabolism of dynorphin A 1-13 in human blood and plasma
    • Muller S, Hochhaus G. 1995. Metabolism of dynorphin A 1-13 in human blood and plasma. Pharm Res 12:1165-1170.
    • (1995) Pharm Res , vol.12 , pp. 1165-1170
    • Muller, S.1    Hochhaus, G.2
  • 32
    • 0345034782 scopus 로고    scopus 로고
    • Assessment of complex peptide degradation pathways via structured multicompartmental modeling approaches: The metabolism of dynorphin A1-13 and related fragments in human plasma
    • Muller S, Hutson A, Arya V, Hochhaus G. 1999. Assessment of complex peptide degradation pathways via structured multicompartmental modeling approaches: the metabolism of dynorphin A1-13 and related fragments in human plasma. J Pharm Sci 88:938-944.
    • (1999) J Pharm Sci , vol.88 , pp. 938-944
    • Muller, S.1    Hutson, A.2    Arya, V.3    Hochhaus, G.4
  • 33
    • 0037093714 scopus 로고    scopus 로고
    • Electrospray LC-MS/MS quantitation, stability, and preliminary pharmacokinetics of bradykinin antagonist polypeptide B201 (NSC 710295) in the mouse
    • Feng WY, Chan KK, Covey JM. 2002. Electrospray LC-MS/MS quantitation, stability, and preliminary pharmacokinetics of bradykinin antagonist polypeptide B201 (NSC 710295) in the mouse. J Pharm Biomed Anal 28:601-612.
    • (2002) J Pharm Biomed Anal , vol.28 , pp. 601-612
    • Feng, W.Y.1    Chan, K.K.2    Covey, J.M.3
  • 34
    • 0022383813 scopus 로고
    • Administered peptides inhibit the degradation of endogenous peptides. The dilemma of distinguishing direct from indirect effects
    • LaBella FS, Geiger JD, Glavin GB. 1985. Administered peptides inhibit the degradation of endogenous peptides. The dilemma of distinguishing direct from indirect effects. Peptides 6:645-660.
    • (1985) Peptides , vol.6 , pp. 645-660
    • LaBella, F.S.1    Geiger, J.D.2    Glavin, G.B.3
  • 36
    • 0026504158 scopus 로고
    • Half-life of exogenous growth hormone following suppression of endogenous growth hormone secretion with somatostatin in type I (insulin-dependent) diabetes mellitus
    • Mullis PE, Pal BR, Matthews DR, Hindmarsh PC, Phillips PE, Dunger DB. 1992. Half-life of exogenous growth hormone following suppression of endogenous growth hormone secretion with somatostatin in type I (insulin-dependent) diabetes mellitus. Clin Endocrinol (Oxf) 36:255-263.
    • (1992) Clin Endocrinol (Oxf) , vol.36 , pp. 255-263
    • Mullis, P.E.1    Pal, B.R.2    Matthews, D.R.3    Hindmarsh, P.C.4    Phillips, P.E.5    Dunger, D.B.6
  • 37
    • 0031791711 scopus 로고    scopus 로고
    • Novel approaches for oral delivery of macromolecules
    • Fasano A. 1998. Novel approaches for oral delivery of macromolecules. J Pharm Sci 87:1351-1356.
    • (1998) J Pharm Sci , vol.87 , pp. 1351-1356
    • Fasano, A.1
  • 40
    • 0031765907 scopus 로고    scopus 로고
    • Role of P-glycoprotein and cytochrome P450 3A in limiting oral absorption of peptides and peptidomimetics
    • Wacher VJ, Silverman JA, Zhang Y, Benet LZ. 1998. Role of P-glycoprotein and cytochrome P450 3A in limiting oral absorption of peptides and peptidomimetics. J Pharm Sci 87:1322-1330.
    • (1998) J Pharm Sci , vol.87 , pp. 1322-1330
    • Wacher, V.J.1    Silverman, J.A.2    Zhang, Y.3    Benet, L.Z.4
  • 41
    • 0022668268 scopus 로고
    • Pharmacokinetics of gonadotropin-releasing hormone and its analogs
    • Handelsman DJ, Swerdloff RS. 1986. Pharmacokinetics of gonadotropin-releasing hormone and its analogs. Endocr Rev 7:95-105.
    • (1986) Endocr Rev , vol.7 , pp. 95-105
    • Handelsman, D.J.1    Swerdloff, R.S.2
  • 42
    • 0032572918 scopus 로고    scopus 로고
    • Subcutaneous compared with intravenous epoetin in patients receiving hemodialysis
    • Department of Veterans Affairs Cooperative Study Group on Erythropoietin in Hemodialysis Patients
    • Kaufman JS, Reda DJ, Fye CL, Goldfarb DS, Henderson WG, Kleinman JG, Vaamonde CA. 1998. Subcutaneous compared with intravenous epoetin in patients receiving hemodialysis. Department of Veterans Affairs Cooperative Study Group on Erythropoietin in Hemodialysis Patients. N Engl J Med 339:578-583.
    • (1998) N Engl J Med , vol.339 , pp. 578-583
    • Kaufman, J.S.1    Reda, D.J.2    Fye, C.L.3    Goldfarb, D.S.4    Henderson, W.G.5    Kleinman, J.G.6    Vaamonde, C.A.7
  • 43
    • 0034020054 scopus 로고    scopus 로고
    • Lymphatic transport of proteins after subcutaneous administration
    • Porter CJ, Charman SA. 2000. Lymphatic transport of proteins after subcutaneous administration. J Pharm Sci 89:297-310.
    • (2000) J Pharm Sci , vol.89 , pp. 297-310
    • Porter, C.J.1    Charman, S.A.2
  • 44
    • 0023804898 scopus 로고
    • Recombinant human interferon alpha-2a: Delivery to lymphoid tissue by selected modes of application
    • Supersaxo A, Hein W, Gallati H, Steffen H. 1988. Recombinant human interferon alpha-2a: Delivery to lymphoid tissue by selected modes of application. Pharm Res 5:472-476.
    • (1988) Pharm Res , vol.5 , pp. 472-476
    • Supersaxo, A.1    Hein, W.2    Gallati, H.3    Steffen, H.4
  • 45
    • 0025287316 scopus 로고
    • Effect of molecular weight on the lymphatic absorption of water-soluble compounds following subcutaneous administration
    • Supersaxo A, Hein WR, Steifen H. 1990. Effect of molecular weight on the lymphatic absorption of water-soluble compounds following subcutaneous administration. Pharm Res 7:167-169.
    • (1990) Pharm Res , vol.7 , pp. 167-169
    • Supersaxo, A.1    Hein, W.R.2    Steifen, H.3
  • 46
    • 0027492969 scopus 로고
    • Renal, metabolic, and hemodynamic side-effects of interleukin-2 and/or interferon alpha: Evidence of a risk/benefit advantage of subcutaneous therapy
    • Schomburg A, Kirchner H, Atzpodien J. 1993. Renal, metabolic, and hemodynamic side-effects of interleukin-2 and/or interferon alpha: Evidence of a risk/benefit advantage of subcutaneous therapy. J Cancer Res Clin Oncol 119:745-755.
    • (1993) J Cancer Res Clin Oncol , vol.119 , pp. 745-755
    • Schomburg, A.1    Kirchner, H.2    Atzpodien, J.3
  • 47
    • 0034826771 scopus 로고    scopus 로고
    • Treating diabetes with aerosolized insulin
    • Laube BL. 2001. Treating diabetes with aerosolized insulin. Chest 120:998-1068.
    • (2001) Chest , vol.120 , pp. 998-1068
    • Laube, B.L.1
  • 50
    • 0035666058 scopus 로고    scopus 로고
    • A two-year randomized, placebo-controlled trial of dornase alfa in young patients with cystic fibrosis with mild lung function abnormalities
    • Quan JM, Tiddens HA, Sy JP, McKenzie SG, Montgomery MD, Robinson PJ, Wohl ME, Konstan MW. 2001. A two-year randomized, placebo-controlled trial of dornase alfa in young patients with cystic fibrosis with mild lung function abnormalities. J Pediatr 139:813-820.
    • (2001) J Pediatr , vol.139 , pp. 813-820
    • Quan, J.M.1    Tiddens, H.A.2    Sy, J.P.3    McKenzie, S.G.4    Montgomery, M.D.5    Robinson, P.J.6    Wohl, M.E.7    Konstan, M.W.8
  • 52
    • 0027793362 scopus 로고
    • Review: Clinical opportunities provided by the nasal administration of peptides
    • Harris AS. 1993. Review: Clinical opportunities provided by the nasal administration of peptides. J Drug Target 1:101-116.
    • (1993) J Drug Target , vol.1 , pp. 101-116
    • Harris, A.S.1
  • 53
    • 0037062327 scopus 로고    scopus 로고
    • Intranasal delivery could be used to administer drugs directly to the brain
    • Lawrence D. 2002. Intranasal delivery could be used to administer drugs directly to the brain. Lancet 359:1674.
    • (2002) Lancet , vol.359 , pp. 1674
    • Lawrence, D.1
  • 54
    • 0000537043 scopus 로고    scopus 로고
    • Intranasal adminstration of insulin-like growth factor-1 (IGF-1): A noninvasive CNS-drug delivery strategy for bypassing the blood-brain barrier
    • Thorne RG, Lagalwar S, Rahman YE, Frey WH II. 1999. Intranasal adminstration of insulin-like growth factor-1 (IGF-1): A noninvasive CNS-drug delivery strategy for bypassing the blood-brain barrier. Growth Horm IGF Res 9:387.
    • (1999) Growth Horm IGF Res , vol.9 , pp. 387
    • Thorne, R.G.1    Lagalwar, S.2    Rahman, Y.E.3    Frey II, W.H.4
  • 55
    • 0035875455 scopus 로고    scopus 로고
    • Intranasal administration of insulin-like growth factor-I bypasses the bloodbrain barrier and protects against focal cerebral ischemic damage
    • Liu XF, Fawcett JR, Thorne RG, DeFor TA, Frey WH 2nd. 2001. Intranasal administration of insulin-like growth factor-I bypasses the bloodbrain barrier and protects against focal cerebral ischemic damage. J Neurol Sci 187:91-97.
    • (2001) J Neurol Sci , vol.187 , pp. 91-97
    • Liu, X.F.1    Fawcett, J.R.2    Thorne, R.G.3    DeFor, T.A.4    Frey II, W.H.5
  • 56
    • 0029125922 scopus 로고
    • Ultrasound-mediated transdermal protein delivery
    • Mitragotri S, Blankschtein D, Langer R. 1995. Ultrasound-mediated transdermal protein delivery. Science 269:850-853.
    • (1995) Science , vol.269 , pp. 850-853
    • Mitragotri, S.1    Blankschtein, D.2    Langer, R.3
  • 57
    • 0036436744 scopus 로고    scopus 로고
    • Iontophoresis-based transdermal delivery systems
    • Kanikkannan N. 2002. Iontophoresis-based transdermal delivery systems. BioDrugs 16:339-347.
    • (2002) BioDrugs , vol.16 , pp. 339-347
    • Kanikkannan, N.1
  • 58
    • 0037423771 scopus 로고    scopus 로고
    • Transdermal iontophoresis of insulin. V. Effect of terpenes
    • Pillai O, Panchagnula R. 2003. Transdermal iontophoresis of insulin. V. Effect of terpenes. J Controlled Release 88:287-296.
    • (2003) J Controlled Release , vol.88 , pp. 287-296
    • Pillai, O.1    Panchagnula, R.2
  • 59
    • 0027104246 scopus 로고
    • Effect of iontophoresis on in vitro skin permeation of an analogue of growth hormone releasing factor in the hairless guinea pig model
    • Kumar S, Char H, Patel S, Piemontese D, Iqbal K, Malick AW, Neugroschel E, Behl CR. 1992. Effect of iontophoresis on in vitro skin permeation of an analogue of growth hormone releasing factor in the hairless guinea pig model. J Pharm Sci 81:635-639.
    • (1992) J Pharm Sci , vol.81 , pp. 635-639
    • Kumar, S.1    Char, H.2    Patel, S.3    Piemontese, D.4    Iqbal, K.5    Malick, A.W.6    Neugroschel, E.7    Behl, C.R.8
  • 62
    • 0038350680 scopus 로고    scopus 로고
    • Oral peptide and protein delivery: Unfulfilled promises?
    • Shen WC. 2003. Oral peptide and protein delivery: unfulfilled promises? Drug Discov Today 8:607-608.
    • (2003) Drug Discov Today , vol.8 , pp. 607-608
    • Shen, W.C.1
  • 63
    • 0036779424 scopus 로고    scopus 로고
    • Protein drug oral delivery: The recent progress
    • Lee HJ. 2002. Protein drug oral delivery: The recent progress. Arch Pharm Res 25:572-584.
    • (2002) Arch Pharm Res , vol.25 , pp. 572-584
    • Lee, H.J.1
  • 65
    • 0033786629 scopus 로고    scopus 로고
    • Oral delivery of glucagon-like peptide-1 in a modified polymer preparation normalizes basal glycaemia in diabetic db/db mice
    • Joseph JW, Kalitsky J, St-Pierre S, Brubaker PL. 2000. Oral delivery of glucagon-like peptide-1 in a modified polymer preparation normalizes basal glycaemia in diabetic db/db mice. Diabetologia 43:1319-1328.
    • (2000) Diabetologia , vol.43 , pp. 1319-1328
    • Joseph, J.W.1    Kalitsky, J.2    St-Pierre, S.3    Brubaker, P.L.4
  • 68
    • 4344560699 scopus 로고
    • Clinical and preclinical studies with recombinant human proteins: Effect of antibody production
    • Garzone P, Colburn W, Mokotoff M, editors. Cincinnati, OH: Harvey Whitney Books
    • Working P, Cossum P. 1991. Clinical and preclinical studies with recombinant human proteins: Effect of antibody production. In: Garzone P, Colburn W, Mokotoff M, editors. Petides, peptoids, and proteins. Vol. 3. Cincinnati, OH: Harvey Whitney Books, pp 158-168.
    • (1991) Petides, Peptoids, and Proteins , vol.3 , pp. 158-168
    • Working, P.1    Cossum, P.2
  • 69
    • 0034744952 scopus 로고    scopus 로고
    • Interferon-beta (INF-beta) antibodies in interferon-betala- and interferon-betalb-treated multiple sclerosis patients. Prevalence, kinetics, cross-reactivity, and factors enhancing interferon-beta immunogenicity in vivo
    • Perini P, Facchinetti A, Bulian P, Massaro AR, Pascalis DD, Bertolotto A, Biasi G, Gallo P. 2001. Interferon-beta (INF-beta) antibodies in interferon-betala- and interferon-betalb-treated multiple sclerosis patients. Prevalence, kinetics, cross-reactivity, and factors enhancing interferon-beta immunogenicity in vivo. Eur Cytokine Netw 12:56-61.
    • (2001) Eur Cytokine Netw , vol.12 , pp. 56-61
    • Perini, P.1    Facchinetti, A.2    Bulian, P.3    Massaro, A.R.4    Pascalis, D.D.5    Bertolotto, A.6    Biasi, G.7    Gallo, P.8
  • 70
    • 17844380498 scopus 로고    scopus 로고
    • Pegylation: A novel process for modifying pharmacokinetics
    • Harris JM, Martin NE, Modi M. 2001. Pegylation: A novel process for modifying pharmacokinetics. Clin Pharmacokinet 40:539-551.
    • (2001) Clin Pharmacokinet , vol.40 , pp. 539-551
    • Harris, J.M.1    Martin, N.E.2    Modi, M.3
  • 71
    • 0043261498 scopus 로고    scopus 로고
    • Pegylation: Engineering improved biopharmaceuticals for oncology
    • Molineux G. 2003. Pegylation: Engineering improved biopharmaceuticals for oncology. Pharmacotherapy 23:3S-8S.
    • (2003) Pharmacotherapy , vol.23
    • Molineux, G.1
  • 72
    • 0037311091 scopus 로고    scopus 로고
    • Improved pharmacokinetics and reduced antibody reactivity of lysostaphin conjugated to polyethylene glycol
    • Walsh S, Shah A, Mond J. 2003. Improved pharmacokinetics and reduced antibody reactivity of lysostaphin conjugated to polyethylene glycol. Antimicrob Agents Chemother 47:554-558.
    • (2003) Antimicrob Agents Chemother , vol.47 , pp. 554-558
    • Walsh, S.1    Shah, A.2    Mond, J.3
  • 73
    • 0042999388 scopus 로고    scopus 로고
    • Pegaspargase: A review of clinical studies
    • Graham ML. 2003. Pegaspargase: A review of clinical studies. Adv Drug Deliv Rev 55:1293-1302.
    • (2003) Adv Drug Deliv Rev , vol.55 , pp. 1293-1302
    • Graham, M.L.1
  • 74
    • 0042259169 scopus 로고    scopus 로고
    • Pharmacokinetics of pegfilgrastim
    • Zamboni WC. 2003. Pharmacokinetics of pegfilgrastim. Pharmacotherapy 23:9S-14S.
    • (2003) Pharmacotherapy , vol.23
    • Zamboni, W.C.1
  • 76
    • 0027472285 scopus 로고
    • Atrial natriuretic peptide. An overview of clinical pharmacology and pharmacokinetics
    • Tan AC, Russel FG, Thien T, Benraad TJ. 1993. Atrial natriuretic peptide. An overview of clinical pharmacology and pharmacokinetics. Clin Pharmacokinet 24:28-45.
    • (1993) Clin Pharmacokinet , vol.24 , pp. 28-45
    • Tan, A.C.1    Russel, F.G.2    Thien, T.3    Benraad, T.J.4
  • 77
    • 2842572177 scopus 로고
    • Peptide, peptoid, and protein pharmacokinetics/pharmacodynamics
    • Garzone P, Colburn W, Mokotoff M, editors. Cincinnati, OH: Harvey Whitney Books
    • Colburn W. 1991. Peptide, peptoid, and protein pharmacokinetics/ pharmacodynamics. In: Garzone P, Colburn W, Mokotoff M, editors. Petides, peptoids, and proteins. Vol. 3. Cincinnati, OH: Harvey Whitney Books, pp 94-115.
    • (1991) Petides, Peptoids, and Proteins , vol.3 , pp. 94-115
    • Colburn, W.1
  • 78
    • 0036073843 scopus 로고    scopus 로고
    • Clinical pharmacokinetics of depot leuprorelin
    • Periti P, Mazzei T, Mini E. 2002. Clinical pharmacokinetics of depot leuprorelin. Clin Pharmacokinet 41:485-504.
    • (2002) Clin Pharmacokinet , vol.41 , pp. 485-504
    • Periti, P.1    Mazzei, T.2    Mini, E.3
  • 81
    • 4344568345 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamics of peptide and protein drugs
    • Crommelin D, Sindelar R, editors. Amsterdam: Harwood Academic Publishers
    • Braeckman R. 1997. Pharmacokinetics and pharmacodynamics of peptide and protein drugs. In: Crommelin D, Sindelar R, editors. Pharmaceutical biotechnology. Amsterdam: Harwood Academic Publishers, pp 101-122.
    • (1997) Pharmaceutical Biotechnology , pp. 101-122
    • Braeckman, R.1
  • 83
    • 0027493822 scopus 로고
    • Clinical pharmacokinetics of octreotide. Therapeutic applications in patients with pituitary tumours
    • Chanson P, Timsit J, Harris AG. 1993. Clinical pharmacokinetics of octreotide. Therapeutic applications in patients with pituitary tumours. Clin Pharmacokinet 25:375-391.
    • (1993) Clin Pharmacokinet , vol.25 , pp. 375-391
    • Chanson, P.1    Timsit, J.2    Harris, A.G.3
  • 84
    • 0021745698 scopus 로고
    • Mean residence time in peripheral tissue: A linear disposition parameter useful for evaluating a drug's tissue distribution
    • Veng-Pedersen P, Gillespie W. 1984. Mean residence time in peripheral tissue: A linear disposition parameter useful for evaluating a drug's tissue distribution. J Pharmacokinet Biopharm 12:535-543.
    • (1984) J Pharmacokinet Biopharm , vol.12 , pp. 535-543
    • Veng-Pedersen, P.1    Gillespie, W.2
  • 85
    • 0019945174 scopus 로고
    • Model-independent steady-state volume of distribution
    • Straughn AB. 1982. Model-independent steady-state volume of distribution. J Pharm Sci 71:597-598.
    • (1982) J Pharm Sci , vol.71 , pp. 597-598
    • Straughn, A.B.1
  • 86
    • 0019974468 scopus 로고
    • Noncompartmental determination of the steady-state volume of distribution for any mode of administration
    • Perrier D, Mayersohn M. 1982. Noncompartmental determination of the steady-state volume of distribution for any mode of administration. J Pharm Sci 71:372-373.
    • (1982) J Pharm Sci , vol.71 , pp. 372-373
    • Perrier, D.1    Mayersohn, M.2
  • 89
    • 0036570288 scopus 로고    scopus 로고
    • The role of the transferrin-transferrin-receptor system in drug delivery and targeting
    • Li H, Sun H, Qian ZM. 2002. The role of the transferrin-transferrin- receptor system in drug delivery and targeting. Trends Pharmacol Sci 23:206-209.
    • (2002) Trends Pharmacol Sci , vol.23 , pp. 206-209
    • Li, H.1    Sun, H.2    Qian, Z.M.3
  • 90
    • 0036245040 scopus 로고    scopus 로고
    • Pharmacokinetics and brain uptake of biotinylated basic fibroblast growth factor conjugated to a blood-brain barrier drug delivery system
    • Wu D, Song BW, Vinters HV, Pardridge WM. 2002. Pharmacokinetics and brain uptake of biotinylated basic fibroblast growth factor conjugated to a blood-brain barrier drug delivery system. J Drug Target 10:239-245.
    • (2002) J Drug Target , vol.10 , pp. 239-245
    • Wu, D.1    Song, B.W.2    Vinters, H.V.3    Pardridge, W.M.4
  • 91
    • 0028279458 scopus 로고
    • Transport of human recombinant brain-derived neurotrophic factor (BDNF) through the rat blood-brain barrier in vivo using vector-mediated peptide drug delivery
    • Pardridge WM, Kang YS, Buciak JL. 1994. Transport of human recombinant brain-derived neurotrophic factor (BDNF) through the rat blood-brain barrier in vivo using vector-mediated peptide drug delivery. Pharm Res 11:738-746.
    • (1994) Pharm Res , vol.11 , pp. 738-746
    • Pardridge, W.M.1    Kang, Y.S.2    Buciak, J.L.3
  • 92
    • 0032905244 scopus 로고    scopus 로고
    • Safety and pharmacokinetics of an intramuscular monoclonal antibody (SB 209763) against respiratory syncytial virus (RSV) in infants and young children at risk for severe RSV disease
    • Meissner HC, Groothuis JR, Rodriguez WJ, et al. 1999. Safety and pharmacokinetics of an intramuscular monoclonal antibody (SB 209763) against respiratory syncytial virus (RSV) in infants and young children at risk for severe RSV disease. Antimicrob Agents Chemother 43:1183-1188.
    • (1999) Antimicrob Agents Chemother , vol.43 , pp. 1183-1188
    • Meissner, H.C.1    Groothuis, J.R.2    Rodriguez, W.J.3
  • 93
    • 0026578042 scopus 로고
    • Presence of endo-oligopeptidase (EC 3.4.22.19), a putative neuropeptide-metabolizing endopeptidase in cells of the immune system
    • Paik SH, Betti F, Camargo AC, de Oliveira ES. 1992. Presence of endo-oligopeptidase (EC 3.4.22.19), a putative neuropeptide-metabolizing endopeptidase in cells of the immune system. J Neuroimmunol 38:35-44.
    • (1992) J Neuroimmunol , vol.38 , pp. 35-44
    • Paik, S.H.1    Betti, F.2    Camargo, A.C.3    De Oliveira, E.S.4
  • 94
    • 0018692485 scopus 로고
    • Renal filtration, transport, and metabolism of low-molecular-weight proteins: A review
    • Maack T, Johnson V, Kau ST, Figueiredo J, Sigulem D. 1979. Renal filtration, transport, and metabolism of low-molecular-weight proteins: A review. Kidney Int 16:251-270.
    • (1979) Kidney Int , vol.16 , pp. 251-270
    • Maack, T.1    Johnson, V.2    Kau, S.T.3    Figueiredo, J.4    Sigulem, D.5
  • 95
    • 0028332155 scopus 로고
    • Effects of route and formulation on clinical pharmacokinetics of interleukin-2
    • Anderson PM, Sorenson MA. 1994. Effects of route and formulation on clinical pharmacokinetics of interleukin-2. Clin Pharmacokinet 27:19-31.
    • (1994) Clin Pharmacokinet , vol.27 , pp. 19-31
    • Anderson, P.M.1    Sorenson, M.A.2
  • 96
    • 0029558702 scopus 로고
    • Disposition characteristics of recombinant human interleukin-11 after a bolus intravenous administration in mice
    • Takagi A, Masuda H, Takakura Y, Hashida M. 1995. Disposition characteristics of recombinant human interleukin-11 after a bolus intravenous administration in mice. J Pharmacol Exp Ther 275:537-543.
    • (1995) J Pharmacol Exp Ther , vol.275 , pp. 537-543
    • Takagi, A.1    Masuda, H.2    Takakura, Y.3    Hashida, M.4
  • 97
    • 0017701073 scopus 로고
    • Renal extraction, filtration, absorption, and catabolism of growth hormone
    • Johnson V, Maack T. 1977. Renal extraction, filtration, absorption, and catabolism of growth hormone. Am J Physiol 233:F185-F196.
    • (1977) Am J Physiol , vol.233
    • Johnson, V.1    Maack, T.2
  • 99
    • 0033001525 scopus 로고    scopus 로고
    • Ultrastructural model for size selectivity in glomerular filtration
    • Edwards A, Daniels BS, Deen WM. 1999. Ultrastructural model for size selectivity in glomerular filtration. Am J Physiol 276:F892-F902.
    • (1999) Am J Physiol , vol.276
    • Edwards, A.1    Daniels, B.S.2    Deen, W.M.3
  • 102
    • 0018992424 scopus 로고
    • Hydrolysis and transport of small peptides by the proximal tubule
    • Carone FA, Peterson DR. 1980. Hydrolysis and transport of small peptides by the proximal tubule. Am J Physiol 238:F151-F158.
    • (1980) Am J Physiol , vol.238
    • Carone, F.A.1    Peterson, D.R.2
  • 103
    • 0020317205 scopus 로고
    • Renal tubular processing of small peptide hormones
    • Carone FA, Peterson DR, Flouret G. 1982. Renal tubular processing of small peptide hormones. J Lab Clin Med 100:1-14.
    • (1982) J Lab Clin Med , vol.100 , pp. 1-14
    • Carone, F.A.1    Peterson, D.R.2    Flouret, G.3
  • 104
    • 0033659819 scopus 로고    scopus 로고
    • Physiological and pharmacological implications of peptide transporters, PEPT1 and PEPT2
    • Inui K, Terada T, Masuda S, Saito H. 2000. Physiological and pharmacological implications of peptide transporters, PEPT1 and PEPT2. Nephrol Dial Transplant 15(Suppl 6):11-13.
    • (2000) Nephrol Dial Transplant , vol.15 , Issue.SUPPL. 6 , pp. 11-13
    • Inui, K.1    Terada, T.2    Masuda, S.3    Saito, H.4
  • 105
    • 0030761208 scopus 로고    scopus 로고
    • Cellular and molecular mechanisms of renal peptide transport
    • Daniel H, Herget M. 1997. Cellular and molecular mechanisms of renal peptide transport. Am J Physiol 273:F1-F8.
    • (1997) Am J Physiol , vol.273
    • Daniel, H.1    Herget, M.2
  • 107
    • 0023481833 scopus 로고
    • Luminal and basolateral uptake of insulin in isolated, perfused, proximal tubules
    • Nielsen S, Nielsen JT, Christensen EI. 1987. Luminal and basolateral uptake of insulin in isolated, perfused, proximal tubules. Am J Physiol 253:F857-F867.
    • (1987) Am J Physiol , vol.253
    • Nielsen, S.1    Nielsen, J.T.2    Christensen, E.I.3
  • 108
    • 0031935556 scopus 로고    scopus 로고
    • Peritubular transport of ochratoxin A in rabbit renal proximal tubules
    • Groves CE, Morales M, Wright SH. 1998. Peritubular transport of ochratoxin A in rabbit renal proximal tubules. J Pharmacol Exp Ther 284:943-948.
    • (1998) J Pharmacol Exp Ther , vol.284 , pp. 943-948
    • Groves, C.E.1    Morales, M.2    Wright, S.H.3
  • 109
    • 0030600141 scopus 로고    scopus 로고
    • Endosomal proteolysis of internalized proteins
    • Authier F, Posner BI, Bergeron JJ. 1996. Endosomal proteolysis of internalized proteins. FEBS Lett 389:55-60.
    • (1996) FEBS Lett , vol.389 , pp. 55-60
    • Authier, F.1    Posner, B.I.2    Bergeron, J.J.3
  • 110
    • 0025063975 scopus 로고
    • Clearance of tissue plasminogen activator by mannose and galactose receptors in the liver
    • Smedsrod B, Einarsson M. 1990. Clearance of tissue plasminogen activator by mannose and galactose receptors in the liver. Thromb Haemost 63:60-66.
    • (1990) Thromb Haemost , vol.63 , pp. 60-66
    • Smedsrod, B.1    Einarsson, M.2
  • 111
    • 0035114992 scopus 로고    scopus 로고
    • Identification of insulin domains important for binding to and degradation by endosomal acidic insulinase
    • Authier F, Danielsen GM, Kouach M, Briand G, Chauvet G. 2001. Identification of insulin domains important for binding to and degradation by endosomal acidic insulinase. Endocrinology 142:276-2789.
    • (2001) Endocrinology , vol.142 , pp. 276-2789
    • Authier, F.1    Danielsen, G.M.2    Kouach, M.3    Briand, G.4    Chauvet, G.5
  • 112
    • 0037088652 scopus 로고    scopus 로고
    • Endosomal proteolysis of internalized insulin at the C-terminal region of the B chain by cathepsin D
    • Authier F, Metioui M, Fabrega S, Kouach M, Briand G. 2002. Endosomal proteolysis of internalized insulin at the C-terminal region of the B chain by cathepsin D. J Biol Chem 277:9437-9446.
    • (2002) J Biol Chem , vol.277 , pp. 9437-9446
    • Authier, F.1    Metioui, M.2    Fabrega, S.3    Kouach, M.4    Briand, G.5
  • 113
    • 0028998783 scopus 로고
    • Proteolysis of glucagon within hepatic endosomes by membrane-associated cathepsins B and D
    • Authier F, Mort JS, Bell AW, Posner BI, Bergeron JJ. 1995. Proteolysis of glucagon within hepatic endosomes by membrane-associated cathepsins B and D. J Biol Chem 270:15798-15807.
    • (1995) J Biol Chem , vol.270 , pp. 15798-15807
    • Authier, F.1    Mort, J.S.2    Bell, A.W.3    Posner, B.I.4    Bergeron, J.J.5
  • 114
    • 0026756089 scopus 로고
    • Low density lipoprotein receptor-related protein/alpha 2-macroglobulin receptor is an hepatic receptor for tissue-type plasminogen activator
    • Bu G, Williams S, Strickland DK, Schwartz AL. 1992. Low density lipoprotein receptor-related protein/alpha 2-macroglobulin receptor is an hepatic receptor for tissue-type plasminogen activator. Proc Natl Acad Sci USA 89:7427-7431.
    • (1992) Proc Natl Acad Sci USA , vol.89 , pp. 7427-7431
    • Bu, G.1    Williams, S.2    Strickland, D.K.3    Schwartz, A.L.4
  • 115
    • 0027998106 scopus 로고
    • Pharmacologic target-mediated drug disposition
    • Levy G. 1994. Pharmacologic target-mediated drug disposition. Clin Pharmacol Ther 56:248-252.
    • (1994) Clin Pharmacol Ther , vol.56 , pp. 248-252
    • Levy, G.1
  • 117
    • 0035888750 scopus 로고    scopus 로고
    • Development of a monoclonal anti-immunoglobulin E antibody (omalizumab) for the treatment of allergic respiratory disorders
    • Schulman ES. 2001. Development of a monoclonal anti-immunoglobulin E antibody (omalizumab) for the treatment of allergic respiratory disorders. Am J Respir Grit Care Med 164:S6-S11.
    • (2001) Am J Respir Grit Care Med , vol.164
    • Schulman, E.S.1
  • 118
    • 0030440886 scopus 로고    scopus 로고
    • Tissue distribution and complex formation with IgE of an anti-IgE antibody after intravenous administration in cynomolgus monkeys
    • Fox JA, Hotaling TE, Struble C, Ruppel J, Bates DJ, Schoenhoff MB. 1996. Tissue distribution and complex formation with IgE of an anti-IgE antibody after intravenous administration in cynomolgus monkeys. J Pharmacol Exp Ther 279:1000-1008.
    • (1996) J Pharmacol Exp Ther , vol.279 , pp. 1000-1008
    • Fox, J.A.1    Hotaling, T.E.2    Struble, C.3    Ruppel, J.4    Bates, D.J.5    Schoenhoff, M.B.6
  • 119
    • 0032713216 scopus 로고    scopus 로고
    • Dose escalation and pharmacokinetic study of a humanized anti-HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer
    • Tokuda Y, Watanabe T, Omuro Y, Ando M, Katsumata N, Okumura A, Ohta M, Fujii H, Sasaki Y, Niwa T, Tajima T. 1999. Dose escalation and pharmacokinetic study of a humanized anti-HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer. Br J Cancer 81:1419-1425.
    • (1999) Br J Cancer , vol.81 , pp. 1419-1425
    • Tokuda, Y.1    Watanabe, T.2    Omuro, Y.3    Ando, M.4    Katsumata, N.5    Okumura, A.6    Ohta, M.7    Fujii, H.8    Sasaki, Y.9    Niwa, T.10    Tajima, T.11
  • 120
    • 0036468260 scopus 로고    scopus 로고
    • Rapid accumulation and internalization of radiolabeled herceptin in an inflammatory breast cancer xenograft with vasculogenic mimicry predicted by the contrast-enhanced dynamic MRI with the macromolecular contrast agent G6-(lB4M-Gd)(256)
    • Kobayashi H, Shirakawa K, Kawamoto S, et al. 2002. Rapid accumulation and internalization of radiolabeled herceptin in an inflammatory breast cancer xenograft with vasculogenic mimicry predicted by the contrast-enhanced dynamic MRI with the macromolecular contrast agent G6-(lB4M-Gd)(256). Cancer Res 62:860-866.
    • (2002) Cancer Res , vol.62 , pp. 860-866
    • Kobayashi, H.1    Shirakawa, K.2    Kawamoto, S.3
  • 121
    • 0028034458 scopus 로고
    • Dose-dependent plasma clearance of human epidermal growth factor in rats
    • Murakami T, Misaki M, Masuda S, Higashi Y, Fuwa T, Yata N. 1994. Dose-dependent plasma clearance of human epidermal growth factor in rats. J Pharm Sci 83:1400-1403.
    • (1994) J Pharm Sci , vol.83 , pp. 1400-1403
    • Murakami, T.1    Misaki, M.2    Masuda, S.3    Higashi, Y.4    Fuwa, T.5    Yata, N.6
  • 123
    • 0029053166 scopus 로고
    • Saturable uptake of a recombinant human granulocyte colony-stimulating factor derivative, nartograstim, by the bone marrow and spleen of rats in vivo
    • Kuwabara T, Uchimura T, Takai K, Kobayashi H, Kobayashi S, Sugiyama Y. 1995. Saturable uptake of a recombinant human granulocyte colony-stimulating factor derivative, nartograstim, by the bone marrow and spleen of rats in vivo. J Pharmacol Exp Ther 273:1114-1122.
    • (1995) J Pharmacol Exp Ther , vol.273 , pp. 1114-1122
    • Kuwabara, T.1    Uchimura, T.2    Takai, K.3    Kobayashi, H.4    Kobayashi, S.5    Sugiyama, Y.6
  • 124
    • 0032955949 scopus 로고    scopus 로고
    • The pharmacokinetic principles behind scaling from preclinical results to phase I protocols
    • Mahmood I, Balian JD. 1999. The pharmacokinetic principles behind scaling from preclinical results to phase I protocols. Clin Pharmacokinet 36:1-11.
    • (1999) Clin Pharmacokinet , vol.36 , pp. 1-11
    • Mahmood, I.1    Balian, J.D.2
  • 125
    • 0036356378 scopus 로고    scopus 로고
    • Interspecies scaling: Predicting oral clearance in humans
    • Mahmood I. 2002. Interspecies scaling: Predicting oral clearance in humans. Am J Ther 9:35-42.
    • (2002) Am J Ther , vol.9 , pp. 35-42
    • Mahmood, I.1
  • 126
    • 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 10:201-227.
    • (1982) J Pharmacokinet Biopharm , vol.10 , pp. 201-227
    • Boxenbaum, H.1
  • 127
    • 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 8:1351-1359.
    • (1991) Pharm Res , vol.8 , pp. 1351-1359
    • Mordenti, J.1    Chen, S.A.2    Moore, J.A.3    Ferraiolo, B.L.4    Green, J.D.5
  • 128
    • 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, Mendoza JL, Escandon E, Fei D, Meng YG, Modi NB. 1999. Preclinical pharmacokinetics, interspecies scaling, and tissue distribution of a humanized monoclonal antibody against vascular endothelial growth factor. J Pharmacol Exp Ther 288:371-378.
    • (1999) J Pharmacol Exp Ther , vol.288 , pp. 371-378
    • Lin, Y.S.1    Nguyen, C.2    Mendoza, J.L.3    Escandon, E.4    Fei, D.5    Meng, Y.G.6    Modi, N.B.7
  • 129
    • 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 93:177-185.
    • (2004) J Pharm Sci , vol.93 , pp. 177-185
    • Mahmood, I.1
  • 130
    • 0030819215 scopus 로고    scopus 로고
    • Basic concepts of pharmacokinetic/pharmacodynamic (PK/PD) modelling
    • Meibohm B, Derendorf H. 1997. Basic concepts of pharmacokinetic/ pharmacodynamic (PK/PD) modelling. Int J Clin Pharmacol Ther 35:401-413.
    • (1997) Int J Clin Pharmacol Ther , vol.35 , pp. 401-413
    • Meibohm, B.1    Derendorf, H.2
  • 131
    • 0032974197 scopus 로고    scopus 로고
    • Modeling of pharmacokinetic/pharmacodynamic (PK/PD) relationships: Concepts and perspectives
    • Derendorf H, Meibohm B. 1999. Modeling of pharmacokinetic/pharmacodynamic (PK/PD) relationships: Concepts and perspectives. Pharm Res 16:176-185.
    • (1999) Pharm Res , vol.16 , pp. 176-185
    • Derendorf, H.1    Meibohm, B.2
  • 132
    • 0030849120 scopus 로고    scopus 로고
    • An evaluation of the integration of pharmacokinetic and pharmacodynamic principles in clinical drug development. Experience within Hoffmann La Roche
    • Reigner BG, Williams PE, Patel IH, Steimer JL, Peck C, van Brummelen P. 1997. An evaluation of the integration of pharmacokinetic and pharmacodynamic principles in clinical drug development. Experience within Hoffmann La Roche. Clin Pharmacokinet 33:142-152.
    • (1997) Clin Pharmacokinet , vol.33 , pp. 142-152
    • Reigner, B.G.1    Williams, P.E.2    Patel, I.H.3    Steimer, J.L.4    Peck, C.5    Van Brummelen, P.6
  • 133
    • 0030890279 scopus 로고    scopus 로고
    • Relevance of the application of pharmacokinetic-pharmacodynamic modelling concepts in drug development. The "wooden shoe" paradigm
    • Breimer DD, Danhof M. 1997. Relevance of the application of pharmacokinetic-pharmacodynamic modelling concepts in drug development. The "wooden shoe" paradigm. Clin Pharmacokinet 32:259-267.
    • (1997) Clin Pharmacokinet , vol.32 , pp. 259-267
    • Breimer, D.D.1    Danhof, M.2
  • 134
    • 0033673839 scopus 로고    scopus 로고
    • Optimizing the science of drug development: Opportunities for better candidate selection and accelerated evaluation in humans
    • Lesko LJ, Rowland M, Peck CC, Blaschke TF. 2000. Optimizing the science of drug development: Opportunities for better candidate selection and accelerated evaluation in humans. J Clin Pharmacol 40:803-814.
    • (2000) J Clin Pharmacol , vol.40 , pp. 803-814
    • Lesko, L.J.1    Rowland, M.2    Peck, C.C.3    Blaschke, T.F.4
  • 135
    • 0028075942 scopus 로고
    • Mechanism-based pharmacodynamic modeling
    • Levy G. 1994. Mechanism-based pharmacodynamic modeling. Clin Pharmacol Ther 56:356-358.
    • (1994) Clin Pharmacol Ther , vol.56 , pp. 356-358
    • Levy, G.1
  • 137
    • 0036202314 scopus 로고    scopus 로고
    • Dose-effect relationship for several coagulation markers during administration of the direct thrombin inhibitor S 18326 in healthy subjects
    • Gaussem P, Dubar M, le Bonniec B, Richard-Lordereau I, Jochemsen R, Aiach M. 2002. Dose-effect relationship for several coagulation markers during administration of the direct thrombin inhibitor S 18326 in healthy subjects. Br J Clin Pharmacol 53:147-154.
    • (2002) Br J Clin Pharmacol , vol.53 , pp. 147-154
    • Gaussem, P.1    Dubar, M.2    Le Bonniec, B.3    Richard-Lordereau, I.4    Jochemsen, R.5    Aiach, M.6
  • 139
    • 0344948140 scopus 로고    scopus 로고
    • A pharmacokinetic/pharmacodynamic model for recombinant human growth hormone effects on induction of insulin-like growth factor I in monkeys
    • Sun YN, Lee HJ, Almon RR, Jusko WJ. 1999. A pharmacokinetic/ pharmacodynamic model for recombinant human growth hormone effects on induction of insulin-like growth factor I in monkeys. J Pharmacol Exp Ther 289:1523-1532.
    • (1999) J Pharmacol Exp Ther , vol.289 , pp. 1523-1532
    • Sun, Y.N.1    Lee, H.J.2    Almon, R.R.3    Jusko, W.J.4
  • 140
    • 0031442094 scopus 로고    scopus 로고
    • Comparison of a direct and indirect population pharmacodynamic model: Application to recombinant human erythropoietin in athletes
    • Bressolle F, Audran M, Gareau R, Pham TN, Gomeni R. 1997. Comparison of a direct and indirect population pharmacodynamic model: application to recombinant human erythropoietin in athletes. J Pharmacokinet Biopharm 25:263-275.
    • (1997) J Pharmacokinet Biopharm , vol.25 , pp. 263-275
    • Bressolle, F.1    Audran, M.2    Gareau, R.3    Pham, T.N.4    Gomeni, R.5
  • 141
    • 0033968587 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamics of a humanized monoclonal antibody to factor IX in cynomolgus monkeys
    • Benincosa LJ, Chow FS, Tobia LP, Kwok DC, Davis CB, Jusko WJ. 2000. Pharmacokinetics and pharmacodynamics of a humanized monoclonal antibody to factor IX in cynomolgus monkeys. J Pharmacol Exp Ther 292:810-816.
    • (2000) J Pharmacol Exp Ther , vol.292 , pp. 810-816
    • Benincosa, L.J.1    Chow, F.S.2    Tobia, L.P.3    Kwok, D.C.4    Davis, C.B.5    Jusko, W.J.6
  • 143
    • 0034146307 scopus 로고    scopus 로고
    • Pharmacokinetic-pharmacodynamic modeling of testosterone and luteinizing hormone suppression by cetrorelix in healthy volunteers
    • Pechstein B, Nagaraja NV, Hermann R, Romeis P, Locher M, Derendorf H. 2000. Pharmacokinetic-pharmacodynamic modeling of testosterone and luteinizing hormone suppression by cetrorelix in healthy volunteers. J Clin Pharmacol 40:266-274.
    • (2000) J Clin Pharmacol , vol.40 , pp. 266-274
    • Pechstein, B.1    Nagaraja, N.V.2    Hermann, R.3    Romeis, P.4    Locher, M.5    Derendorf, H.6


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