Biotherapeutic bioanalysis: A multi-indication case study review

Bioanalysis

Volumn 3, Issue 6, 2011, Pages 623-643

  Myler, Heather A ^a   Given, Allison ^b   Kolz, Karen ^c   Mora, Johanna R ^a   Hristopoulos, George ^c  

^a BRISTOL MYERS SQUIBB   (United States)

^b PFIZER INC   (United States)

^c MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; BETA1A INTERFERON; BEVACIZUMAB; CETUXIMAB; DENOSUMAB; DULANERMIN; GEMTUZUMAB OZOGAMICIN; HUMAN GROWTH HORMONE; HUMAN INSULIN; INFLIXIMAB; INSULIN ASPART; INSULIN GLARGINE; INSULIN GLULISINE; INSULIN LISPRO; INTERFERON BETA SERINE; IPILIMUMAB; METHOTREXATE; NATALIZUMAB; NECITUMUMAB; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; OBINUTUZUMAB; OMALIZUMAB; PANITUMUMAB; RECOMBINANT ALPHA2A INTERFERON; RECOMBINANT ALPHA2B INTERFERON; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RITUXIMAB; TEV TROPIN; TICILIMUMAB; TRASTUZUMAB; UNCLASSIFIED DRUG; UNINDEXED DRUG;

ACUTE GRANULOCYTIC LEUKEMIA; ALLERGIC ASTHMA; ALLERGY; ANEMIA; ANKYLOSING SPONDYLITIS; BIOLOGICAL THERAPY; BREAST CANCER; CACHEXIA; CHRONIC KIDNEY FAILURE; CHRONIC LYMPHATIC LEUKEMIA; COLORECTAL CANCER; CONDYLOMA ACUMINATUM; CROHN DISEASE; CYTOTOXICITY; DIABETES MELLITUS; DRUG ACTIVITY; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG PROTEIN BINDING; FOLLICULAR LYMPHOMA; GLIOBLASTOMA; GROWTH HORMONE DEFICIENCY; HAIRY CELL LEUKEMIA; HEAD AND NECK CARCINOMA; HEMATOLOGY; HEPATITIS B; HEPATITIS C; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNOGENICITY; INFECTION; JUVENILE RHEUMATOID ARTHRITIS; KAPOSI SARCOMA; LUNG NON SMALL CELL CANCER; LUNG SMALL CELL CANCER; MELANOMA; METABOLISM; MICROFLUIDICS; MULTIPLE SCLEROSIS; MYELOID LEUKEMIA; NEUTROPENIA; NONHODGKIN LYMPHOMA; ONCOLOGY; POSTMENOPAUSE OSTEOPOROSIS; PRADER WILLI SYNDROME; PROSTATE CANCER; PROTEIN EXPRESSION; PSORIASIS VULGARIS; PSORIATIC ARTHRITIS; REVIEW; RHEUMATOID ARTHRITIS; SHORT BOWEL SYNDROME; SHORT STATURE; SMALL FOR DATE INFANT; TREATMENT INDICATION; TURNER SYNDROME;

ANIMALS; ANTIBODIES, MONOCLONAL; BIOLOGICAL PRODUCTS; CHEMISTRY TECHNIQUES, ANALYTICAL; HUMANS; PHARMACEUTICAL PREPARATIONS; RECOMBINANT PROTEINS;

EID: 79953108779     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.11.33     Document Type: Review

References (124)

1. Hughes B. Antibody-drug conjugates for cancer: Poised to deliver? Nat. Rev. Drug Disc. 9, 665-667 (2010).
2. Phillips GDL, Li G, Dugger DL et al. Targeting HER2-positive breast cancer with trastuzumab-DM1, an antibody-cytotoxic drug conjugate. Cancer Res. 68(22), 9280-9290 (2008).
3. Niculescu-Duvaz I. Trastuzumab emtansine, an antibody-drug conjugate for the treatment of HER2+ metastatic breast cancer. Curr. Opin. Mol. Ther. 12(3), 350-360 (2010).
4. Krop IE, Beeram M, Modi S et al. Phase I study of trastuzumab-DM1, an HER2 antibody-drug conjugate, given every 3 weeks to patients with HER2-positive metastatic breast cancer. J. Clin. Oncol. 28(16), 2698-2704 (2010).
5. Junttila TT, Li G, Parsons K, Phillips GL, Sliwkowski MX. Trastuzumab-DM1 (T-DM1) retains all of the mechanisms of action of trastuzumab and efficiently inhibits growth of lapatinib insensitive breast cancer. Breast Cancer Res Treat. DOI: 10.1007/s10549-010-1090-x (2010) (Epub ahead of print).
6. Bruno R, Washington CB, Lu JF, Lieberman G, Banken L, Klein P. Population pharmacokinetics of trastuzumab in patients with HER2+ metastatic breast cancer. Cancer Chemotherapy Pharmacol. 56, 361-369 (2005). (Pubitemid 41095399)
7. Tan AR, Moore DF, Hidalgo M et al. Pharmacokinetics of cetuximab after administration of escalating single dosing and weekly fixed dosing in patients with solid tumors. Clin. Cancer Res. 12(21), 6517-6522 (2006). (Pubitemid 44799726)
8. Lee J, Ma H. Specificity and selectivity evaluations of ligand binding assay of protein therapeutics against concomitant drugs and related endogenous proteins. AAPS J. 9(2), E164-E170 (2007). nn Describes how to evaluate bioanalytical assay specificity and selectivity, including interference and crossreactivity from spiked analyte or biological samples, respectively.
9. Manni A, Trout D, Verderame MF et al. Effect of a-difluoromethyl- ornithine on the expression and function of the epidermal growth factor receptor in human breast epithelial cells in culture. Breast Cancer Res. 68, 139-146 (2001). (Pubitemid 32964311)
10. Lee JW, Kelley M, King LE, et al. Bioanalytical approaches to quantify 'total' and 'free' therapeutic antibodies and their targets: Technical challenges and PK/PD applications over the course of drug development. AAPS J.13(1), 99-110 (2010). nn Collaborative White Paper describing the bioanalytical methodologies used to measure bound and unbound analyte and the consequences of such measurement on pharmacokinetic and pharmacodynamic data interpretation.
11. Pitti R, Marsters S, Ruppert S et al. Induction of apoptosis by Apo-2 ligand, a new member of the tumor necrosis factor cytokine family. J. Biol. Chem. 271(22), 12687-12690 (1996). (Pubitemid 26175834)
12. Fesik S. Promoting apoptosis as a strategy for cancer drug discovery. Nat. Rev. Cancer 5, 876-85 (2005). (Pubitemid 41746032)
13. Ashkenazi A, Pai R, Fong S et al. Safety and antitumor activity of recombinant soluble Apo2 ligand. J. Clin. Inv. 104(2), 155-162 (1999).
14. Soria J-C, Smit E, Khayat D et al. Phase 1b study of dulanermin (recombinant human Apo2L/TRAIL) in combination with paclitaxel, carboplatin, and bevacizumab in patients with advanced non-squamous non-small-cell lung cancer. J. Clin. Onc. 28(9), 1527-1533 (2010).
15. Herbst R, Eckhardt S, Kurzrock R et al. Phase I dose-escalation study of recombinant human Apo2l/trail, a dual proapoptotic receptor agonist, in patients with advanced cancer. J. Clin. Onc. 28(17), 2839-2846 (2010).
16. Lawrence D, Shahrokh Z, Marsters S et al. Differential hepatocyte toxicity of recombinant Apo2L/TRAIL versions. Nat. Med. 7(4), 383-385 (2001).
17. Weisman MH, Moreland LW, Furst DE et al. Efficacy, pharmacokinetics, and safety assessment of adalimumab, a fully human anti-tumor necrosis factor-a monoclonal antibody, in adults with rheumatoid arthritis receiving concomitant methotrexate: A pilot study. Clin. Ther. 25(6), 1700-1721 (2003). (Pubitemid 36801943)
18. Xu Z, Seitz K, Fasanmade A et al. Population pharmacokinetics of infliximab in patients with ankylosing spondylitis. J. Clin. Pharmacol. 48, 681-695 (2008). (Pubitemid 351713154)
19. Ternant D, Mulleman D, Degenne D et al. An enzyme-linked immunosorbent assay for therapeutic drug monitoring of infliximab. Ther. Drug Monitor. 28(2), 169-174 (2006). (Pubitemid 44314944)
20. Wolbink GJ, Voskuyl AE, Lems WF et al. Relationship between serum and trough infliximab levels, pretreatment C reactive protein levels, and clinical response to infliximab treatment in patients with rheumatoid arthritis. Ann. Rheum. 64(5), 704-707 (2005). (Pubitemid 40559296)
21. Nestorov I, Zitnik R, DeVries T, Nakanishi AM, Wang A, Banfield C. Pharmacokinetics of subcutaneously administered etanercept in subjects with psoriasis. Br. J. Clin. Pharmacol. 62(4), 435-445 (2006). (Pubitemid 44401526)
22. Manicourt DH, Triki R, Fukuda K, Devogelaer JP, DeDexchaisnes CN, Thonar EJ. Levels of circulating tumor necrosis factora and interleuikin-6 in patients with rheumatoid arthritis. Arthritis Rheum.36(4), 490-499 (1993).
23. Reff ME, Carner K, Chambers KS, et al. Depletion of B cells in vivo by a chimeric mouse human monoclonal antibody CD20. Blood 83, 435-445 (1994). (Pubitemid 24030569)
24. DG Maloney, TM Lilies, DK Czerwinski, et al. Phase I clinical trial using escalating single-dose infusion of chimeric anti-CD20 monoclonal antibody (IDEC-C2B8) in patients with recurrent B-cell lymphoma. Blood 84(8), 2457-2466 (1994). n Use of multiple biomarkers to understand the effect of rituximab on circulating B cells and subsequent antibody production, in addition to methods used to measure drug. (Pubitemid 24317376)
25. Maloney DG, Grillo-López AJ, Bodkin DJ, et al. IDEC-C2B8: Results of a Phase I multiple-dose trial in patients with relapsed non-Hodgkin's lymphoma. J. Clin. Oncol. 15, 3266-3274 (1997). (Pubitemid 27419340)
26. Maloney DG, Grillo-López AJ, White CA, et al. IDEC-C2B8 (Rituximab®) anti-CD20 monoclonal antibody therapy in patients with relapsed non-Hodgkin's lymphoma. Blood 90, 2188-2195 (1997). (Pubitemid 27392702)
27. Cohen SB, P Emery, Greenwald MW, et al. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy. Arthritis & Rheumatism 54(9), 2793-2806 (2006).
28. Looney RJ, Anolik JH, Campbell D et al. B cell depletion as a novel treatment for systemic lupus erythematosus. A Phase I/II dose-escalation trial of rituximab. Arthritis Rheum. 50, 2580-2589 (2004). (Pubitemid 39062719)
29. Lowe PJ, Tannenbaum S, Gautier A, Jimenez P. Relationship between omalizumab pharmacokinetics, IgE pharmacodynamics and symptoms in patients with severe persistent allergic (IgE-mediated) asthma. Brit. J. Clin. Pharmacol. 68(1), 61-76 (2009).
30. Davis FM, Gossett LA, Pinkston KL et al. Can anti-IgE be used to treat allergy? Springer Semin Immunopatholo. 15, 51-73 (1993). (Pubitemid 23175440)
31. Liu J, Lester P, Builder S, Shire SJ. Characterization of complex formation by humanized anti-IgE monoclonal antibody and monoclonal human IgE. Biochemistry 34, 10474-10482 (1995).
32. Hamilton RG, Marcotte GV, Saini SS. Immunological methods for quantifying free and total serum IgE levels in allergy patients receiving omalizumab (Xolair®) therapy. J. Immunol. Method. 303, 81-91 (2005). (Pubitemid 41169948)
33. Hamilton RG, Adkinson Jr NF. In vitro assays for the diagnosis of IgE mediated disorders. J. Allergy Clin. Immunol. 114(2), 213-225 (2004). (Pubitemid 39127422)
34. Casale TB, Bernstein IL, Busse WW et al. Use of an anti-IgE humanized monoclonal antibody in ragweed-induced allergic rhinitis. J. Allergy Clin. Immunol. 100(1), 110-121 (1997). (Pubitemid 27328539)
35. Stanhope R, Sorgel F, Gravel P, Schuetz YBP, Zabransky M, Muenzberg M. Bioequivalence studies of omnitrope, the first biosimilar/ rHGH follow-on protein: Two comparative Phase 1 randomized studies and population pharmacokinetic analysis. J. Clin. Pharm. 50(11) 1339-1348 (2010).
36. Declerck PJ, Dareendeliler F, Goth M et al. Biosimilars: Controversies as illustrated by rHGH. Curr. Med. Res. Opin. 26(5), 1219-1229 (2010).
37. Brugts MP, Luermans JGLM, Lentjes EGWM et al. Heterophilic antibodies may be a cause of falsely low total IGF-1 levels. Eur. J. Endocrinol. 161, 561-565 (2009).
38. Fuhr U, Tuculanu D, Berghout A, Balser S, Schwebig A, Saenger P. Bioequivalence between novel ready-to-use liquid formulations of the recombinant human GH omnitrope and the original lyophilized formulations for reconstitution of omnitrope and genotropin. Eur. J. Endocrinol. 162, 1051-1058 (2010).
39. Walvoord EC, de la Pena A, Park S et al. Inhaled growth hormone (GH) compared with subcutaneous GH in children with GH deficiency: Pharmacokinetics, pharmacodynamics, and safety. J. Clin. Endocrinol. Metab. 94(6), 2052-2059 (2009).
40. Webster R, Xie R, Didier E et al. Pegylation of somatropin (recombinant human growth hormone): Impact on its clearance in humans. Xenobiotica 38(19), 1340-1351 (2008).
41. Frysk J, Andreasen CM, Fisker S. Determination of free growth hormone. J. Clin. Endocrinol Metab. 93(8), 3008-3014 (2008).
42. Hansen TK, Fisker S, Hansen B, Sorensen HH, Christiansen JS, Jorgensen JOL, Orskov H. Impact of GHBP interference on estimates of GH and GH pharmacokinetics. Clin. Endocrinol. 57, 779-786 (2002). (Pubitemid 36963006)
43. Jan T, Shaw MA, Baumann G. Effects of growth hormone-binding proteins on serum growth hormone measurements. J. Clin. Endocrin. Met. 72(2), 387-391 (1991). (Pubitemid 21921704)
44. Myler HA, McVay S, Kratszch J. Troubleshooting PEG-HGH detection supporting pharmacokinetic evaluation in growth hormone deficient patients. J. Pharmocol. Toxicol. Methods 61, 92-97 (2010).
45. Kotenuik PJ, Nguyen HQ, McCabe J et al. Denosumab, a fully human monoclonal antibody to RANKL inhibits bone resorption and increases BMD in knock-in mice that express chimeric (murine/human) RANKL. J. Bone Min. Res. 24(2), 182-195 (2009).
46. CHMP assessment report for Prolia, procedure number EMEA/H/C/001120.
47. Wang J, Lee J, Burns D, Doherty D, Brunner L, Peterson M, DeSilva B. 'Fit-forpurpose' method validation and application of a biomarker (C-terminal telopeptides of type 1 collagen) in denosumab clinical studies. AAPS J. 11(2), 385-394 (2009).
48. Marathe A, Peterson MC, Mager DE. Integrated cellular bone homeostasis model for denosumab pharmacodynamics in multiple myeloma patients. J. Pharmacol. Exp. Therp. 326(2), 555-562 (2008).
49. Vosoughi R, Freedman M. Therapy of MS. Clin. Neurology Neurosurgery. 112, 365-385 (2010).
50. ser in healthy volunteers and its effect on serum neopterin. Pharm. Res. 10(4), 567-572 (1993). (Pubitemid 23113049)
51. Paolicelli D, Direnzo V, Trojano M. Review of interferon b-1b in the treatment of early and relapsing multiple sclerosis. Biologics: Targets Therapy 3, 369-376 (2009).
52. Alam J, Goelz S, Rioux P et al. Comparative pharmacokinetics and pharmacodynamics of two recombinant human interferon β-1a (IFNβ-1a) products administered intramuscularly in healthy male and female volunteers. Pharm. Res. 14(4), 546-549 (1997). (Pubitemid 27205021)
53. Munafo A, Trinchard-Lugan I, Nguyen TXQ, Buraglio M. Comparative pharmacokinetics and pharmacodynamics of recombinant human interferon β-1a after intramuscular and subcutaneous administration. Eur. J. Neur. 5, 187-193 (1998). (Pubitemid 28142571)
54. Deisenhammer F, Mayringer I, Harvery J et al. A comparative study of the relative bioavailability of different interferon b preparations. Neurology 54(11), 2055-2060 (2000). (Pubitemid 30397201)
55. Buchwalder PA, Buclin T, Trinchard I et al. Pharmacokinetics and pharmacodynamics of IFN-b1a in healthy volunteers. J. Interferon Cytokine Res. 20, 857-866 (2000).
56. Salmon P, Contonnec JY Le, Galazka A et al. Pharmacokinetics and pharmacodynamics of recombinant human interferon-b in healthy male volunteers. J. Interferon Cytokine Res. 16, 759-764 (1996). (Pubitemid 26389112)
57. Goodin D, Frohman E, Garmany G et al. Disease modifying therapies in multiple sclerosis: Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Am. Acad Neur. 58, 169-178 (2002). (Pubitemid 34086933)
58. Markowitz C. Interferon-b: Mechanism of action and dosing issues. Neurology 68(24 Suppl. 4), S8-S11 (2007). (Pubitemid 46897272)
59. Pepinsky RB, Lepage D, Gill A et al. Improved pharmacokinetic properties of a polyethylene glycol-modified form of interferon-β-1a with preserved in vitro bioactivity. J. Pharm. Exp. Ther. 297(3), 1059-1066 (2001). (Pubitemid 32472504)
60. Huber C, Batchelor JR, Fuchs D et al. Immune response-associated production of neopterin. J. Exp. Med. 160, 310-316 (1984).
61. Bach M, Huang S-W, Hong R. b2- microglobulin: Association with lymphocyte receptors. Science 182, 1350-1352 (1973).
62. Eskildsen S, Justesen J, Schierup MH, Hartmann R. Characterization of the 2'-5'oligoadenylate synthetase ubiquitin-like family. Nucleic Acids Res. 31(12), 3166-3173 (2003). (Pubitemid 37441776)
63. Sturzebecher S, Maibauer R, Heuner A et al. Pharmacodynamic comparison of single doses of IFN- b1a and IFN-b1b in healthy volunteers. J. Interferon Cytokine Res. 19, 1257-1264 (1999).
64. Pachner A, Bertolotti A, Deisenhammer F. Measurement of MxA mRNA or protein as a biomarker of IFNb bioactivity. Neurology 61(9 Suppl. 5), S24-S26 (2003).
65. Richtsteiger R, Henke-Gendo C, Schmidtke M et al. Quantitative multiplex real-time PCR for the sensitive detection of interferon b gene induction and viral suppression of interferon b expression. Cytokine 24, 190-200 (2003). (Pubitemid 37330121)
66. Vosslamber S, van Baarsen LGM, Verweij C. Pharmacogenomics of IFN-b in multiple sclerosis: Toward a personalized medicine approach. Pharmacogenomics 10(1), 97-108 (2009).
67. Goertsches R, Hecker M, Zettl U. Monitoring of multiple sclerosis immunotherapy. J. Neurol. 255(Suppl. 6), 48-57 (2008).
68. Comabella M, Martin R. Genomics in multiple sclerosis - current state and future directions. J. Neuroimm. 187, 1-8 (2007). (Pubitemid 47001533)
69. Vandenbark A, Huan J, Agotsch M et al. Interferon-β-1a treatment increases CD56bright natural killer cells and CD4+CD25+ Foxp3 expression in subjects with multiple sclerosis. J. Neuroimm. 215, 125-128 (2009).
70. Santos R, Weinstock-Guttman B, Tamaño- Blanco M et al. Dynamics of interferon-b modulated mRNA biomarkers in multiple sclerosis patients with anti-interferon-b neutralizing antibodies. J. Neuroimm. 176, 125-133 (2006). (Pubitemid 44080329)
71. Sellebjerg F, Krakauer M, Hesse D et al. Identification of new sensitive biomarkers for the in vivo response to interferon-b treatment in multiple sclerosis using DNA-array evaluation. Eur. J. Neur. 16, 1291-1298 (2009).
72. Egrie JC, Browne JK. Development and characterization of novel erythropoesis stimulating protein (NESP). Br J Cancer. 84(Suppl. 1), 3-10 (2001). (Pubitemid 32453429)
73. Khankin EV, Mutter WP, Tamez H et al. Soluble erythropoietin receptor contributes to erythropoietin resistance in end-stage renal disease. PLoS ONE 5(2), e9246 (2010).
74. Olech R, Rock M, Kalensky C et. al. The effect of soluble erythropoietin receptor on EPO ELISA and ECL assays for antibody screening and blood level determinations. Presented at: AAPS Annual Meeting 16-20 November 2008, Atlanta, GA, USA.
75. Radwanski E, Perentesis G, Jacobs S et al. Pharmacokinetics of interferon α-2b in healthy volunteers. J. Clin. Pharmacol. 27, 432-435 (1987).
76. Protzman WP, Minnicozzi M, Jacobs S, Surprenant DI, Schwartz J, Oden EM. Immunoradiometric assay of a recombinant human α-2interferon (SCH 30500). J. Clin. Micro. 596-599 (1985). (Pubitemid 15239281)
77. Kirkwood JM, Ernstoff MS, Davis CA, Reiss M, Ferraresi R, Rudnick SA. Comparison of intramuscular and intravenous recombinant α-2 interferon in melanoma and other cancers. Ann. Int. Med. 103, 32-36 (1985). (Pubitemid 15068495)
78. Khakoo S, Glue P, Grellier L et al. Ribaviran and interferon α-2b in chronic hepatitis C: Assessment of possible pharmacokinetics and pharmacodynamic interactions. Br. J. Clin. Pharmacol. 46, 563-570 (1998). (Pubitemid 28522120)
79. Gonzalez-Peralta RP, Kelly DA, Haber B et al. Interferon α-2b in combination with ribavirin for the treatment of chronic hepatitis C in children: Efficacy, safety, and pharmacokinetics. Hepatology 42, 1010-1018 (2005). (Pubitemid 43112667)
80. Obenauer-Kutner LJ, Jacobs SJ, Kolz K, Tobias LM, Bordens RW. A highly sensitive electrochemiluminescence immunoassay for interferon α-2b in human serum. J. Immuno. Meth. 206, 25-33 (1997). n Validation of a method other than ELISA to quantify a recombinant DNA drug product. (Pubitemid 27395862)
81. Glue P, Fang JWS, Rouzier-Panis R et al. Hepatitis C Intervention Therapy Group. Pegylated interferon α-2b: Pharmacokinetics, pharmacodynamics, safety and preliminary efficacy data. Clin. Pharmacol. Ther. 68, 556-567 (2000).
82. Talpaz M, Rakhit A, Rittweger K, et al. Phase I evaluation of a 40kDa branched-chain long-actingpegylated interferon-a-2a with and without cytarabine in patients with chronic myelogenous leukemia. Clin. Cancer Res. 11, 6247-6255 (2005). (Pubitemid 41262955)
83. Motzer RJ, Rakhit A, Ginsberg M, et al. Phase I trial of 40-kd branched pegylated interferon a-2a for patients with advanced renal cell carcinoma. J. Clin. Oncol. 19, 1312-1319 (2001). (Pubitemid 32202535)
84. Asmuth DM, Murphy RL, Rosenkranz SL et al. Safety, tolerability, and mechanism of antiretroviral activity of pegylated interferon a-2a in HIV-1- monoinfected participants: A Phase II clinical trial. J. Infect. Diseases. 201, 1686-1696 (2010).
85. Suppiah V, Moldovan M, Ahlenstiel G et al. IL-28B is associated with response to chronic hepatitis C interferon-a and ribavirin therapy. Nat. Genet. 41(10), 1100-1104 (2009).
86. Tanaka Y, Nishida N, Sugiyama M et al. Genome-wide association of IL28B with response to pegylated interferon-a and ribavirin therapy for chronic hepatitis C. Nat. Genet. 41(10), 1105-1109 (2009).
87. Xu K, Saad OM, Baudys J, Williams L, Kaur S. Bioanalytical strategies for antibody drug conjugate (ADC) biopharmaceutical development: Characterization of trastuzumab-MCC-DM1 in plasma by affinity mass spectrometry. AAPS NBC poster session 1 (2007).
88. Rhyne PW, Wang OT, Zhang YJ et al. Electrochemiluminescence in bioanalysis. Bioanalysis 1(5), 919-935 (2009).
89. Peng K, Siradze K, Quarmby V et al. Clinical immunogenicity specificity assessments: A platform evaluation. J. Pharm. Biomed. Analy. 54, 629-635 (2011).
90. Gustafsson M, Hirschberg D, Palmberg C, Jörnvall H, Bergman T. Integrated sample preparation and MALDI mass spectrometry on a microfluidic compact disk. Anal. Chem. 76, 345-350 (2004). (Pubitemid 38090770)
91. Hirschberg D, Jägerbrink T, Samskog J et al. Detection of phosphorylated peptides in proteomic analyses using microfluidic compact disk technology. Anal. Chem. 76, 5864-5871 (2004). (Pubitemid 39328142)
92. Pihl J, Karlsson M, Chiu DT. Microfluidic technologies in drug discovery. DDT 10(20), 1377-1383 (2005). (Pubitemid 41501792)
93. Honda N, Lindberg U, Andersson P, Hoffmann S, Takei H. Simultaneous multiple immunoassays in a compact disc-shape microfluidic device based on centrifugal force. Clin. Chem. 51(10), 1955-1961 (2005). (Pubitemid 41368195)
94. Inganäs M, Dérand H, Eckerseen A et al. Integrated microfluidic compact disc device with potential use in both centralized and point of care laboratory settings. Clin. Chem. 51(10), 1985-1987 (2005). n First description of the Gyrolab platform and its application to sandwich immunoassays. (Pubitemid 41368200)
95. Rivera E, Petterson FE, Inganäs M, Paulie S, Grönvik KO. The Rb1 fraction of ginseng elicits a balanced Th1 and Th2 immune response. Vaccine 23, 5411-5419 (2005). (Pubitemid 41579313)
96. Lund T, Mangsbo SM, Scholz H et al. Resolvin E1 reduces proinflammatory markers in human pancreatic islets in vitro. Exp. Clin. Endocrinol. Diabetes 118, 237-244 (2010).
97. Mora JR, Obenauer-Kutner L, Patel V. Application of the Gyrolab platform to ligand binding assays: A user's perspective. Bioanalysis 2(10), 1711-1715 (2010).
98. Eriksson C, Agaton C, Kange R et al. Microfluidic analysis of antibody specificity in a compact disk format. J. Proteome Res. 5, 1568-1574 (2005). (Pubitemid 44036130)
99. Inganäs M, Österlund K. Reaping the benefits of assay miniaturization. Pharmaceutical Technology Europe 20(11), 1711-1715 (2008).
100. Vectibux® (panitumumab). Prescribing Information. Amgen Inc, Thousand Oaks, CA, USA 2010.
101. Erbitux® (cetuximab). Prescribing Information. ImClone Systems Inc; Bristol- Meyers Squibb, Princeton NJ, USA 2010.
102. Avastin® (bevacizumab). Prescribing Information. Genentech Inc, South San Francisco, CA, USA 2009.
103. Remicade® (infliximab). Prescribing Information. Centocor, Malvern, PA; 2002.
104. Humira® (adalimumab). Prescribing Information. Abbott Laboratories, North Chicago, IL, USA 2010.
105. Enbrel® (etanercept). Prescribing Information. Amgen, Thousand Oaks, CA, USA 2010.
106. Nutropin® Prescribing Information. Genentech Inc, San Francisco, CA, USA 2006.
107. Nutropin AQ® Prescribing Information. Genentech Inc, San Francisco, CA, USA 2008.
108. Genotropin® Prescribing Information. Pharmacia and Upjohn Company, Kalamazoo, MI, USA 2006.
109. Humatrope® Prescribing Information. Eli Lilly and Company, Indianapolis, IN, USA 2006.
110. Serostim® Prescribing Information. Serono, Rockland, MA, USA 2004.
111. Saizen® Prescribing Information. Serono, Rockland, MA, USA 2005.
112. Norditropin® Prescribing Information. Novo Nordisk, Princeton, NJ, USA 2006.
113. Zorbtive® Prescribing Information. Serono, Rockland, MA, USA 2004.
114. Omnitrope® Prescribing Information. Sandoz Inc, Princeton, NJ, USA 2006.
115. Tev-Tropin® Prescribing Information. Gate Pharmaceuticals/TEVA, Sellersville, PA, USA 2006.
116. Orencia® Prescribing Information. Bristol- Myers Squibb, Princeton, NJ, USA 2009.
117. Byetta® Prescribing Information. Amylin Pharmaceuticals, Inc., San Diego, CA, USA 2010.
118. Prolia® Prescribing Information. Amgen Inc. Thousand Oaks, CA, USA 2010.
119. Tysabri® (natalizumab). Prescribing Information. Biogen Idec, Inc., Cambridge, MA, USA 2010.
120. Bseron® (Interferon b-1b). Prescribing Information. Bayer Healthcare Pharmaceuticals Inc, Montville, NJ, USA 2010.
121. Avonex® (IFN-β-1a). Prescribing Information. Biogen Idec, Inc., Cambridge, MA, USA 2008.
122. Rebif® (Interferon β-1a). Prescribing Information. EMD Serono, Inc., Rockland, MA, USA; Pfizer Inc., NY, USA 2009.
123. Procrit® (epoetin a). Prescribing Information. Amgen Inc. Thousand Oaks, CA, USA; Ortho Biotech Products Raritan NJ, USA 2007.
124. Aranesp® (darbepoetin a). Prescribing Information. Amgen Inc. Thousand Oaks, CA, USA 2010.