-
1
-
-
84856710491
-
Biosimilars: Impact of biologic product life cycle and European experience on the regulatory trajectory in the United States
-
10.1016/j.clinthera.2011.12.005
-
Ahmed I, Kaspar B, Sharma U (2012) Biosimilars: impact of biologic product life cycle and European experience on the regulatory trajectory in the United States. Clin Ther 34(2):400-419
-
(2012)
Clin Ther
, vol.34
, Issue.2
, pp. 400-419
-
-
Ahmed, I.1
Kaspar, B.2
Sharma, U.3
-
2
-
-
46349104050
-
FDA balks at Myozyme scale-up
-
1:CAS:528:DC%2BD1cXmvVequrk%3D 10.1038/nbt0608-592
-
Mack G (2008) FDA balks at Myozyme scale-up. Nat Biotechnol 26(6):592
-
(2008)
Nat Biotechnol
, vol.26
, Issue.6
, pp. 592
-
-
Mack, G.1
-
3
-
-
79957493056
-
A comparative study of monosaccharide composition analysis as a carbohydrate test for biopharmaceuticals
-
1:CAS:528:DC%2BC3MXmslKgsb0%3D 10.1016/j.biologicals.2011.04.002
-
Harazono A, Kobayashi T, Kawasaki N, Itoh S, Tada M, Hashii N, Ishii A, Arato T, Yanagihara S, Yagi Y, Koga A, Tsuda Y, Kimura M, Sakita M, Kitamura S, Yamaguchi H, Mimura H, Murata Y, Hamazume Y, Sato T, Natsuka S, Kakehi K, Kinoshita M, Watanabe S, Yamaguchi T (2011) A comparative study of monosaccharide composition analysis as a carbohydrate test for biopharmaceuticals. Biologicals 39(3):171-180
-
(2011)
Biologicals
, vol.39
, Issue.3
, pp. 171-180
-
-
Harazono, A.1
Kobayashi, T.2
Kawasaki, N.3
Itoh, S.4
Tada, M.5
Hashii, N.6
Ishii, A.7
Arato, T.8
Yanagihara, S.9
Yagi, Y.10
Koga, A.11
Tsuda, Y.12
Kimura, M.13
Sakita, M.14
Kitamura, S.15
Yamaguchi, H.16
Mimura, H.17
Murata, Y.18
Hamazume, Y.19
Sato, T.20
Natsuka, S.21
Kakehi, K.22
Kinoshita, M.23
Watanabe, S.24
Yamaguchi, T.25
more..
-
4
-
-
0026641016
-
Different culture methods lead to differences in glycosylation of a murine IgG monoclonal antibody
-
1:CAS:528:DyaK38Xlt12mur0%3D
-
Patel TP, Parekh RB, Moellering BJ, Prior CP (1992) Different culture methods lead to differences in glycosylation of a murine IgG monoclonal antibody. Biochem J 285(Pt 3):839-845
-
(1992)
Biochem J
, vol.285
, Issue.PART 3
, pp. 839-845
-
-
Patel, T.P.1
Parekh, R.B.2
Moellering, B.J.3
Prior, C.P.4
-
5
-
-
84872142761
-
Interpretation of protein quantitation using the Bradford assay: Comparison with two calculation models
-
1:CAS:528:DC%2BC3sXhtlCjur8%3D 10.1016/j.ab.2012.10.045
-
Ku HK, Lim HM, Oh KH, Yang HJ, Jeong JS, Kim SK (2013) Interpretation of protein quantitation using the Bradford assay: comparison with two calculation models. Anal Biochem 434(1):178-180
-
(2013)
Anal Biochem
, vol.434
, Issue.1
, pp. 178-180
-
-
Ku, H.K.1
Lim, H.M.2
Oh, K.H.3
Yang, H.J.4
Jeong, J.S.5
Kim, S.K.6
-
6
-
-
1542350348
-
High-sensitivity enzyme immunoassay for C-reactive protein in dried blood spots
-
1:CAS:528:DC%2BD2cXhvVChsL8%3D 10.1373/clinchem.2003.029488
-
McDade TW, Burhop J, Dohnal J (2004) High-sensitivity enzyme immunoassay for C-reactive protein in dried blood spots. Clin Chem 50(3):652-654
-
(2004)
Clin Chem
, vol.50
, Issue.3
, pp. 652-654
-
-
McDade, T.W.1
Burhop, J.2
Dohnal, J.3
-
7
-
-
81155161875
-
Quantification of human growth hormone by amino acid composition analysis using isotope dilution liquid-chromatography tandem mass spectrometry
-
1:CAS:528:DC%2BC3MXhtFSjsrnN 10.1016/j.chroma.2011.07.053
-
Jeong JS, Lim HM, Kim SK, Ku HK, Oh KH, Park SR (2011) Quantification of human growth hormone by amino acid composition analysis using isotope dilution liquid-chromatography tandem mass spectrometry. J Chromatogr A 1218:6596-6602
-
(2011)
J Chromatogr A
, vol.1218
, pp. 6596-6602
-
-
Jeong, J.S.1
Lim, H.M.2
Kim, S.K.3
Ku, H.K.4
Oh, K.H.5
Park, S.R.6
-
8
-
-
58149197941
-
Proteolytic-based method for the identification of human growth hormone
-
1:CAS:528:DC%2BD1MXhvVGgtb4%3D 10.1111/j.1556-4029.2008.00928.x
-
Wisniewski ES, Rees DK, Chege EW (2009) Proteolytic-based method for the identification of human growth hormone. J Forensic Sci 54(1):122-127
-
(2009)
J Forensic Sci
, vol.54
, Issue.1
, pp. 122-127
-
-
Wisniewski, E.S.1
Rees, D.K.2
Chege, E.W.3
-
9
-
-
69749093430
-
Application of amino acid analysis using hydrophilic interaction liquid chromatography coupled with isotope dilution mass spectrometry for peptide and protein quantification
-
1:CAS:528:DC%2BD1MXhtFams7vK 10.1016/j.jchromb.2009.07.027
-
Kato M, Kato H, Eyama S, Takatsu A (2009) Application of amino acid analysis using hydrophilic interaction liquid chromatography coupled with isotope dilution mass spectrometry for peptide and protein quantification. J Chromatogr B Anal Technol Biomed Life Sci 877:3059-3064
-
(2009)
J Chromatogr B Anal Technol Biomed Life Sci
, vol.877
, pp. 3059-3064
-
-
Kato, M.1
Kato, H.2
Eyama, S.3
Takatsu, A.4
-
10
-
-
77958457907
-
Quantification of protein calibrants by amino acid analysis using isotope dilution mass spectrometry
-
1:CAS:528:DC%2BC3cXhtleqtbvK 10.1016/j.ab.2010.08.037
-
Munoz A, Kral R, Schimmel H (2011) Quantification of protein calibrants by amino acid analysis using isotope dilution mass spectrometry. Anal Biochem 408(1):124-131
-
(2011)
Anal Biochem
, vol.408
, Issue.1
, pp. 124-131
-
-
Munoz, A.1
Kral, R.2
Schimmel, H.3
-
11
-
-
41849119779
-
Toward Systeme International d'Unite-traceable protein quantification: From amino acids to proteins
-
1:CAS:528:DC%2BD1cXkslejsbc%3D 10.1016/j.ab.2008.02.010
-
Burkitt WI, Pritchard C, Arsene C, Henrion A, Bunk D, O'Connor G (2008) Toward Systeme International d'Unite-traceable protein quantification: from amino acids to proteins. Anal Biochem 376(2):242-251
-
(2008)
Anal Biochem
, vol.376
, Issue.2
, pp. 242-251
-
-
Burkitt, W.I.1
Pritchard, C.2
Arsene, C.3
Henrion, A.4
Bunk, D.5
O'Connor, G.6
-
12
-
-
0032489017
-
Effect of the hydrolysis method on the determination of the amino acid composition of proteins
-
1:CAS:528:DyaK1cXntlSltA%3D%3D 10.1016/S0021-9673(97)00983-7
-
Weiss M, Manneberg M, Juranville JF, Lahm HW, Fountoulakis M (1998) Effect of the hydrolysis method on the determination of the amino acid composition of proteins. J Chromatogr A 795(2):263-275
-
(1998)
J Chromatogr A
, vol.795
, Issue.2
, pp. 263-275
-
-
Weiss, M.1
Manneberg, M.2
Juranville, J.F.3
Lahm, H.W.4
Fountoulakis, M.5
-
13
-
-
77955425309
-
Highly sensitive determination of recombinant human erythropoietin-alpha in aptamer-based affinity probe capillary electrophoresis with laser-induced fluorescence detection
-
1:CAS:528:DC%2BC3cXpvFOgsLc%3D 10.1016/j.chroma.2010.06.072
-
Shen R, Guo L, Zhang Z, Meng Q, Xie J (2010) Highly sensitive determination of recombinant human erythropoietin-alpha in aptamer-based affinity probe capillary electrophoresis with laser-induced fluorescence detection. J Chromatogr A 1217(35):5635-5641
-
(2010)
J Chromatogr A
, vol.1217
, Issue.35
, pp. 5635-5641
-
-
Shen, R.1
Guo, L.2
Zhang, Z.3
Meng, Q.4
Xie, J.5
-
14
-
-
29144460986
-
The role of erythropoietin therapy in the critically ill
-
10.1016/j.tmrv.2005.08.002
-
Corwin HL (2006) The role of erythropoietin therapy in the critically ill. Transfus Med Rev 20(1):27-33
-
(2006)
Transfus Med Rev
, vol.20
, Issue.1
, pp. 27-33
-
-
Corwin, H.L.1
-
15
-
-
84878205044
-
Mass spectrometric glycoform profiling of the innovator and biosimilar erythropoietin and darbepoetin by LC/ESI-MS
-
1:CAS:528:DC%2BC3sXhtVWgtbnP 10.1016/j.jpba.2013.04.031
-
Harazono A, Hashii N, Kuribayashi R, Nakazawa S, Kawasaki N (2013) Mass spectrometric glycoform profiling of the innovator and biosimilar erythropoietin and darbepoetin by LC/ESI-MS. J Pharm Biomed Anal 83:65-74
-
(2013)
J Pharm Biomed Anal
, vol.83
, pp. 65-74
-
-
Harazono, A.1
Hashii, N.2
Kuribayashi, R.3
Nakazawa, S.4
Kawasaki, N.5
-
16
-
-
0037974734
-
Asialoerythropoietin is a nonerythropoietic cytokine with broad neuroprotective activity in vivo
-
1:CAS:528:DC%2BD3sXktlygsLY%3D 10.1073/pnas.1031753100
-
Erbayraktar S, Grasso G, Sfacteria A, Xie QW, Coleman T, Kreilgaard M, Torup L, Sager T, Erbayraktar Z, Gokmen N, Yilmaz O, Ghezzi P, Villa P, Fratelli M, Casagrande S, Leist M, Helboe L, Gerwein J, Christensen S, Geist MA, Pedersen LO, Cerami-Hand C, Wuerth JP, Cerami A, Brines M (2003) Asialoerythropoietin is a nonerythropoietic cytokine with broad neuroprotective activity in vivo. Proc Natl Acad Sci U S A 100(11):6741-6746
-
(2003)
Proc Natl Acad Sci U S A
, vol.100
, Issue.11
, pp. 6741-6746
-
-
Erbayraktar, S.1
Grasso, G.2
Sfacteria, A.3
Xie, Q.W.4
Coleman, T.5
Kreilgaard, M.6
Torup, L.7
Sager, T.8
Erbayraktar, Z.9
Gokmen, N.10
Yilmaz, O.11
Ghezzi, P.12
Villa, P.13
Fratelli, M.14
Casagrande, S.15
Leist, M.16
Helboe, L.17
Gerwein, J.18
Christensen, S.19
Geist, M.A.20
Pedersen, L.O.21
Cerami-Hand, C.22
Wuerth, J.P.23
Cerami, A.24
Brines, M.25
more..
-
17
-
-
0030871219
-
Separation methods for glycoprotein analysis and preparation
-
1:CAS:528:DyaK2sXmvFWitLs%3D 10.1016/S0378-4347(97)00155-2
-
Kishino S, Miyazaki K (1997) Separation methods for glycoprotein analysis and preparation. J Chromatogr B Biomed Sci Appl 699(1-2):371-381
-
(1997)
J Chromatogr B Biomed Sci Appl
, vol.699
, Issue.1-2
, pp. 371-381
-
-
Kishino, S.1
Miyazaki, K.2
-
18
-
-
0017184389
-
A rapid and sensitive method for the quantitation of microgram quantities of protein utilizing the principle of protein-dye binding
-
1:CAS:528:DyaE28XksVehtrY%3D 10.1016/0003-2697(76)90527-3
-
Bradford MM (1976) A rapid and sensitive method for the quantitation of microgram quantities of protein utilizing the principle of protein-dye binding. Anal Biochem 72:248-254
-
(1976)
Anal Biochem
, vol.72
, pp. 248-254
-
-
Bradford, M.M.1
-
20
-
-
76149105245
-
The international vocabulary of metrology, basic and general concepts and associated terms (VIM), 3rd edition
-
BIPM I, IFCC, ILAC, ISO, IUPAC, IUPAP, OIML. 2012(E/F)
-
BIPM I, IFCC, ILAC, ISO, IUPAC, IUPAP, OIML (2012) The international vocabulary of metrology, basic and general concepts and associated terms (VIM), 3rd edition. JCGM 200:2012(E/F)
-
(2012)
JCGM
, vol.200
-
-
-
21
-
-
33845295483
-
Development of a sensitive size exclusion HPLC method with fluorescence detection for the quantitation of recombinant human erythropoietin (r-HuEPO) aggregates
-
1:CAS:528:DC%2BD28Xht12rtLzE 10.1016/j.jpba.2006.06.006
-
Gunturi SR, Ghobrial I, Sharma B (2007) Development of a sensitive size exclusion HPLC method with fluorescence detection for the quantitation of recombinant human erythropoietin (r-HuEPO) aggregates. J Pharm Biomed Anal 43(1):213-221
-
(2007)
J Pharm Biomed Anal
, vol.43
, Issue.1
, pp. 213-221
-
-
Gunturi, S.R.1
Ghobrial, I.2
Sharma, B.3
-
22
-
-
0037458584
-
Glycolysis and glutamate accumulation into synaptic vesicles. Role of glyceraldehyde phosphate dehydrogenase and 3-phosphoglycerate kinase
-
1:CAS:528:DC%2BD3sXht1aqt7o%3D 10.1074/jbc.M211617200
-
Ikemoto A, Bole DG, Ueda T (2003) Glycolysis and glutamate accumulation into synaptic vesicles. Role of glyceraldehyde phosphate dehydrogenase and 3-phosphoglycerate kinase. J Biol Chem 278(8):5929-5940
-
(2003)
J Biol Chem
, vol.278
, Issue.8
, pp. 5929-5940
-
-
Ikemoto, A.1
Bole, D.G.2
Ueda, T.3
-
23
-
-
58149147240
-
Sample preparation and fractionation for proteome analysis and cancer biomarker discovery by mass spectrometry
-
1:CAS:528:DC%2BD1MXktlShsL0%3D
-
Ahmed FE (2009) Sample preparation and fractionation for proteome analysis and cancer biomarker discovery by mass spectrometry. J Sep Sci 32(5-6):771-798
-
(2009)
J Sep Sci
, vol.32
, Issue.5-6
, pp. 771-798
-
-
Ahmed, F.E.1
-
24
-
-
0031784879
-
Hydrolysis and amino acid composition of proteins
-
1:CAS:528:DyaK1MXjsFah 10.1016/S0021-9673(98)00721-3
-
Fountoulakis M, Lahm HW (1998) Hydrolysis and amino acid composition of proteins. J Chromatogr A 826(2):109-134
-
(1998)
J Chromatogr A
, vol.826
, Issue.2
, pp. 109-134
-
-
Fountoulakis, M.1
Lahm, H.W.2
-
25
-
-
77950898128
-
Evaluation of measurement data: Guide to the expression of uncertainty in measurement (GUM)
-
BIPM I, IFCC, ILAC, ISO, IUPAC, IUPAP, OIML (ed). 2008
-
BIPM I, IFCC, ILAC, ISO, IUPAC, IUPAP, OIML (ed) (2008) Evaluation of measurement data: guide to the expression of uncertainty in measurement (GUM), vol JCGM 100:2008.
-
(2008)
JCGM
, vol.100
-
-
-
26
-
-
73649093464
-
Estimating uncertainty in analytical procedures based on chromatographic techniques
-
1:CAS:528:DC%2BC3cXotlSrug%3D%3D 10.1016/j.chroma.2009.03.078
-
Konieczka P, Namiesnik J (2010) Estimating uncertainty in analytical procedures based on chromatographic techniques. J Chromatogr A 1217(6):882-891
-
(2010)
J Chromatogr A
, vol.1217
, Issue.6
, pp. 882-891
-
-
Konieczka, P.1
Namiesnik, J.2
-
27
-
-
84862831054
-
High accuracy analysis of glucose in human serum by isotope dilution liquid chromatography-tandem mass spectrometry
-
1:CAS:528:DC%2BC38Xit12is7g%3D 10.1016/j.cca.2012.01.025
-
Chen Y, Liu Q, Yong S, Lee TK (2012) High accuracy analysis of glucose in human serum by isotope dilution liquid chromatography-tandem mass spectrometry. Clin Chim Acta 413(7-8):808-813
-
(2012)
Clin Chim Acta
, vol.413
, Issue.7-8
, pp. 808-813
-
-
Chen, Y.1
Liu, Q.2
Yong, S.3
Lee, T.K.4
|