-
1
-
-
65649105815
-
Safety, tolerability, pharmacokinetics, and immunogenicity of motavizumab, a humanized, enhanced-potency monoclonal antibody for the prevention of respiratory syncytial virus infection in at-risk children
-
Abarca K., Jung E., Fernandez P., Zhao L., Harris B., Connor E.M., Losonsky G.A. Safety, tolerability, pharmacokinetics, and immunogenicity of motavizumab, a humanized, enhanced-potency monoclonal antibody for the prevention of respiratory syncytial virus infection in at-risk children. Pediatr. Infect. Dis. J. 2009, 28:267.
-
(2009)
Pediatr. Infect. Dis. J.
, vol.28
, pp. 267
-
-
Abarca, K.1
Jung, E.2
Fernandez, P.3
Zhao, L.4
Harris, B.5
Connor, E.M.6
Losonsky, G.A.7
-
2
-
-
58149154725
-
Validation of analytic methods for biomarkers used in drug development
-
Chau C.H., Rixe O., McLeod H., Figg W.D. Validation of analytic methods for biomarkers used in drug development. Clin. Cancer Res. 2008, 14:5967.
-
(2008)
Clin. Cancer Res.
, vol.14
, pp. 5967
-
-
Chau, C.H.1
Rixe, O.2
McLeod, H.3
Figg, W.D.4
-
3
-
-
78649689433
-
From research to regulated: challenges in transferring methods
-
Chowdhury F., Williams A.P. From research to regulated: challenges in transferring methods. Bioanalysis 2010, 1:285.
-
(2010)
Bioanalysis
, vol.1
, pp. 285
-
-
Chowdhury, F.1
Williams, A.P.2
-
4
-
-
67449149486
-
Development and validation of an enzyme-linked immunosorbent assay for the quantification of trastuzumab in human serum and plasma
-
Damen C.W., de Groot E.R., Heij M., Boss D.S., Schellens J.H., Rosing H., Beijnen J.H., Aarden L.A. Development and validation of an enzyme-linked immunosorbent assay for the quantification of trastuzumab in human serum and plasma. Anal. Biochem. 2009, 391:114.
-
(2009)
Anal. Biochem.
, vol.391
, pp. 114
-
-
Damen, C.W.1
de Groot, E.R.2
Heij, M.3
Boss, D.S.4
Schellens, J.H.5
Rosing, H.6
Beijnen, J.H.7
Aarden, L.A.8
-
5
-
-
10744230729
-
Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules
-
DeSilva B., Smith W., Weiner R., Kelley M., Smolec J., Lee B., Khan M., Tacey R., Hill H., Celniker A. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. 2003, 20:1885.
-
(2003)
Pharm. Res.
, vol.20
, pp. 1885
-
-
DeSilva, B.1
Smith, W.2
Weiner, R.3
Kelley, M.4
Smolec, J.5
Lee, B.6
Khan, M.7
Tacey, R.8
Hill, H.9
Celniker, A.10
-
6
-
-
0033989957
-
Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective
-
Findlay J.W., Smith W.C., Lee J.W., Nordblom G.D., Das I., DeSilva B.S., Khan M.N., Bowsher R.R. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J. Pharm. Biomed. Anal. 2000, 21:1249.
-
(2000)
J. Pharm. Biomed. Anal.
, vol.21
, pp. 1249
-
-
Findlay, J.W.1
Smith, W.C.2
Lee, J.W.3
Nordblom, G.D.4
Das, I.5
DeSilva, B.S.6
Khan, M.N.7
Bowsher, R.R.8
-
7
-
-
65649146104
-
Development and validation of cell-based ELISA for the quantification of trastuzumab in human plasma
-
Jamieson D., Cresti N., Verrill M.W., Boddy A.V. Development and validation of cell-based ELISA for the quantification of trastuzumab in human plasma. J. Immunol. Methods 2009, 345:106.
-
(2009)
J. Immunol. Methods
, vol.345
, pp. 106
-
-
Jamieson, D.1
Cresti, N.2
Verrill, M.W.3
Boddy, A.V.4
-
8
-
-
0036890997
-
Immune responses to therapeutic proteins in humans-clinical significance, assessment and prediction
-
Koren E., Zuckerman L.A., Mire-Sluis A.R. Immune responses to therapeutic proteins in humans-clinical significance, assessment and prediction. Curr. Pharm. Biotechnol. 2002, 3:349.
-
(2002)
Curr. Pharm. Biotechnol.
, vol.3
, pp. 349
-
-
Koren, E.1
Zuckerman, L.A.2
Mire-Sluis, A.R.3
-
9
-
-
32544451155
-
Fit-for-purpose method development and validation for successful biomarker measurement
-
Lee J.W., Devanarayan V., Barrett Y.C., Weiner R., Allinson J., Fountain S., Keller S., Weinryb I., Green M., Duan L., Rogers J.A., Millham R., O'Brien P.J., Sailstad J., Khan M., Ray C., Wagner J.A. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res. 2006, 23:312.
-
(2006)
Pharm. Res.
, vol.23
, pp. 312
-
-
Lee, J.W.1
Devanarayan, V.2
Barrett, Y.C.3
Weiner, R.4
Allinson, J.5
Fountain, S.6
Keller, S.7
Weinryb, I.8
Green, M.9
Duan, L.10
Rogers, J.A.11
Millham, R.12
O'Brien, P.J.13
Sailstad, J.14
Khan, M.15
Ray, C.16
Wagner, J.A.17
-
10
-
-
61349180127
-
Fit for purpose? A case study: validation of immunological endpoint assays for the detection of cellular and humoral responses to anti-tumour DNA fusion vaccines
-
Mander A., Chowdhury F., Low L., Ottensmeier C.H. Fit for purpose? A case study: validation of immunological endpoint assays for the detection of cellular and humoral responses to anti-tumour DNA fusion vaccines. Cancer Immunol. Immunother. 2009, 58:789.
-
(2009)
Cancer Immunol. Immunother.
, vol.58
, pp. 789
-
-
Mander, A.1
Chowdhury, F.2
Low, L.3
Ottensmeier, C.H.4
-
11
-
-
13844315800
-
Development and validation of ELISA for herceptin detection in human serum
-
Maple L., Lathrop R., Bozich S., Harman W., Tacey R., Kelley M., Danilkovitch-Miagkova A. Development and validation of ELISA for herceptin detection in human serum. J. Immunol. Methods 2004, 295:169.
-
(2004)
J. Immunol. Methods
, vol.295
, pp. 169
-
-
Maple, L.1
Lathrop, R.2
Bozich, S.3
Harman, W.4
Tacey, R.5
Kelley, M.6
Danilkovitch-Miagkova, A.7
-
12
-
-
73849103192
-
Rheumatoid factor interference in a tacrolimus immunoassay
-
Martin B.B., Marquet P., Ferrer J.M., Puig B.C., Bennasar A.B., Prieto M.R., Marques R.F. Rheumatoid factor interference in a tacrolimus immunoassay. Ther. Drug Monit. 2009, 31:743.
-
(2009)
Ther. Drug Monit.
, vol.31
, pp. 743
-
-
Martin, B.B.1
Marquet, P.2
Ferrer, J.M.3
Puig, B.C.4
Bennasar, A.B.5
Prieto, M.R.6
Marques, R.F.7
-
13
-
-
3142534409
-
Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
-
Mire-Sluis A.R., Barrett Y.C., Devanarayan V., Koren E., Liu H., Maia M., Parish T., Scott G., Shankar G., Shores E., Swanson S.J., Taniguchi G., Wierda D., Zuckerman L.A. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J. Immunol. Methods 2004, 289:1.
-
(2004)
J. Immunol. Methods
, vol.289
, pp. 1
-
-
Mire-Sluis, A.R.1
Barrett, Y.C.2
Devanarayan, V.3
Koren, E.4
Liu, H.5
Maia, M.6
Parish, T.7
Scott, G.8
Shankar, G.9
Shores, E.10
Swanson, S.J.11
Taniguchi, G.12
Wierda, D.13
Zuckerman, L.A.14
-
14
-
-
60349087476
-
Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies
-
Muller P.Y., Brennan F.R. Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies. Clin. Pharmacol. Ther. 2009, 85:247.
-
(2009)
Clin. Pharmacol. Ther.
, vol.85
, pp. 247
-
-
Muller, P.Y.1
Brennan, F.R.2
-
15
-
-
73349094029
-
A step-wise approach for transfer of immunogenicity assays during clinical drug development
-
Tatarewicz S., Moxness M., Weeraratne D., Zhou L., Hale M., Swanson S.J., Chirmule N. A step-wise approach for transfer of immunogenicity assays during clinical drug development. AAPS J. 2009, 11:526.
-
(2009)
AAPS J.
, vol.11
, pp. 526
-
-
Tatarewicz, S.1
Moxness, M.2
Weeraratne, D.3
Zhou, L.4
Hale, M.5
Swanson, S.J.6
Chirmule, N.7
-
16
-
-
33847732132
-
Immunogenicity screening in protein drug development
-
Van W.I., Gansemans Y., Parren P.W., Stas P., Lasters I. Immunogenicity screening in protein drug development. Expert Opin. Biol. Ther. 2007, 7:405.
-
(2007)
Expert Opin. Biol. Ther.
, vol.7
, pp. 405
-
-
Van, W.I.1
Gansemans, Y.2
Parren, P.W.3
Stas, P.4
Lasters, I.5
-
17
-
-
53849119826
-
Development, validation, and clinical implementation of an assay to measure total antibody response to naglazyme (galsulfase)
-
White J.T., Martell L.A., Van T.A., Boyer R., Warness L., Taniguchi G.T., Foehr E. Development, validation, and clinical implementation of an assay to measure total antibody response to naglazyme (galsulfase). AAPS J. 2008, 10:363.
-
(2008)
AAPS J.
, vol.10
, pp. 363
-
-
White, J.T.1
Martell, L.A.2
Van, T.A.3
Boyer, R.4
Warness, L.5
Taniguchi, G.T.6
Foehr, E.7
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