-
1
-
-
10744230729
-
Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules
-
DeSilva B, Smith W, Weiner R et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. 20(11), 1885-1900 (2003).
-
(2003)
Pharm. Res.
, vol.20
, Issue.11
, pp. 1885-1900
-
-
Desilva, B.1
Smith, W.2
Weiner, R.3
-
2
-
-
3142534409
-
Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
-
Mire-Sluis AR, Barrett YC, Devanarayan V et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J. Immunol. Methods 289(1), 1-16 (2004).
-
(2004)
J. Immunol. Methods
, vol.289
, Issue.1
, pp. 1-16
-
-
Mire-Sluis, A.R.1
Barrett, Y.C.2
Devanarayan, V.3
-
3
-
-
0034469255
-
Bioanalytical method validation- A revisit with a decade of progress
-
Shah V P, Midha KK, Findlay JW et al. Bioanalytical method validation- A revisit with a decade of progress. Pharm. Res. 17(12), 1551-1557 (2000).
-
(2000)
Pharm. Res.
, vol.17
, Issue.12
, pp. 1551-1557
-
-
Shah, V.P.1
Midha, K.K.2
Findlay, J.W.3
-
4
-
-
32544451155
-
Fit-for-purpose method development and validation for successful biomarker measurement
-
Lee JW, Devanarayan V, Barrett YC et al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res. 23(2), 312-328 (2006).
-
(2006)
Pharm. Res.
, vol.23
, Issue.2
, pp. 312-328
-
-
Lee, J.W.1
Devanarayan, V.2
Barrett, Y.C.3
-
5
-
-
39449114054
-
Biomarker method validation in anticancer drug development
-
Cummings J, Ward TH, Greystoke A et al. Biomarker method validation in anticancer drug development. Br. J. Pharmacol. 153(4), 646-656 (2008).
-
(2008)
Br. J. Pharmacol.
, vol.153
, Issue.4
, pp. 646-656
-
-
Cummings, J.1
Ward, T.H.2
Greystoke, A.3
-
6
-
-
33847397009
-
The history of bioanalytical method validation and regulation: Evolution of a guidance document on bioanalytical methods validation
-
Shah VP. The history of bioanalytical method validation and regulation: evolution of a guidance document on bioanalytical methods validation. AAPS J. 9, E43-E47 (2007).
-
(2007)
AAPS J.
, vol.9
-
-
Shah, V.P.1
-
7
-
-
0034852176
-
Workshop on bioanalytical methods validation for macromolecules: Summary report
-
Miller KJ, Bowsher RR, Celniker A et al. Workshop on bioanalytical methods validation for macromolecules: summary report. Pharm. Res. 18(9), 1373-1383 (2001).
-
(2001)
Pharm. Res.
, vol.18
, Issue.9
, pp. 1373-1383
-
-
Miller, K.J.1
Bowsher, R.R.2
Celniker, A.3
-
8
-
-
4544304960
-
Multiplex bead array assays for detection of soluble cytokines: Comparisons of sensitivity and quantitative values among kits from multiple manufacturers
-
Khan SS, Smith MS, Reda D et al. Multiplex bead array assays for detection of soluble cytokines: comparisons of sensitivity and quantitative values among kits from multiple manufacturers. Cytometry B Clin. Cytom. 61(1), 35-39 (2004).
-
(2004)
Cytometry B Clin. Cytom.
, vol.61
, Issue.1
, pp. 35-39
-
-
Khan, S.S.1
Smith, M.S.2
Reda, D.3
-
9
-
-
0035043203
-
Immunoassay standardization: Is it possible, who is responsible, who is capable?
-
Stenman UH. Immunoassay standardization: is it possible, who is responsible, who is capable? Clin. Chem. 47(5), 815-820 (2001).
-
(2001)
Clin. Chem.
, vol.47
, Issue.5
, pp. 815-820
-
-
Stenman, U.H.1
-
10
-
-
57249089001
-
Validation and comparison of two multiplex technologies, luminex and mesoscale discovery for human cytokine profling
-
Chowdhury F, Williams A, Johnson P. Validation and comparison of two multiplex technologies, luminex and mesoscale discovery for human cytokine profling. J. Immunol. Methods 340(1), 55-64 (2009).
-
(2009)
J. Immunol. Methods
, vol.340
, Issue.1
, pp. 55-64
-
-
Chowdhury, F.1
Williams, A.2
Johnson, P.3
-
11
-
-
33846599701
-
Immunoaffnity CE in clinical ana lysis of body fuids and tissues
-
Amundsen LK, Siren H. Immunoaffnity CE in clinical ana lysis of body fuids and tissues. Electrophoresis 28(1-2), 99-113 (2007).
-
(2007)
Electrophoresis
, vol.28
, Issue.1-2
, pp. 99-113
-
-
Amundsen, L.K.1
Siren, H.2
-
12
-
-
0034091322
-
The diagnostic properties of rheumatoid arthritis antibodies recognizing a cyclic citrullinated peptide
-
Schellekens GA, Visser H, de Jong BA et al. The diagnostic properties of rheumatoid arthritis antibodies recognizing a cyclic citrullinated peptide. Arthritis Rheum. 43(1), 155-163 (2000).
-
(2000)
Arthritis Rheum.
, vol.43
, Issue.1
, pp. 155-163
-
-
Schellekens, G.A.1
Visser, H.2
De Jong, B.A.3
|