-
1
-
-
0042625050
-
An analysis of the SFSTP guide on validation of chromatographic bioanalytical methods: Progress and limitations
-
Boulanger B, Chiap P, Dewe W, Crommen J, Hubert P (2003) An analysis of the SFSTP guide on validation of chromatographic bioanalytical methods: progress and limitations. J Pharm Biomed Anal 32: 753-765
-
(2003)
J Pharm Biomed Anal
, vol.32
, pp. 753-765
-
-
Boulanger, B.1
Chiap, P.2
Dewe, W.3
Crommen, J.4
Hubert, P.5
-
2
-
-
67650476312
-
A risk-based analysis of the AAPS conference report on quantitative bioanalytical methods validation and implementation
-
Boulanger B, Rozet E, Moonen F, Rudaz S, Hubert P (2009) A risk-based analysis of the AAPS conference report on quantitative bioanalytical methods validation and implementation. J Chromatogr B Analyt Technol Biomed Life Sci 877: 2235-2243
-
(2009)
J Chromatogr B Analyt Technol Biomed Life Sci
, vol.877
, pp. 2235-2243
-
-
Boulanger, B.1
Rozet, E.2
Moonen, F.3
Rudaz, S.4
Hubert, P.5
-
3
-
-
75149113069
-
Can molecular biomarker-based patient selection in phase i trials accelerate anticancer drug development?
-
Carden CP, Sarker D, Postel-Vinay S, Yap TA, Attard G, Banerji U, Garrett MD, Thomas GV, Workman P, Kaye SB, de Bono JS (2010) Can molecular biomarker-based patient selection in phase I trials accelerate anticancer drug development? Drug Discov Today 15: 88-97
-
(2010)
Drug Discov Today
, vol.15
, pp. 88-97
-
-
Carden, C.P.1
Sarker, D.2
Postel-Vinay, S.3
Yap, T.A.4
Attard, G.5
Banerji, U.6
Garrett, M.D.7
Thomas, G.V.8
Workman, P.9
Kaye, S.B.10
De Bono, J.S.11
-
4
-
-
34548558675
-
Qualification of M30 and M65 ELISAs as surrogate biomarkers of cell death: Long term antigen stability in cancer patient plasma
-
Cummings J, Ranson M, Butt F, Moore D, Dive C (2007) Qualification of M30 and M65 ELISAs as surrogate biomarkers of cell death: long term antigen stability in cancer patient plasma. Cancer Chemother Pharmacol 60: 921-924
-
(2007)
Cancer Chemother Pharmacol
, vol.60
, pp. 921-924
-
-
Cummings, J.1
Ranson, M.2
Butt, F.3
Moore, D.4
Dive, C.5
-
5
-
-
39449114054
-
Biomarker method validation in anticancer drug development
-
Cummings J, Ward TH, Greystoke A, Ranson M, Dive C (2008) Biomarker method validation in anticancer drug development. Br J Pharmacol 153: 646-656
-
(2008)
Br J Pharmacol
, vol.153
, pp. 646-656
-
-
Cummings, J.1
Ward, T.H.2
Greystoke, A.3
Ranson, M.4
Dive, C.5
-
6
-
-
63749097010
-
Phase i trial of AEG35156 administered as a 7-day and 3-day continuous intravenous infusion in patients with advanced refractory cancer
-
Dean E, Jodrell D, Connolly K, Danson S, Jolivet J, Durkin J, Morris S, Jowle D, Ward T, Cummings J, Dickinson G, Aarons L, Lacasse E, Robson L, Dive C, Ranson M (2009) Phase I trial of AEG35156 administered as a 7-day and 3-day continuous intravenous infusion in patients with advanced refractory cancer. J Clin Oncol 27: 1660-1666
-
(2009)
J Clin Oncol
, vol.27
, pp. 1660-1666
-
-
Dean, E.1
Jodrell, D.2
Connolly, K.3
Danson, S.4
Jolivet, J.5
Durkin, J.6
Morris, S.7
Jowle, D.8
Ward, T.9
Cummings, J.10
Dickinson, G.11
Aarons, L.12
Lacasse, E.13
Robson, L.14
Dive, C.15
Ranson, M.16
-
7
-
-
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 (2003) Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res 20: 1885-1900
-
(2003)
Pharm Res
, vol.20
, pp. 1885-1900
-
-
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
-
8
-
-
68249147642
-
Workshop report and follow-up-AAPS Workshop on current topics in GLP bioanalysis: Assay reproducibility for incurred samples-implications of Crystal City recommendations
-
Fast DM, Kelley M, Viswanathan CT, O'Shaughnessy J, King SP, Chaudhary A, Weiner R, DeStefano AJ, Tang D (2009) Workshop report and follow-up-AAPS Workshop on current topics in GLP bioanalysis: Assay reproducibility for incurred samples-implications of Crystal City recommendations. AAPS J 11: 238-241
-
(2009)
AAPS J
, vol.11
, pp. 238-241
-
-
Fast, D.M.1
Kelley, M.2
Viswanathan, C.T.3
O'Shaughnessy, J.4
King, S.P.5
Chaudhary, A.6
Weiner, R.7
Destefano, A.J.8
Tang, D.9
-
9
-
-
34347402781
-
Validation of analytical methods based on accuracy profiles
-
Feinberg M (2007) Validation of analytical methods based on accuracy profiles. J Chromatogr A 1158: 174-183
-
(2007)
J Chromatogr A
, vol.1158
, pp. 174-183
-
-
Feinberg, M.1
-
10
-
-
9944255782
-
New advances in method validation and measurement uncertainty aimed at improving the quality of chemical data
-
Feinberg M, Boulanger B, Dewe W, Hubert P (2004) New advances in method validation and measurement uncertainty aimed at improving the quality of chemical data. Anal Bioanal Chem 380: 502-514
-
(2004)
Anal Bioanal Chem
, vol.380
, pp. 502-514
-
-
Feinberg, M.1
Boulanger, B.2
Dewe, W.3
Hubert, P.4
-
11
-
-
57149111489
-
Specificity and accuracy data for ligand-binding assays for macromolecules should be interpreted with caution
-
Findlay JW (2008) Specificity and accuracy data for ligand-binding assays for macromolecules should be interpreted with caution. AAPS J 10: 433-434
-
(2008)
AAPS J
, vol.10
, pp. 433-434
-
-
Findlay, J.W.1
-
12
-
-
67650139598
-
Some important considerations for validation of ligand-binding assays
-
Findlay JW (2009) Some important considerations for validation of ligand-binding assays. J Chromatogr B Analyt Technol Biomed Life Sci 877: 2191-2197
-
(2009)
J Chromatogr B Analyt Technol Biomed Life Sci
, vol.877
, pp. 2191-2197
-
-
Findlay, J.W.1
-
13
-
-
0033989957
-
Validation of immunoassays for bioanalysis: A pharmaceutical industry perspective
-
Findlay JW, Smith WC, Lee JW, Nordblom GD, Das I, DeSilva BS, Khan MN, Bowsher RR (2000) Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J Pharm Biomed Anal 21: 1249-1273
-
(2000)
J Pharm Biomed Anal
, vol.21
, pp. 1249-1273
-
-
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
-
14
-
-
43049111423
-
Optimisation of circulating biomarkers of cell death for routine clinical use
-
Greystoke A, Cummings J, Ward TH, Simpson K, Renehan A, Butt F, Moore D, Gietema J, Blackhall F, Ranson M, Hughes A, Dive C (2008) Optimisation of circulating biomarkers of cell death for routine clinical use. Ann Oncol 19: 990-995
-
(2008)
Ann Oncol
, vol.19
, pp. 990-995
-
-
Greystoke, A.1
Cummings, J.2
Ward, T.H.3
Simpson, K.4
Renehan, A.5
Butt, F.6
Moore, D.7
Gietema, J.8
Blackhall, F.9
Ranson, M.10
Hughes, A.11
Dive, C.12
-
15
-
-
68449100184
-
Evaluation of circulating tumor cells and serological cell death biomarkers in small cell lung cancer patients undergoing chemotherapy
-
Hou JM, Greystoke A, Lancashire L, Cummings J, Ward T, Board R, Amir E, Hughes S, Krebs M, Hughes A, Ranson M, Lorigan P, Dive C, Blackhall FH (2009) Evaluation of circulating tumor cells and serological cell death biomarkers in small cell lung cancer patients undergoing chemotherapy. Am J Pathol 175: 808-816
-
(2009)
Am J Pathol
, vol.175
, pp. 808-816
-
-
Hou, J.M.1
Greystoke, A.2
Lancashire, L.3
Cummings, J.4
Ward, T.5
Board, R.6
Amir, E.7
Hughes, S.8
Krebs, M.9
Hughes, A.10
Ranson, M.11
Lorigan, P.12
Dive, C.13
Blackhall, F.H.14
-
16
-
-
67650380136
-
Biomarkers of response and resistance to antiangiogenic therapy
-
Jain RK, Duda DG, Willett CG, Sahani DV, Zhu AX, Loeffler JS, Batchelor TT, Sorensen AG (2009) Biomarkers of response and resistance to antiangiogenic therapy. Nat Rev Clin Oncol 6: 327-338
-
(2009)
Nat Rev Clin Oncol
, vol.6
, pp. 327-338
-
-
Jain, R.K.1
Duda, D.G.2
Willett, C.G.3
Sahani, D.V.4
Zhu, A.X.5
Loeffler, J.S.6
Batchelor, T.T.7
Sorensen, A.G.8
-
17
-
-
34249277443
-
Key elements of bioanalytical method validation for macromolecules
-
Kelley M, DeSilva B (2007) Key elements of bioanalytical method validation for macromolecules. AAPS J 9: E156-E163
-
(2007)
AAPS J
, vol.9
-
-
Kelley, M.1
Desilva, B.2
-
18
-
-
32544451155
-
Fit-for-purpose method development and validation for successful biomarker measurement
-
Lee JW, Devanarayan V, Barrett YC, Weiner R, Allinson J, Fountain S, Keller S, Weinryb I, Green M, Duan L, Rogers JA, Millham R, O'Brien PJ, Sailstad J, Khan M, Ray C, Wagner JA (2006) Fit-for-purpose method development and validation for successful biomarker measurement. Pharm Res 23: 312-328
-
(2006)
Pharm Res
, vol.23
, pp. 312-328
-
-
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
-
19
-
-
33845205234
-
Biomarker assay translation from discovery to clinical studies in cancer drug development: Quantification of emerging protein biomarkers
-
Lee JW, Figeys D, Vasilescu J (2007) Biomarker assay translation from discovery to clinical studies in cancer drug development: quantification of emerging protein biomarkers. Adv Cancer Res 96: 269-298
-
(2007)
Adv Cancer Res
, vol.96
, pp. 269-298
-
-
Lee, J.W.1
Figeys, D.2
Vasilescu, J.3
-
20
-
-
20944433395
-
Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: A conference report
-
Lee JW, Weiner RS, Sailstad JM, Bowsher RR, Knuth DW, O'Brien PJ, Fourcroy JL, Dixit R, Pandite L, Pietrusko RG, Soares HD, Quarmby V,Vesterqvist OL, Potter DM, Witliff JL, Fritche HA, O'Leary T, Perlee L, Kadam S, Wagner JA (2005) Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report. Pharm Res 22: 499-511
-
(2005)
Pharm Res
, vol.22
, pp. 499-511
-
-
Lee, J.W.1
Weiner, R.S.2
Sailstad, J.M.3
Bowsher, R.R.4
Knuth, D.W.5
O'Brien, P.J.6
Fourcroy, J.L.7
Dixit, R.8
Pandite, L.9
Pietrusko, R.G.10
Soares, H.D.11
Quarmby, V.12
Vesterqvist, O.L.13
Potter, D.M.14
Witliff, J.L.15
Fritche, H.A.16
O'Leary, T.17
Perlee, L.18
Kadam, S.19
Wagner, J.A.20
more..
-
21
-
-
28544446695
-
Biomarkers in cancer staging, prognosis and treatment selection
-
Ludwig JA, Weinstein JN (2005) Biomarkers in cancer staging, prognosis and treatment selection. Nat Cancer Rev 5: 845-856
-
(2005)
Nat Cancer Rev
, vol.5
, pp. 845-856
-
-
Ludwig, J.A.1
Weinstein, J.N.2
-
22
-
-
68949085124
-
Protein aggregation: Pathways, induction factors and analysis
-
Mahler HC, Friess W, Grauschopf U, Kiese S (2009) Protein aggregation: pathways, induction factors and analysis. J Pharm Sci 98: 2909-2934
-
(2009)
J Pharm Sci
, vol.98
, pp. 2909-2934
-
-
Mahler, H.C.1
Friess, W.2
Grauschopf, U.3
Kiese, S.4
-
23
-
-
63449108223
-
Effective incorporation of biomarkers into phase II trials
-
McShane LM, Hunsberger S, Adjei AA (2009) Effective incorporation of biomarkers into phase II trials. Clin Cancer Res 15: 1898-1905
-
(2009)
Clin Cancer Res
, vol.15
, pp. 1898-1905
-
-
McShane, L.M.1
Hunsberger, S.2
Adjei, A.A.3
-
24
-
-
34247894006
-
Best practices during bioanalytical method validation for the characterisation of assay reagents and the evaluation of analyte stability in assay standards, quality controls and study samples
-
Nowatzke W, Wood E (2007) Best practices during bioanalytical method validation for the characterisation of assay reagents and the evaluation of analyte stability in assay standards, quality controls and study samples. AAPS J 9: E117-E122
-
(2007)
AAPS J
, vol.9
-
-
Nowatzke, W.1
Wood, E.2
-
25
-
-
34447107152
-
Using tolerance intervals in pre-study validation of analytical methods to predict in-study results. The fit-for-future-purpose concept
-
Rozet E, Hubert C, Ceccato A, Dewe W, Ziemons E, Moonen F, Michail K, Wintersteiger R, Streel B, Boulanger B, Hubert P (2007) Using tolerance intervals in pre-study validation of analytical methods to predict in-study results. The fit-for-future-purpose concept. J Chromatogr A 1158: 126-137
-
(2007)
J Chromatogr A
, vol.1158
, pp. 126-137
-
-
Rozet, E.1
Hubert, C.2
Ceccato, A.3
Dewe, W.4
Ziemons, E.5
Moonen, F.6
Michail, K.7
Wintersteiger, R.8
Streel, B.9
Boulanger, B.10
Hubert, P.11
-
26
-
-
33845293253
-
Pharmacodynamic biomarkers for molecular cancer therapeutics
-
Sarker D, Workman P (2007) Pharmacodynamic biomarkers for molecular cancer therapeutics. Adv Cancer Res 96: 213-268
-
(2007)
Adv Cancer Res
, vol.96
, pp. 213-268
-
-
Sarker, D.1
Workman, P.2
-
27
-
-
0026336726
-
Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies. Conference report
-
Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A, Layloff T, Viswanathan CT, Cook CE, McDowall RD (1991) Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Conference report. Eur J Drug Metab Pharmacokinet 16: 249-255
-
(1991)
Eur J Drug Metab Pharmacokinet
, vol.16
, pp. 249-255
-
-
Shah, V.P.1
Midha, K.K.2
Dighe, S.3
McGilveray, I.J.4
Skelly, J.P.5
Yacobi, A.6
Layloff, T.7
Viswanathan, C.T.8
Cook, C.E.9
McDowall, R.D.10
-
28
-
-
0034469255
-
Bioanalytical method validation-a revisit with a decade of progress
-
Shah VP, Midha KK, Findlay JW, Hill HM, Hulse JD, McGilveray IJ, McKay G, Miller KJ, Patnaik RN, Powell ML, Tonelli A, Viswanathan CT, Yacobi A (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
Hill, H.M.4
Hulse, J.D.5
McGilveray, I.J.6
McKay, G.7
Miller, K.J.8
Patnaik, R.N.9
Powell, M.L.10
Tonelli, A.11
Viswanathan, C.T.12
Yacobi, A.13
-
29
-
-
70350163204
-
Biomarker-driven early clinical trials in oncology: A paradigm shift in drug development
-
Tan DS, Thomas GV, Garrett MD, Banerji U, de Bono JS, Kaye SB, Workman P (2009) Biomarker-driven early clinical trials in oncology: a paradigm shift in drug development. Cancer J 15: 406-420
-
(2009)
Cancer J
, vol.15
, pp. 406-420
-
-
Tan, D.S.1
Thomas, G.V.2
Garrett, M.D.3
Banerji, U.4
De Bono, J.S.5
Kaye, S.B.6
Workman, P.7
-
30
-
-
33847184252
-
Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays
-
Viswanathan CT, Bansal S, Booth B, Destefano AJ, Rose MJ, Sailstad J, Shah VP, Skelly JP, Swann PG, Weiner R (2007) Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. Pharm Res 9: E30-E42
-
(2007)
Pharm Res
, vol.9
-
-
Viswanathan, C.T.1
Bansal, S.2
Booth, B.3
Destefano, A.J.4
Rose, M.J.5
Sailstad, J.6
Shah, V.P.7
Skelly, J.P.8
Swann, P.G.9
Weiner, R.10
|