-
1
-
-
0035100888
-
Biomarkers and surrogate end points: Preferred definitions and conceptual framework
-
Biomarkers Definitions Working Group. Biomarkers and surrogate end points: preferred definitions and conceptual framework. Clin. Pharmacol. Ther. 69, 89-95 (2001).
-
(2001)
Clin. Pharmacol. Ther.
, vol.69
, pp. 89-95
-
-
-
4
-
-
34047177929
-
Biomarker qualification pilot process at the US Food and Drug Administration
-
Goodsaid F, Frueh F. Biomarker qualification pilot process at the US Food and Drug Administration. AAPS J. 9(1), E105-E108 (2007).
-
(2007)
AAPS J.
, vol.9
, Issue.1
, pp. E105-E108
-
-
Goodsaid, F.1
Frueh, F.2
-
5
-
-
80052059669
-
Qualifying biomarkers for use in drug development: A US Food and Drug Administration overview
-
Woodcock J, Buckman S, Goodsaid F et al. Qualifying biomarkers for use in drug development: a US Food and Drug Administration overview. Expert Opin. Med. Diagn. 5(5), 369-374 (2011).
-
(2011)
Expert Opin. Med. Diagn.
, vol.5
, Issue.5
, pp. 369-374
-
-
Woodcock, J.1
Buckman, S.2
Goodsaid, F.3
-
11
-
-
84942484786
-
Ridge regression: Biased estimation for nonorthogonal problems
-
Hocrl AE, Kennard R. Ridge regression: biased estimation for nonorthogonal problems. Technometrics 12, 55-67 (1970).
-
(1970)
Technometrics
, vol.12
, pp. 55-67
-
-
Hocrl, A.E.1
Kennard, R.2
-
12
-
-
85194972808
-
Regession shrinkage and selection via the lasso
-
Tibshirani R. Regession shrinkage and selection via the lasso. J. Royal Statistical Society Series B, 58, 267-288 (1996).
-
(1996)
J. Royal Statistical Society Series B
, vol.58
, pp. 267-288
-
-
Tibshirani, R.1
-
13
-
-
31744433060
-
Diagnosis using predictive probabilities without cut-offs
-
Choi YK, Johnson WO, Thurmond MC. Diagnosis using predictive probabilities without cut-offs. Stat. Med. 25(4), 699-717 (2006).
-
(2006)
Stat. Med.
, vol.25
, Issue.4
, pp. 699-717
-
-
Choi, Y.K.1
Johnson, W.O.2
Thurmond, M.C.3
-
14
-
-
84911962987
-
Multiplicity and replicability: Two sides of the same coin
-
Bretz F, Westfall P. Multiplicity and replicability: two sides of the same coin. Pharm. Stat. 13(6), 343-4 (2014).
-
(2014)
Pharm. Stat.
, vol.13
, Issue.6
, pp. 343-344
-
-
Bretz, F.1
Westfall, P.2
-
16
-
-
84947808036
-
Special statistical topics about biomarker qualification
-
Benain X. Special statistical topics about biomarker qualification, Webinar. (2014). http://c-path. org
-
(2014)
Webinar
-
-
Benain, X.1
-
17
-
-
84947760914
-
Statistical issues associated with biomarker qualification
-
Schipper M. Statistical issues associated with biomarker qualification, Webinar. (2014). http://c-path. org
-
(2014)
Webinar
-
-
Schipper, M.1
-
18
-
-
85054397346
-
Regulatory issues in use of biomarkers in drug development
-
Chapman and Hall, Boca Raton, FL
-
Chakravarty A. Regulatory issues in use of biomarkers in drug development. In: Clinical and Statistical Considerations in Personalized Medicine. Chapman and Hall, Boca Raton, FL, 313-331 (2014).
-
(2014)
Clinical and Statistical Considerations in Personalized Medicine
, pp. 313-331
-
-
Chakravarty, A.1
-
19
-
-
33645061021
-
Retrospective validation of genomic biomarkers-what are the questions, challenges and strategies for developing useful relationships to clinical outcomes-workshop summary
-
Wang SJ, Cohen N, Katz DA, Ruano G, Shaw P, Spear B. Retrospective validation of genomic biomarkers-what are the questions, challenges and strategies for developing useful relationships to clinical outcomes-workshop summary. Pharmacogenomics J. 6, 82-88 (2006).
-
(2006)
Pharmacogenomics J.
, vol.6
, pp. 82-88
-
-
Wang, S.J.1
Cohen, N.2
Katz, D.A.3
Ruano, G.4
Shaw, P.5
Spear, B.6
-
22
-
-
77952138048
-
Renal biomarker qualification submission: A dialog between the FDA-EMEA and predictive safety testing consortium
-
Dieterle F, Sistare F, Goodsaid F et al. Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium. Nat. Biotechnol. 28, 455-462 (2010).
-
(2010)
Nat. Biotechnol.
, vol.28
, pp. 455-462
-
-
Dieterle, F.1
Sistare, F.2
Goodsaid, F.3
-
23
-
-
77952164644
-
Urinary clusterin, cystatin C, ?2-microglobulin and total protein as markers to detect drug-induced kidney injury
-
Dieterle F, Perentes F, Cordier A et al. Urinary clusterin, cystatin C, ?2-microglobulin and total protein as markers to detect drug-induced kidney injury. Nat. Biotechnol. 28, 463-469 (2010).
-
(2010)
Nat. Biotechnol.
, vol.28
, pp. 463-469
-
-
Dieterle, F.1
Perentes, F.2
Cordier, A.3
-
24
-
-
80051703759
-
Biological qualification of biomarkers of chemical-induced renal toxicity in two strains of male rat
-
Harpur E, Ennulat D, Hoffman D et al. Biological qualification of biomarkers of chemical-induced renal toxicity in two strains of male rat. Toxicol. Sci. 122, 235-252 (2011).
-
(2011)
Toxicol. Sci.
, vol.122
, pp. 235-252
-
-
Harpur, E.1
Ennulat, D.2
Hoffman, D.3
-
25
-
-
84883451317
-
Qualification of cardiac troponins for nonclinical use: A regulatory perspective
-
Hausner EA, Hicks KA, Leighton JK et al. Qualification of cardiac troponins for nonclinical use: a regulatory perspective. Regul. Toxicol. Pharmacol. 67, 108-114 (2013).
-
(2013)
Regul. Toxicol. Pharmacol.
, vol.67
, pp. 108-114
-
-
Hausner, E.A.1
Hicks, K.A.2
Leighton, J.K.3
-
26
-
-
84927676328
-
Catalyzing the Critical Path Initiative: FDA's progress in drug development activities
-
Parekh A, Buckman-Garner S, McCune S et al. Catalyzing the Critical Path Initiative: FDA's progress in drug development activities. Clin. Pharmacol. Ther. 97(3), 221-233 (2015).
-
(2015)
Clin. Pharmacol. Ther.
, vol.97
, Issue.3
, pp. 221-233
-
-
Parekh, A.1
Buckman-Garner, S.2
McCune, S.3
-
27
-
-
84947814165
-
-
FDA. LOS webpage. http://www. fda. gov
-
LOS Webpage
-
-
-
28
-
-
84947712877
-
-
FDA. CPIM Webpage. http://www. fda. gov
-
CPIM
-
-
-
30
-
-
84940540059
-
Biomarker qualification: Toward a multiple stakeholder framework for biomarker development, regulatory acceptance, and utilization
-
Amur S, LaVange L, Zineh I et al. Biomarker qualification: toward a multiple stakeholder framework for biomarker development, regulatory acceptance, and utilization. Clin. Pharmacol. Ther. 98(1), 34-46 (2015).
-
(2015)
Clin. Pharmacol. Ther.
, vol.98
, Issue.1
, pp. 34-46
-
-
Amur, S.1
LaVange, L.2
Zineh, I.3
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