-
1
-
-
0030226051
-
Efficacy measures: Surrogates or clinical outcomes
-
Blue JW, Colburn WA. Efficacy measures: surrogates or clinical outcomes. J Clin Pharmacol 1996; 36:767-770.
-
(1996)
J Clin Pharmacol
, vol.36
, pp. 767-770
-
-
Blue, J.W.1
Colburn, W.A.2
-
2
-
-
0030884335
-
The contribution of clinical pharmacology surrogates and models to drug development: A critical appraisal
-
Rolan P. The contribution of clinical pharmacology surrogates and models to drug development: a critical appraisal. Br J Clin Pharmacol 1997; 44:219-225.
-
(1997)
Br J Clin Pharmacol
, vol.44
, pp. 219-225
-
-
Rolan, P.1
-
3
-
-
0035100888
-
Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework
-
Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints:preferred definitions and conceptual framework. Clin Pharmacol Ther 2001; 69:89.
-
(2001)
Clin Pharmacol Ther
, vol.69
, pp. 89
-
-
-
4
-
-
0035037328
-
Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: Criteria, validation, strategies
-
Lesko LJ, Atkinson AJ. Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies. Annu Rev Pharmacol Toxicol 2001; 41:347-366.
-
(2001)
Annu Rev Pharmacol Toxicol
, vol.41
, pp. 347-366
-
-
Lesko, L.J.1
Atkinson, A.J.2
-
5
-
-
0142121432
-
Trends in development and approval times for new therapeutics in the United States
-
Reichert JM. Trends in development and approval times for new therapeutics in the United States. Nat Rev Drug Discov 2003; 2:695.
-
(2003)
Nat Rev Drug Discov
, vol.2
, pp. 695
-
-
Reichert, J.M.1
-
6
-
-
0036441844
-
The value of improving the productivity of the drug development process: Faster times and better decisions
-
DiMasi JA. The value of improving the productivity of the drug development process:faster times and better decisions. Pharmacoeconomics 20(suppl 3):1.
-
Pharmacoeconomics
, vol.20
, pp. 1
-
-
DiMasi, J.A.1
-
7
-
-
0037374498
-
The price of innovation: New estimates of drug development costs
-
DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econom 2003; 22:151.
-
(2003)
J Health Econom
, vol.22
, pp. 151
-
-
DiMasi, J.A.1
Hansen, R.W.2
Grabowski, H.G.3
-
8
-
-
0038004636
-
Clinical biomarkers in drug discovery and development
-
Frank R, Hargreaves R. Clinical biomarkers in drug discovery and development. Nat Rev Drug Discov 2003; 2:566.
-
(2003)
Nat Rev Drug Discov
, vol.2
, pp. 566
-
-
Frank, R.1
Hargreaves, R.2
-
9
-
-
4344645978
-
Can the pharmaceutical industry reduce attrition rates?
-
Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 2004; 3:711.
-
(2004)
Nat Rev Drug Discov
, vol.3
, pp. 711
-
-
Kola, I.1
Landis, J.2
-
10
-
-
2542641907
-
-
Challenge and opportunity on the critical path to new medical products. United States Food and Drug Administration
-
Innovation or stagnation? Challenge and opportunity on the critical path to new medical products. United States Food and Drug Administration, 2004.
-
(2004)
Innovation or stagnation
-
-
-
11
-
-
32544451155
-
Fit-for-purpose method development and validation for successful biomarker measurment
-
[Epub ahead of print]
-
Lee JW, Devanarayan V, Barrett YC, et al. Fit-for-purpose method development and validation for successful biomarker measurment. Pharmaceutical Res 2006; [Epub ahead of print].
-
(2006)
Pharmaceutical Res
-
-
Lee, J.W.1
Devanarayan, V.2
Barrett, Y.C.3
-
12
-
-
0141642224
-
Medicine. The NIH roadmap
-
Zerhouni E. Medicine. The NIH roadmap. Science 2003; 302:63-72. http:// nihroadmap.nih.gov.
-
(2003)
Science
, vol.302
, pp. 63-72
-
-
Zerhouni, E.1
-
13
-
-
0036399255
-
Overview of biomarkers and surrogate endpoints in drug development
-
Wagner JA. Overview of biomarkers and surrogate endpoints in drug development. Disease Markers 2002; 18:41-46.
-
(2002)
Disease Markers
, vol.18
, pp. 41-46
-
-
Wagner, J.A.1
-
14
-
-
0031000842
-
An approach to the validation of markers for use in AIDS clinical trials
-
Mildvan D, Landay A, De Gruttola V, Machado SG, Kagan J. An approach to the validation of markers for use in AIDS clinical trials. Clin Infect Dis 1997; 24:764-774.
-
(1997)
Clin Infect Dis
, vol.24
, pp. 764-774
-
-
Mildvan, D.1
Landay, A.2
De Grandi, F.3
Machado, S.G.4
Kagan, J.5
-
16
-
-
0035908491
-
Phases of biomarker development for early detection of cancer
-
Sullivan Pepe M, Etzioni R, Feng Z, Potter JD, Thompson ML, Thornquist M, Winget M, Yasui Y. Phases of biomarker development for early detection of cancer. J Natl Cancer Inst 2001; 93:1054-1061.
-
(2001)
J Natl Cancer Inst
, vol.93
, pp. 1054-1061
-
-
Sullivan Pepe, M.1
Etzioni, R.2
Feng, Z.3
Potter, J.D.4
Thompson, M.L.5
Thornquist, M.6
Winget, M.7
Yasui, Y.8
-
17
-
-
33845203143
-
Biomarkers: Applications in drug development
-
Bjornsson TD. Biomarkers: applications in drug development. Eur Pharmaceut Rev 2005; 1:17-21.
-
(2005)
Eur Pharmaceut Rev
, vol.1
, pp. 17-21
-
-
Bjornsson, T.D.1
-
18
-
-
0026011647
-
Mortality and morbidity of patients receiving encainide, flecainide or placebo: The cardiac arrhythmia suppression trial
-
Echt DS, Liebon PR, Mitchell B, Peters RW, Obias-Manno D. Mortality and morbidity of patients receiving encainide, flecainide or placebo: the cardiac arrhythmia suppression trial. N Engl J Med 1991; 324:781-788.
-
(1991)
N Engl J Med
, vol.324
, pp. 781-788
-
-
Echt, D.S.1
Liebon, P.R.2
Mitchell, B.3
Peters, R.W.4
Obias-Manno, D.5
-
19
-
-
0027987849
-
Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: The Scandinavian Simvastatin Survival Study (4S)
-
Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994; 344:1383-1389.
-
(1994)
Lancet
, vol.344
, pp. 1383-1389
-
-
|