-
1
-
-
39649084919
-
The FDA critical path initiative and its influence on new drug development
-
Woodcock J, Woosley R. The FDA critical path initiative and its influence on new drug development. Annu Rev Med 2008; 59: 1-12.
-
(2008)
Annu Rev Med
, vol.59
, pp. 1-12
-
-
Woodcock, J.1
Woosley, R.2
-
2
-
-
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: 711-715.
-
(2004)
Nat Rev Drug Discov
, vol.3
, pp. 711-715
-
-
Kola, I.1
Landis, J.2
-
3
-
-
44649133246
-
A perspective on characterizing benefits and risks derived from clinical trials: Can we do more?
-
O'Neill RT. A perspective on characterizing benefits and risks derived from clinical trials: Can we do more? Drug Inf J 2008;42: 235-245.
-
Drug Inf J 2008
, vol.42
, pp. 235-245
-
-
O'Neill, R.T.1
-
4
-
-
33750854903
-
Adaptive designs: Terminology and classifi-cation
-
Dragalin V. Adaptive designs: Terminology and classifi-cation. Drug Inf J 2006; 40: 425-435.
-
(2006)
Drug Inf J
, vol.40
, pp. 425-435
-
-
Dragalin, V.1
-
5
-
-
0012838924
-
Adaptive Bayesian designs for dose-ranging drug trials
-
Gatsonis C, Carlin B, Carriquiry A. (eds) Springer, New York
-
Berry DA, Müller P, Grieve AP, et al. Adaptive Bayesian designs for dose-ranging drug trials. In Gatsonis C, Carlin B, Carriquiry A. (eds). Case Studies in Bayesian Statistics. V. Springer, New York, 2001, pp. 99-181.
-
(2001)
Case Studies in Bayesian Statistics. V.
, pp. 99-181
-
-
Berry, D.A.1
Müller, P.2
Grieve, A.P.3
-
6
-
-
36248961734
-
Innovative approaches for designing and analyzing adaptive dose-ranging trials
-
Bornkamp B, Bretz F, Dmitrienko A, et al. Innovative approaches for designing and analyzing adaptive dose-ranging trials. JBiopharm Stat2007; 17: 965-995.
-
(2007)
JBiopharm Stat
, vol.17
, pp. 965-995
-
-
Bornkamp, B.1
Bretz, F.2
Dmitrienko, A.3
-
7
-
-
33745956991
-
An adaptive dose-finding design incorporating both toxicity and efficacy
-
Zhang W, Sargent D, Mandrekar S. An adaptive dose-finding design incorporating both toxicity and efficacy. Stat Med 2006; 25: 2365-83.
-
(2006)
Stat Med
, vol.25
, pp. 2365-83
-
-
Zhang, W.1
Sargent, D.2
Mandrekar, S.3
-
8
-
-
20744435134
-
A Bayesian Approach to jointly modeling toxicity and biomarker expression in a phase I/II dose-finding trial
-
Bekele BN, Shen Y. A Bayesian Approach to jointly modeling toxicity and biomarker expression in a phase I/II dose-finding trial. Biometrics 2005; 61: 343-354.
-
(2005)
Biometrics
, vol.61
, pp. 343-354
-
-
Bekele, B.N.1
Shen, Y.2
-
9
-
-
32044450843
-
Adaptive designs for dose-finding based on efficacy-toxicity response
-
Dragalin V, Fedorov V. Adaptive designs for dose-finding based on efficacy-toxicity response. J Stat Plan Infer 2006; 36: 1800-1823.
-
(2006)
J Stat Plan Infer
, vol.36
, pp. 1800-1823
-
-
Dragalin, V.1
Fedorov, V.2
-
10
-
-
0036277621
-
The bivariate continual reassessment method: Extending the CRM to phase i trials of two competing outcomes
-
Braun TM. The bivariate continual reassessment method: extending the CRM to phase I trials of two competing outcomes. Control Clin Trials 2002; 23: 240-256.
-
(2002)
Control Clin Trials
, vol.23
, pp. 240-256
-
-
Braun, T.M.1
-
11
-
-
36248936689
-
Dose finding designs for continuous responses and binary utility
-
Fedorov V, Wu Y. Dose finding designs for continuous responses and binary utility. J Biopharm Stat 2007; 17: 1085-1096.
-
(2007)
J Biopharm Stat
, vol.17
, pp. 1085-1096
-
-
Fedorov, V.1
Wu, Y.2
-
12
-
-
0031953966
-
A strategy for dose-finding and safety monitoring based on efficacy and adverse out-comes in phase I/II clinical trials
-
Thall PF, Russell KE. A strategy for dose-finding and safety monitoring based on efficacy and adverse out-comes in phase I/II clinical trials. Biometrics 1998; 54: 251-264.
-
(1998)
Biometrics
, vol.54
, pp. 251-264
-
-
Thall, P.F.1
Russell, K.E.2
-
13
-
-
4444272419
-
Dose-finding based on efficacy-toxicity trade-offs
-
Thall PF, Cook JD. Dose-finding based on efficacy-toxicity trade-offs. Biometrics 2004; 60: 684-693.
-
(2004)
Biometrics
, vol.60
, pp. 684-693
-
-
Thall, P.F.1
Cook, J.D.2
-
14
-
-
4444252640
-
Optimal designs and limiting optimal designs for a trinomial response
-
Fan SK, Chaloner K. Optimal designs and limiting optimal designs for a trinomial response. J Stat Plan Infer 2004; 126: 347-360.
-
(2004)
J Stat Plan Infer
, vol.126
, pp. 347-360
-
-
Fan, S.K.1
Chaloner, K.2
-
15
-
-
0033637096
-
Sequential designs for phase i clinical trials with late-onset toxicities
-
Cheung YK, Chappell R. Sequential designs for phase I clinical trials with late-onset toxicities. Biometrics 2000; 56: 1177-1182.
-
(2000)
Biometrics
, vol.56
, pp. 1177-1182
-
-
Cheung, Y.K.1
Chappell, R.2
-
16
-
-
0242694372
-
ASTIN: An adaptive dose-response study of UK-279,276 in acute ischemic stroke
-
Krams M, Lees KR, Hacke W, et al. ASTIN: An adaptive dose-response study of UK-279,276 in acute ischemic stroke. Stroke 2003; 34: 2543-2548.
-
(2003)
Stroke
, vol.34
, pp. 2543-2548
-
-
Krams, M.1
Lees, K.R.2
Hacke, W.3
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