-
1
-
-
0007862538
-
Clinical safety data management: Definitions and standards for expedited reporting
-
ICH E2A
-
ICH E2A. Clinical safety data management: definitions and standards for expedited reporting. Federal Register 1995; 60:11284-11287.
-
(1995)
Federal Register
, vol.60
, pp. 11284-11287
-
-
-
2
-
-
0003712368
-
Structure and content of clinical study reports
-
ICH E3
-
ICH E3. Structure and content of clinical study reports. Federal Register 1996; 61:37320-37343.
-
(1996)
Federal Register
, vol.61
, pp. 37320-37343
-
-
-
3
-
-
0032537894
-
Statistical principles for clinical trials
-
ICH E9
-
ICH E9. Statistical principles for clinical trials. Federal Register 1998; 63:49583-49598.
-
(1998)
Federal Register
, vol.63
, pp. 49583-49598
-
-
-
4
-
-
0034080455
-
Pooling in integrated safety databases
-
McEntegart DJ. Pooling in integrated safety databases. Drug Information Journal 2000; 34:495-499.
-
(2000)
Drug Information Journal
, vol.34
, pp. 495-499
-
-
McEntegart, D.J.1
-
5
-
-
0031772665
-
Safety analysis in controlled clinical trials
-
Chuang-Stein Ch. Safety analysis in controlled clinical trials. Drug Information Journal 1998; 32:1363S-1372S.
-
(1998)
Drug Information Journal
, vol.32
-
-
Chuang-Stein, Ch.1
-
6
-
-
0023225299
-
Statistical analyses of adverse event data from clinical trials, special emphasis on serious events
-
O'Neill RT. Statistical analyses of adverse event data from clinical trials, special emphasis on serious events. Drug Information Journal 1987; 21:9-20.
-
(1987)
Drug Information Journal
, vol.21
, pp. 9-20
-
-
O'Neill, R.T.1
-
7
-
-
0029000369
-
Statistical concepts in the planning and evaluation of drug safety from clinical trials in drug development: Issues on international harmonisation
-
O'Neill RT. Statistical concepts in the planning and evaluation of drug safety from clinical trials in drug development: issues on international harmonisation. Statistics in Medicine 1995; 14:1117-1127.
-
(1995)
Statistics in Medicine
, vol.14
, pp. 1117-1127
-
-
O'Neill, R.T.1
-
9
-
-
0029004978
-
Defining, monitoring and combining safety information in clinical trials
-
Enas GG, Goldstein DJ. Defining, monitoring and combining safety information in clinical trials. Statistics in Medicine 1995; 14:1099-1111.
-
(1995)
Statistics in Medicine
, vol.14
, pp. 1099-1111
-
-
Enas, G.G.1
Goldstein, D.J.2
-
10
-
-
79953752268
-
Regression analysis of multivariate incomplete failure time data by modelling marginal distributions
-
Wei U, Lin DY, Weissfeld L. Regression analysis of multivariate incomplete failure time data by modelling marginal distributions. Journal of the American Statistical Association 1989; 84:1065-1073.
-
(1989)
Journal of the American Statistical Association
, vol.84
, pp. 1065-1073
-
-
Wei, U.1
Lin, D.Y.2
Weissfeld, L.3
-
12
-
-
21144472187
-
Flexible methods for analyzing survival data using splines, with applications to breast cancer prognosis
-
Gray RJ. Flexible methods for analyzing survival data using splines, with applications to breast cancer prognosis. Journal of the American Statistical Association 1992; 87:942-951.
-
(1992)
Journal of the American Statistical Association
, vol.87
, pp. 942-951
-
-
Gray, R.J.1
-
13
-
-
0027995401
-
Spline-based tests in survival analysis
-
Gray RJ. Spline-based tests in survival analysis. Biometrics 1994; 50:640-652.
-
(1994)
Biometrics
, vol.50
, pp. 640-652
-
-
Gray, R.J.1
-
14
-
-
0347363884
-
Inference in spline-based models for multiple time-to-event data, with applications to a breast cancer prevention trial
-
Berhane K, Weissfeld LA. Inference in spline-based models for multiple time-to-event data, with applications to a breast cancer prevention trial. Biometrics 2003; 59:859-868.
-
(2003)
Biometrics
, vol.59
, pp. 859-868
-
-
Berhane, K.1
Weissfeld, L.A.2
-
15
-
-
0027940746
-
Cox regression analysis of multivariate failure time data: The marginal approach
-
Lin DY. Cox regression analysis of multivariate failure time data: the marginal approach. Statistics in Medicine 1994; 13:2233-2247.
-
(1994)
Statistics in Medicine
, vol.13
, pp. 2233-2247
-
-
Lin, D.Y.1
-
16
-
-
0016794660
-
Partial likelihood
-
Cox DR. Partial likelihood. Biometrika 1975; 62:269-276.
-
(1975)
Biometrika
, vol.62
, pp. 269-276
-
-
Cox, D.R.1
-
17
-
-
0032611191
-
Hypothesis testing of hazard ratio parameters in marginal models for multivariate failure time data
-
Cai J. Hypothesis testing of hazard ratio parameters in marginal models for multivariate failure time data. Lifetime Data Analysis 1999; 5:39-53.
-
(1999)
Lifetime Data Analysis
, vol.5
, pp. 39-53
-
-
Cai, J.1
-
18
-
-
0031842292
-
Metrifonte treatment of the cognitive deficits of Alzheimer's disease
-
Metrifonate Study Group
-
Cummings JL, Cyrus PA, Bieber F, Mas J, Orazem J, Gulanski B, Metrifonate Study Group. Metrifonte treatment of the cognitive deficits of Alzheimer's disease. Neurology 1998; 50:1214-1221.
-
(1998)
Neurology
, vol.50
, pp. 1214-1221
-
-
Cummings, J.L.1
Cyrus, P.A.2
Bieber, F.3
Mas, J.4
Orazem, J.5
Gulanski, B.6
-
19
-
-
0031842293
-
Metrifonte benefits cognitive, behavioral and global function in Alzheimer's disease patients
-
Morris JC, Cyrus PA, Orazem J, Mas J, Bieber F, Ruzicka BB, Gulanski B. Metrifonte benefits cognitive, behavioral and global function in Alzheimer's disease patients. Neurology 1998; 50:1222-1230.
-
(1998)
Neurology
, vol.50
, pp. 1222-1230
-
-
Morris, J.C.1
Cyrus, P.A.2
Orazem, J.3
Mas, J.4
Bieber, F.5
Ruzicka, B.B.6
Gulanski, B.7
-
20
-
-
0032749775
-
A multicentre, randomised, double-blind, placebo controlled study to evaluate the efficacy, tolerability, and safety of two doses of metrifonate in patients with mild-to-moderate Alzheimer's disease: The MALT study
-
MALT Study Group
-
Dubois B, McKeith I, Orgogozo J-M, Collins O, Meulien D, MALT Study Group. A multicentre, randomised, double-blind, placebo controlled study to evaluate the efficacy, tolerability, and safety of two doses of metrifonate in patients with mild-to-moderate Alzheimer's disease: the MALT study. International Journal of Geriatric Psychiatry 1999; 14:973-982.
-
(1999)
International Journal of Geriatric Psychiatry
, vol.14
, pp. 973-982
-
-
Dubois, B.1
McKeith, I.2
Orgogozo, J.-M.3
Collins, O.4
Meulien, D.5
-
21
-
-
0033060809
-
The effects of metrifonate on the cognitive, behavioral, and functional performance of Alzheimer's disease patients
-
Metrifonate Study Group
-
Raskind MA, Cyrus PA, Ruzicka BB, Gulanski BI. The effects of metrifonate on the cognitive, behavioral, and functional performance of Alzheimer's disease patients. Metrifonate Study Group. Journal of Clinical Psychiatry 1999; 60:318-325.
-
(1999)
Journal of Clinical Psychiatry
, vol.60
, pp. 318-325
-
-
Raskind, M.A.1
Cyrus, P.A.2
Ruzicka, B.B.3
Gulanski, B.I.4
-
22
-
-
0001646484
-
Cox's regression model for counting processes: A large sample study
-
Andersen PK, Gill RD. Cox's regression model for counting processes: a large sample study. Annals of Statistics 1982; 10:1100-1120.
-
(1982)
Annals of Statistics
, vol.10
, pp. 1100-1120
-
-
Andersen, P.K.1
Gill, R.D.2
-
23
-
-
0000916716
-
Estimating equations for hazard ratio parameters based on correlated failure time data
-
Cai J, Prentice RL. Estimating equations for hazard ratio parameters based on correlated failure time data. Biometrika 1995; 82:151-164.
-
(1995)
Biometrika
, vol.82
, pp. 151-164
-
-
Cai, J.1
Prentice, R.L.2
-
25
-
-
0000406422
-
Checking the marginal Cox model for correlated failure time data
-
Spiekerman CF, Lin DY. Checking the marginal Cox model for correlated failure time data. Biometrika 1996; 83:143-156.
-
(1996)
Biometrika
, vol.83
, pp. 143-156
-
-
Spiekerman, C.F.1
Lin, D.Y.2
|