-
2
-
-
0345056369
-
Do clinical trials reflect drug potential? A review of FDA evaluation of new antidepressants
-
Presented at 11-14 June
-
Hooper M, Amsterdam JD. Do clinical trials reflect drug potential? A review of FDA evaluation of new antidepressants. Presented at NCDEU 39th Annual Meeting, Boca Raton, FL. 11-14 June, 1998.
-
(1998)
NCDEU 39th Annual Meeting, Boca Raton, FL
-
-
Hooper, M.1
Amsterdam, J.D.2
-
3
-
-
33646649531
-
Impact of pharmacometrics on drug approval and labeling decisions: A survey of 42 new drug applications
-
DOI 10.1208/aapsj070351
-
VA Bhattaram BP Booth RP Ramchandani BN Beasley Y Wang V Tandon, et al. 2005 Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications AAPS J 7 E503 E512 16353928 10.1208/aapsj070351 (Pubitemid 41574302)
-
(2005)
AAPS Journal
, vol.7
, Issue.3
, pp. 51
-
-
Bhattaram, V.A.1
Booth, B.P.2
Ramchandani, R.P.3
Beasley, B.N.4
Wang, Y.5
Tandon, V.6
Duan, J.Z.7
Baweja, R.K.8
Marroum, P.J.9
Uppoor, R.S.10
Rahman, N.A.11
Sahajwalla, C.G.12
Powell, J.R.13
Mehta, M.U.14
Gobburu, J.V.S.15
-
4
-
-
33846573411
-
Impact of pharmacometric reviews on new drug approval and labeling decisions - A survey of 31 new drug applications submitted between 2005 and 2006
-
DOI 10.1038/sj.clpt.6100051, PII 6100051
-
VA Bhattaram C Bonapace DM Chilukuri JZ Duan C Garnett JV Gobburu, et al. 2007 Impact of pharmacometric reviews on new drug approval and labeling decisions-a survey of 31 new drug applications submitted between 2005 and 2006 Clin Pharmacol Ther 81 213 21 17259946 10.1038/sj.clpt.6100051 1:STN:280:DC%2BD2s%2FlsFersA%3D%3D (Pubitemid 46174818)
-
(2007)
Clinical Pharmacology and Therapeutics
, vol.81
, Issue.2
, pp. 213-221
-
-
Bhattaram, V.A.1
Bonapace, C.2
Chilukuri, D.M.3
Duan, J.Z.4
Garnett, C.5
Gobburu, J.V.S.6
Jang, S.H.7
Kenna, L.8
Lesko, L.J.9
Madabushi, R.10
Men, Y.11
Powell, J.R.12
Qiu, W.13
Ramchandani, R.P.14
Tornoe, C.W.15
Wang, Y.16
Zheng, J.J.17
-
6
-
-
65249191379
-
Quantitative disease, drug and trial models
-
18851702 10.1146/annurev.pharmtox.011008.145613 1:CAS:528: DC%2BD1MXisV2jsb8%3D
-
J Gobburu LJ Lesko 2009 Quantitative disease, drug and trial models Annu Rev Pharmacol Toxicol 49 291 301 18851702 10.1146/annurev.pharmtox.011008.145613 1:CAS:528:DC%2BD1MXisV2jsb8%3D
-
(2009)
Annu Rev Pharmacol Toxicol
, vol.49
, pp. 291-301
-
-
Gobburu, J.1
Lesko, L.J.2
-
7
-
-
33745779940
-
Model-based drug development: The road to quantitative pharmacology
-
DOI 10.1007/s10928-006-9010-8
-
L Zhang V Sinha ST Forgue S Callies L Ni R Peck, et al. 2006 Model-based drug development: the road to quantitative pharmacology J PKPD 33 3 369 393 1:CAS:528:DC%2BD28XhtlWjtrrJ (Pubitemid 44020386)
-
(2006)
Journal of Pharmacokinetics and Pharmacodynamics
, vol.33
, Issue.3
, pp. 369-393
-
-
Zhang, L.1
Sinha, V.2
Forgue, S.T.3
Callies, S.4
Ni, L.5
Peck, R.6
Allerheiligen, S.R.B.7
-
8
-
-
73349136256
-
Endpoints and analyses to discern disease-modifying drug effects in early Parkinson's disease
-
19521783 10.1208/s12248-009-9123-2 1:CAS:528:DC%2BD1MXhsFGmur7M
-
VA Bhattaram O Siddiqui L Kapcala J Gobburu 2009 Endpoints and analyses to discern disease-modifying drug effects in early Parkinson's disease AAPS J 11 456 64 19521783 10.1208/s12248-009-9123-2 1:CAS:528:DC%2BD1MXhsFGmur7M
-
(2009)
AAPS J
, vol.11
, pp. 456-64
-
-
Bhattaram, V.A.1
Siddiqui, O.2
Kapcala, L.3
Gobburu, J.4
-
9
-
-
0002083004
-
Power prior distributions for regression models
-
10.1214/ss/1009212673
-
J Ibrahim M Chen 2000 Power prior distributions for regression models Stat Sci 15 46 60 10.1214/ss/1009212673
-
(2000)
Stat Sci
, vol.15
, pp. 46-60
-
-
Ibrahim, J.1
Chen, M.2
-
10
-
-
0026452038
-
Methodologic aspects of a population pharmacodynamic model for cognitive effects in Alzheimer patients treated with tacrine
-
1454835 10.1073/pnas.89.23.11466 1:CAS:528:DyaK3sXntlGgsQ%3D%3D
-
NH Holford KE Peace 1992 Methodologic aspects of a population pharmacodynamic model for cognitive effects in Alzheimer patients treated with tacrine Proc Natl Acad Sci USA 89 11466 70 1454835 10.1073/pnas.89.23.11466 1:CAS:528:DyaK3sXntlGgsQ%3D%3D
-
(1992)
Proc Natl Acad Sci USA
, vol.89
, pp. 11466-70
-
-
Holford, N.H.1
Peace, K.E.2
-
11
-
-
0035038023
-
Drug treatment effects on disease progression
-
DOI 10.1146/annurev.pharmtox.41.1.625
-
PL Chan NH Holford 2001 Drug treatment effects on disease progression Annu Rev Pharmacol Toxicol 41 625 59 11264471 10.1146/annurev.pharmtox.41.1.625 1:CAS:528:DC%2BD3MXjsVaqt7s%3D (Pubitemid 32385901)
-
(2001)
Annual Review of Pharmacology and Toxicology
, vol.41
, pp. 625-659
-
-
Chan, P.L.S.1
Holford, N.H.G.2
-
12
-
-
33745786419
-
Disease progression and pharmacodynamics in Parkinson disease - Evidence for functional protection with levodopa and other treatments
-
DOI 10.1007/s10928-006-9012-6
-
NH Holford PL Chan JG Nutt K Kieburtz I Shoulson 2006 Disease progression and pharmacodynamics in Parkinson disease-evidence for functional protection with levodopa and other treatments J Pharmacokinet Pharmacodyn 33 281 311 16625427 10.1007/s10928-006-9012-6 1:CAS:528:DC%2BD28Xms1Oisr0%3D (Pubitemid 44020383)
-
(2006)
Journal of Pharmacokinetics and Pharmacodynamics
, vol.33
, Issue.3
, pp. 281-311
-
-
Holford, N.H.G.1
Chan, P.L.S.2
Nutt, J.G.3
Kieburtz, K.4
Shoulson, I.5
-
13
-
-
19744378296
-
Levodopa and the progression of Parkinson's disease
-
DOI 10.1056/NEJMoa033447
-
Parkinson Study Group 2004 Levodopa and the progression of Parkinson's disease NEJM 351 2498 508 10.1056/NEJMoa033447 (Pubitemid 39603163)
-
(2004)
New England Journal of Medicine
, vol.351
, Issue.24
-
-
Fahn, S.1
-
14
-
-
0036894795
-
A controlled trial of rasagiline in early Parkinson disease: The tempo study
-
DOI 10.1001/archneur.59.12.1937
-
Parkinson Study Group 2002 A controlled trial of rasagiline in early Parkinson disease: the TEMPO study Arch Neurol. 59 12 1937 43 10.1001/archneur.59.12.1937 (Pubitemid 35424653)
-
(2002)
Archives of Neurology
, vol.59
, Issue.12
, pp. 1937-1943
-
-
Siderowf, A.1
Stern, M.2
Shoulson, I.3
Kieburtz, K.4
Oakes, D.5
Day, D.6
Shinaman, A.7
Plumb, S.8
Fahn, S.9
Blindauer, K.10
Lew, M.11
Hurtig, H.12
Lloyd, M.13
Hauser, R.14
Gauger, L.15
Golbe, L.16
Wojcieszek, J.17
Belden, J.18
Feigin, A.19
Klimek, M.L.20
Shannon, B.21
Ondo, W.22
Hunter, C.23
Calabrese, V.24
Atchison, P.25
Allen, C.26
Marshall, F.27
Berry, D.28
Gardiner, I.29
Miyasaki, J.30
Del Rizzo, L.31
Mendis, T.32
Mendis, N.33
Gray, P.34
Hubble, J.35
Betcher, K.36
Pahwa, R.37
Molho, E.38
Brown, D.39
Shulman, L.40
Rajput, A.41
Ewanishin, M.42
Stacy, M.43
Williamson, K.44
Bertoni, J.45
Peterson, C.46
Tuite, P.47
Ebbitt, B.48
Shannon, K.49
Jaglin, J.50
Tanner, C.51
Marek, K.52
Stavris, K.53
Aminoff, M.J.54
DiMinno, M.55
Dowling, G.56
Kang, U.J.57
Richman, J.58
Sethi, K.59
Martin, W.60
King, P.61
McInnes, G.62
Adler, C.63
LeWitt, P.64
DeAngelis, M.65
Schear, M.66
Gordon, M.F.67
Winnick, R.68
Feldman, R.69
Thomas, C.-A.70
Conn, K.71
Brocht, A.72
Chadwick, C.73
Connolly, J.74
Daigneault, S.75
Eberly, S.76
Bausch, J.77
Josephson, L.78
Oliva, R.79
Schwid, S.80
Lang, A.81
Cox, C.82
Irvine, C.83
Nutt, J.84
White, W.85
Oren, S.86
Levy, R.87
Eyal, E.88
Ladkani, D.89
Houck, W.90
more..
-
15
-
-
30444433394
-
Non-linearity of Parkinson's disease progression: Implications for sample size calculations in clinical trials
-
DOI 10.1191/1740774505cn125oa
-
P Guimaraes K Kieburtz CG Goetz J Elm Y Palesch P Huang, et al. 2005 Nonlinearity of Parkinson's disease progression: implication for sample size calculation in clinical trials Clin Trials 2 509 18 16422311 10.1191/1740774505cn125oa (Pubitemid 43075658)
-
(2005)
Clinical Trials
, vol.2
, Issue.6
, pp. 509-518
-
-
Guimaraes, P.1
Kieburtz, K.2
Goetz, C.G.3
Elm, J.J.4
Palesch, Y.Y.5
Huang, P.6
Ravina, B.7
Tanner, C.M.8
Tilley, B.C.9
-
16
-
-
84972492387
-
Inference from iterative simulation using multiple sequences (with discussion)
-
10.1214/ss/1177011136
-
A Gelman DB Rubin 1992 Inference from iterative simulation using multiple sequences (with discussion) Stat Sci 7 457 511 10.1214/ss/1177011136
-
(1992)
Stat Sci
, vol.7
, pp. 457-511
-
-
Gelman, A.1
Rubin, D.B.2
-
18
-
-
0001880068
-
The Bayesian analysis of population pharmacokinetic models
-
JC Wakefield 1996 The Bayesian analysis of population pharmacokinetic models J Am Stat Ass 91 61 76
-
(1996)
J Am Stat Ass
, vol.91
, pp. 61-76
-
-
Wakefield, J.C.1
-
19
-
-
0029949041
-
Bayesian individualization via sampling-based methods
-
DOI 10.1007/BF02353512
-
JC Wakefield 1996 Bayesian individualisation via sampling-based methods J Pharmacokinet Biopharm 24 103 131 8827585 10.1007/BF02353512 1:STN:280:DyaK28visFWgtg%3D%3D (Pubitemid 26253195)
-
(1996)
Journal of Pharmacokinetics and Biopharmaceutics
, vol.24
, Issue.1
, pp. 103-131
-
-
Wakefield, J.1
-
20
-
-
17344363383
-
Bayesian approaches to randomized clinical trials (with discussion)
-
10.2307/2983527
-
DJ Spiegelhalter L Freedman MKB Parmar 1994 Bayesian approaches to randomized clinical trials (with discussion) J Roy Stat Soc Ser A 157 357 415 10.2307/2983527
-
(1994)
J Roy Stat Soc ser A
, vol.157
, pp. 357-415
-
-
Spiegelhalter, D.J.1
Freedman, L.2
Parmar, M.K.B.3
-
22
-
-
0002841516
-
Elicitation of prior distributions
-
D.A. Berry D.K. Stangl (eds). Marcel Dekker New York
-
Chaloner K. Elicitation of prior distributions. In: Berry DA, Stangl DK, editors. Bayesian biostatistics. New York: Marcel Dekker; 1996. p. 141-56.
-
(1996)
Bayesian Biostatistics
, pp. 141-156
-
-
Chaloner, K.1
-
23
-
-
0035961574
-
Quantifying and documenting prior beliefs in clinical trials
-
DOI 10.1002/sim.694
-
K Chaloner FS Rhame 2001 Quantifying and documenting prior beliefs in clinical trials Stat Med 20 581 600 11223902 10.1002/sim.694 1:STN:280:DC%2BD3M3isF2jsA%3D%3D (Pubitemid 32166421)
-
(2001)
Statistics in Medicine
, vol.20
, Issue.4
, pp. 581-600
-
-
Chaloner, K.1
Rhame, F.S.2
-
27
-
-
67649376266
-
The relationship between the power prior and hierarchical models
-
10.1214/06-BA118
-
M Chen J Ibrahim 2006 The relationship between the power prior and hierarchical models Bayesian Anal 1 551 74 10.1214/06-BA118
-
(2006)
Bayesian Anal
, vol.1
, pp. 551-74
-
-
Chen, M.1
Ibrahim, J.2
-
28
-
-
0037290198
-
Prior elicitation for model selection and estimation in generalzied linear mixed models
-
10.1016/S0378-3758(02)00285-9
-
H Chen J Ibrahim Q Shao RE Weiss 2003 Prior elicitation for model selection and estimation in generalzied linear mixed models J Stat Plan Inf 111 57 76 10.1016/S0378-3758(02)00285-9
-
(2003)
J Stat Plan Inf
, vol.111
, pp. 57-76
-
-
Chen, H.1
Ibrahim, J.2
Shao, Q.3
Weiss, R.E.4
-
29
-
-
80052806423
-
Bayesian analysis using power priors with application to pediatric quality of care
-
10.4172/2155-6180.1000103
-
B Neelon AJ O'Malley 2010 Bayesian analysis using power priors with application to pediatric quality of care J Biomet Biostat 1 1 9 10.4172/2155-6180.1000103
-
(2010)
J Biomet Biostat
, vol.1
, pp. 1-9
-
-
Neelon, B.1
O'Malley, A.J.2
-
30
-
-
25444484077
-
Posterior predictive assessment of model fitness via realized discrepancies
-
A Gelman A Meng H Stern 1996 Posterior predictive assessment of model fitness via realized discrepancies Stat Sin 6 733 807 (Pubitemid 126706389)
-
(1996)
Statistica Sinica
, vol.6
, Issue.4
, pp. 733-807
-
-
Gelman, A.1
Meng, X.-L.2
Stern, H.3
-
31
-
-
0042742904
-
Posterior predicitve p values
-
10.1214/aos/1176325622
-
X Meng 1994 Posterior predicitve p values Ann Stat 22 1142 1160 10.1214/aos/1176325622
-
(1994)
Ann Stat
, vol.22
, pp. 1142-1160
-
-
Meng, X.1
-
33
-
-
4243828610
-
Informative drop-out in longitudinal data analysis
-
10.2307/2986113
-
P Diggle MG Kenward 1994 Informative drop-out in longitudinal data analysis Applied Statistics 43 49 73 10.2307/2986113
-
(1994)
Applied Statistics
, vol.43
, pp. 49-73
-
-
Diggle, P.1
Kenward, M.G.2
-
34
-
-
84950452119
-
Modeling the drop-out mechanism in repeated-measures studies
-
10.2307/2291350
-
RJA Little 1995 Modeling the drop-out mechanism in repeated-measures studies J Am Stat Assoc 90 1112 1121 10.2307/2291350
-
(1995)
J Am Stat Assoc
, vol.90
, pp. 1112-1121
-
-
Little, R.J.A.1
|