-
1
-
-
78449288140
-
Conditional approval and approval under special circumstance as regulatory instruments for stimulating responsible drug innovation in Europe
-
Boon W.P., Moors E.H., Meijer A., Schellekens H. Conditional approval and approval under special circumstance as regulatory instruments for stimulating responsible drug innovation in Europe. Clin. Pharmacol. Ther. 2010, 88(6):848-853.
-
(2010)
Clin. Pharmacol. Ther.
, vol.88
, Issue.6
, pp. 848-853
-
-
Boon, W.P.1
Moors, E.H.2
Meijer, A.3
Schellekens, H.4
-
2
-
-
77957366833
-
Trial design issues and treatment effect modeling in multi-regional schizophrenia trials
-
Chen Y.F., Wang S.J., Khin N.A., Hung H.M., Laughren T.P. Trial design issues and treatment effect modeling in multi-regional schizophrenia trials. Pharm. Stat. 2010, 9(3):217-229.
-
(2010)
Pharm. Stat.
, vol.9
, Issue.3
, pp. 217-229
-
-
Chen, Y.F.1
Wang, S.J.2
Khin, N.A.3
Hung, H.M.4
Laughren, T.P.5
-
3
-
-
53249132632
-
Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma
-
Eichler H.G., Pignatti F., Flamion B., Leufkens H., Breckenridge A. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma. Nat. Rev. Drug Discov. 2008, 7(10):818-826.
-
(2008)
Nat. Rev. Drug Discov.
, vol.7
, Issue.10
, pp. 818-826
-
-
Eichler, H.G.1
Pignatti, F.2
Flamion, B.3
Leufkens, H.4
Breckenridge, A.5
-
4
-
-
79960048069
-
Bridging the efficacy-effectiveness gap: a regulatory's perspective on addressing variability of drug response
-
Eichler H.G., Abadie E., Breckenridge A., Flamion B., Gustafsson L.L., Leufkens H., Rowland M., Schneider C.K., Bloechl-Daum B. Bridging the efficacy-effectiveness gap: a regulatory's perspective on addressing variability of drug response. Nat. Rev. Drug Discov. 2011, 10(7):495-506.
-
(2011)
Nat. Rev. Drug Discov.
, vol.10
, Issue.7
, pp. 495-506
-
-
Eichler, H.G.1
Abadie, E.2
Breckenridge, A.3
Flamion, B.4
Gustafsson, L.L.5
Leufkens, H.6
Rowland, M.7
Schneider, C.K.8
Bloechl-Daum, B.9
-
5
-
-
73449112663
-
Antidepressant drug effects and depression severity: a patient-level meta-analysis
-
Fournier J.C., DeRubeis R.J., Hollon S.D., Dimidjian S., Amsterdam J.D., Shelton R.C., Fawcett J. Antidepressant drug effects and depression severity: a patient-level meta-analysis. J. Am. Med. Assoc. 2010, 303(1):47-53.
-
(2010)
J. Am. Med. Assoc.
, vol.303
, Issue.1
, pp. 47-53
-
-
Fournier, J.C.1
DeRubeis, R.J.2
Hollon, S.D.3
Dimidjian, S.4
Amsterdam, J.D.5
Shelton, R.C.6
Fawcett, J.7
-
6
-
-
79960321432
-
Efficacy of antidepressants: a re-analysis and re-interpretation of the Kirsch data
-
Fountoulakis K.N., Möller H.J. Efficacy of antidepressants: a re-analysis and re-interpretation of the Kirsch data. Int. J. Neuropsychopharmacol. 2011, 14(3):405-412.
-
(2011)
Int. J. Neuropsychopharmacol.
, vol.14
, Issue.3
, pp. 405-412
-
-
Fountoulakis, K.N.1
Möller, H.J.2
-
8
-
-
79954431135
-
Placebo, Prozac and PLoS: significant lessons for psychopharmacology
-
Horder J., Matthews P., Waldmann R. Placebo, Prozac and PLoS: significant lessons for psychopharmacology. J. Psychopharmacol. 2010, 22.
-
(2010)
J. Psychopharmacol.
, pp. 22
-
-
Horder, J.1
Matthews, P.2
Waldmann, R.3
-
9
-
-
75149154694
-
The risk of death among adult participants in trials of antipsychotic drugs in schizophrenia
-
Isaac M., Koch A. The risk of death among adult participants in trials of antipsychotic drugs in schizophrenia. Eur. Neuropsychopharmacol. 2010, 20(3):139-145.
-
(2010)
Eur. Neuropsychopharmacol.
, vol.20
, Issue.3
, pp. 139-145
-
-
Isaac, M.1
Koch, A.2
-
10
-
-
79955486643
-
Exploratory analysis of efficacy data from major depressive disorder trials submitted to the US Food and Drug Administration in support of new drug applications
-
Khin N.A., Chen Y.F., Yanf Y., Yang P., Laughren T.P. Exploratory analysis of efficacy data from major depressive disorder trials submitted to the US Food and Drug Administration in support of new drug applications. J. Clin. Psychiatry 2011, 72(4):467-468.
-
(2011)
J. Clin. Psychiatry
, vol.72
, Issue.4
, pp. 467-468
-
-
Khin, N.A.1
Chen, Y.F.2
Yanf, Y.3
Yang, P.4
Laughren, T.P.5
-
11
-
-
39849093340
-
Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration
-
Kirsch I., Deacon B.J., Huedo-Medina T.B., Scoboria A., Moore T.J., Johnson B.T. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med. 2008, 5(2):e45.
-
(2008)
PLoS Med.
, vol.5
, Issue.2
-
-
Kirsch, I.1
Deacon, B.J.2
Huedo-Medina, T.B.3
Scoboria, A.4
Moore, T.J.5
Johnson, B.T.6
-
12
-
-
48749084610
-
A regulatory apologia-a review of placebo-controlled studies in regulatory submissions of new-generation antidepressants
-
Melander H., Salmonson T., Abadie E., van Zwieten-Boot B. A regulatory apologia-a review of placebo-controlled studies in regulatory submissions of new-generation antidepressants. Eur. Neuropsychopharmacol. 2008, 18(9):623-627.
-
(2008)
Eur. Neuropsychopharmacol.
, vol.18
, Issue.9
, pp. 623-627
-
-
Melander, H.1
Salmonson, T.2
Abadie, E.3
van Zwieten-Boot, B.4
-
13
-
-
79956367508
-
Lessons learned from placebo groups in antidepressant trials
-
Mora M.S., Nestoriuc Y., Rief W. Lessons learned from placebo groups in antidepressant trials. Philos. Trans. R. Soc. B 2011, 366:1879-1888.
-
(2011)
Philos. Trans. R. Soc. B
, vol.366
, pp. 1879-1888
-
-
Mora, M.S.1
Nestoriuc, Y.2
Rief, W.3
-
14
-
-
79955422795
-
European perspective on risk management and drug safety
-
Raine J., Wisse L., Blackburn S., Eichler H.G., Breckenridge A. European perspective on risk management and drug safety. Clin. Pharmacol. Ther. 2011, 89(5):650-654.
-
(2011)
Clin. Pharmacol. Ther.
, vol.89
, Issue.5
, pp. 650-654
-
-
Raine, J.1
Wisse, L.2
Blackburn, S.3
Eichler, H.G.4
Breckenridge, A.5
-
15
-
-
76949104143
-
Factors associates with success of marketing authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency
-
Regnstrom J., Koenig F., Aronsson B., Reimer T., Svendsen K., Tsigkos S., Flamion B., Eichler H.G., Vamvakas S. Factors associates with success of marketing authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency. Eur. J. Clin. Pharmacol. 2010, 66(1):39-48.
-
(2010)
Eur. J. Clin. Pharmacol.
, vol.66
, Issue.1
, pp. 39-48
-
-
Regnstrom, J.1
Koenig, F.2
Aronsson, B.3
Reimer, T.4
Svendsen, K.5
Tsigkos, S.6
Flamion, B.7
Eichler, H.G.8
Vamvakas, S.9
-
16
-
-
77950328267
-
Does inclusion of a placebo arm influence response to active antidepressant treatment in randomized controlled trials? Results from pooled and meta-analyses
-
Sinyor M., Levitt A.J., Cheung A.H., Schaffer A., Kiss A., Dowlati Y., LanctÔt K.L. Does inclusion of a placebo arm influence response to active antidepressant treatment in randomized controlled trials? Results from pooled and meta-analyses. J. Clin. Psychiatry 2010, 71(3):270-279.
-
(2010)
J. Clin. Psychiatry
, vol.71
, Issue.3
, pp. 270-279
-
-
Sinyor, M.1
Levitt, A.J.2
Cheung, A.H.3
Schaffer, A.4
Kiss, A.5
Dowlati, Y.6
LanctÔt, K.L.7
-
17
-
-
0035055164
-
Short-term efficacy of tricyclic antidepressants revisited: a meta-analytic study
-
Storosum J.G., Elferink A.J.A., Zwieten van B.J., Brink van den W., Gersons B.P.R., Broekmans A.W. Short-term efficacy of tricyclic antidepressants revisited: a meta-analytic study. Eur. Neuropsychopharmacol. 2001, 11:173-179.
-
(2001)
Eur. Neuropsychopharmacol.
, vol.11
, pp. 173-179
-
-
Storosum, J.G.1
Elferink, A.J.A.2
Zwieten van, B.J.3
Brink van den, W.4
Gersons, B.P.R.5
Broekmans, A.W.6
-
18
-
-
1242337447
-
Natural course and placebo response in short-term, placebo-controlled studies in major depression: a meta-analysis of published and non-published studies
-
Storosum J.G., Elferink A.J., van Zwieten B.J., van den Brink W., Huyser J. Natural course and placebo response in short-term, placebo-controlled studies in major depression: a meta-analysis of published and non-published studies. Pharmacopsychiatry 2004, 37(1):32-36.
-
(2004)
Pharmacopsychiatry
, vol.37
, Issue.1
, pp. 32-36
-
-
Storosum, J.G.1
Elferink, A.J.2
van Zwieten, B.J.3
van den Brink, W.4
Huyser, J.5
|