-
1
-
-
19444372555
-
Arzneimittelrecht - Kommentar mit amtlichen Begründungen, weiteren Materialien und einschlägigen Rechtsvorschriften sowie Sammlung gerichtlicher Entscheidungen
-
Deutscher Apothekerverlag, Stuttgart
-
Kloesel A, Cyran W (2002) Arzneimittelrecht - Kommentar mit amtlichen Begründungen, weiteren Materialien und einschlägigen Rechtsvorschriften sowie Sammlung gerichtlicher Entscheidungen. Deutscher Apothekerverlag, Stuttgart
-
(2002)
-
-
Kloesel, A.1
Cyran, W.2
-
2
-
-
19444378813
-
Guidance for Industry - E8 General Considerations for Clinical Trials
-
ICH
-
ICH (1997) Guidance for Industry - E8 General Considerations for Clinical Trials. http://www.ich.org/pdfICH/e8.pdf
-
(1997)
-
-
-
3
-
-
0242389364
-
Guidance for Industry - E9 Statistical Principles for Clinical Trials
-
ICH
-
ICH (1998) Guidance for Industry - E9 Statistical Principles for Clinical Trials. http://www.fda.gov/cder/guidance/ICH_E9-fnl.PDF
-
(1998)
-
-
-
4
-
-
12244293715
-
Guideline for Industry - Choice of Control Group and Related Issues in Clinical Trials
-
ICH ICH-E10
-
ICH (2000) Guideline for Industry - Choice of Control Group and Related Issues in Clinical Trials. ICH-E10. http://www.ich.org/pdfICH/ e10step4.pdf
-
(2000)
-
-
-
5
-
-
0003419282
-
Note for guidance on the Clinical Investigation of Medicinal Products in the Treatment of Schizophrenia
-
Committee for Proprietary Medicinal Products C Document ID: CPMP/EWP/559/95
-
Committee for Proprietary Medicinal Products C (1998) Note for guidance on the Clinical Investigation of Medicinal Products in the Treatment of Schizophrenia. http://www.emea.eu.int. Document ID: CPMP/EWP/559/95
-
(1998)
-
-
-
6
-
-
0141615125
-
Note For Guidance on Clinical Investigation of Medicinal Products in the Treatment of Depression (Revision 1)
-
Committee for Proprietary Medicinal Products C Document ID: cpmp/ewp/518/97
-
Committee for Proprietary Medicinal Products C (2002) Note For Guidance on Clinical Investigation of Medicinal Products in the Treatment of Depression (Revision 1). http://www.emea.eu.int. Document ID: Cpmp/ewp/518/97
-
(2002)
-
-
-
7
-
-
0034687076
-
Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 2: Practical issues and specific cases
-
Ellenberg SS, Temple R (2000) Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 2: practical issues and specific cases. Ann Intern Med 133:464-470
-
(2000)
Ann. Intern. Med.
, vol.133
, pp. 464-470
-
-
Ellenberg, S.S.1
Temple, R.2
-
8
-
-
0034655574
-
The use of placebo control groups in the assessment of psychiatric drugs: An historical context
-
Leber P (2000) The use of placebo control groups in the assessment of psychiatric drugs: An historical context. Biol Psychiatry 47:699-706
-
(2000)
Biol. Psychiatry
, vol.47
, pp. 699-706
-
-
Leber, P.1
-
9
-
-
0037070795
-
Placebo-controlled trials and the Declaration of Helsinki
-
Lewis JA, Jonsson B, Kreutz G et al. (2002) Placebo-controlled trials and the Declaration of Helsinki. Lancet 359:1337-1340
-
(2002)
Lancet
, vol.359
, pp. 1337-1340
-
-
Lewis, J.A.1
Jonsson, B.2
Kreutz, G.3
-
10
-
-
0034687072
-
Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: Ethical and scientific issues
-
Temple R, Ellenberg SS (2000) Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: ethical and scientific issues. Ann Intern Med 133:455-463
-
(2000)
Ann. Intern. Med.
, vol.133
, pp. 455-463
-
-
Temple, R.1
Ellenberg, S.S.2
-
11
-
-
0034210108
-
Does placebo help establish equivalence in trials of new antidepressants?
-
Barbui C, Violante A, Garattini S (2000) Does placebo help establish equivalence in trials of new antidepressants? Eur Psychiatr, 15:268-273
-
(2000)
Eur. Psychiatr.
, vol.15
, pp. 268-273
-
-
Barbui, C.1
Violante, A.2
Garattini, S.3
-
12
-
-
0037389433
-
Update on unethical use of placebos in randomised trials
-
Michels KB, Rothman KJ (2003) Update on unethical use of placebos in randomised trials. Bioethics 17:188-204
-
(2003)
Bioethics
, vol.17
, pp. 188-204
-
-
Michels, K.B.1
Rothman, K.J.2
-
13
-
-
0036510817
-
What makes placebo-controlled trials unethical?
-
Miller FG, Brody H (2002) What makes placebo-controlled trials unethical? Am J Bioeth 2:3-9
-
(2002)
Am. J. Bioeth.
, vol.2
, pp. 3-9
-
-
Miller, F.G.1
Brody, H.2
-
14
-
-
1242321234
-
Placebo in the investigation of psychotropic drugs, especially antidepressants
-
Puzynski S (2004) Placebo in the investigation of psychotropic drugs, especially antidepressants. Sci Eng Ethics 10:135-142
-
(2004)
Sci. Eng. Ethics
, vol.10
, pp. 135-142
-
-
Puzynski, S.1
-
15
-
-
0029957698
-
Placebo mania
-
Rothman KJ (1996) Placebo mania. BMJ 313:3-4
-
(1996)
BMJ
, vol.313
, pp. 3-4
-
-
Rothman, K.J.1
-
16
-
-
0028070548
-
The continuing unethical use of placebo controls
-
Rothman KJ, Michels KB (1994) The continuing unethical use of placebo controls. N Engl J Med, 331:394-398
-
(1994)
N. Engl. J. Med.
, vol.331
, pp. 394-398
-
-
Rothman, K.J.1
Michels, K.B.2
-
17
-
-
0000601871
-
Declaration of Helsinki. Amended by the 52nd WMA General Assembly
-
World Medical Association Edinburgh, Scotland, October 2000
-
World Medical Association (2000) Declaration of Helsinki. Amended by the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000. JAMA 284:3043-3045
-
(2000)
JAMA
, vol.284
, pp. 3043-3045
-
-
-
19
-
-
0035822254
-
Adjusting Europe's drug regulation to public health needs
-
Garattini S, Bertele V (2001) Adjusting Europe's drug regulation to public health needs. Lancet 358:64-67
-
(2001)
Lancet
, vol.358
, pp. 64-67
-
-
Garattini, S.1
Bertele, V.2
-
20
-
-
0036042044
-
Assay sensitivity, failed clinical trials, and the conduct of science
-
Otto MW, Nierenberg AA (2002) Assay sensitivity, failed clinical trials, and the conduct of science. Psychother Psychosom 71:241-243
-
(2002)
Psychother. Psychosom.
, vol.71
, pp. 241-243
-
-
Otto, M.W.1
Nierenberg, A.A.2
-
21
-
-
0034038179
-
Equivalence and noninferiority trials
-
Siegel JP (2000) Equivalence and noninferiority trials. Am Heart J 139:S166-170
-
(2000)
Am. Heart J.
, vol.139
-
-
Siegel, J.P.1
-
22
-
-
19444380550
-
The pros and cons of noninferiority (equivalence) trials
-
Guess H, Kleinman A, Kusek J, Engel L (eds) BMJ Books, London
-
Pocock S (2002) The pros and cons of noninferiority (equivalence) trials. In: Guess H, Kleinman A, Kusek J, Engel L (eds) The science of the placebo - toward an interdisciplinary research agenda. BMJ Books, London, pp 236-248
-
(2002)
The Science of the Placebo - Toward an Interdisciplinary Research Agenda
, pp. 236-248
-
-
Pocock, S.1
-
23
-
-
0035180445
-
The scientific and ethical basis for placebo-controlled trials in depression and schizophrenia: An FDA perspective
-
Laughren TP (2001) The scientific and ethical basis for placebo-controlled trials in depression and schizophrenia: An FDA perspective. Eur Psychiatry 16:418-423
-
(2001)
Eur. Psychiatry
, vol.16
, pp. 418-423
-
-
Laughren, T.P.1
-
24
-
-
0024443991
-
Hazards of inference: The active control investigation
-
discussion S64-68
-
Leber PD (1989) Hazards of inference: The active control investigation. Epilepsia 30 [Suppl 1]:S57-63; discussion S64-68
-
(1989)
Epilepsia
, vol.30
, Issue.SUPPL. 1
-
-
Leber, P.D.1
-
25
-
-
0037051872
-
Placebo response in studies of major depression: Variable, substantial, and growing
-
Walsh BT, Seidman SN, Sysko R, Gould M (2002) Placebo response in studies of major depression: Variable, substantial, and growing. Jama 287:1840-1847
-
(2002)
Jama
, vol.287
, pp. 1840-1847
-
-
Walsh, B.T.1
Seidman, S.N.2
Sysko, R.3
Gould, M.4
-
26
-
-
0036195182
-
National Depressive and Manic-Depressive Association consensus statement on the use of placebo in clinical trials of mood disorders
-
Charney DS, Nemeroff CB, Lewis L et al. (2002) National Depressive and Manic-Depressive Association consensus statement on the use of placebo in clinical trials of mood disorders. Arch Gen Psychiatry 59:262-270
-
(2002)
Arch. Gen. Psychiatry
, vol.59
, pp. 262-270
-
-
Charney, D.S.1
Nemeroff, C.B.2
Lewis, L.3
-
27
-
-
0035174728
-
Design of clinical trials of antidepressants: Should a placebo control arm be included?
-
Fritze J, Möller HJ (2001) Design of clinical trials of antidepressants: Should a placebo control arm be included? CNS Drugs 15:755-764
-
(2001)
CNS Drugs
, vol.15
, pp. 755-764
-
-
Fritze, J.1
Möller, H.J.2
-
29
-
-
0142122890
-
Scientific and ethical issues in the use of placebo and active controls in clinical trials
-
Ellenberg SS (2003) Scientific and ethical issues in the use of placebo and active controls in clinical trials. J Bone Miner Res 18:1121-1124
-
(2003)
J. Bone Miner. Res.
, vol.18
, pp. 1121-1124
-
-
Ellenberg, S.S.1
-
30
-
-
0034656391
-
The use of placebos in randomized clinical trials of mood disorders: Well justified, but improvements in design are indicated
-
Charney DS (2000) The use of placebos in randomized clinical trials of mood disorders: Well justified, but improvements in design are indicated. Biol Psychiatry 47:687-688
-
(2000)
Biol. Psychiatry
, vol.47
, pp. 687-688
-
-
Charney, D.S.1
-
31
-
-
0034115764
-
The placebo problem remains
-
Michels KB (2000) The placebo problem remains. Arch Gen Psychiatry 57:321-322
-
(2000)
Arch. Gen. Psychiatry
, vol.57
, pp. 321-322
-
-
Michels, K.B.1
-
32
-
-
0037067837
-
Unnecessary use of placebo controls: The case of asthma clinical trials
-
Miller FG, Shorr AF (2002) Unnecessary use of placebo controls: The case of asthma clinical trials. Arch Intern Med 162:1673-1677
-
(2002)
Arch. Intern. Med.
, vol.162
, pp. 1673-1677
-
-
Miller, F.G.1
Shorr, A.F.2
-
33
-
-
0034033736
-
Symptom reduction and suicide risk in patients treated with placebo in antidepressant clinical trials: An analysis of the Food and Drug Administration database
-
Khan A, Warner HA, Brown WA (2000) Symptom reduction and suicide risk in patients treated with placebo in antidepressant clinical trials: An analysis of the Food and Drug Administration database. Arch Gen Psychiatry 57:311-317
-
(2000)
Arch. Gen. Psychiatry
, vol.57
, pp. 311-317
-
-
Khan, A.1
Warner, H.A.2
Brown, W.A.3
-
34
-
-
0038135174
-
Suicide rates in clinical trials of SSRIs, other antidepressants, and placebo: Analysis of FDA reports
-
Khan A, Khan S, Kolts R, Brown WA (2003) Suicide rates in clinical trials of SSRIs, other antidepressants, and placebo: Analysis of FDA reports. Am J Psychiatry 160:790-792
-
(2003)
Am. J. Psychiatry
, vol.160
, pp. 790-792
-
-
Khan, A.1
Khan, S.2
Kolts, R.3
Brown, W.A.4
-
36
-
-
0034849763
-
Symptom reduction and suicide risk among patients treated with placebo in antipsychotic clinical trials: An analysis of the food and drug administration database
-
Khan A, Khan SR, Leventhal RM, Brown WA (2001) Symptom reduction and suicide risk among patients treated with placebo in antipsychotic clinical trials: An analysis of the food and drug administration database. Am J Psychiatry 158:1449-1454
-
(2001)
Am. J. Psychiatry
, vol.158
, pp. 1449-1454
-
-
Khan, A.1
Khan, S.R.2
Leventhal, R.M.3
Brown, W.A.4
-
37
-
-
0037383596
-
Suicide risk in placebo vs active treatment in placebo-controlled trials for schizophrenia
-
Storosum JG, van Zwieten BJ, Wohlfarth T et al. (2003) Suicide risk in placebo vs active treatment in placebo-controlled trials for schizophrenia. Arch Gen Psychiatry 60:365-368
-
(2003)
Arch. Gen. Psychiatry
, vol.60
, pp. 365-368
-
-
Storosum, J.G.1
van Zwieten, B.J.2
Wohlfarth, T.3
-
38
-
-
0034655931
-
Placebo-controlled trials in psychiatric research: An ethical perspective
-
Miller FG (2000) Placebo-controlled trials in psychiatric research: An ethical perspective. Biol Psychiatry 47:707-716
-
(2000)
Biol. Psychiatry
, vol.47
, pp. 707-716
-
-
Miller, F.G.1
-
39
-
-
0036194057
-
Improving clinical trials - American Society of Clinical Psychopharmacology Recommendations
-
Klein DF, Thase ME, Endicott J et al. (2002) Improving clinical trials - American Society of Clinical Psychopharmacology Recommendations. Arch Gen Psychiatry 59:272-278
-
(2002)
Arch. Gen. Psychiatry
, vol.59
, pp. 272-278
-
-
Klein, D.F.1
Thase, M.E.2
Endicott, J.3
-
40
-
-
0037051918
-
Placebo in clinical trials for depression: Complexity and necessity
-
Kupfer DJ, Frank E (2002) Placebo in clinical trials for depression: complexity and necessity. JAMA 287:1853-1854
-
(2002)
JAMA
, vol.287
, pp. 1853-1854
-
-
Kupfer, D.J.1
Frank, E.2
-
41
-
-
2642566700
-
Sind placebokontrollierte Studien zum Wirksamkeitsbeweis von Antidepressiva notwendig?
-
Möller H (2004) Sind placebokontrollierte Studien zum Wirksamkeitsbeweis von Antidepressiva notwendig? Nervenarzt 75:421-424
-
(2004)
Nervenarzt
, vol.75
, pp. 421-424
-
-
Möller, H.1
-
42
-
-
1242284496
-
The necessity and the value of placebo
-
Singer EA (2004) The necessity and the value of placebo. Sci Eng Ethics 10:51-56
-
(2004)
Sci. Eng. Ethics
, vol.10
, pp. 51-56
-
-
Singer, E.A.1
-
43
-
-
0037312999
-
The Declaration of Helsinki and clinical trials: A focus on placebo-controlled trials in schizophrenia
-
Carpenter WT Jr, Appelbaum PS, Levine RJ (2003) The Declaration of Helsinki and clinical trials: A focus on placebo-controlled trials in schizophrenia. Am J Psychiatry 160:356-362
-
(2003)
Am. J. Psychiatry
, vol.160
, pp. 356-362
-
-
Carpenter Jr., W.T.1
Appelbaum, P.S.2
Levine, R.J.3
|