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1.
Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines Agency.
Ther Innov Regul Sci
; 57(1): 79-85, 2023 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-35972722
2.
Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.
Ther Innov Regul Sci
; 56(5): 753-764, 2022 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-35610469
3.
Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK.
Clin Pharmacol Ther
; 112(1): 31-43, 2022 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-34358334
4.
Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice Workshop.
Clin Pharmacol Ther
; 108(5): 949-963, 2020 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-31958142
5.
Correction to: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.
Ther Innov Regul Sci
; 56(5): 767, 2022 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-35666455
6.
Publisher Correction: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.
Ther Innov Regul Sci
; 56(5): 765-766, 2022 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-35637424
7.
Summary of findings from the FDA regulatory science forum on measuring sexual dysfunction in depression trials.
J Clin Psychiatry
; 76(8): 1050-9, 2015 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-26335083
8.
Regulatory and scientific issues in studies to evaluate sexual dysfunction in antidepressant drug trials.
J Clin Psychiatry
; 76(8): 1060-3, 2015 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-26214346
9.
Course of improvement in depressive symptoms to a single intravenous infusion of ketamine vs add-on riluzole: results from a 4-week, double-blind, placebo-controlled study.
Neuropsychopharmacology
; 37(6): 1526-33, 2012 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-22298121
10.
A randomized add-on trial of an N-methyl-D-aspartate antagonist in treatment-resistant bipolar depression.
Arch Gen Psychiatry
; 67(8): 793-802, 2010 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-20679587
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