Zobrazeno 1 - 10
of 20
pro vyhledávání: '"Mary E. Nilsson"'
Autor:
Brenda J. Crowe, Seta Shahin, Melvin Munsaka, Mary E. Nilsson, Wei Wang, Greg Ball, Greg Anglin
Publikováno v:
Statistics in Biopharmaceutical Research
article-version (VoR) Version of Record
article-version (VoR) Version of Record
In this paper, we provide guidance on how standard safety analyses and reporting of clinical trial safety data may need to be modified, given the potential impact of the COVID-19 pandemic. The impact could include missed visits, alternative methods f
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e4e1d40a9620b491493cbc32b4dca6e8
https://doi.org/10.1080/19466315.2020.1804444
https://doi.org/10.1080/19466315.2020.1804444
Autor:
Brenda J. Crowe, Paul S. Horn, Charles M. Beasley, Rebeka Tabbey, Robert A. Dean, Lieling Wu, Mary E. Nilsson, Ryan T. Hietpas
Publikováno v:
Therapeutic Innovation & Regulatory Science. 51:683-737
Reference limits used in clinical medicine to screen and manage patients are typically developed nonparametrically using reference values from a limited number of healthy subjects using a 95th percentile reference interval. We have evaluated alternat
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::74a2a51ab9ef779b0b5b5ca3c480d30d
https://doi.org/10.1177/2168479017700679
https://doi.org/10.1177/2168479017700679
Autor:
Lieling Wu, Brenda J. Crowe, Rebeka Tabbey, Robert A. Dean, Paul S. Horn, Ryan T. Hietpas, Mary E. Nilsson, Charles M. Beasley
The objective of this research was to compute reference limits using reference values from patients entering pharmaceutical development clinical trials by the nonparametric method and the robust method of Horn and Pesce, with and without outlier excl
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b0bb60637f5b4d17247fa29240ade399
Publikováno v:
Advances in Collating and Using Trial Data. :20-36
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::f08ceff9c39d4390c289a5a92813c45e
https://doi.org/10.4155/ebo.13.631
https://doi.org/10.4155/ebo.13.631
Publikováno v:
Journal of Biopharmaceutical Statistics. 23:26-42
Patients and prescribers need to be fully informed regarding the safety profile of approved medications. This includes knowledge and information regarding whether an adverse event of interest exhibits a potential dose-response relationship. In order
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ac13b76dfd23dfccc8cdb1b81c29fb2a
https://doi.org/10.1080/10543406.2013.735761
https://doi.org/10.1080/10543406.2013.735761
Publikováno v:
Journal of Child and Adolescent Psychopharmacology. 17:713-718
This meta-analysis assessed aggression and/or hostility-related events in children and adolescents treated with fluoxetine (n = 376) compared with placebo (n = 255). Aggression and/or hostility-related events were identified in 2.1% of fluoxetine- ve
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5df615271a0fe677c23265d407b5b7dc
https://doi.org/10.1089/cap.2006.0138
https://doi.org/10.1089/cap.2006.0138
Publikováno v:
Journal of Child and Adolescent Psychopharmacology. 14:412-417
The aim of this study was to assess the safety of subchronic fluoxetine treatment for major depressive disorder (MDD) in children and adolescents.Patients received up to 19 weeks of treatment with fluoxetine, 10 mg-60 mg daily. Safety was evaluated t
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0ae87fc45314d3c82413eac471fbb6be
https://doi.org/10.1089/cap.2004.14.412
https://doi.org/10.1089/cap.2004.14.412
Autor:
Sharon L. Hoog, Karen Dineen Wagner, Daniel E. Ernest, Jennie G. Jacobson, John H. Heiligenstein, Mary E. Nilsson, Graham J. Emslie, Eileen Brown
Publikováno v:
Journal of the American Academy of Child & Adolescent Psychiatry. 41:1205-1215
This report presents results from the acute treatment phase of a clinical trial designed to confirm efficacy of a fixed dose of 20 mg of fluoxetine in children and adolescents with major depressive disorder (MDD).After a 3-week screening period, 122
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::682aa161569274faa5cf3f6ca396a84d
https://doi.org/10.1097/00004583-200210000-00010
https://doi.org/10.1097/00004583-200210000-00010
Autor:
Stephanie C. Koke, Mary E. Nilsson
Publikováno v:
Drug Information Journal. 35:1289-1299
Summaries of safety data collected in a clinical trial typically include an analysis of the crude rate of treatment-emergent signs and symptoms. This paper outlines the issues in defining treatment-emergent events and discusses the impact of choosing
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::4255d9209def3e6f67cb83318e543702
https://doi.org/10.1177/009286150103500425
https://doi.org/10.1177/009286150103500425
Publikováno v:
Clinical Therapeutics. 22:1319-1330
A 1993 meta-analysis of US Investigational New Drug clinical trials of fluoxetine reinforced this agent's more favorable adverse-event profile compared with tricyclic antidepressants (TCAs).The present meta-analysis sought to provide a reanalysis of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3436ea032adaf486779534210de3590b
https://doi.org/10.1016/s0149-2918(00)83028-3
https://doi.org/10.1016/s0149-2918(00)83028-3