Abstract:
:A universal framework for the evaluation of the benefit-risk assessment of medicines during development by pharmaceutical companies and in the regulatory review by regulatory authorities is considered of value, as it would result in the systematic structured approach to support transparency in decision making. Several organizations have developed frameworks over the past few years, including those recommended by pharmaceutical companies such as the PhRMA BRAT (Pharmaceutical Research and Manufacturers of America Benefit-Risk Action Team) and the BRAIN (Benefit-Risk Assessment in New and Old Drugs) as well as frameworks advanced by regulatory agencies, including the FDA 5-step framework and the EMA PrOACT-URL. However, a review of the criteria-including logical soundness, comprehensiveness, acceptability of results, practicality, specificity and sensitivity, presentation (visualization), and scope proposed for the development of a universal framework-demonstrated that all these different frameworks described can be incorporated into UMBRA (Universal Methodology for Benefit-Risk Assessment).
journal_name
Ther Innov Regul Scijournal_title
Therapeutic innovation & regulatory scienceauthors
Walker S,McAuslane N,Liberti L,Leong J,Salek Sdoi
10.1177/2168479014547421subject
Has Abstractpub_date
2015-01-01 00:00:00pages
17-25issue
1eissn
2168-4790issn
2168-4804journal_volume
49pub_type
杂志文章abstract:BACKGROUND:This study compared the timing, regulatory marketing authorization decisions, and the final labeling for products submitted to Swissmedic to those submitted to European Medicines Agency (EMA) and the US Food & Drug Administration (FDA). METHODS:The Centre for Innovation in Regulatory Science (CIRS) conducte...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479016655841
更新日期:2016-11-01 00:00:00
abstract::Confirmation of efficacy in pediatric drug development has traditionally required large, fully powered efficacy studies that have proven to have major feasibility and ethical challenges. Extrapolation of efficacy in the framework provided by the US Food and Drug Administration and European Medicines Agency is an appro...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479013500286
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abstract::The American Statistical Association and DIA have created an interdisciplinary working group of drug safety experts from academia, industry and regulatory backgrounds to explore the future direction for safety monitoring. This introduction to the series explains the background and rationale for this special section. ...
journal_title:Therapeutic innovation & regulatory science
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abstract:BACKGROUND:Uncertain ascertainment of events in clinical trials has been noted for decades. To correct possible bias, Clinical Endpoint Committees (CECs) have been employed as a critical element of trials to ensure consistent and high-quality endpoint evaluation, especially for cardiovascular endpoints. However, the ef...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00206-3
更新日期:2021-01-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
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journal_title:Therapeutic innovation & regulatory science
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journal_title:Therapeutic innovation & regulatory science
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journal_title:Therapeutic innovation & regulatory science
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journal_title:Therapeutic innovation & regulatory science
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journal_title:Therapeutic innovation & regulatory science
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章,评审
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479013513891
更新日期:2014-01-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479018778528
更新日期:2019-03-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479013478952
更新日期:2013-05-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00197-1
更新日期:2021-01-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章,评审
doi:10.1007/s43441-019-00087-1
更新日期:2020-05-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479015578154
更新日期:2015-05-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479014567317
更新日期:2015-07-01 00:00:00
abstract:OBJECTIVE:To identify, evaluate, and characterize the variety, quality, and intent of the health economics and outcomes research studies being conducted in SAARC (South Asian Association for Regional Cooperation) nations. METHODS:Studies published in English language between 1990 and 2015 were retrieved from Medline d...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章,评审
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更新日期:2018-05-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
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journal_title:Therapeutic innovation & regulatory science
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journal_title:Therapeutic innovation & regulatory science
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更新日期:2018-07-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479018795854
更新日期:2019-07-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
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更新日期:2019-01-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
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journal_title:Therapeutic innovation & regulatory science
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journal_title:Therapeutic innovation & regulatory science
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