| State of the art in benefit-risk analysis: Medicines. | |
| | |
MedLine Citation:
|
PMID: 21683115 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
|
Benefit-risk assessment in medicine has been a valuable tool in the regulation of medicines since the 1960s. Benefit-risk assessment takes place in multiple stages during a medicine's life-cycle and can be conducted in a variety of ways, using methods ranging from qualitative to quantitative. Each benefit-risk assessment method is subject to its own specific strengths and limitations. Despite its widespread and long-time use, benefit-risk assessment in medicine is subject to debate and suffers from a number of limitations and is currently still under development. This state of the art review paper will discuss the various aspects and approaches to benefit-risk assessment in medicine in a chronological pathway. The review will discuss all types of benefit-risk assessment a medicinal product will undergo during its lifecycle, from Phase I clinical trials to post-marketing surveillance and health technology assessment for inclusion in public formularies. The benefit-risk profile of a drug is dynamic and differs for different indications and patient groups. In the end of this review we conclude benefit-risk analysis in medicine is a developed practice that is subject to continuous improvement and modernisation. Improvement not only in methodology, but also in cooperation between organizations can improve benefit-risk assessment. |
| | |
Authors:
|
J M Luteijn; B C White; H Gunnlaugsdóttir; F Holm; N Kalogeras; O Leino; S H Magnússon; G Odekerken; M V Pohjola; M J Tijhuis; J T Tuomisto; O Ueland; P A McCarron; H Verhagen |
Related Documents
:
|
22403015 - The clinical implementation of whole genome sequencing: a conversation with seven scien... 22114865 - An observational study of the discrediting of cox-2 nsaids in australia: vioxx or class... 3701815 - Affective changes in faculty development fellows in family medicine. 21886515 - Health technology assessment and private payers' coverage of personalized medicine. 21762965 - Minimally invasive methods for bulbar urethral strictures: a survey of members of the a... 14728225 - Approaches for guideline versioning using glif. |
Publication Detail:
|
Type: JOURNAL ARTICLE Date: 2011-6-12 |
Journal Detail:
|
Title: Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association Volume: - ISSN: 1873-6351 ISO Abbreviation: - Publication Date: 2011 Jun |
Date Detail:
|
Created Date: 2011-6-20 Completed Date: - Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 8207483 Medline TA: Food Chem Toxicol Country: - |
Other Details:
|
Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
|
Copyright © 2011 Elsevier Ltd. All rights reserved. |
Affiliation:
|
University of Ulster, School of Nursing, Shore Road, Newtownabbey (Jordanstown) BT37 0QB, United Kingdom. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
|
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: State of the art in benefit-risk analysis: Consumer perception.
Next Document: Non-clinical safety and pharmacokinetic evaluations of propylene glycol aerosol in Sprague-Dawley ra...