標題: Titlebook: Benefit-Risk Assessment of Medicines; The Development and James Leong,Sam Salek,Stuart Walker Book 2015 Springer International Publishing [打印本頁] 作者: Wilder 時間: 2025-3-21 18:15
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書目名稱Benefit-Risk Assessment of Medicines讀者反饋學(xué)科排名
作者: 收養(yǎng) 時間: 2025-3-21 21:48 作者: florid 時間: 2025-3-22 02:29
,Benefit–Risk Assessment of Medicines by Pharmaceutical Companies and Regulatory Authorities,es bear the responsibility to ensure that the approved products demonstrate the efficacy and safety as shown in the clinical trial data submitted. However, such regulatory decisions are largely based on clinical judgment and the local medical context in each country. In a bid to minimize subjectivit作者: antiquated 時間: 2025-3-22 08:29 作者: FLEET 時間: 2025-3-22 12:30
,Implementation of the Benefit–Risk Assessment Template by Mature Agencies, Chap. . showed that both regulatory agencies and pharmaceutical companies believe that a benefit–risk framework would enhance the quality (transparency and consistency) of decision-making; provide documentation for a systematic, structured discussion; and act as a tool for communication. A tool was作者: legislate 時間: 2025-3-22 13:57 作者: Eviction 時間: 2025-3-22 20:58
,Communicating Benefit–Risk Decisions by US FDA, EMA, TGA, and Health Canada,nd the separate assessment of benefits and risks, the emphasis is now on the balance between the two, having to justify the potential harms in view of the efficacy claims. In a changing society where the demand is for transparency of such decision-making processes, there is now a major challenge to 作者: FUSC 時間: 2025-3-22 22:41 作者: 某人 時間: 2025-3-23 03:02 作者: BALE 時間: 2025-3-23 06:41 作者: neolith 時間: 2025-3-23 12:35
https://doi.org/10.1007/978-3-540-49141-5ce for their decision-making processes. A universal framework (CMR 2008) would be of value and should be applicable to both pharmaceutical companies and regulatory agencies resulting in a standardized framework for benefit–risk assessment to support transparency in decision-making.作者: Frenetic 時間: 2025-3-23 16:18
https://doi.org/10.1007/978-1-4612-1104-4enefit–risk decisions are transparent and communicated to stakeholders for accountability. Hence, there is a need to find appropriate tools to enhance communication in a manner that it would uphold transparency, consistency, and standards.作者: 混合,攙雜 時間: 2025-3-23 22:01
Infinite Dimensional K?hler Manifolds the efficacy claims. In a changing society where the demand is for transparency of such decision-making processes, there is now a major challenge to adequately communicate relevant information to stakeholders. The articulation of benefit–risk decisions remains both a responsibility and an opportunity.作者: OREX 時間: 2025-3-24 01:56
,Development of a Universal Benefit–Risk Framework and Template,ce for their decision-making processes. A universal framework (CMR 2008) would be of value and should be applicable to both pharmaceutical companies and regulatory agencies resulting in a standardized framework for benefit–risk assessment to support transparency in decision-making.作者: 貝雷帽 時間: 2025-3-24 04:38 作者: browbeat 時間: 2025-3-24 07:40 作者: Habituate 時間: 2025-3-24 14:11
Lecture Notes in Physics Monographsniversal framework that is able to meet the needs of the various stakeholders. Based on the background information reviewed thus far, it appears that a universal benefit–risk assessment framework should:作者: 兒童 時間: 2025-3-24 16:58
Loop Algebras and the Virasoro Algebra,y for such important decisions, there have been attempts to utilize quantitative approaches in assessing benefits and risks of a medicine (EMA 2009). As a result, pharmaceutical companies have also initiated the use of quantitative approaches in developing their products for submission to the regulatory authorities (Levitan et al. 2011).作者: 夾克怕包裹 時間: 2025-3-24 22:47 作者: lobster 時間: 2025-3-25 02:54 作者: 心胸狹窄 時間: 2025-3-25 07:01 作者: medieval 時間: 2025-3-25 10:05
Approaches to Utilizing Decision-Making Framework,niversal framework that is able to meet the needs of the various stakeholders. Based on the background information reviewed thus far, it appears that a universal benefit–risk assessment framework should:作者: GROG 時間: 2025-3-25 15:23
,Benefit–Risk Assessment of Medicines by Pharmaceutical Companies and Regulatory Authorities,y for such important decisions, there have been attempts to utilize quantitative approaches in assessing benefits and risks of a medicine (EMA 2009). As a result, pharmaceutical companies have also initiated the use of quantitative approaches in developing their products for submission to the regulatory authorities (Levitan et al. 2011).作者: Invertebrate 時間: 2025-3-25 17:33
,Implementation of the Benefit–Risk Assessment Template by Mature Agencies, thus developed (Chap. .) with inputs from the Consortium (consisting of TGA, Health Canada, Swissmedic, and HSA), and the resulting universal Benefit–Risk (BR) Template was designed to enhance communication and documentation of benefit–risk decisions. This study aims to review the potential value of the BR Template for regulatory agencies.作者: 專心 時間: 2025-3-25 22:53 作者: Detain 時間: 2025-3-26 01:44
http://image.papertrans.cn/b/image/183420.jpg作者: 止痛藥 時間: 2025-3-26 05:36 作者: 供過于求 時間: 2025-3-26 10:33
978-3-319-36767-5Springer International Publishing Switzerland 2015作者: 異端 時間: 2025-3-26 13:36
Lecture Notes in Physics Monographsefficacy. As patients are not equipped to make a scientific assessment, regulators play an important role in controlling the access to safe and effective medicines. Two of the key elements highlighted by the World Health Organization (WHO 2003) for effective regulation of medicines included strong c作者: LIMN 時間: 2025-3-26 19:22 作者: 高調(diào) 時間: 2025-3-26 23:43
Loop Algebras and the Virasoro Algebra,es bear the responsibility to ensure that the approved products demonstrate the efficacy and safety as shown in the clinical trial data submitted. However, such regulatory decisions are largely based on clinical judgment and the local medical context in each country. In a bid to minimize subjectivit作者: 依法逮捕 時間: 2025-3-27 03:06 作者: 哀求 時間: 2025-3-27 07:07
https://doi.org/10.1007/978-3-540-49141-5 Chap. . showed that both regulatory agencies and pharmaceutical companies believe that a benefit–risk framework would enhance the quality (transparency and consistency) of decision-making; provide documentation for a systematic, structured discussion; and act as a tool for communication. A tool was作者: probate 時間: 2025-3-27 13:25
https://doi.org/10.1007/978-1-4612-1104-4initiatives to introduce a quantitative approach into the review process. Given the current setting, it is important that both the processes and the benefit–risk decisions are transparent and communicated to stakeholders for accountability. Hence, there is a need to find appropriate tools to enhance作者: 襲擊 時間: 2025-3-27 17:17 作者: 標準 時間: 2025-3-27 21:07 作者: 機制 時間: 2025-3-28 02:01
Book 2015 approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globall作者: 縮減了 時間: 2025-3-28 03:32
Conclusions and Future Directions,s the beginning of a challenge to implement a universal framework, as these stakeholders are striving to develop a framework specific to their own jurisdictions and suited to their purposes. Without a universal framework, the current lack of consistency in making regulatory decisions and transparenc作者: 充滿裝飾 時間: 2025-3-28 06:23
