Pharmaceutical Medicine最新文献_第5页

Drug Repurposing for Spinal Cord Injury: Progress Towards Therapeutic Intervention for Primary Factors and Secondary Complications. 药物再利用治疗脊髓损伤：主要因素和继发并发症的治疗干预进展。

IF 2.5

Pharmaceutical Medicine Pub Date : 2023-11-01 Epub Date: 2023-09-12 DOI: 10.1007/s40290-023-00499-3

Lahanya Guha, Hemant Kumar

{"title":"Drug Repurposing for Spinal Cord Injury: Progress Towards Therapeutic Intervention for Primary Factors and Secondary Complications.","authors":"Lahanya Guha, Hemant Kumar","doi":"10.1007/s40290-023-00499-3","DOIUrl":"10.1007/s40290-023-00499-3","url":null,"abstract":"Spinal cord injury (SCI) encompasses a plethora of complex mechanisms like the involvement of major cell death pathways, neurodegeneration of spinal cord neurons, overexpression of glutaminergic transmission and inflammation cascade, along with different co-morbidities like neuropathic pain, urinary and sexual dysfunction, respiratory and cardiac failures, making it one of the leading causes of morbidity and mortality globally. Corticosteroids such as methylprednisolone and dexamethasone, and non-steroidal anti-inflammatory drugs such as naproxen, aspirin and ibuprofen are the first-line treatment options for SCI, inhibiting primary and secondary progression by preventing inflammation and action of reactive oxygen species. However, they are constrained by a short effective drug administration window and their pharmacological action being limited to symptomatic relief of the secondary effects related to spinal cord injury only. Although post-injury rehabilitation treatments may enable functional recovery, they take a long time to show results. Drug repurposing might be an innovative method for expanding therapy alternatives, utilising drugs that are already approved by various esteemed federal agencies throughout the world. Reutilising a drug molecule to treat SCI can eliminate the need for expensive and lengthy drug discovery processes and pave the way for new therapeutic approaches in SCI. This review summarises marketed drugs that could be repurposed based on their safety and efficacy data. We also discuss their mechanisms of action and provide a list of repurposed drugs under clinical trials for SCI therapy.","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10217082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

The Value and Deliverables of Medical Affairs: Affiliate Perspectives and Future Expectations. 医疗事务的价值和可交付成果：附属机构视角和未来期望。

IF 2.5

Pharmaceutical Medicine Pub Date : 2023-11-01 Epub Date: 2023-10-03 DOI: 10.1007/s40290-023-00501-y

Anupma Dhanda Farrington, Anne Grete Frøstrup, Palle Dahl

引用次数: 0

Journey from an Enabler to a Strategic Leader: Integration of the Medical Affairs Function in ESG Initiatives and Values. 从推动者到战略领导者的历程：医疗事务职能在ESG倡议和价值观中的整合。

IF 2.5

Pharmaceutical Medicine Pub Date : 2023-11-01 Epub Date: 2023-07-18 DOI: 10.1007/s40290-023-00485-9

Daniel Furtner, Gabor Hutas, Bryan Jie Wen Tan, Roland Meier

{"title":"Journey from an Enabler to a Strategic Leader: Integration of the Medical Affairs Function in ESG Initiatives and Values.","authors":"Daniel Furtner, Gabor Hutas, Bryan Jie Wen Tan, Roland Meier","doi":"10.1007/s40290-023-00485-9","DOIUrl":"10.1007/s40290-023-00485-9","url":null,"abstract":"Like most private enterprises, the pharmaceutical industry has deeply rooted environmental, social, and governance (ESG) matters that challenge its long-term sustainability. Overcoming these external challenges requires collaborative and proactive steps as well as procedures guiding the adoption of ESG principles by all internal stakeholders. Environmental challenges such as climate change, and in addition the changes in society, have resulted in the need for governance addressing and coordinating efforts. The core function of medical affairs (MA) is connecting with stakeholders within a company and also between the company and external stakeholders. In this article, we describe the involvement of MA in several aspects of ESG, as a contributor, partner, and implementer. MA has a significant opportunity to emerge as a leading function involved in ESG strategies and their tactical implementation. Although the involvement of MA in the environment pillar of ESG is less, the function can implement changes relating to the conduct of meetings, clinical studies, and the digitalization of medical education via virtual platforms. Due to its patient centricity, MA is tasked to address social determinants of health to improve patients' outcomes. As a linking function within a company and with its external stakeholders, MA can provide proactive input in policy generation and enable effective governance by adherence to standards of accountability, ethics, and compliance, as well as transparency. Championing ESG is a collective responsibility that transcends any single department. It mandates a company-wide commitment. MA represents an essential pivot point in catalyzing the integration of ESG principles within industry, contributing to a healthcare ecosystem that is not merely more sustainable and ethical but also more conducive to patient health and public well-being.","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/94/09/40290_2023_Article_485.PMC10587287.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10190053","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

The Pharmaceutical Year That Was, 2023. 制药年，2023年。

IF 2.5

Pharmaceutical Medicine Pub Date : 2023-11-01 Epub Date: 2023-09-13 DOI: 10.1007/s40290-023-00500-z

Anthony W Fox

引用次数: 0

Strengthening the Pharmacovigilance System in Mexico: Implementation of VigiFlow and VigiLyze, as ICSR and Signal Detection Management Systems. 加强墨西哥的药物警戒系统：VigiFlow和VigiLyze作为ICSR和信号检测管理系统的实施。

IF 2.5

Pharmaceutical Medicine Pub Date : 2023-11-01 Epub Date: 2023-10-07 DOI: 10.1007/s40290-023-00490-y

Gandi Rayón-Ramírez, Salvador Alvarado-López, Rosa Camacho-Sandoval, Miriam J Loera, Alejandro E Svarch, Jorge Alcocer-Varela

{"title":"Strengthening the Pharmacovigilance System in Mexico: Implementation of VigiFlow and VigiLyze, as ICSR and Signal Detection Management Systems.","authors":"Gandi Rayón-Ramírez, Salvador Alvarado-López, Rosa Camacho-Sandoval, Miriam J Loera, Alejandro E Svarch, Jorge Alcocer-Varela","doi":"10.1007/s40290-023-00490-y","DOIUrl":"10.1007/s40290-023-00490-y","url":null,"abstract":"Pharmacovigilance (PV) activities aim to identify potential risks of medicines and vaccines after they have been authorised in the market by collecting and analysing information on suspected adverse events from different stakeholders. These can be captured and transmitted electronically in the form of Individual Case Safety Reports (ICSRs). Hence, up-to-date ICSRs management systems, like VigiFlow and signal detection and management systems as VigiLyze, have an important role in the PV system of a country. In 2019, after various attempts to establish a PV database that could fulfil the needs of the country, Mexico's National Regulatory Authority, COFEPRIS (Federal Commission for the Prevention against Sanitary Risks) decided to implement these tools. This has been a successful project that is still ongoing, it has involved national and international organisations, and has required the participation and integration of different components of the national PV system. The implementation of these tools has allowed COFEPRIS to increase its reporting trends and quality of reporting, while contributing to make more efficient interactions and processes with PV stakeholders, even during the COVID-19 pandemic. It has also allowed them to strengthen their commitment to the WHO-Programme for International Drug Monitoring, while highlighting opportunities for improvement in the national PV scenario and in the PV tools themselves. The aim of this article is to describe the implementation process, give an overview of current results regarding ICSR data and processes, and highlight the achievements, challenges, and opportunities for improvement after the three years since the beginning of the project.","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41143762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Association of Clinical Research Professionals (ACRP) 2023 Annual Conference. 临床研究专业人员协会(ACRP) 2023年年会。

IF 2.5

Pharmaceutical Medicine Pub Date : 2023-09-01 DOI: 10.1007/s40290-023-00491-x

Sue Pochon

引用次数: 0

Major Pharmaceutical Conferences and Courses: December 2023 to January 2024. 主要药学会议和课程:2023年12月至2024年1月。

IF 2.5

Pharmaceutical Medicine Pub Date : 2023-09-01 DOI: 10.1007/s40290-023-00493-9

引用次数: 0

Correction to: The Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard: Improving Transparency of Regulatory Activities. 修正:风险评估和缓解战略(REMS)公共仪表板:提高监管活动的透明度。

IF 2.5

Pharmaceutical Medicine Pub Date : 2023-09-01 DOI: 10.1007/s40290-023-00497-5

Gita A Toyserkani, Joann H Lee, Esther H Zhou

引用次数: 0

The Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard: Improving Transparency of Regulatory Activities. 风险评估和缓解策略（REMS）公共仪表板：提高监管活动的透明度。

IF 2.5

Pharmaceutical Medicine Pub Date : 2023-09-01 Epub Date: 2023-07-08 DOI: 10.1007/s40290-023-00489-5

Gita A Toyserkani, Joann H Lee, Esther H Zhou

{"title":"The Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard: Improving Transparency of Regulatory Activities.","authors":"Gita A Toyserkani, Joann H Lee, Esther H Zhou","doi":"10.1007/s40290-023-00489-5","DOIUrl":"10.1007/s40290-023-00489-5","url":null,"abstract":"This brief paper aims to describe the Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard launched by the US Food and Drug Administration (FDA) in December 2021. The FDA REMS Public Dashboard can be accessed through the REMS@FDA website. The dashboard was developed in Qlik Sense® to support a user-friendly interactive web-based tool that allows healthcare providers, patients, researchers, pharmaceutical companies, and regulators to readily access and visualize REMS information. The dashboard includes eight separate pages to capture information on all REMS, active REMS, REMS with elements to assure safe use, shared system REMS, REMS modifications, REMS revisions, released REMS, and REMS Summary; for REMS programs approved from 2008 to the present. Most of the pages allow users to choose different REMS characteristics to visualize and stratify the data by variables such as REMS approval time, application type, or REMS elements. This interactive platform is intended to allow users to quickly visualize trends over time and locate details of the REMS programs to inform emerging research and regulatory issues in the context of current drug safety. The FDA continues to explore ways to enhance public access of the REMS information in near real-time through the REMS Public Dashboard.","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10100750","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Where is European Regulation 536/2014 Taking Us? 欧洲第536/2014号法规将我们带向何方？

IF 2.5

Pharmaceutical Medicine Pub Date : 2023-09-01 Epub Date: 2023-06-24 DOI: 10.1007/s40290-023-00487-7

Anthony W Fox

引用次数: 0