发布求助
文献互助 智能选刊 最新文献

Pharmaceuticals, policy and law最新文献

筛选
英文 中文
Innovation and paediatric medicine: Stories from two European networks 创新和儿科医学:来自两个欧洲网络的故事
Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2010-0281
C. Giaquinto
{"title":"Innovation and paediatric medicine: Stories from two European networks","authors":"C. Giaquinto","doi":"10.3233/PPL-2010-0281","DOIUrl":"https://doi.org/10.3233/PPL-2010-0281","url":null,"abstract":"","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"16 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133464599","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
Trialing plasma protein therapies for rare disorders: Thinking outside the box 试验血浆蛋白治疗罕见疾病:跳出框框思考
Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2009-0230
A. Farrugia
{"title":"Trialing plasma protein therapies for rare disorders: Thinking outside the box","authors":"A. Farrugia","doi":"10.3233/PPL-2009-0230","DOIUrl":"https://doi.org/10.3233/PPL-2009-0230","url":null,"abstract":"The application of evidence-based medicine to the indications addressed by plasma protein therapies is problematic. So-called Level 1 evidence in the form of randomized clinical trials using classical designs to demonstrate efficacy is seldom possible, because the small numbers of patients denies the appropriate level of power from being built in the trial design. In addition, patient accrual is difficult because of understandable patient resistance and “fatigue” at the number of trials. Efforts to address this by regulating agencies over the past years have yielded promising policies in some areas, which recognize the inherent problems and outline practical solutions. The use of patient registries to accrue safety and efficacy data, while rapidly becoming accepting an accepted component as a basis for pre-market review and approval, is also promising as a basis for the incorporation of post-market data, through Phase 4 surveys, of approved therapies. As such, innovative thinking to address the problem of rare disorders may also lead to desirable reform in all aspects of regulation, with a shift from pre- to post-market review.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"51 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132456151","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: 4
Clinical trials in neonates: The FP7 TINN experience 新生儿临床试验:FP7 TINN经验
Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2010-0278
É. Jacqz-Aigrain
{"title":"Clinical trials in neonates: The FP7 TINN experience","authors":"É. Jacqz-Aigrain","doi":"10.3233/PPL-2010-0278","DOIUrl":"https://doi.org/10.3233/PPL-2010-0278","url":null,"abstract":"In the recent years, several major progresses have been achieved in neonatal care, with an increased understanding of the perinatal risks and sequels. However, the evaluation of medicines in neonates remains very limited, with more than 90% of drugs being used unlabelled in neonatal intensive care units (NICUs). Neonates constitute a peculiar population that can be affected by unique diseases (respiratory distress syndrome, patent ductus arteriosus, primary pulmunary hypertension, infections) and unique susceptibilities, which can even be more frequent in pre-terms (necrotising enterocolitis, retinopathy of prematurity, intraventricular hemorrahage, neurodevelopmental toxicity). In addition, there are important pharmacological parameters that affect drug disposition and effects in neonatal period and have to be taken into account in the evaluation of a treatment, such as the gestational and post natal ages, the immaturity of the renal hepatic clearance mechanisms, and the CNS distribution of the medicinal products.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"21 3-4","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133205288","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
Off-label and unlicensed use of medicines for children 未经许可和标签外使用儿童药物
Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2009-0209
A. Neubert, M. Felisi, Alessandro Bonifazi, C. Manfredi, I. Wong, A. Ceci
{"title":"Off-label and unlicensed use of medicines for children","authors":"A. Neubert, M. Felisi, Alessandro Bonifazi, C. Manfredi, I. Wong, A. Ceci","doi":"10.3233/PPL-2009-0209","DOIUrl":"https://doi.org/10.3233/PPL-2009-0209","url":null,"abstract":"The lack of specific drugs and labelling recommendations for the paediatric population is a longstanding problem. Physicians frequently prescribe marketed medicines as off-label on the basis of clinical practice and medical knowledge. Moreover ‘unapproved’ drugs are employed in different formulations, routes, combinations to adapt them to children. TEDDY studied the definitions of off-label and unlicensed use of medicines in paediatrics as defined by regulatory agencies and by scientific literature. This study confirmed the need for a common definition for unlicensed and off-label uses to be incorporated into the European legislation. On the basis of the results of this investigation, TEDDY conducted a survey in order to reach a common definition with the intention to favour the use of a European official regulatory terminology and facilitate pharmaco-epidemiological research. The definitions will be circulated within the scientific community and recommended to be adopted by relevant regulatory authorities.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"95 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127617300","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: 6
Adverse drug reactions reporting in children 儿童药物不良反应报告
Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2009-0204
K. Verhamme, F. Bonifazi, A. Ceci, P. Elferink-Stinkens, M. Murray, A. Neubert, A. Nicolosi, B. Stricker, I. Wong, M. Sturkenboom
{"title":"Adverse drug reactions reporting in children","authors":"K. Verhamme, F. Bonifazi, A. Ceci, P. Elferink-Stinkens, M. Murray, A. Neubert, A. Nicolosi, B. Stricker, I. Wong, M. Sturkenboom","doi":"10.3233/PPL-2009-0204","DOIUrl":"https://doi.org/10.3233/PPL-2009-0204","url":null,"abstract":"K. Verhammea, F. Bonifazib, A. Cecic,∗, P. Elferink-Stinkensa, M. Murrayd, A. Neubertd, A. Nicolosie, B. Strickera, I. Wongd and M. Sturkenbooma aPharmacoepidemiology Unit, Departments of Medical Informatics and Epidemiology & Biostatistics, Erasmus University Medical Center, Rotterdam, The Netherlands bI.RI.D.I.A. srl, Health Care Engineering, Bari, Italy cConsorzio per Valutazioni Biologiche e Farmacologiche, Pavia, Italy dCentre for Paediatric Pharmacy Research, The School of Pharmacy and Institute of Child Health, University of London, London, UK eConsiglio Nazionale delle Ricerche Istituto di Tecnologie Biomediche, Milan, Italy","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"30 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115358111","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: 7
A single European pharmaceutical market: Does maximum harmonization enhance medicinal product innovation? 单一的欧洲药品市场:最大程度的统一是否能促进药品创新?
Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-130357
A. Faeh
{"title":"A single European pharmaceutical market: Does maximum harmonization enhance medicinal product innovation?","authors":"A. Faeh","doi":"10.3233/PPL-130357","DOIUrl":"https://doi.org/10.3233/PPL-130357","url":null,"abstract":"The pharmaceutical sector in the European Union is innovative, but not innovative enough to compete on the world market. This article addresses this issue from the perspective of market harmonization, since the European Commission perceives – according to the ‘European 2020 Flagship Initiative – Innovation Union’ – market fragmentation to be one of the major causes of the lack of innovation. In order to establish if maximum harmonization benefits innovation, two distinct legal regimes in the pharmaceutical sector will be compared. The general rules for medicinal products are weighed against the orphan medicinal products scheme. The latter is subject to uniform Union rules specifically introduced to stimulate research and development and has led to the development of a number of new products. The article shows that the most radical positive integration depends to a large extent on the prospect of it yielding revenue for the innovator. Hence, fuller harmonization can benefit innovation, but it is just as important, if not more important, to address other factors such as pricing, reimbursement and patent protection.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"44 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114666853","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
Relevance of PK and PKPD modelling in rare diseases PK和PKPD模型在罕见疾病中的相关性
Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2010-0271
O. Pasqua, M. Felisi
{"title":"Relevance of PK and PKPD modelling in rare diseases","authors":"O. Pasqua, M. Felisi","doi":"10.3233/PPL-2010-0271","DOIUrl":"https://doi.org/10.3233/PPL-2010-0271","url":null,"abstract":"Evidence from a limited population may be inappropriate to characterise exposure-response relationships and subsequently define dosing recommendations for a wider target group. This limitation is particularly important if standard trial designs and data analysis methods are used to assess pharmacokinetics and pharmacodynamics. Models are a theoretical representation of a phenomenon. According to this definition, PKPD models can be applied to the development of new compounds, enabling inferences about efficacy and safety, which cannot be obtained otherwise. © 2010 - Network of Centres for Study of Pharmaceutical Law. All rights reserved.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"86 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129408497","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
Pharmacoeconomics and developing nations 药物经济学和发展中国家
Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2011-0339
Lorenzo A. Villa and, Grant H. Skrepnek
{"title":"Pharmacoeconomics and developing nations","authors":"Lorenzo A. Villa and, Grant H. Skrepnek","doi":"10.3233/PPL-2011-0339","DOIUrl":"https://doi.org/10.3233/PPL-2011-0339","url":null,"abstract":"The scarcity of resources within both industrialized and developing nations has catalyzed the adoption of more formalized approaches to support decisionmaking, particularly within healthcare. In many instances, however, the unique aspects present within developing countries may not permit the direct translation of pharmacoeconomic guidelines or recommendations from high-income economies. The purpose of this paper is to delineate the key attributes that differentiate pharmacoeconomics within developing nations, including the potential barriers to implementation and policy considerations involved. Through its approach to comprehensively assess costs and outcomes of technologies, pharmacoeconomic methodologies may help foster the optimal allocation of resources to improve the effectiveness, efficiency, and equity of healthcare delivery for societies worldwide.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"29 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129919267","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: 3
Limits to the legal deliberation of science questions: A case study of borderline medical products in Europe 科学问题法律审议的限制:欧洲边缘医疗产品的案例研究
Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-120351
N. Chowdhury
{"title":"Limits to the legal deliberation of science questions: A case study of borderline medical products in Europe","authors":"N. Chowdhury","doi":"10.3233/PPL-120351","DOIUrl":"https://doi.org/10.3233/PPL-120351","url":null,"abstract":"Borderline medical products have continued to pose as a challenge to regulators of cosmetics, medical devices and pharmaceutical products in Europe. Borderline products refer to products that exhibit multiple product characteristics and therefore could potentially straddle a minimum of two product regulatory categories. Legislation solutions in the form of the ‘rule of doubt’ provisions function on the principle of adoption of a higher burden in case of confusion exist. Although they do provide immediate solutions, they fail in ensuring legal certainty to all the principal stakeholders. This article discusses the jurisprudence on borderline products based on national and European case law. While this jurisprudence clarifies several regulatory points of conflict, it is in many ways limited. Questions of regulatory categorization are essentially science questions – that are evolving – and are therefore bound to escape determinative categories propounded within European regulations. The solution lies in appreciating the role played by deliberative institutional networks that are active contributors of regulatory disciplines and ensuring mechanisms by which judges will be able to access scientific knowledge on this issue.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"14 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128823949","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: 4
Paediatric status and off-label use of drugs in children in Italy, United Kingdom and the Netherlands 意大利、英国和荷兰儿童的儿科状况和说明书外用药情况
Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2009-0210
M. Sturkenboom, M. Felisi, C. Manfredi, A. Neubert, L. Cantarutti, R. Padula, Fatma E. Sen, K. Verhamme
{"title":"Paediatric status and off-label use of drugs in children in Italy, United Kingdom and the Netherlands","authors":"M. Sturkenboom, M. Felisi, C. Manfredi, A. Neubert, L. Cantarutti, R. Padula, Fatma E. Sen, K. Verhamme","doi":"10.3233/PPL-2009-0210","DOIUrl":"https://doi.org/10.3233/PPL-2009-0210","url":null,"abstract":"","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"18 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125305734","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: 6
首页 上一页 下一页 尾页
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整，为了账户安全，请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
请完成安全验证×
相关产品
×
本文献相关产品
联系我们：info@booksci.cn Book学术提供免费学术资源搜索服务，方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号：481959085
Book学术官方微信