Drug information journal : DIJ / Drug Information Association最新文献_第10页

Patient Nonadherence in Clinical Trials: Could There Be a Link to Postmarketing Patient Safety? 临床试验中的患者不依从:是否与上市后患者安全有关?

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-01-01 DOI: 10.1177/0092861511428300

Dorothy L. Smith

{"title":"Patient Nonadherence in Clinical Trials: Could There Be a Link to Postmarketing Patient Safety?","authors":"Dorothy L. Smith","doi":"10.1177/0092861511428300","DOIUrl":"https://doi.org/10.1177/0092861511428300","url":null,"abstract":"Patient nonadherence is one of the most complex problems facing clinical investigators. It not only affects clinical trial results but also could affect the clinical efficacy and safety of a medication after it has been approved for usage in the general population. Research shows that up to 30% of clinical trial participants may be discarding their study medications prior to study visits. Undetected poor adherence can result in overestimation of the dosage and underestimation of the adverse event profile. Patients in the general population will be at risk if they take the study dose but have a higher rate of patient adherence than the study participants in the clinical trial. This becomes an issue if patients after the launch receive more effective patient education than study participants in clinical trials and are more adherent. Several interventions to increase study participant adherence are recommended. The goal of study investigators should be to reach a high clinical trial participant adherence level that will not require an increase in sample size to maintain power of the study. This will give health professionals assurance that patient safety is not in danger because the dose and adverse event profile would be based on a higher level of patient adherence than would be expected in the general population after the launch.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"52 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132005644","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: 19

An Appraisal of Good Regulatory Review Practices in the Gulf Cooperation Council States 对海湾合作委员会成员国良好监管审查做法的评价

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-01-01 DOI: 10.1177/0092861511427110

R. Al-Essa, S. Salek, S. Walker

引用次数: 7

The Ditchley Transparency Manifesto 迪奇利透明宣言

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-01-01 DOI: 10.1177/0092861511427858

R. Lofstedt, F. Bouder

引用次数: 2

Editor-in-Chief’s Commentary: SAGE Publishes the Drug Information Journal 总编辑评论:SAGE出版《药物信息杂志》

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-01-01 DOI: 10.1177/0092861511432445

J. R. Turner

引用次数: 0

CPI™ Certification as Predictor of Clinical Investigators’ Regulatory Compliance CPI™认证作为临床研究者法规遵从性的预测器

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-01-01 DOI: 10.1177/0092861511427862

D. Vulcano

引用次数: 4

Cobert’s Manual of Drug Safety and Pharmacovigilance 《科伯特药品安全和药物警戒手册》

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-01-01 DOI: 10.1177/0092861511427860

E. Tabor

引用次数: 3

Experiences With the Approval of Clinical Trials in Germany: Results of a Survey of Research-Based Pharmaceutical Companies 德国批准临床试验的经验:对研究型制药公司的调查结果

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-01-01 DOI: 10.1177/0092861511429281

T. Ruppert, B. Pfeiffer

引用次数: 0

Regulatory Review Process in the Gulf Cooperation Council States: Similarities and Differences 海湾合作委员会成员国的监管审查程序:异同

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-01-01 DOI: 10.1177/0092861511427674

R. Al-Essa, S. Salek, S. Walker

{"title":"Regulatory Review Process in the Gulf Cooperation Council States: Similarities and Differences","authors":"R. Al-Essa, S. Salek, S. Walker","doi":"10.1177/0092861511427674","DOIUrl":"https://doi.org/10.1177/0092861511427674","url":null,"abstract":"This study compared the assessment models and the regulatory review processes conducted in the Gulf Cooperation Council (GCC) region. A questionnaire was completed by the 7 GCC regulatory authorities (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, United Arab Emirates [UAE], and Yemen) providing details of the regulatory review processes and timelines in the region. The results showed that Kuwait, Qatar, and Yemen use the verification model; Bahrain and Oman use an abridged review; and Saudi Arabia and UAE conduct a full review. There were 3 common phases in the GCC regulatory review process: submission, evaluation, and authorization. Key milestones within each phase were also common—receipt and validation, queuing, scientific assessment, sample analysis, sponsors’ interaction, pricing, and decision making—but target approval times and the order of some activities were different among the member states as some processes are performed in parallel rather than sequentially. The resulting similarities and differences provided an opportunity to propose a standardized regulatory review process for the GCC region.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"329 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115386895","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

The Electronic Common Technical Document (eCTD): An International Pro/Con Analysis of the Pharmaceutical Product Electronic Submission Process 电子通用技术文件(eCTD):药品电子提交过程的国际赞成/反对分析

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-01-01 DOI: 10.1177/0092861511427871

Andreas Suchanek, H. Ostermann

{"title":"The Electronic Common Technical Document (eCTD): An International Pro/Con Analysis of the Pharmaceutical Product Electronic Submission Process","authors":"Andreas Suchanek, H. Ostermann","doi":"10.1177/0092861511427871","DOIUrl":"https://doi.org/10.1177/0092861511427871","url":null,"abstract":"The International Conference on Harmonisation’s electronic Common Technical Document (eCTD) endeavors to significantly change the pharmaceutical submission process. After decades of using paper, the goal is the electronic transfer of drug applications and their review across submission formats, procedures, and regions. However, it is still unclear whether implementing eCTD really brings more advantages than disadvantages and, if so, for what kind of companies. After an expert interview was conducted in 2009, this research study was formed as an international survey officially supported by the European Medicines Agency in 2010. Overall, 963 responses were received, and 397 were used for the subsequent study analysis. Although a three-fourths majority of those with eCTD experience reported disadvantages in implementing eCTD, an overwhelming majority of the same group reported advantages that outweighed the disadvantages, some of them significantly. More than three-quarters of individuals with eCTD experience were able to shorten their total time to approval, and more than 90% of this group was able to demonstrate cost savings relative to paper submissions, regardless of their company kind, size, or number of submissions.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"64 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116531104","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: 5

Improving Time to Pharmaceutical Approval: An Analysis of the Prescription Drug User Fee Act Process 缩短药品审批时间:对《处方药用户收费法》流程的分析

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-01-01 DOI: 10.1177/0092861511429262

A. Masciale, P. L. DeSantis, J. Siegel

{"title":"Improving Time to Pharmaceutical Approval: An Analysis of the Prescription Drug User Fee Act Process","authors":"A. Masciale, P. L. DeSantis, J. Siegel","doi":"10.1177/0092861511429262","DOIUrl":"https://doi.org/10.1177/0092861511429262","url":null,"abstract":"The Prescription Drug User Fee Act of 1992 (PDUFA) established pharmaceutical review performance goals and authorized the US Food and Drug Administration (FDA) to collect user fees in conjunction with pharmaceutical marketing applications. There have been 3 subsequent reauthorizations of PDUFA; the most recent, referred to as PDUFA IV, was enacted with the Food and Drug Administration Amendments Act of 2007. PDUFA IV is set to expire on September 30, 2012, and it is expected that another reauthorization (herein referred to as PDUFA V) will be enacted before PDUFA IV expires. Industry and FDA, with stakeholder input, have held technical discussions to develop and agree upon performance goals for PDUFA V, which are proposed for congressional consideration. The discussions took place amid concerns that drug approvals were taking longer under PDUFA IV than under previous PDUFA programs. This article presents an analysis of the FDA’s Center for Drug Evaluation and Research application approval data, assessing changes in time from submission to approval and identifying and addressing hypotheses regarding the causes of those changes. The analyses support the potential for the proposed goals and process changes in the PDUFA V agreement to lead to improvements in overall approval time.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"60 7","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114024466","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