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The Physicians’ Labeling Rule: An Evaluation of Compliance
Springer Science and Business Media LLC - Tập 45 - Trang 277-290 - 2011
Amy L. Ebel, Thomas G. Cantu, Stuart Hobbs, Paula R. Rogenes, Melissa Beaman, Maryann Ziemba
The primary purpose of this study was to evaluate compliance of newly approved labeling with the Physicians’ Labeling Rule (PLR). Labeling (prescribing information) for 221 products in PLR format approved during the first 30 months following the regulation effective date were compared with requirements set by the PLR regulation, as well as with available FDA guidances and prespecified best practic...... hiện toàn bộ
Implementation of a Biomarker into Drug Development: Example of Identifying the Right Imaging “Tool” for an Oncology Study
Springer Science and Business Media LLC - - 2007
Barry T. Peterson, Timothy J. McCarthy, Philip S. Murphy
A Comparison of the Quality of Data, Assessed Using Query Rates, From Clinical Trials Conducted Across Developed Versus Emerging Global Regions
Springer Science and Business Media LLC - Tập 46 - Trang 455-463 - 2012
Pankaj B. Desai, Christopher Anderson, William K. Sietsema
With increasing globalization of clinical trials, there is a growing concern regarding the quality of data generated from clinical studies conducted in some of the emerging regions. This concern has not been comprehensively addressed thus far because there is limited public access to restricted databases. In this study, we utilized data from 26 large phase II/III trials conducted in multiple regio...... hiện toàn bộ
Review of: Fundamentals of US Regulatory Affairs, 7th ed.
Springer Science and Business Media LLC - Tập 45 - Trang 825-826 - 2011
Edward Tabor
International Conference on Harmonization-Good Clinical Practices Update
Springer Science and Business Media LLC - Tập 32 - Trang 1143-1147 - 1998
Bette L. Barton
This paper presents an introduction to the “International Conference on Harmonization Good Clinical Practices Consolidated Guideline” for professionals who are already familiar with Food and Drug Administration (FDA) clinical trial standards. A brief background on the International Conference on Harmonization (ICH) is provided. ICH-GCP is then compared to FDA standards. ICH guidelines are well sup...... hiện toàn bộ
Product Launch and the Strategies, Processes, and Operations of Medical Affairs to Support Start-Up Companies
Springer Science and Business Media LLC - Tập 41 - Trang 743-759 - 2007
Ronald P. Evens, Mario Sylvestri
For a launch of the first product by a start-up company, the medical affairs (MA) team plays both strategic and operational roles. Launch presents a brand-new and urgent situation at a company with limited experiences, staff, and budget. A structured set of processes for analysis, planning, implementation, and follow-up are cited to assist a start-up in this new endeavor. This article discusses th...... hiện toàn bộ
Development of an Established Name: Analyzing Stem Based United States Adopted Naming
Springer Science and Business Media LLC - Tập 41 - Trang 661-672 - 2007
Patrick M. Carpenter, Robyn A. Bruce
Objectives: This retrospective analysis classifies US adopted naming (USAN) stems based on how the stem is defined. This analysis seeks to identify “commonalities” among stems, discuss medication errors due to drug name issues, identify inconsistencies of the stem-based naming system, and discuss possible solutions to the problem, including education of health care providers.Methods: Stems were ta...... hiện toàn bộ
Utilization of Drug Information Systems by Medical Representatives in the Japanese Pharmaceutical Industry
Springer Science and Business Media LLC - Tập 32 - Trang 761-767 - 1998
Manai Yamamoto, Tomoko Iizuka, Hisako Negi, Mayumi Shimizu, Shoichi Funabashi, Seizaburo Okada
For full utilization of a drug information database system by users, education and support activities are indispensable. Daiichi Pharmaceutical Co., Ltd. ’s PMS Administration Department has facilitated familiarization of users with its in-house database systems and improved their utilization through an in-house training campaign, analysis of information retrieved (log files), feedback on the resu...... hiện toàn bộ
Measuring the Incidence, Causes, and Repercussions of Protocol Amendments
Springer Science and Business Media LLC - Tập 45 - Trang 265-275 - 2011
Kenneth A. Getz, Rachael Zuckerman, Anne B. Cropp, Anna L. Hindle, Randy Krauss, Kenneth I. Kaitin
Drug development companies frequently amend finalized clinical trial protocols. Yet the incidence, causes, and impact of protocol amendments have never been quantified. Tufts Center for the Study of Drug Development (Tufts CSDD) conducted a study, in collaboration with 17 large and midsized pharmaceutical and biotechnology companies, examining more than 3,400 clinical trial protocols across develo...... hiện toàn bộ
Emerging Trends in US Oncological Approvals: A 13-Year Review (1999–2011)
Springer Science and Business Media LLC - Tập 46 - Trang 344-357 - 2012
Jing Huang, Wenze Zhang, Debra Bowen, Joemy Tam, Hsiaohui Wu, Man Fung
Advances in medicine, clinical trial design, and statistical methods affect product approvals. Over the last decade, there were many breakthroughs in the development of novel cancer therapies, including the wide application of biomarkers in drug development. Understanding trends and patterns of trial design and data submissions that lead to the approval of these novel agents assists oncologists, i...... hiện toàn bộ
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