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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
Transition Challenges for Collaboration Agreement of Drug Regulatory Authorities in European Union Associated Countries: Focus on Bulgaria
Springer Science and Business Media LLC - Tập 35 - Trang 935-939 - 2001
Borislav N. Borissov, Maria J. Popova, Rozalina A. Koulaksazova
The article focuses on the challenges faced by the Collaboration Agreement of Drug Regulatory Authorities in European Union Associated Countries (CADREAC) in harmonization with European Union pharmaceutical standards. The beneficial impact of different forms of collaboration and the national acheivements of the Bulgarian Drug Agency are reviewed. In the harmonization process, drug regulatory autho... hiện toàn bộ
Understanding the Differences and Effectively Transitioning between the US Integrated Summaries of Effectiveness and Safety (ISE/ISS) and the CTD Summaries of Clinical Efficacy and Safety (SCE/SCS)
Springer Science and Business Media LLC - Tập 44 - Trang 641-648 - 2010
David N. Schwartz, Michael J. Umen, Kathy Nomides, Mary Vanderhoof
The adoption in 2000 of the Common Technical Document (CTD) format for marketing applications notwithstanding, the US regulations requiring an integrated summary of effectiveness (ISE) and an integrated summary of safety (ISS) remain in effect. Many applicants, however, have attempted to use the CTD module 2 clinical summaries, specifically the summary of clinical efficacy (SCE) and the summary of... hiện toàn bộ
Whatever Happened to the T-Test?
Springer Science and Business Media LLC - Tập 31 Số 3 - Trang 745-750 - 1997
J Seldrup
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
Monitoring Response to Treatment in the Development of Anti-Cancer Drugs Using Positron Emission Tomography (PET)
Springer Science and Business Media LLC - - 1999
Helen Young, Cathryn Brock, Paula Wells, Pat Price
Current assessment of the effect of anticancer drugs relies on measurement of tumor volume using structural imaging modalities such as CT/MRI. Functional imaging allows assessment of tumor physiology and metabolism in vivo. These measurements are more directly related to the anticancer drug target and may provide more specific and sensitive methods of assessing anticancer drug activity and respons... hiện toàn bộ
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
Imaging Biomarker Applications in Oncology Drug Development
Springer Science and Business Media LLC - - 2007
Janet C. Miller, Homer H. Pien, A. Gregory Sorensen
At present, drug development is a long and costly process with an unacceptably high failure rate. As a result, both the Food and Drug Administration and the pharmaceutical industry have shown interest in using biomarkers of clinical response. Biomarker imaging is noninvasive, allows serial data collection, and lessens interpatient variability because each individual can serve as his or her own con... 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
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