2 resultados para European Medicines Agency
em Institutional Repository of Leibniz University Hannover
Resumo:
Background: Non-small cell lung cancer (NSCLC) imposes a substantial burden on patients, health care systems and society due to increasing incidence and poor survival rates. In recent years, advances in the treatment of metastatic NSCLC have resulted from the introduction of targeted therapies. However, the application of these new agents increases treatment costs considerably. The objective of this article is to review the economic evidence of targeted therapies in metastatic NSCLC. Methods: A systematic literature review was conducted to identify cost-effectiveness (CE) as well as cost-utility studies. Medline, Embase, SciSearch, Cochrane, and 9 other databases were searched from 2000 through April 2013 (including update) for full-text publications. The quality of the studies was assessed via the validated Quality of Health Economic Studies (QHES) instrument. Results: Nineteen studies (including update) involving the MoAb bevacizumab and the Tyrosine-kinase inhibitors erlotinib and gefitinib met all inclusion criteria. The majority of studies analyzed the CE of first-line maintenance and second-line treatment with erlotinib. Five studies dealt with bevacizumab in first-line regimes. Gefitinib and pharmacogenomic profiling were each covered by only two studies. Furthermore, the available evidence was of only fair quality. Conclusion: First-line maintenance treatment with erlotinib compared to Best Supportive Care (BSC) can be considered cost-effective. In comparison to docetaxel, erlotinib is likely to be cost-effective in subsequent treatment regimens as well. The insights for bevacizumab are miscellaneous. There are findings that gefitinib is cost-effective in first- and second-line treatment, however, based on only two studies. The role of pharmacogenomic testing needs to be evaluated. Therefore, future research should improve the available evidence and consider pharmacogenomic profiling as specified by the European Medicines Agency. Upcoming agents like crizotinib and afatinib need to be analyzed as well. © Lange et al.
Resumo:
The most promising concept for low frequency (millihertz to hertz) gravitational wave observatories are laser interferometric detectors in space. It is usually assumed that the noise floor for such a detector is dominated by optical shot noise in the signal readout. For this to be true, a careful balance of mission parameters is crucial to keep all other parasitic disturbances below shot noise. We developed a web application that uses over 30 input parameters and considers many important technical noise sources and noise suppression techniques to derive a realistic position noise budget. It optimizes free parameters automatically and generates a detailed report on all individual noise contributions. Thus one can easily explore the entire parameter space and design a realistic gravitational wave observatory. In this document we describe the different parameters, present all underlying calculations, and compare the final observatory's sensitivity with astrophysical sources of gravitational waves. We use as an example parameters currently assumed to be likely applied to a space mission proposed to be launched in 2034 by the European Space Agency. The web application itself is publicly available on the Internet at http://spacegravity.org/designer. Future versions of the web application will incorporate the frequency dependence of different noise sources and include a more detailed model of the observatory's residual acceleration noise.