1,720,979 research outputs found
Low molecular weight heparins copies : have they to be considered generics or biosimilars?
No full textLow molecular weight heparins (LMWHs) represent a class of compounds widely used in the prophylaxis of thrombosis in patients undergoing to surgical interventions. They are manufactured by chemical or enzymatic degradation of heparin which is obtained by extraction from porcine gut. According to the depolymerisation method, LMWHs differ for composition, average molecular weight and distribution and physico-chemical properties. As a consequence, their therapeutic indications present some differences. The expiration of protection rights gives the opportunity to the development of copies of the innovator’s product. In this case, the Marketing Authorisation Application can be handled as an abridged application presenting a reduced dossier. FDA classifies LMWHs chemicals and the copies are referred as generics; while EMA considers as biological medicines and the copies are referred as biosimilars. As a consequence, EMA requires appropriate powered clinical trials to establish comparable efficacy and safety between copies and innovator product, while FDA requires only in human pharmacodynamic studies. The quality, efficacy and safety of LMWHs represent a hot topic continuously debated and in evolution as demonstrated by the continuous revision of the existing guidelines. Conceivably, taking into account the intrinsic variability of LMWHs obtained also by using the same depolymerization method and the objective current impossibility to completely characterize such complex compounds, a conservative approach is desirable as it guarantees a higher level of safeness for the patient’s health. Reasonably, a reduction of the amount of clinical studies required by EMA, supported by a more specific chemical and analytical characterization, is the best direction to be pursued in order to ease the introduction on the market of the biosimilar products of LMWHs assuring at the same time the efficacy and safety of these drugs
Low molecular weight heparins copies: are they considered to be generics or biosimilars?
No full textThe protection rights of low molecular weight heparins (LMWHs) are expired or are expiring, so the extent and nature of the studies required to obtain a market authorization for LMWH copies represents a hot topic. FDA classifies LMWHs as semisynthetic drugs and their copies as generics whereas the EMA views them as biological medicines and consequently their copies as biosimilars. Consequently, FDA requires only in vivo pharrnacodynamic studies, while EMA requires also clinical trials. The current work reviews the chemical composition and therapeutic indications of LMWs available in the EU and USA markets to discuss the two different approaches. Because LMWHs show a high intrinsic variability and a complete characterization is not viable, a conservative approach is desirable
Going Beyond Counting First Authors in Author Co-citation Analysis
Full text linkThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
Variations on the Author
Full text link“Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
Appropriate Similarity Measures for Author Cocitation Analysis
Full text linkWe provide a number of new insights into the methodological discussion about author cocitation analysis. We first argue that the use of the Pearson correlation for measuring the similarity between authors’ cocitation profiles is not very satisfactory. We then discuss what kind of similarity measures may be used as an alternative to the Pearson correlation. We consider three similarity measures in particular. One is the well-known cosine. The other two similarity measures have not been used before in the bibliometric literature. Finally, we show by means of an example that our findings have a high practical relevance.information science;Pearson correlation;cosine;similarity measure;author cocitation analysis
Dispelling the Myths Behind First-author Citation Counts
Full text linkWe conducted a full-scale evaluative citation analysis study of scholars in the XML research field to explore just how different from each other author rankings resulting from different citation counting methods actually are, and to demonstrate the capability of emerging data and tools on the Web in supporting more realistic citation counting methods. Our results contest some common arguments for the continued
use of first-author citation counts in the evaluation of scholars, such as high correlations between author rankings by first-author citation counts and other citation
counting methods, and high costs of using more realistic citation counting methods that are not well-supported by the ISI databases. It is argued that increasingly available digital full text research papers make it possible for citation analysis studies to go beyond what the ISI databases have directly supported and to employ more
sophisticated methods
koamabayili/VECTRON-author-checklist: VECTRON author checklist
No full textWe have done our best to complete the author checklist relating to the use of animals in the hut study. Note that the objective for the hut study was to evaluate the IRS treatment applications for residual efficacy against Anopheles mosquitoes, including the local An. coluzzii mosquito population. Cows were only used to attract mosquitoes into the huts and no tests were carried out directly on the cows. The author checklist is intended for use with studies where experiments are carried out on animals, which is why we have had such difficulty in completing this for the hut study, as many of the questions do not relate to how the cows were used
- …
