Search results for "Human use"
showing 6 items of 6 documents
Breaking the waves: Human use of marine bivalves in a microtidal range coast during the Upper Pleistocene and the Early Holocene, Vestíbulo chamber, …
2016
Abstract This paper presents the results obtained from the study of the bivalves recovered during the archaeological excavations in the Vestibulo chamber of Nerja Cave (Malaga, southern Spain) carried out by Professor Francisco Jorda Cerda between 1983 and 1987. These excavations recovered the archaeological record of the sequence from the Gravettian to the Neolithic. The mollusc remains from the Vestibulo chamber of Nerja Cave record constitute an extraordinary collection, composed of more than 136000 specimens which correspond to more than 78 kg. In this work, only marine bivalves were studied. The bivalve remains are more than 124000 specimens, corresponding to more than 65 kg from 31 ta…
"The human use of human beings": Interdisciplinarity, transdisciplinarity and all that in biophysics and beyond.
2017
Abstract Biophysics, just by looking at its name, indicates an interdisciplinary scientific activity, although the notion of interdisciplinarity, as such, seems to be not widely or specifically discussed by biophysicists. The same seems to have happened as well in the early stages of the development of cybernetics, notably in Norbert Wiener's writings. This situation seems to contrast with what has happened in subsequent developments of cybernetics ideas, notably in general system theory and cognitive sciences. After a few general reflections on the notion of interdisciplinarity, its sophisticated variants and the path leading to the birth of cognitive science, we shall refer to Wiener's th…
Safety assessment of nanoparticles for drug delivery by means of classic in vitro assays and beyond.
2016
Nanoparticles (NPs) are particularly promising tools for drug delivery and targeting, but to date, only a relatively small number of nanoscale drug delivery systems have been officially approved for drug therapy. Therapeutic NPs are designed for human use and consequently have to withstand critical toxicological analysis, which plays a pivotal role in the decision on the future practical realization of the respective drug-delivery concepts. Nanotoxicology is still a maturing discipline that often lacks profound analysis of non-acute, sub-lethal effects. Areas covered: In this review, a representative selection of current in vitro assays for cell culture-based assessment of nanotoxicity is d…
New European legislation on pharmacovigilance
2011
TheEuropeanParliament and theCouncil of the EuropeanUnion have recently adoptedRegulation (EU) No 1235/20101 and Directive 2010/84/EU2 concerning the pharmacovigilance of medicinal products for human use. These and other European institutions have been laying down rules on the subject for decades, but this is the first time they have enacted legislation specifically and (almost) exclusively regulating pharmacovigilance. This paper analyzes the context, causes, objectives, key points and challenges of the new legislation.
Regulatory evaluation of Glybera in Europe — two committees, one mission
2013
Representing the first gene therapy to be approved in the Western world, alipogene tiparvovec (Glybera; Uniqure) has recently been said to have had a “substantial impact from a regulatory perspective” (Nature Rev. Drug Discov. 11, 664; 2012) 1 . The therapy was granted marketing authorization in the European Union for the treatment of lipoprotein lipase deficiency, which results in a clinically heterogeneous condition with a risk of potentially life-threatening pancreatitis 2 , at the end of 2012. The decision followed a positive opinion by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) 3
Lipid Delivery Systems for Nucleic-Acid-Based-Drugs: From Production to Clinical Applications
2019
In the last years the rapid development of Nucleic Acid Based Drugs (NABDs) to be used in gene therapy has had a great impact in the medical field, holding enormous promise, becoming “the latest generation medicine” with the first ever siRNA-lipid based formulation approved by the United States Food and Drug Administration (FDA) for human use, and currently on the market under the trade name Onpattro™. The growth of such powerful biologic therapeutics has gone hand in hand with the progress in delivery systems technology, which is absolutely required to improve their safety and effectiveness. Lipid carrier systems, particularly liposomes, have been proven to be the most su…