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Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Levetiracetam.

2015

Literature and experimental data relevant for the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing levetiracetam are reviewed. Data on solubility and permeability suggest that levetiracetam belongs to class I of the biopharmaceutical classification system (BCS). Levetiracetam's therapeutic use, its wide therapeutic index, and its favorable pharmacokinetic properties make levetiracetam a valid candidate for the BCS-based biowaiver approach. Further, no BE studies with levetiracetam IR formulations in which the test formulation failed to show BE with the comparator have been reported in the open lit…

“Extracorporeal shock wave therapy for lateral epicondylitis—a double blind randomized controlled trial” by C. A. Speed et al., J Orthop Res 2002;20:…

2003

Studies of monolayer/substrate adhesion as function of the monolayer headgroup charge: DMPE and DMPA

1991

The variation of the work of adhesion between lipid monolayers and a plane silicon oxide surface in a typical LB-configuration is measured as function of the subphase pH. The adhesion energy is deduced via fluorescence microscopy from the equilibrium meniscus height. With increasing pH the negative headgroup charge of both, dimyristoylphosphatidylethanolamine (DMPE) and dimyristoylphosphatidic acid (DMPA) monolayers increases. The increasing charge of DMPE is reflected in a measured decrease of the work of adhesion at higher pH. The DMPA/SiO2 interaction is not affected by increasing headgroup charges. These results are qualitatively understood in terms of an electrostatic double layer inte…

Scientific power in the Spanish press during the Pandemic : a portrait of new leaders while explaining its risk

2021

This work is based on the mediatisation of society theory, which establishes more attached importance and the presence of the mass media as mediators in various social processes, as well as on Production Studies, that analyse creative skills to draw an audience, to apply these theories to the media representation of the COVID-19 pandemic. The objective is to analyse how the generalist media have represented male/female scientists, who have become social benchmarks during the first COVID-19 wave in Spain. Our initial hypothesis considers that the purpose of the mediatisation of scientific discourse was to contribute answers to, and to keep society calm, in an uncertainty context. By content …

Graphic readings and digital configurations: Akragas, Girgenti and Agrigento

2018

The study deals with a graphic analysis of the city of Agrigento through the identification of the territorial, urban and architectural peculiarities that have designed its evolution. Starting from the landscape representations realized since the sixteenth century, the views from the sea by Spannocchi, the glances on the apric territory by Pancrazi, the Hellenic ruins inside the medieval Girgenti by Martorana and the Grand Tour travelers’ productions, the urban transformations of Agrigento are reconstructed starting from the points of view adopted by the draftsmen. The aim is to provide a description through images of the multiple points of view with respect to which the territory has been …

Mesoporous inorganic nanoscale particles for drug adsorption and controlled release.

2018

The review provides an overview of the mesoporous inorganic particles employed as drug delivery systems for controlled and sustained release of drugs. We have classified promising nanomaterials for drug delivery on the basis of their natural or synthetic origin. Nanoclays are available in different morphologies (nanotubes, nanoplates and nanofibers) and they are typically available at low cost from natural resources. The surface chemistry of nanoclays is versatile for targeted modifications to control loading and release properties. Synthetic nanomaterials (imogolite, laponite and mesoporous silica) present the advantages of well-established purity and availability with size features that …

Oxcarbazepine does not affect the anticoagulant activity of warfarin.

1992

The possible interaction of the antiepileptic drug oxcarbazepine (OCBZ) on the anticoagulant effect of warfarin was investigated in 10 healthy male volunteers. After reaching steady-state conditions by repeated administration of warfarin, the prothrombin time (Quick value) was assessed before and after single (600 mg) and multiple dosing (450 mg twice daily in 1 week) of OCBZ. In 7 of the 10 volunteers with evaluable data, the prothrombin time was not significantly different (paired t test) from baseline either after single (p = 0.299) or repeated dosing (p = 0.333), indicating that OCBZ does not interact to any relevant extent with the hypothrombinemic effect of warfarin.

Micellar electrokinetic capillary chromatography for therapeutic drug monitoring of carbamazepine and its main metabolites.

1998

In carbamazepine (CBZ) therapy the concomitant monitoring of concentrations of CBZ and its metabolites is strictly recommended, primarily to avoid toxic side effects. Currently, clinical routine monitoring of CBZ is accomplished by high-performance liquid chromatography or immunological methods. In this study a micellar electrokinetic capillary chromatographic (MECC) method was developed for routine drug monitoring of CBZ and its main metabolites, carbamazepine 10,11-diol and carbamazepine 10,11-epoxide, in human serum or plasma samples. The MECC method enabled baseline separation of all analytes within 2.5 min. The assay revealed sufficient precision and sensitivity and the results of eith…

Review of the safety, tolerability, and drug interactions of the new antifungal agents caspofungin and voriconazole

2003

Managing invasive fungal infections often presents a challenge for clinicians in the treatment of immunocompromised patients. Two very different systemic antifungal agents, voriconazole and caspofungin, have recently been introduced into the market place. Voriconazole is a new triazole antifungal, while caspofungin is the first echinocandin antifungal. Voriconazole acts by inhibiting the synthesis of ergosterol in the fungal cell membrane. Caspofungin inhibits beta-1,3-D-glucan synthesis in the cell wall, a target present in fungal cells, but absent from mammalian cells. Both agents are broad-spectrum, with efficacy against invasive Aspergillus and Candida infections. The safety and tolerab…

In vitro activity of fluconazole, voriconazole and caspofungin against clinical yeast isolates.

2007

Predicting the clinical outcome of a systemic mycosis is often a difficult task, especially when microbiological resistance is one of the factors contributing to therapeutic failure. Some of these factors are host-related--e.g. immune state, site and severity of infection, poor compliance to therapy--while others are associated with the drug's characteristics--e.g. dosage, type of compound (fungistatic/fungicidal), pharmacokinetic properties and drug-drug interactions. In the last few years, clinicians have been confronted with the problem of selecting the most appropriate antifungal therapy for systemic infections and have highlighted the need for a reliable method to assay the in vitro su…