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Litigation trends in the EU, EU Member States, and UK
Published in Andrea Parziale, The Law of Off-label Uses of Medicines, 2023
Suppose that a patient injured by an off-label use succeeds in demonstrating both product defectiveness and causation. Also in such circumstances, the manufacturer may escape liability by invoking one of the exemptions outlined by Article 7 PLD. In pharmaceutical PL cases, one of the most relevant exemptions is the so-called development risk (or unknown risk) defence (Article 7(e) PLD). This defence enables the manufacturer to avoid liability if they prove that the state of scientific and technical knowledge at the time the manufacturer put the product into circulation did not allow to discover the existence of the defect.
Piezoelectric Thin Films for MEMS Applications
Published in Iniewski Krzysztof, Integrated Microsystems, 2017
For the deposition of the piezoelectric materials, especially PZT-based perovskite thin films, several methods have been studied: chemical solution deposition (CSD; sol–gel deposition) [4], chemical vapor deposition (CVD) [5,6], pulsed laser deposition (PLD) [7], and sputtering [8]. Those three methods can produce well-crystallized PZT thin films; however, each of them has both advantages and disadvantages from the viewpoint of piezoelectric MEMS, respectively. The CSD method can produce PZT thin films without expensive deposition apparatus based on the vacuum system, and it is relatively easy to prepare PZT thin films with perovskite structure. However, the thickness of the layer by the single spin coating process is typically as thin as ~0.1 μm, and the thick PZT films more than 1 μm, which is usually required in order to obtain sufficient piezoelectric actuation or sensing, have to be prepared by the multispin coating process. Therefore, the repetition of the spin coating and drying processes needs a long time to accomplish the total deposition.
Introduction to Report
Published in Kitsakorn Locharoenrat, Research Methodologies for Beginners, 2017
So far, different methods have been carried out for such films, such as, halide vapor phase epitaxy (HVPE) [3], metal-organic chemical vapor deposition (MOCVD) [4], pulsed laser deposition (PLD) [5], molecular beam epitaxy (MBE) [6], single ion beam sputtering (SIBS) [7], and double ion beam sputtering (DIBS) [8]. However, they have drawback because the specimens have been prepared under high temperature conditions. This might lead to degradation of the substrates and the films during deposition. Therefore, low temperature preparations of the AlN films are more attractive and very important. In this contribution, we then introduce radio frequency reactive magnetron sputtering to fabricate the AlN films under low temperature conditions.
Hydroxyapatite as a biomaterial – a gift that keeps on giving
Published in Drug Development and Industrial Pharmacy, 2020
Behrad Ghiasi, Yahya Sefidbakht, Sina Mozaffari-Jovin, Behnaz Gharehcheloo, Mehrnoush Mehrarya, Arash Khodadadi, Maryam Rezaei, Seyed Omid Ranaei Siadat, Vuk Uskoković
Combination of HA with metallic implants is one strategy for creating implants with more promising properties. Table 2 sums up some of the examples of implants containing HA as one of their components and also lists some of their key structural features and properties. For instance, HA can be coated onto the surface of metallic implants using various methods, such as biomimetic precipitation from simulated body fluid [124], sol gel [125,126], electrophoretic deposition [112], pulsed laser deposition [127], plasma spray [128], or sputtering techniques [129]. Among the metallic implants, titanium and its alloys have been most widely used as implants due to the lower elastic modulus, biocompatibility, mechanical properties, and excellent corrosion resistance . However, they are bioinert and to render them bioactive, coating with HA is a strategy often resorted to. This is, of course, not the only way to increase the bioactivity of metallic implants and improve their osseointegration. For example, methods such as hydrofluoric acid treatment [130] and collagen coating [131] have been used with success. However, among multiple physical and chemical methods for modifying the surface of metallic implants, the deposition of HA still stands forth as one of the simplest and most economical of methods. By chemically modifying the surface, it goes beyond the simple imposition of topographic changes via etching, while it is also less expensive and less immunologically risky approach compared to that of amending the surface with proteins.
An overview on the advantages and limitations of 3D printing of microneedles
Published in Pharmaceutical Development and Technology, 2021
Emine Dilek Ozyilmaz, Aybuke Turan, Tansel Comoglu
In a study, rigid microneedle arrays have been printed from an acrylate-based polymer using micro SLA. Pulsed laser deposition has been used to deposit silver and zinc oxide coatings on the surfaces of microneedle array structures created by visible light dynamic mask micro SLA. Agar diffusion experiments have been used to show the antimicrobial function of the coated microneedle array structures. This study shows that light-based technologies, including visible light dynamic mask micro SLA and pulsed laser deposition, can be used to generate micro-needles with antimicrobial properties for the treatment of local skin infections (Gittard et al. 2011).
Biomedical applications and toxicities of carbon nanotubes
Published in Drug and Chemical Toxicology, 2022
Shiv Kumar Prajapati, Akanksha Malaiya, Payal Kesharwani, Deeksha Soni, Aakanchha Jain
Numerous methods are available for the synthesis of CNTs. But the major production methods are the following: arc discharge method, laser ablation, and chemical vapor deposition. Arc discharge method produces both SWCNTs and MWCNTs with a small number of structural defects. It requires higher temperature (above 1700 °C) for synthesis of CNTs. In this, two graphite rods placed at a few millimeters distant are connected to power supply and current of 50–100 A is passed between electrodes. Carbon vaporizes into plasma and deposits on cathode which contains CNTs. The arc discharge method yields SWCNTs of 0.6–1.4 nm diameter while it forms MWCNTs with an inner diameter of 1–3 nm and an outer diameter of 10 nm approximately (Aqel et al.2012; Mahajan et al.2018). The principle and mechanism of laser ablation methods are analogous to the former method. The difference is that it requires intense laser pulses rather than electricity and generates carbon gas to form CNTs. This method is also known as pulsed laser deposition process (PLD). It is the advanced method to synthesize SWCNTs exhibiting high quality and purity. This method synthesizes lengthy bundles of CNTs with the size ranging between 5 and 20 µm and a diameter of 1–2 nm (Saifuddin et al.2012). It is also possible to produce MWCNTs, but the method is quite expensive since it necessitates laser and high power (Kaur et al.2019). In the chemical vapor deposition (CVD) method, catalytic breakdown of carbon monoxide or hydrocarbon occurs by the use of transient metal catalysts. In this, the substrate is placed in furnace and hydrocarbons (ethane, methane benzene, toluene, etc.). The electron beam is used as a source of energy. On the decomposition of gas, the carbon atom liberates and after thermal annealing, the atom recombines to form CNTs. This method forms SWCNTs of 0.6–4 nm and MWCNTs of 10–240 nm. The CVD method is easy for scale up at industrial production. It usually forms MWCNTs and quiet pure SWCNTs (Sharma et al.2015).