Search results for: Saja M. Alhabardi
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 6

Search results for: Saja M. Alhabardi

6 Predictors of Post-marketing Regulatory Actions Concerning Hepatotoxicity

Authors: Salwa M. Almomen, Mona A. Almaghrabi, Saja M. Alhabardi, Adel A. Alrwisan

Abstract:

Background: Hepatotoxicity is a major reason for medication withdrawal from the markets. Unfortunately, serious adverse hepatic effects can occur after marketing with limited indicators during clinical development. Therefore, finding possible predictors for hepatotoxicity might guide the monitoring program of various stakeholders. Methods: We examined the clinical review documents for drugs approved in the US from 2011 to 2016 to evaluate their hepatic safety profile. Predictors: we assessed whether these medications meet Hy’s Law with hepatotoxicity grade ≥ 3, labeled hepatic adverse effects at approval, or accelerated approval status. Outcome: post-marketing regulatory action related to hepatotoxicity, including product withdrawal or updates to warning, precaution, or adverse effects sections. Statistical analysis: drugs were included in the analysis from the time of approval until the end of 2019 or the first post-marketing regulatory action related to hepatotoxicity, whichever occurred first. The hazard ratio (HR) was estimated using Cox-regression analysis. Results: We included 192 medications in the study. We classified 48 drugs as having grade ≥ 3 hepatotoxicities, 43 had accelerated approval status, and 74 had labeled information about hepatotoxicity prior to marketing. The adjusted HRs for post-marketing regulatory action for products with grade ≥ 3 hepatotoxicity was 0.61 (95% confidence interval [CI], 0.17-2.23), 0.92 (95%CI, 0.29-2.93) for a drug approved via accelerated approval program, and was 0.91 (95%CI, 0.33-2.56) for drugs with labeled hepatotoxicity information at approval time. Conclusion: This study does not provide conclusive evidence on the association between post-marketing regulatory action and grade ≥ 3 hepatotoxicity, accelerated approval status, or availability of labeled information at approval due to sampling size and channeling bias.

Keywords: accelerated approvals, hepatic adverse effects, drug-induced liver injury, hepatotoxicity predictors, post-marketing withdrawal

Procedia PDF Downloads 123
5 Status of Reintroduced Houbara Bustard Chlamydotis macqueeni in Saudi Arabia

Authors: Mohammad Zafar-ul Islam

Abstract:

The breeding programme of Houbara bustard was started in Saudi Arabia in 1986 to undertake the restoration of native species such as Houbara through a programme of re-introduction, involving the release of captive-bred birds in the wild. Two sites were selected for houbara re-introduction, i.e., Mahazat as-Sayd and Saja Umm Ar-Rimth protected areas in 1988 and 1998 respectively. Both the areas are fenced fairly level, sandy plain with a few rock outcrops. Captive bred houbara have been released in Mahazat since 1992 by NWRC and those birds have been successfully breeding since then. The nesting season of the houbara at Mahazat recorded from February to May and on an average 20-25 nests are located each year but no nesting recorded in Saja. Houbara are monitored using radio transmitters through aerial tracking technique and also a vehicle for terrestrial tracking. Total population of houbara in Mahazat is roughly estimated around 300-400 birds, using the following: N = n1+n2+n3+n4+n5 (n1 = released or wild-born, radio, regularly monitored/checked; n2 = radio tagged missing; n3 = wild born chicks not recorded; n4 = wild born chicks, recorded but not tagged; n5 = immigrants). However, in Saja only 4-7 individuals of houbara have been survived since 2001 because most of the birds are predated immediately after the release. The mean annual home was also calculated using Kernel and Convex polygons methods with Range VII software. The minimum density of houbara was also calculated. In order to know the houbara movement or their migration to other regions, two captive-reared male houbara that were released into the wild and one wild born female were fitted with Platform Transmitter Terminals (PTT). The home range shows that wild-born female has larger movement than two males. More areas need to be selected for reintroduction programme to establish the network of sites to provide easy access to move these birds and mingle with the wild houbara. Some potential sites have been proposed which require more surveys to check the habitat suitability.

Keywords: re-introduction, survival rate, home range, Saudi Arabia

Procedia PDF Downloads 378
4 High Temperature Oxidation of Additively Manufactured Silicon Carbide/Carbon Fiber Nanocomposites

Authors: Saja M. Nabat Al-Ajrash, Charles Browning, Rose Eckerle, Li Cao, Robyn L. Bradford, Donald Klosterman

Abstract:

An additive manufacturing process and subsequent pyrolysis cycle were used to fabricate SiC matrix/carbon fiber hybrid composites. The matrix was fabricated using a mixture of preceramic polymer and acrylate monomers, while polyacrylonitrile (PAN) precursor was used to fabricate fibers via electrospinning. The precursor matrix and reinforcing fibers at 0, 2, 5, or 10 wt% were printed using digital light processing, and both were simultaneously pyrolyzed to yield the final ceramic matrix composite structure. After pyrolysis, XRD and SEAD analysis proved the existence of SiC nanocrystals and turbostratic carbon structure in the matrix, while the reinforcement phase was shown to have a turbostratic carbon structure similar to commercial carbon fibers. Thermogravimetric analysis (TGA) in the air up to 1400 °C was used to evaluate the oxidation resistance of this material. TGA results showed some weight loss due to oxidation of SiC and/or carbon up to about 900 °C, followed by weight gain to about 1200 °C due to the formation of a protective SiO2 layer. Although increasing carbon fiber content negatively impacted the total mass loss for the first heating cycle, exposure of the composite to second-run air revealed negligible weight chance. This is explained by SiO2 layer formation, which acts as a protective film that prevents oxygen diffusion. Oxidation of SiC and the formation of a glassy layer has been proven to protect the sample from further oxidation, as well as provide healing of surface cracks and defects, as revealed by SEM analysis.

Keywords: silicon carbide, carbon fibers, additive manufacturing, composite

Procedia PDF Downloads 42
3 Preceramic Polymers Formulations for Potential Additive Manufacturing

Authors: Saja M. Nabat Al-Ajrash, Charles Browning, Rose Eckerle, Li Cao

Abstract:

Three preceramic polymer formulations for potential use in 3D printing technologies were investigated. The polymeric precursors include an allyl hydrido polycarbosilane (SMP-10), SMP-10/1,6-dexanediol diacrylate (HDDA) mixture, and polydimethylsiloxane (PDMS). The rheological property of the polymeric precursors, including the viscosity within a wide shear rate range was compared to determine the applicability in additive manufacturing technology. The structural properties of the polymeric solutions and their photocureability were investigated using Fourier transform infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC). Moreover, thermogravimetric analysis (TGA) and X-ray diffraction (XRD) were utilized to study polymeric to ceramic conversion for versatile precursors. The prepared precursor resin proved to have outstanding photo-curing properties and the ability to transform to the silicon carbide phase at temperatures as low as 850 °C. The obtained ceramic was fully dense with nearly linear shrinkage and a shiny, smooth surface after pyrolysis. Furthermore, after pyrolysis to 1350 °C and TGA analysis, PDMS polymer showed the highest onset decomposition temperature and the lowest retained weight (52 wt%), while SMP.10/HDDA showed the lowest onset temperature and ceramic yield (71.7 wt%). In terms of crystallography, the ceramic matrix composite appeared to have three coexisting phases, including silicon carbide, and silicon oxycarbide. The results are very promising to fabricate ceramic materials working at high temperatures with complex geometries.

Keywords: preceramic polymer, silicon carbide, photocuring, allyl hydrido polycarbosilane, SMP-10

Procedia PDF Downloads 95
2 Structural Characterization of the 3D Printed Silicon Carbon/Carbon Fibers Nanocomposites

Authors: Saja M. Nabat Al-Ajrash, Charles Browning, Rose Eckerle, Li Cao

Abstract:

A process that utilizes a combination of additive manufacturing (AM), a preceramic polymer, and a chopped carbon fiber precursorto fabricate Silicon Carbon/ Carbon fibers (SiC/C) composites have been developed. The study has shown a promising, cost-effective, and efficient route to fabricate complex SiC/C composites using additive manufacturing. A key part of this effort was the mapping of the material’s microstructure through the thickness of the composite. Microstructural features in the pyrolyzed composites through the successive AM layers, such as defects, crystal size and their distribution, interatomic spacing, chemical bonds, were investigated using high-resolution scanning and transmission electron microscopy. As a result, the microstructure developed in SiC/C composites after printing, cure, and pyrolysis has been successfully mapped through the thickness of the derived composites. Dense and nearly defect-free parts after polymer to ceramic conversion were observed. The ceramic matrix composite displayed three coexisting phases, including silicon carbide, silicon oxycarbide, and turbostratic carbon. Lattice fringes imaging and X-Ray Diffraction analysis showed well-defined SiC and turbostratic carbon features. The cross-sectional mapping of the printed-then-pyrolyzed structures has confirmed consistent structural and chemical features within the internal layers of the AM parts. Noteworthy, however, is that a crust-like area with high crystallinity has been observed in the first and last external layers. Not only do these crust-like regions have structural characteristics distinct from the internal layers, but they also have elemental distributions different than the internal layers.

Keywords: SiC, preceramic polymer, additive manufacturing, ceramic

Procedia PDF Downloads 46
1 The Work Conditions of Women Refugees: The Case of Syrian Refugees in Lebanon

Authors: Saja Al Zoubi, Humam Wardeh

Abstract:

This study aims to shed light on the work conditions of female refugees and the most important constraints and challenges preventing them from accessing good earning work. The study was conducted in the Syrian refugee camps in Bekaa province, Lebanon, with a field survey carried out between 2016-2017 through face-to-face interviews of 69 female refugee workers, in addition to 4 focus groups. The results show that 97% of the Syrian female refugees are agricultural workers, they form more than 53% of the agricultural labor work among the refugees. Women predominantly perform all agricultural activities (Planting, weeding, fertilization, irrigation, compacting, cutting, sorting, packaging), except the carriage of heavy objects and sometimes irrigation are exclusive for men. The female child labor is 66% of the child labor. To maintain the livelihoods of their families, women accept to be paid for 4-8 $/day with gender gap around 6 $/day. Women’s acceptance of these low wages is one of the main reasons for landowners’ preference of hiring women under bad work conditions. The less educated and skilled (40% of the women are illiterate, and 2% have some skills) women are more likely to be limited to farm work. In addition, there are other reasons as traditions, labor market demand and other challenges related to security and legal issues. This study finds that enhancing the women capacities (for both refugees and host community) through vocational training and cooperative micro enterprises matched with income generating activities and opening new market channels for local manufactured products can play important role to improve the work skills and conditions, and that can improve the livelihood of their families. The study also recommends to adopt a strategy by all humanitarian agencies to make the aid on educating children condition.

Keywords: agricultural work conditions, gender wage gap, women refugees, work constraints

Procedia PDF Downloads 105