Framework for the quality assurance of 'omics technologies considering GLP requirements

‘Omics technologies are gaining importance to support regulatory toxicity studies. Prerequisites for performing ‘omics studies considering GLP principles were discussed at the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) Workshop Applying ‘omics technologies in Chemical Risk Assessment. A GLP environment comprises a standard operating procedure system, proper pre-planning and documentation, and inspections of independent quality assurance staff. To prevent uncontrolled data changes, the raw data obtained in the respective ‘omics data recording systems have to be specifically defined. Further requirements include transparent and reproducible data processing steps, and safe data storage and archiving procedures. The software for data recording and processing should be validated, and data changes should be traceable or disabled. GLP-compliant quality assurance of ‘omics technologies appears feasible for many GLP requirements. However, challenges include (i) defining, storing, and archiving the raw data; (ii) transparent descriptions of data processing steps; (iii) software validation; and (iv) ensuring complete reproducibility of final results with respect to raw data. Nevertheless, ‘omics studies can be supported by quality measures (e.g., GLP principles) to ensure quality control, reproducibility and traceability of experiments. This enables regulators to use ‘omics data in a fit-for-purpose context, which enhances their applicability for risk assessment

Preparation and Evaluation of Poly(Ethylene Glycol)–Poly(Lactide) Micelles as Nanocarriers for Oral Delivery of Cyclosporine A

A series of monomethoxy poly(ethylene glycol)–poly(lactide) (mPEG–PLA) diblock copolymers were designed according to polymer–drug compatibility and synthesized, and mPEG–PLA micelle was fabricated and used as a nanocarrier for solubilization and oral delivery of Cyclosporine A (CyA). CyA was efficiently encapsulated into the micelles with nanoscaled diameter ranged from 60 to 96 nm with a narrow size distribution. The favorable stabilities of CyA-loaded polymeric micelles were observed in simulated gastric and intestinal fluids. The in vitro drug release investigation demonstrated that drug release was retarded by polymeric micelles. The enhanced intestinal absorption of CyA-loaded polymeric micelles, which was comparable to the commercial formulation of CyA (Sandimmun Neoral®), was found. These suggested that polymeric micelles might be an effective nanocarrier for solubilization of poorly soluble CyA and further improving oral absorption of the drug

Charcoal and firewood use in urban areas of developing countries: Drivers, consequences, and the need for clean cooking solutions

Abstract: This study examines the key drivers behind the continued reliance on traditional biomass fuels such as charcoal and firewood in urban areas of developing countries, including the city of Lubumbashi. The paper focuses on economic constraints, health problems associated with the use of these fuels, the environmental consequences of growing use and also looks at the alternatives for cooking and their accessibility. The various reasons behind the growing and constant use of charcoal and firewood are examined in the context of the city of Lubumbashi and other developing countries. However, the continuous supply of charcoal and firewood not only contributes to the degradation of forests and the extinction of species, but also disrupts the livelihoods of forest-dependent families and exacerbates soil erosion. The charcoal production process is intrinsically damaging to both the environment and human well-being. Not only does it emit large quantities of CO2, contributing to atmospheric pollution, but it also presents health risks for both producers and users. The smoke and soot generated during charcoal production expose people to harmful substances, leading to adverse health effects and even premature death, particularly among children. This review also discusses the impact of this production and use on the education of women and children, who are responsible for cooking and harvesting firewood, resulting in a higher illiteracy rate among women. Faced with the need to take global action to mitigate the impact of climate change, global carbon dioxide emissions must be drastically reduced to meet the Paris Agreement target of zero net emissions by 2050. A practical and sustainable solution is discussed in this review as an alternative to traditional cooking systems namely solar cooking, which offers enormous potential, provided it is accessible, and is an excellent alternative to the heavy reliance on biomass for household energy needs in developing countries

Carrier lifetime, Diffusion Length and Mobility in (100) CVD Diamond Samples Pre-treated in an O2/H2-plasma.

In this article, (100) Ib diamond substrates are pre-treated for different durations in an O2/H2-plasma, influencing the etching of defects like unepitaxial crystals, flat top hillocks, and pyramidal hillocks [1-3]. Such procedure is used to prevent those to incorporate into the ~ 100μm thick CVD diamond film, which is subsequently grown on top. While the surface morphology and structure of substrates and films are studied by SEM, the time-resolved Light-Induced Transient Grating (LITG) technique provides information on the excess carrier parameters close to the front surface of the grown layers. This technique is particularly useful as it does not requires a separation of the CVD film from its substrate. It will be shown that O2/H2-plasma treatments of more than 150 minutes but less than 240 minutes largely reduce the incorporation of defects in the bulk of the grown film. This, in turn, influences the carrier dynamics as measured by LITG, but also the surface roughness and growth rate as shown by SEM