Product counterfeiting is a pervasive crime that involves the unauthorized use of a legitimate trademark, a violation of intellectual property rights. Counterfeiting is also one of many forms of global illicit trade, mirroring legitimate markets in structure and reach. Counterfeit goods span nearly every product category from luxury items and electronics to pharmaceuticals and military components, posing risks that range from consumer deception to threats to public health. The globalization of commerce and trade and the rise of e-commerce and social media have significantly expanded counterfeiters' reach, enabling them to exploit legitimate supply chains and marketplaces and reach consumers around the world. The production and distribution of counterfeit goods often involve sophisticated networks, including legitimate businesses and transnational criminal organizations, and are sometimes linked to human trafficking and forced labor. Despite regulatory efforts and public-private partnerships aimed at curbing counterfeiting, enforcement remains challenging due to the complexity of global supply chains and the difficulty in distinguishing counterfeit operations from legitimate ones. This article describes what product counterfeiting is and addresses how markets for counterfeit goods represent an illicit parallel market that is in many ways intermingled with aspects of legitimate markets. The role of consumers as drivers of demand for counterfeits is addressed, and motivations for consumers' willful purchase of counterfeit goods are explored. This article also provides exploratory insights about the supply chains for some of these products.
Transepithelial/transendothelial electrical resistance (TEER) is a widely accepted electrical parameter to assess barrier integrity and suitability of in vitro cellular barriers for transport studies. TEER measurement has advantages over traditional permeability measurements as a quick, label-free, and non-invasive method. TEER measurement has an added advantage that it can be performed in real -time if the measurement electrodes are integrated into a microfluidic organ-on-chip device such as BBB-on-chip. As evidenced by literature, TEER measurements for various cell types have been reported with both commercially available equipment and custom-built microfluidic implementations. The design versatility of BBBs-on-chips along with the numerous factors affecting TEER can complicate comparison of TEER results reported from various laboratories. Therefore, to achieve meaningful comparison and consensus between TEER reported from various BBBs-on-chips, it is important to understand various factors that affect TEER. The aim of this chapter is to introduce TEER and its significance, explore the different TEER measurement protocols along with their strengths and weaknesses, and review numerous factors that affect TEER.
The US Food and Drug Administration (FDA) published an inventory of harmful and potentially harmful constituents (HPHCs), which lists 93 chemicals (FDA 93) linked to the serious health effects of tobacco use. Some of the chemical compounds in the FDA 93 list were not characterized in earlier studies due to methodological limitations at that time. Leveraging new analytical methods, the current study quantitatively assessed an expanded list of 108 HPHCs in the tobacco heating system (THS) aerosol compared with smoke from the 3R4F reference cigarette. Analyses were conducted by Labstat International ULC, an independent laboratory accredited by the Standard Council of Canada to ISO/IEC 17025:2017, on two different THS HeatStick variants (regular and menthol) together with the THS version 2.2 and the 3R4F reference cigarette smoke using a Health Canada Intense smoking regime. Of the 108 HPHCs assessed in this study, 105 were either below the limits of quantification or showed substantial reductions in THS aerosol relative to cigarette smoke (all >45%), with no increased HPHC levels in the THS aerosol relative to cigarette smoke. Aside from nicotine, anabasine, and polonium-210 (210Po) which was near the limits of detection), the average reduction in the levels of HPHCs in the aerosol of THS compared with 3R4F reference cigarette smoke was >91.6% (Regular) and >92.2% (Menthol). The results for the two THS tobacco stick variants were remarkably similar. These results confirm that the elimination of combustion in THS results in a substantial reduction of HPHCs relative to cigarette smoke.
Pulmonary drug delivery (PDD) involves flow and deposition of aerosol particles acting as carriers of drugs delivered onto the surface of the airways. As a direct consequence, optimal PDD requires controlling of drug aerosolization processes and deep understanding of multiphase flows in complex geometry of the airways including aerosol particle dynamics during the transient inhalation cycles. A chemical engineering-based approache can be effectively used to analyze these processes and help in designing optimized drug formulations and more effective drug delivery devices (inhalers). One of prerequisites of improved PDD is the knowledge of in vivo–in vitro correlation (IVIVC) for inhaled drugs that would allow establishment of the relationships between aerosol quality determined using ex vivo methods (such as determination of particle size, deposition in reconstructed anatomical structures, pharmacokinetics/pharmacodynamics using in vitro cellular systems, or in silico modeling of aerosol dynamics) in connection to the clinical effects. This manuscript discusses the challenges of the IVIVC analyses for aerosol delivery systems. The primary focus is given to the physical and physicochemical constraints in the PDD that can be effectively described and investigated using engineering approaches.
