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In many countries, including patients are legally entitled to request copies of their clinical notes. However, this process remains time-consuming and burdensome, and it remains unclear how much of the medical record must be made available. Online access to notes offers a way to overcome these challenges and in around 10 countries worldwide, via secure web-based portals, many patients are now able to read at least some of the narrative reports written by clinicians (‘open notes’). However, even in countries that have implemented the practice many clinicians have resisted the idea remaining doubtful of the value of opening notes, and anticipating patients will be confused or anxious by what they read. Against this scepticism, a growing body of qualitative and quantitative research reveals that patients derive multiple benefits from reading their notes. We address the contrasting perceptions of this practice innovation, and claim that the divergent views of patients and clinicians can be explained as a case of epistemic injustice. Using a range of evidence, we argue that patients are vulnerable to (oftentimes, non-intentional) epistemic injustice. Nonetheless, we conclude that the marginalisation of patients’ access to their health information exemplifies a form of epistemic exclusion, one with practical and ethical consequences including for patient safety.Stroke treatment has dramatically improved in recent decades. However, although new treatments have reduced its mortality and the severity of its physical and cognitive sequelae, many people still have incapacitating disabilities following a stroke. Depression is the most common psychiatric disorder following stroke; it is important to recognise and treat as it limits motor and cognitive rehabilitation. Antidepressant medication is an effective treatment and can improve adherence to clinically recommended physical and cognitive tasks, thereby enhancing functional remodelling of neuronal pathways and improving rehabilitation outcomes.Virus filtration has been demonstrated to be an effective and robust dedicated viral clearance step that is used in biopharmaceutical manufacturing processes. Here we present virus filtration data from a multi-company collaboration with data compiled from WuXi Advanced Therapies’ and Charles River Laboratories’ internal viral clearance databases spanning more than 25 years. The data were sorted by virus removal and type and then further subdivided into murine leukemia virus only, pseudorabies virus only, and reovirus type 3 only categories to allow for analyses of viral clearance results. A total of 2311 virus filtrations were analyzed, comprised of 1516 murine leukemia virus, 385 pseudorabies virus, and 410 reovirus type 3 virus filtrations. These data provide clear evidence that will help supplement both internal and industry-wide initiatives focused on using prior knowledge for the creation of modular claims for small virus retentive filters and allow better allocations of resources typically spent on potentially unnecessary studies.The dropping of glass vials based on negligence or accidental events that occur during the preparation or mixing of injectable drugs are examples of instances of occupational exposures occurring in a clinical setting. To reduce such risks, several types of glass vial packaging have been developed. We herein compared the resistance of base- and cup-type packaged vials to breakage and scattering of contents during falls with control vials. The falling heights at which test products were dropped were set to 70, 135, and 180 cm. Compared with the control group, appearance changes were inhibited in the cup-type groups. Significant differences were found between the cup-type and control groups at heights of 135 and 180 cm. Next, resistance of packaging to spilling and scattering of solution from the vial was determined. There was no scattering in any types of vials at a height of 70 cm because they were not broken. However, at heights of 135 and 180 cm, the mean scattering distance in the control groups were 50 and 70.6 cm, respectively. At these heights, some vials in the base-type and cup-type group were also cracked, but the solution stayed completely inside the covering packaging, indicating an obvious antiscattering ability. Vials packed in cup- and base-type packaging would lower the risk of the exposure of hazardous drugs during vial breakages. Because the base-type packaging did not show significant antibreakage effects, the cup-type packaging is more suited for hazardous drug packaging. However, cup-type packaging requires equipment investments from pharmaceutical manufacturers. Thus, cost-effectiveness and the target drug profile should be evaluated, and the use of cup- and base-type packaging, as well as control, forms should be selected accordingly.During storage and distribution of a packaged drug product, chemical substances present in or on the packaging may leach into the drug product, potentially adversely affecting the drug product’s key quality attributes, including safety. Thus, the packaging is profiled for extractables as potential leachables and/or the drug product is profiled for leachables over shelf-life via the process of chemical characterization. In so doing, the packaging and the packaged drug product are qualified as being suited for their intended use. It is reasonable to propose that the extent of chemical characterization required to qualify the packaging and the packaged drug product depends on the risk that leached substances could adversely affect drug product quality; the higher the risk, the more extensive and rigorous the required qualification. selleck chemicals Although regulatory guidance supports and advocates such a risk-based approach to chemical characterization, the existing guidance is founded on an overly simplified approach to risk assessment, leading to incongruous risk classifications for certain classes of drug products. Furthermore, the existing guidance no longer links risk to current requirements concerning the extent of chemical characterization necessary to secure regulatory approval of drug product applications. To address these circumstances, this manuscript proposes and justifies a risk classification process (risk evaluation matrix) for drug products and packaging and a risk-based approach to chemical characterization requirements, linking risk to the degree and rigor of the chemical characterization process and establishing chemical characterization requirements for individual risk classes.