A clear scientific and operational need exists for harmonized bioanalytical immunogenicity study reporting to facilitate communication of immunogenicity findings and expedient review by industry and health authorities. To address these key bioanalytical reporting gaps and provide a report structure for documenting immunogenicity results, this cross-industry group was formed to establish harmonized recommendations and a develop a submission template to facilitate agency filings. Provided here are recommendations for reporting clinical anti-drug antibody (ADA) assay results using ligand-binding assay technologies. This publication describes the essential bioanalytical report (BAR) elements such as the method, critical reagents and equipment, study samples, results, and data analysis, and provides a template for a suggested structure for the ADA BAR. This publication focuses on the content and presentation of the bioanalytical ADA sample analysis report. The interpretation of immunogenicity data, including the evaluation of the impact of ADA on safety, exposure, and efficacy, is out of scope of this publication.
Graphical Abstract
Expected crime rates that enable police forces to contrast recorded and anticipated spatial patterns of crime victimisation offer a valuable tool in evaluating the under-reporting of crime and inform/guide crime reduction initiatives. Prior to this study, police forces had no access to expected burglary maps at the neighbourhood level covering all parts of England and Wales. Drawing on analysis of the Crime Survey for England and Wales and employing a population terrain modelling approach, this paper utilises household and area characteristics to predict the mean residential burglary incidences per 1000 population across all neighbourhoods in England and Wales. The analysis identifies distinct differences in recorded and expected neighbourhood burglary incidences at the Output Area level, providing a catalyst for stimulating further reflection by police officers and crime analysts.
Pubs, clubs, and music festivals are places characterised by increased alcohol consumption. Drinkaware, a UK alcohol awareness charity, delivered two crime-prevention initiatives designed to reduce alcohol-related harm among young adults: the "Drinkaware Crew" initiative implemented at night-time-economy (NTE) venues, and more recently, the Drinkaware "Festival Crew". This paper uses mixed methods to present (a) an outcome evaluation of the societal impact of the "Drinkaware Crew" initiative using routinely collected data; and (b) a process evaluation examining the transferability of the "Drinkaware Crew" initiative to a music festivalcontext. Findings indicate that the Drinkaware Crew occupy a unique gap in existing NTE and festival infrastructures, however, a number of improvements to the data available are recommended to ensure that such initiatives are thoroughly evidence-based.
The ever-increasing overcrowding of the radio spectrum assigned to flight testing telemetry is encouraging changes to aircraft, test items, and ground ranges that restrict telemetry data collection during weapons flight testing. To solve these problems, the 846th Test Support Squadron at Eglin Air Force Base, Florida, designed the Joint Range Instrumentation Pod (JRIP), a standalone telemetry system that provides un-tethered test capability for weapons testing. By collecting telemetered data, Global Positioning System and Inertial Navigation System (GPS/INS) data, and certain aircraft data on-board, the JRIP eliminates the requirement for a ground range when live data viewing is not needed.
The JRIP outer mold line is similar to an AIM-120A/B Advanced Medium Range Air-to-AirMissile, providing compatibility with F-15, F-16, and F-18 aircraft. The JRIP successfully advances instrumentation capability to support open-air flight testing of weapon systems for the Department of Defense, significantly improving test efficiency by optimizing test platform availability, and thereby decreasing testing time and reducing cost. In addition, it serves as a key vessel in the advancement of telemetry modulation technology and practices.
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