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Leveraging Model Master Files for Long-Acting Injectables.
Pharm Res
January 2025
Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, , MD, 20993, USA.
The U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a public workshop on May 2-3, 2024, titled "Considerations and Potential Regulatory Applications for a Model Master File (Lachaine et al Can J Psychiatry.
View Article and Find Full Text PDFThe effect of conflicting versus consistent messaging on older women's support for breast cancer screening cessation.
Patient Educ Couns
January 2025
University of Minnesota Hubbard School of Journalism and Mass Communication, Minneapolis, MN, USA.
Objective: Breast cancer over-screening is common in older women. Messaging about breast cancer screening cessation may reduce over-screening but the broader informational environment often emphasizes screening continuation. We aimed to examine the effect of receiving consistent messages about breast cancer screening cessation versus conflicting messages (i.
View Article and Find Full Text PDFH*10 neutron dosimetry (unlike gamma dosimetry), requires consideration of neutron energy spectra due to the 20× variation of the weight factor over the thermal-to-fast energy range, as well as the neutron radiation field dose rates ranging from cosmic, ~.01 μSv h-1 levels to commonly encountered ~10-200 μSv h-1 in nuclear laboratories/processing plants, and upwards of 104 Sv h-1 in nuclear reactor environments. This paper discusses the outcome of the comparison of spectrum-weighted neutron dosimetry covering thermal-to-fast energy using the novel H*-TMFD spectroscopy-enabled sensor system in comparison with measurements using state-of-the-art neutron dosimetry systems at SRNS-Rotating Spectrometer (ROSPEC), and non-spectroscopic Eberline ASP2E ("Eberline") and Ludlum 42-49B ("Ludlum") survey instrumentation.
View Article and Find Full Text PDFBackground: Mental health remains among the top 10 leading causes of disease burden globally, and there is a significant treatment gap due to limited resources, stigma, limited accessibility, and low perceived need for treatment. Problem Management Plus, a World Health Organization-endorsed brief psychological intervention for mental health disorders, has been shown to be effective and cost-effective in various countries globally but faces implementation challenges, such as quality control in training, supervision, and delivery. While digital technologies to foster mental health care have the potential to close treatment gaps and address the issues of quality control, their development requires context-specific, interdisciplinary, and participatory approaches to enhance impact and acceptance.
View Article and Find Full Text PDFLongitudinal relationships across sleep, physical activity, and mental wellbeing in early-to-mid-adolescence: a developmental cascades investigation.
Qual Life Res
January 2025
Manchester Institute of Education, University of Manchester, Manchester, M13 9PL, UK.
Purpose: Sleep (SL), physical activity (PA), and wellbeing (WB) are three factors linked to positive development in adolescence. Despite theoretical support and some empirical evidence of developmental associations between these factors, few studies have rigorously investigated reciprocal associations over time separating between-person and within-person effects, and none have investigated all three in concert. Thus, it remains unclear how the interplay between SL, PA and WB unfolds across time within individuals.
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