The Global CRO Council for Bioanalysis (GCC) was formed in September 2010. Since then, the representatives of the member companies come together periodically to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry. The 4th GCC Closed Forum brought together experts from bioanalytical CROs to share and discuss recent issues in regulated bioanalysis, such as the impact of coadministered drugs on stability, some differences between European Medicines Agency and US FDA bioanalytical guidance documents and lessons learned following recent Untitled Letters. Recent 483s and agency findings, as well as issues on method carryover, were also part of the topics discussed.
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http://dx.doi.org/10.4155/bio.12.48 | DOI Listing |
Eur J Radiol
December 2024
Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Radiology, Berlin, Germany; Berlin Institute of Health at Charité - Universitätsmedizin Berlin, BIH Biomedical Innovation Academy, Berlin, Germany Berlin Institute of Health, Berlin, Germany. Electronic address:
Background: The Prostate Imaging-Reporting and Data System (PI-RADS) calls for reporting the prostate index lesion and the location within the transition (TZ) or peripheral zone (PZ) and location on a corresponding sector map. The aim of this study was to train a deep learning DL-based algorithm for automatic prostate sector mapping and to validate its' performance.
Methods: An automatic 24-sector grid-map (ASG) of the prostate was developed, based on an automatic zone-specific deep learning segmentation of the prostate.
Cancer
December 2024
Division of Public Health, Department of Family & Preventive Medicine, University of Utah School of Medicine, and Huntsman Cancer Institute, Salt Lake City, Utah, USA.
Introduction: The relations between coffee and tea consumption and head and neck cancer (HNC) incidence are unclear. With increasing global HNC burden, this study aims to examine the association between coffee, tea, and HNC.
Methods: A pooled analysis of 9548 HNC cases and 15,783 controls from 14 individual-level case-control studies was conducted from the International Head and Neck Cancer Epidemiology consortium.
Lancet Reg Health West Pac
December 2024
WHO Collaborating Centre for Antimicrobial Resistance, The University of Melbourne at Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
Background: Fiji is a Pacific Island nation grappling with the increasing threat of antimicrobial resistance (AMR). While genomic technologies are increasingly utilised to understand the emergence and spread of AMR globally, its application to inform outbreak responses in low- and middle-income settings has not been reported.
Methods: Through an established capacity building program, suspected carbapenem-resistant organisms (CRO) identified at Colonial War Memorial Hospital in Fiji (Jan 2022-Oct 2023) underwent whole genome sequencing and analysis.
Clin Otolaryngol
December 2024
Department of Medical, Surgical and Health Sciences, Section of Otolaryngology, University of Trieste, Trieste, Italy.
Introduction: Artificial Intelligences (AIs) are changing the way information is accessed and consumed globally. This study aims to evaluate the information quality provided by AIs ChatGPT4 and Claude2 concerning reconstructive surgery for head and neck cancer.
Methods: Thirty questions on reconstructive surgery for head and neck cancer were directed to both AIs and 16 head and neck surgeons assessed the responses using the QAMAI questionnaire.
Transl Oncol
January 2025
Division of Molecular Oncology, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, via Franco Gallini 2, Aviano (PN), 33081, Italy. Electronic address:
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