Definition of particle visibility threshold in parenteral drug products - towards standardization of visual inspection operator qualification.

The detectability size threshold of visible particles (″visibility″ size) in the context of visual inspection of parenteral drug products has been an elusive target for several decades. The current common sense, also reflected in official guidelines, dictates that particles of different shapes and morphologies have different ″visibility″ size thresholds, that can range between hundreds and thousands of micrometers. This study demonstrates experimentally for the first time that it is possible to define a single, shape- and morphology- independent detectability size threshold, identical across particles of various types, provided that observation conditions and product attributes are kept constant.

Biomarkers of Intestinal Permeability Are Influenced by Diet in Patients with Ulcerative Colitis-An Exploratory Study.

The disruption of the intestinal epithelial barrier leads to increased intestinal permeability (IP), allowing endotoxins and pathogens to enter the bloodstream contributing to chronic inflammation. Western diets are associated with increased IP, while diets rich in polyphenols, fiber, and omega-3 fats are linked to decreased IP. The relationship between diet, disease activity, and IP in ulcerative colitis (UC) is poorly understood.

Intra- and post-procedural patient-reported experience measures and their correlation with post-ERCP adverse events and unplanned healthcare utilization.

Background:  Post-endoscopic retrograde cholangiopancreatography (ERCP) adverse events (AEs) are common, as is unplanned healthcare utilization (UHU). We aimed to assess potential etiologic associations between intra-/post-procedural patient-reported experience measures (PREMs) and post-ERCP AEs and UHU. METHODS : Prospective data from a multicenter collaborative were used.

The International Association for the Study of Lung Cancer Pleural Mesothelioma Staging Project: Proposal for Revision of the TNM Stage Groupings in the Forthcoming (Ninth) Edition of the TNM Classification for Pleural Mesothelioma.

Introduction: The eighth edition of the TNM classification of pleural mesothelioma (PM) saw substantial changes in T and N components and stage groupings. The International Association for the Study of Lung Cancer collected data into a multinational database to further refine this classification. This ninth edition proposal incorporates changes proposed in the clinical (c)T component but not the pathologic T component, to include size criteria, and further refines TNM stage groupings for PM.

The International Association for the Study of Lung Cancer Mesothelioma Staging Project: Proposals for Revisions of the "T" Descriptors in the Forthcoming Ninth Edition of the TNM Classification for Pleural Mesothelioma.

Introduction: The primary tumor (T) component in the eighth edition of pleural mesothelioma (PM) staging system is based on pleural involvement and extent of invasion. Quantitative assessment of pleural tumor has been found to be prognostic. We explored quantitative and qualitative metrics to develop recommendations for T descriptors in the upcoming ninth edition of the PM staging system.