Publications by authors named "Mitch Clarke"

Nosocomial severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections have severely affected bed capacity and patient flow. We utilized whole-genome sequencing (WGS) to identify outbreaks and focus infection control resources and intervention during the United Kingdom's second pandemic wave in late 2020. Phylogenetic analysis of WGS and epidemiological data pinpointed an initial transmission event to an admission ward, with immediate prior community infection linkage documented.

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Background: Carbapenemase Producing Enterobacterales (CPE) are a global health concern. Nosocomial outbreaks have been reported globally with patient-to-patient transmission felt to be the most frequent route of cross-transmission.

Aim: To describe the investigation and control of an outbreak of healthcare-associated New Delhi Metallo-beta-lactamase (NDM) CPE on a haematology ward, over 2 months.

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The acceptance of foreign comparator products is the most limiting factor for the development and regulatory assessment of generic medicines marketed globally. Bioequivalence studies have to be repeated with the local comparator products of each jurisdiction because it is unknown if the comparators of the different countries are the same product, with the consequent duplication of efforts by regulators and industry alike. The regulatory requirements on the acceptability of foreign comparator products of oral dosage forms differ between countries participating in the Bioequivalence Working Group for Generics of the International Pharmaceutical Regulators Programme.

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Purpose: The Biopharmaceutics Classification System (BCS) based biowaiver is a scientific model which enables the substitution of in vivo bioequivalence studies with in vitro data as evidence of therapeutic equivalence subject to certain conditions. Despite being based on the same principles, BCS-based biowaivers are interpreted and regulated differently among international regulatory agencies. In this survey, the Bioequivalence Working Group (BEWG) of the International Generic Drug Regulators Programme (IGDRP) compared the criteria for BCS-based biowaivers applied by the participating regulators and organisations.

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Aim: The aim of the study was to understand senior infection prevention and control nurses' experiences and perceptions of implementing the day to day aspects of the Code of Hygiene.

Background: The Code of Hygiene is legislative and sets out compliance standards in order to reduce infection rates. It details standards by which health-care providers failing to comply with infection control standards can be subject to improvement notices and actions.

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