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Edaravone for the Treatment of Motor Neurone Disease: A Critical Review of Approved and Alternative Formulations against a Proposed Quality Target Product ProfileEdaravone is one of two main drugs for treating motor neurone disease (MND). This review proposes a specific quality target product profile (QTPP) for edaravone following an appraisal of the issues accounting for the poor clinical uptake of the approved IV and oral liquid edaravone formulations. This is followed by a review of the alternative oral formulations of edaravone described in the published patent and journal literature against the QTPP.
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4CMenB Breadth of Immune Response, Immunogenicity, and Safety: Results from a Phase 3 Randomized, Controlled, Observer Blind Study in Adolescents and Young AdultsMeningococcal serogroup B (MenB) strains are highly diverse. Breadth of immune response for the MenB vaccine, 4CMenB, administered at 0-2, 0-6, or 0-2-6 months, was demonstrated by endogenous complement-human serum bactericidal antibody (enc-hSBA) assay against an epidemiologically relevant panel of 110 MenB strains.
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Net Promoter Score Model for Evaluating Paediatric Medicine Acceptability: Validation and Feasibility StudyMedicine acceptability is crucial for paediatric drug development, yet its assessment remains challenging due to the multifaceted nature of sensory attributes like taste, smell, and mouthfeel. Traditional methods of acceptability evaluation often involve complex questionnaires and lack standardisation, leading to difficulties in a comparative analysis across studies.
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Cardiac monitoring safety assessment framework for early phase group a streptococcal vaccine trialsThis paper presents a comprehensive cardiac safety framework for early clinical development of Streptococcus pyogenes (Group A Streptococcus) vaccines, endorsed by the Strep A Vaccine Global Consortium and the Australian Strep A Vaccine Initiative. Given historical concerns about vaccine-associated acute rheumatic fever, we have established standardized echocardiography protocols integrated with clinical assessment for monitoring cardiac safety in early-phase vaccine trials.
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“You can't heal yourself in that setting and you wouldn't expect other people in this country to”: Yarning about housing and environmental health in remote Aboriginal communitiesRemote Aboriginal communities in Australia are located on traditional lands holding deep cultural significance and meaning for residents. However, systemic inequity rooted in colonisation has driven persistent housing and health disparities, with inadequate environmental health conditions within homes and communities a prominent example.
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Impact of early childhood infection on child development and school performance: a population-based studyChildhood infection might be associated with adverse child development and neurocognitive outcomes, but the results have been inconsistent.
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Respiratory Syncytial Virus Strain Evolution and Mutations in Western Australia in the Context of Nirsevimab ProphylaxisNirsevimab is a long-acting monoclonal antibody used to prevent respiratory syncytial virus (RSV) infection in infants and high-risk children. During the 2024 RSV season in Western Australia, 21 922 doses were administered to infants entering their first season and 1221 doses to at-risk children. In this context, the selection and spread of escape variants are a potential concern. This study aimed to investigate nirsevimab binding site mutations using clinical and wastewater data.
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What influences the implementation of health checks in the prevention and early detection of chronic diseases among Aboriginal and Torres Strait Islander people in Australian health careThis review aims to systematically identify contextual and mechanistic factors that contribute to the success or failure of implementing effective HCs in the prevention and early detection of chronic diseases among Aboriginal and Torres Strait Islander people in Australian primary health care (PHC).
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Factors influencing adult and adolescent completion of treatment for late syphilis: a mixed methods systematic reviewTo identify factors influencing the completion of a three-dose course of weekly intramuscular benzathine penicillin G injections by adults and adolescents with syphilis of unknown duration or late syphilis.
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Pneumococcal carriage, serotype distribution, and antimicrobial susceptibility in Papua New Guinean children vaccinated with PCV10 or PCV13 in a head-to-head trialChildren in Papua New Guinea (PNG) are at high risk of pneumococcal infections. We investigated pneumococcal carriage rates, serotype distribution, and antimicrobial susceptibility in PNG children after vaccination with 10-valent or 13-valent pneumococcal conjugate vaccines (PCV10; PCV13).