Current medical research and opinion
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The totality-of-evidence approach requires that similarity between a proposed biosimilar and a reference biologic is demonstrated across a range of analytical, preclinical, and clinical parameters to establish biosimilarity. We describe the totality of evidence for Sandoz biosimilar pegfilgrastim (LA-EP2006 [marketed as Ziextenzo]) that supported its regulatory approval in Europe and the United States. ⋯ The totality of evidence confirms that Sandoz biosimilar pegfilgrastim matches the reference biologic and will therefore provide equivalent efficacy and safety in all eligible indications.
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This study aimed to develop and validate a predictive algorithm for unsatisfactory response to initial pulmonary arterial hypertension (PAH) therapy using health insurance claims. ⋯ The present claims-based algorithm performed well in predicting time to unsatisfactory response following initial PAH therapy.
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Many biomedical journals follow the International Committee of Medical Journal Editors (ICMJE) recommendations and criteria for authorship. ICMJE criterion 1 provides the basis for selecting authors according to their substantial contributions to the work reported in the publication. Identifying substantial contributions and their application for author selection can be challenging, especially for multicenter studies with large numbers of investigators and contributors. Contributions are not frequently documented during study conduct and authorship decisions may lack transparency, objectivity, and context. ⋯ The Task Force recommendations for objective and consistent interpretation of ICMJE criterion 1 will facilitate an author selection process grounded in the core principles of substantial intellectual contribution to the work's conception or design, or to the acquisition, analysis, or interpretation of data. While these recommendations are focused on author selection practices for industry-sponsored research, they may be applicable to publications in other areas of scientific and biomedical research.
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This study aimed to investigate the effects of a psychological growth camp in the treatment of adolescents at risk of Internet addiction in Taiwan. ⋯ The results indicate that the psychological growth camp without Internet might be effective in treating adolescents with Internet addiction.
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To investigate the efficacy of direct computed tomography venography (CTV) in early and accurate detection of lower extremity venous (LEV) abnormalities. ⋯ Application of CTV for early and accurate detection of LEDV abnormalities including thrombosis has been proven to be efficient. Corresponding benefit in early intervention and reduction of severe complications of such abnormalities is of important value. CTV earned good recognition from medical staff and patients. Hence, it could be considered as part of global health assistance cooperation with developing countries to facilitate enhanced medical services.