Clinical Pharmacology &Therapeutics, EarlyView.External control arms (ECAs) have emerged as important tools to provide benchmark evidence on comparator effectiveness and thereby support regulatory decision making in situations where randomized controlled trials are difficult to conduct. However, how key methodological elements for ECAs are documented and implemented in practice and how residual ...
Suguru Okami, Alexandros Sagkriotis
wiley +1 more source
Scrutinizing the COVID-19 vaccine safety debate. [PDF]
Hum Vaccin ImmunotherBin Abdulrahman K, Bin Abdulrahman A.
europepmc +1 more source
Corporate Social Responsibility and Environmental Management, EarlyView.ABSTRACT Research addressing the microfoundations of corporate social performance (CSP) in small and medium‐sized enterprises (SMEs) remains sparse. This paper aims to investigate how SME managers' ethical ideology affects CSP and examines the mediating role of their CSR orientation (CSRO): economic, legal, ethical, and philanthropic.
Sarah Mohammad Suleiman Alsyoof +2 more
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Risk of autoimmune disease flares after recombinant zoster vaccine: A vaccine safety analysis based on the Vaccine Adverse Event Reporting System database. [PDF]
Hum Vaccin ImmunotherLiu G +5 more
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Epileptic Disorders, EarlyView.Abstract This seminar addresses the complexity of the management of epilepsy in adults with intellectual development disorders (IDD), advocating holistic and multidisciplinary care aligned with the learning objectives of the International League Against Epilepsy. Epilepsy is significantly more prevalent in people with IDD, presenting unique diagnostic,
Elena Fonseca +10 more
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The Immature Infant Liver: Cytochrome P450 Enzymes and their Relevance to Vaccine Safety and SIDS Research. [PDF]
Int J Med SciGoldman GS, Cheng RZ.
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Strengthening New Vaccine Introduction in Low- and Middle-Income Countries: Establishing Hospital-Based Sentinel Surveillance for Vaccine Safety Monitoring. [PDF]
Am J Trop Med HygShaum A +4 more
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Background incidence rates from electronic healthcare databases for vaccine safety monitoring: review of challenges from the COVID-19 vaccination campaign and proposal for best practices. [PDF]
Front Drug Saf RegulGandhi-Banga S +8 more
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Safety of co-administration of COVID-19 and seasonal influenza vaccines in individuals with autoimmune diseases from the Canadian National Vaccine Safety Network. [PDF]
Hum Vaccin ImmunotherSoe P +13 more
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Near real-time surveillance and tree-based data mining to assess the safety of respiratory syncytial virus vaccines in older adults in the vaccine safety datalink. [PDF]
VaccineDonahue JG +28 more
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