Results 101 to 110 of about 129 (121)
British Journal of Clinical Pharmacology, EarlyView.Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer +4 more
wiley +1 more source
British Journal of Clinical Pharmacology, EarlyView.Abstract Aims Risk minimization measures (RMMs) are key regulatory tools to ensure safe medicinal product use. Regulatory guidelines recommend pre‐specifying the targets, or ‘thresholds’, for assessing RMM effectiveness. We aimed to review recent industry‐sponsored post‐authorization safety studies (PASS) that evaluated the effectiveness of RMMs ...
Kexin Zhu +7 more
wiley +1 more source
Applying machine learning to pharmacovigilance data: A proof‐of‐concept study
British Journal of Clinical Pharmacology, EarlyView.Aim Machine learning (ML) applications in pharmacovigilance remain limited and underexplored. Using data from the French National pharmacovigilance database (FNPV), this proof‐of‐concept study aimed to assess the feasibility of using a ML algorithm—eXtreme Gradient Boosting (XGBoost)—combined with SHapley Additive exPlanations (SHAP) analysis, to ...
Romain Barus +6 more
wiley +1 more source
Regulatory harmonization: Evolution, globalization and future directions
British Journal of Clinical Pharmacology, EarlyView.Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm +2 more
wiley +1 more source
British Educational Research Journal, EarlyView.Abstract With growing attention to student agency in academic and policy discourse, international education has become a prominent context for examining how students navigate new cultural, academic, linguistic and social environments. However, much of this discussion attributes student agency to the ‘international’ aspect, while overlooking the ...
Soyoung Lee
wiley +1 more source
British Educational Research Journal, EarlyView.Abstract Study‐abroad programs are increasingly adopted and supported by institutions and governments as a strategic tool for deepening internationalisation and public diplomacy through people‐to‐people, institution‐to‐institution and country‐to‐country connections.
Ly Thi Tran, Thinh Huynh
wiley +1 more source
British Educational Research Journal, EarlyView.Abstract This paper analyses differences in academic achievement associated with attendance at publicly funded private schools and public schools across 11 European countries. Using eight waves of PISA data (2000–2022), we apply OLS, IPW and IPWRA estimators to account for observed heterogeneity and mitigate selection bias.
Priya Maurya +2 more
wiley +1 more source
British Educational Research Journal, EarlyView.Abstract Situating the study within an ecological perspective on language education, this article examines how secondary schools in England present Modern Languages (MLs) on official school websites. Focusing on 44 schools in Local Authorities with the lowest percentage average entry for the Languages pillar of the EBacc, we built a text database ...
Zhu Hua, Yunpeng Du, Elin Arfon
wiley +1 more source
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Language-independent working memory: Evidence from German and French reading span tests
Bulletin of the Psychonomic Society, 2013Naoyuki Osaka +2 more
exaly
Reading comprehension and strategy use in fourth- and fifth-grade French immersion students
Reading and Writing, 2019Deanna Friesen
exaly