Results 31 to 40 of about 972 (189)
British Journal of Clinical Pharmacology, EarlyView.Abstract Despite regulatory progress being made in the past two decades, off‐label drug use in paediatrics remains pervasive, with prevalence estimated between 3% and 97% of prescriptions across different clinical settings. Off‐label use—defined as prescribing outside the conditions described in the Summary of Product Characteristics (SmPC)—is often ...
Tjitske M. van der Zanden +3 more
wiley +1 more source
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
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
Capacity building in medicines development and regulation in Africa—Overview on recent progress
British Journal of Clinical Pharmacology, EarlyView.Aims Despite advances in health research and digital innovation, many African countries continue to face substantial resource constraints, fragmented capacity‐building efforts and a shortage of skilled professionals in medicines development and regulatory science.
Tirhani Maluleke +7 more
wiley +1 more source
British Educational Research Journal, EarlyView.Abstract This study examines the under‐theorized political role and identity of Chinese international students, who emerge as significant actors caught between U.S. soft power ambitions and rising geopolitical suspicion. Amid escalating U.S.‐China tensions, these students are forced to confront environments shaped by competing geopolitical discourses ...
Jing Yu
wiley +1 more source
Business Strategy and the Environment, EarlyView.ABSTRACT The aim of this research is to verify whether institutional quality affects the relationship between green innovation and firm efficiency within the high‐tech manufacturing sectors. To estimate jointly the parameters of a stochastic frontier and the coefficients of a model explaining technical inefficiency, we employed the one‐step estimation ...
Mariarosaria Agostino +2 more
wiley +1 more source
Business Strategy and the Environment, EarlyView.ABSTRACT In response to growing global challenges, this study explores how social entrepreneurship within the Edible City movement contributes to building resilient, sustainable, and equitable urban food systems. Drawing on semistructured interviews with over 70 stakeholders across five cities—Berlin, Andernach, Oslo, Rotterdam, and Havana—we ...
Ina Säumel +6 more
wiley +1 more source
Business Strategy and the Environment, EarlyView.ABSTRACT This study analyzed Industry 4.0 (I4.0) technology applications in agribusiness and the role of strategic stakeholders, engagement methods, and other critical aspects data sharing, confidentiality, integrity, decision‐making, and sector‐specific requirements in promoting circularity.
Simone Sehnem +3 more
wiley +1 more source
Business Strategy and the Environment, EarlyView.ABSTRACT This study examines the role of managerial ability in driving environmental performance and overall environmental, social, and governance (ESG) ratings in the context of the European Union sustainability reporting regulations. Using a sample of 7242 firm‐year observations over the period 2015–2023, our results indicate a structural change in ...
Mihaela Ionașcu +2 more
wiley +1 more source
Elaborating the Motivations and Attitudes Driving Interest in Voluntary Biodiversity Credits
Business Strategy and the Environment, EarlyView.ABSTRACT Global biodiversity loss has prompted the search for new sources of conservation finance, such as voluntary biodiversity credits (VBCs). However, despite optimistic market projections, current uptake of VBCs is limited. Adopting an interpretive approach, we analyse 21 semistructured interviews with early market actors (buyers, sellers ...
Gamze Yakar‐Pritchard +5 more
wiley +1 more source