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
Rotavirus Vaccines at 20 Years: Success, Challenges, and the Road Ahead. [PDF]
Vaccines (Basel)Carter AS +4 more
europepmc +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
Medicines, misinformation and machines: Navigating infodemics in the generative AI era
British Journal of Clinical Pharmacology, EarlyView.Health information is now widely accessed through smartphones, online searches and increasingly through generative artificial intelligence (AI). These systems create new opportunities for communication, and in some routine contexts, well‐governed AI assistants could reduce exposure to lower quality sources by providing cautious, evidence‐aligned ...
Natansh D. Modi +3 more
wiley +1 more source
An ORFV F1L mRNA Vaccine Candidate: Preparation, Immunogenicity, and Comparison with a Commercial Live Vaccine. [PDF]
Animals (Basel)Lin Y, Jiang J, Liu W, Rai KR, Che Y.
europepmc +1 more source
British Educational Research Journal, EarlyView.Abstract In this paper, we explore how neurodivergent ways of being in early education are often gendered. The intersectionalities of gender and neurodivergence often lead to fixed expectations that perpetuate binary interpretations, pathologisations, missed diagnoses and a lack of curated support.
Ruth Churchill Dower, Hannah Hogarth
wiley +1 more source
Current Strategies for Selecting Recombinant Orthopoxvirus Proteins for Immunobiological and Diagnostic Applications. [PDF]
VirusesZhakypbek A +14 more
europepmc +1 more source
What Makes an “Ideal” Cell Line for Recombinant Adeno‐Associated Virus Production?
Biotechnology and Bioengineering, EarlyView.Several host cell types have been used to produce rAAVs to date. Cell line‐specific traits that are beneficial in the context of rAAV manufacturing are reviewed here, with the goal of developing a consensus on the ‘ideal’ characteristics that an rAAV production host should possess (created with Biorender.com).
James Conheady +6 more
wiley +1 more source
Expression and immunogenicity of a rabies virus glycoprotein-HSV-2 ICP35 fusion antigen delivered by an mRNA-LNP formulation. [PDF]
Virus ResLi X +10 more
europepmc +1 more source
Biotechnology and Bioengineering, EarlyView.Genetic engineering (GE) overcomes BCA limits, enabling robust, scalable crop protection. “Super Bioagents” (SBs) use optimized SSs to enhance bioactive molecule delivery. Optimizing SSs enhance precise, sustainable effector deployment for stable disease suppression. SBs use microbiome‐informed design for scalable, next‐gen sustainable crop protection.
Michael Dare Asemoloye
wiley +1 more source