Results 171 to 180 of about 95,506 (252)

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh   +19 more
wiley   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

open access: yesBritish 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

Spermidine Mitigates Immune Cell Senescence and Boosts Vaccine Responses in Healthy Older Adults-A Pilot Study. [PDF]

open access: yesAging Cell
Alsaleh G   +25 more
europepmc   +1 more source

More‐than‐gender? Moving beyond gendered expectations of divergent learners in early childhood education

open access: yesBritish 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

What Makes an “Ideal” Cell Line for Recombinant Adeno‐Associated Virus Production?

open access: yesBiotechnology 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

T-cell responses to primary SARS-CoV-2 vaccination in Down syndrome - From childhood to adulthood. [PDF]

open access: yesHum Vaccin Immunother
Hensen LCM   +7 more
europepmc   +1 more source

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