Capacity building in medicines development and regulation in Africa—Overview on recent progress
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
Potential for use of Al/machine learning for pharmacovigilance: Is there a role for regulators?
British Journal of Clinical Pharmacology, EarlyView.
Christina Gao +3 more
wiley +1 more source
Background Long‐acting intramuscular cabotegravir plus rilpivirine (LA‐CAB + RPV) is an effective maintenance antiretroviral regimen for virologically suppressed people with HIV. However, its use in individuals receiving chronic anticoagulation is limited by concerns regarding intramuscular bleeding risk, and real‐world data are scarce.
Montserrat Laguno +13 more
wiley +1 more source
Optimizing diversity, equity and inclusion in pragmatic clinical trials: Findings from the Pain Management Collaboratory. [PDF]
Lovejoy TI +7 more
europepmc +1 more source
Abstract The mental health and wellbeing of young people has received increasing attention in both research and the wider public discourse. There has been a marked rise in mental health conditions in young people, and the burden of care is increasingly transferred onto schools and teachers.
Thomas Godfrey‐Faussett +6 more
wiley +1 more source
Pragmatic clinical trials for localized prostate cancer: lessons learned and "three sins". [PDF]
Roach M.
europepmc +1 more source
ABSTRACT The biopharmaceutical industry increasingly relies on single‐use technologies (SUT) for operational flexibility. For a long time, SUT was considered more sustainable than stainless‐steel (SST) systems due to water and energy savings. This study re‐evaluates this paradigm via a detailed bottom‐up analysis of the SUT carbon footprint at the 2000
Jan Reiners +4 more
wiley +1 more source
Novel approaches to recruiting clinical sites for embedded pragmatic clinical trials: Insights from the AIM-back trial. [PDF]
Cope TL +7 more
europepmc +1 more source
A General Workflow for Tangential Flow Filtration Perfusion Scale‐Up
ABSTRACT Tangential flow filtration (TFF) perfusion using hollow‐fiber modules offers substantial advantages over other mammalian cell retention technologies. Recently, increased awareness of Starling flow has helped to enhance filtration performance to similar, or even higher levels compared to alternative technologies.
Patrick Romann +20 more
wiley +1 more source
Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials. [PDF]
Marsolo KA +10 more
europepmc +1 more source

