Results 211 to 220 of about 6,158,274 (301)

Potential for use of Al/machine learning for pharmacovigilance: Is there a role for regulators?

British Journal of Clinical Pharmacology, EarlyView.
Christina Gao, Ashley M. Hopkins, Andrew Rowland, Stephen Bacchi   +3 more
wiley   +1 more source

Operationalization of the African Medicines Agency: Retrospective evaluation of the continental centralized pilot procedure timelines to recommendation and national registrations

British Journal of Clinical Pharmacology, EarlyView.
Aims Regulatory inconsistency across Africa causes duplicative assessments, prolonged approvals, and delayed medical access. To inform the African Medicines Agency (AMA), the African Medicines Regulatory Harmonisation (AMRH) piloted Africa's first continental scientific evaluation of human medicinal products.
Alex Juma Ismail, Lerato Moeti, Delese Mimi Darko, Stuart Walker, Sam Salek   +4 more
wiley   +1 more source

Optimizing diversity, equity and inclusion in pragmatic clinical trials: Findings from the Pain Management Collaboratory. [PDF]

J Pain
Lovejoy TI, Midboe AM, Higgins DM, Ali J, Kerns RD, Heapy AA, Nalule EK, Pal N.   +7 more
europepmc   +1 more source

Pragmatic Trials

This chapter explores the role of pragmatic trials in aging research, comparing their characteristics to those of explanatory clinical trials. We additionally conducted an exploratory search of the literature up to February 2024 and identified 1613 ...
Pérez-Nieto, Orlando Rubén, IRAS – One Health Chemical, Mancilla-Galindo, Javier, Kammar-García, Ashuin, IRAS OH Epidemiology Chemical Agents, Fernández-Urrutia, Liliana Aline, Garza-Santiago, Esmeralda   +6 more
core  

Lenacapavir initiation with concomitant primidone: A case report with therapeutic drug monitoring

British Journal of Clinical Pharmacology, EarlyView.
Lenacapavir (LEN), a first‐in‐class capsid inhibitor, has unique pharmacokinetics that enable twice‐yearly dosing. LEN is not extensively metabolized, although it is a substrate of CYP3A4, which introduces drug–drug interactions concerns. As adoption and implementation of LEN for treatment and prevention increase, additional guidance on concomitant ...
Aaron S. Devanathan, Thomas Glowa, Emily M. Thompson, Amanda J. Saylor, Thomas D. Nolin, Sharon A. Riddler, Ken S. Ho   +6 more
wiley   +1 more source

Pragmatic clinical trials for localized prostate cancer: lessons learned and "three sins". [PDF]

Front Oncol
Roach M.
europepmc   +1 more source

Teacher confidence and student engagement with mental health and wellbeing lessons: Learning from an iterative curriculum intervention in schools

British Educational Research Journal, EarlyView.
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, Naomi French, Abbie Simpkin, Julian Turner, Tracey Riseborough, Natalie Coles, Ian Thompson   +6 more
wiley   +1 more source

Novel approaches to recruiting clinical sites for embedded pragmatic clinical trials: Insights from the AIM-back trial. [PDF]

Contemp Clin Trials Commun
Cope TL, George SZ, Hastings SN, France C, Tumminello C, Coffman CJ, Choate A, Lentz TA.   +7 more
europepmc   +1 more source

A General Workflow for Tangential Flow Filtration Perfusion Scale‐Up

Biotechnology and Bioengineering, EarlyView.
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, Ken Lee, Venkatesh Natarajan, Daniel Ley, Claes Nymand Nilsson, David Garcia‐Munzer, Dominik Schieman, Mahbod Hajighasemi, Alex Zaytsev, Jason Friedman, Loic Chappuis, Tobias Habicher, Colin Jaques, Alex Cohen, Matthew Gagnon, Edward Chan, Daniel J. Karst, Philip Giller, Antony Sibilia, Andrew L. Zydney, Thomas K. Villiger   +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]

Contemp Clin Trials
Marsolo KA, Cheville A, Melnick ER, Jarvik JG, Simon GE, Sluka KA, Crofford LJ, Staman KL, Richesson RL, Schlaeger JM, Curtis LH.   +10 more
europepmc   +1 more source