Results 171 to 180 of about 1,094,280 (269)

Zuranolone: A case study in (regulatory) rush to judgement?

British Journal of Clinical Pharmacology, EarlyView.
Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove, Milutin Kostic, Barbara Mintzes, Gianna D'Ambrozio, Allen Shaughnessy   +4 more
wiley   +1 more source

Enhancing rigor and reproducibility: Implementing STAR Methods and the ISSCR Standards Checklist at Stem Cell Reports. [PDF]

Stem Cell Reports
Rossant J.
europepmc   +1 more source

Covenant University Chaplaincy [PDF]

, 2016
Resumption, Checklist
core  

Do drugs approved via expedited approval pathways have therapeutic advantages? A systematic review and meta‐analysis

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, Eliza J. McEwin, Zhicheng Wang, Joel Lexchin, Barbara Mintzes   +4 more
wiley   +1 more source

Development and validation of the Klinefelter-Associated Neurodevelopmental Difficulties (KAND) Checklist: a three-phase mixed-methods study. [PDF]

J Neurodev Disord
Theelen K, Galasso C, Cools W, Gies I, Vanclooster S, Jansen AC.   +5 more
europepmc   +1 more source

Dress Code for your Adherence [PDF]

, 2016
Resumption, Checklist
core  

Empowering citizens to spontaneously report suspected adverse drug reaction: Systematic literature review of interventions and their impact

British Journal of Clinical Pharmacology, EarlyView.
This systematic literature review aimed to identify and characterize existing interventions designed to empower citizens to spontaneously report adverse drug reactions (ADRs) and to determine which interventions have been shown to be the most effective internationally. The research question was structured using the PICO framework.
Margarida Perdigão, Ana Margarida Advinha, Manuel José Lopes, Sofia de Oliveira Martins   +3 more
wiley   +1 more source

Agreement and reliability of global rating versus checklist scores in a high-stakes undergraduate OSCE in Rwanda. [PDF]

BMC Med Educ
Ibrahim OR, McCall N, Bekele A, Zelelew BE, Ojomo O, Belachew AG, Amare EM, Gashaw ZM, Ayana BA, Ndayikeje AN.   +9 more
europepmc   +1 more source

CU Medical Centre [PDF]

, 2016
Resumption, Checklist
core  

APOE genotype and the effect of statins on lipid outcomes: A meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Aim APOE genotype may affect statin therapy response. We conducted a meta‐analysis to update and quantify this association across various outcomes. Methods We searched seven databases (MEDLINE, Scopus, Web of Science, the Cochrane Library, APA PsycINFO, CINAHL Plus and ClinicalTrials.gov) on 9 May 2024.
Innocent G. Asiimwe, Tsegay Gebru, Andrea L. Jorgensen, Munir Pirmohamed, on behalf of the Multimorbidity Mechanism and Therapeutics Research Collaborative   +4 more
wiley   +1 more source