Results 231 to 240 of about 1,414,184 (301)

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola   +5 more
wiley   +1 more source

Pharmacokinetic‐pharmacodynamic modelling of risankizumab using chronic plaque psoriasis real‐world data

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Risankizumab is a high‐cost biologic treatment for chronic plaque psoriasis, an immune‐mediated inflammatory disease presenting with painful red scaly skin lesions. Inter‐individual heterogeneity in treatment response may be better addressed with personalised rather than fixed dosing. We sought to develop a pharmacokinetic/pharmacodynamic (
Charlotte M. Thomas   +16 more
wiley   +1 more source

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

open access: yesBritish 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   +4 more
wiley   +1 more source

Abuse from the First Night: The Dark Reality of Intimate Partner Violence in Child Marriages. [PDF]

open access: yesIran J Public Health
Aghakhani N   +4 more
europepmc   +1 more source

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

open access: yesBritish 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   +3 more
wiley   +1 more source

Help, near and far: a systematic review of post-COVID digital mental health solutions for domestic violence victims. [PDF]

open access: yesFront Public Health
Yu P   +13 more
europepmc   +1 more source

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