Results 151 to 160 of about 116,076 (217)

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

British 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, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

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

Developing medication independence: The experience of UK teenagers

British Journal of Clinical Pharmacology, EarlyView.
Aims There is a progression through childhood from being provided medications by caregivers to having to take responsibility for medications yourself, but little is known about when the transition of adolescents managing medicines begins. The aim of this study was to obtain a cross‐sectional sample of UK adolescents and when they become independent ...
Holly Hutchins, Charlotte King, Louis Bioletti, Tsegay Gebru, Alder Hey Research Ambassadors, Daniel B. Hawcutt   +5 more
wiley   +1 more source

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

String Figuring young children's perspectives of quality in English early childhood education and care

British Educational Research Journal, EarlyView.
Abstract Quality in early childhood education and care (ECEC) is a contested concept and has generally been conceptualised by inter‐related indicators such as staff qualifications, educational environment, policy or child‐to‐staff ratios. There has been a more limited emphasis on how young children might perceive and experience quality.
Nikki Fairchild, Éva Mikuska
wiley   +1 more source

Organizational happiness and its association with organizational commitment: A mixed-methods study among private school teachers in Türkiye. [PDF]

PLoS One
İncekara S, Şahin A.
europepmc   +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, Ashley M. Hopkins, Andrew Rowland, Stephen Bacchi   +3 more
wiley   +1 more source

Individual and school-level factors associated with suspected pediatric eye disorders and referral adherence in an enhanced school-based vision screening program in Ghana. [PDF]

PLOS Glob Public Health
Asare AO, Ablordeppey P, Ansah-Asiedu E, Doku ET, Agbeshie GK, Gle SA, Mensah NAO, Adikah RE, Yeboah CN, Baidoo DA, Darko CK, Arkhurst EE, Watt MH, Acquah EA, Afake H, Agyekum S, Akuffo KO.   +16 more
europepmc   +1 more source

A School-Based Nutrition and Physical Activity Intervention for the Prevention of Childhood Obesity: Study Design and Baseline Findings From a Cluster-Randomized Trial. [PDF]

J Nutr Metab
Nóvoa-Medina Y, Leon SDC, Barreiro-Bautista M, Batista-Dávila V, Fabelo H, Pavlovic S, García-Delgado Y, Jiménez JE, López-López S, Gran Canarian Diabetes and Obesity Research Group, Wägner AM, Peña-Quintana L.   +11 more
europepmc   +1 more source

Moderately positive educational environment with opportunities for improvement: a national study of Ethiopian medical schools using the Dundee Ready Education Environment Measure (DREEM), 2024. [PDF]

BMC Med Educ
Belay LM, Siebeck M, Sendekie TY, Fischer MR, Berndt M.   +4 more
europepmc   +1 more source