Results 161 to 170 of about 3,929 (267)

Characteristics and temporal trends of EU teratological safety signals and information dissemination to healthcare professionals in the Netherlands—A contribution of the ConcePTION project

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Although regulatory responses to safety signals have been studied, pregnancy‐specific data and their dissemination to medical professionals remain unclear. This study examined the characteristics and temporal trends of teratological safety signals prompting the European Medicines Agency to implement risk minimization measures.
Yrea R. J. van Rijt‐Weetink, Rosanne E. Huisman, Jan‐Peter van Wieringen, H. J. M. J. (Ineke) Crijns, Florence P. A. M. van Hunsel, Anneke L. M. Passier, Sander Borgsteede, A. C. G. (Toine) Egberts, Laura M. Yates, Eugène P. van Puijenbroek   +9 more
wiley   +1 more source

Impact of International Accounting Standards in implementation of national securities regulation

This dissertation examines the issues surrounding international accounting standards in securities markets. Chapter one looks at the meaning and place of information in securities transactions, information disclosure under securities regulation and the ...
Nabukeera, Maureen
core  

Personalised Psychological Care in Hospitals: An Organisational Model of Integrated, Patient- and Staff-Centred Services (2019-2024). [PDF]

J Pers Med
Chieffo DPR, Massaroni V, Delle Donne V, Lafuenti L, Monti L, Arcangeli V, Moriconi F, Ferrarese D, Galluzzi R, Mercuri EM, Sani G, Tortora G, Gasbarrini A.   +12 more
europepmc   +1 more source

Effect of esomeprazole on the pharmacokinetics of vepdegestrant, a PROteolysis TArgeting Chimera oestrogen receptor degrader, in healthy participants

British Journal of Clinical Pharmacology, EarlyView.
Aims The aim of this study is to evaluate the effects of multiple doses of esomeprazole, a strong proton pump inhibitor and acid‐reducing agent, on the pharmacokinetics and safety of vepdegestrant, a PROteolysis TArgeting Chimera oestrogen receptor degrader.
Lana Tran, Naihan Chen, Jennifer A. Winton, Kyle T. Matschke, Smita P. Goodman, Kimberly C. Lee, Yuanyuan Zhang, Weiwei Tan   +7 more
wiley   +1 more source

Migrating longitudinal African mental health data from staging to the OMOP common data model within the INSPIRE network datahub. [PDF]

Front Psychiatry
Bhattacharjee T, Mugotitsa B, Ochola M, Momanyi R, Andeso P, Amadi D, Mailosi D, Najjemba L, Greenfield J, Mabe K, Slaymaker E, Todd J, Kiragga A, INSPIRE Network .   +13 more
europepmc   +1 more source

Standardization of measurement and reporting of medication adherence using the TEN‐SPIDERS tool for claims data

British Journal of Clinical Pharmacology, EarlyView.
This study provides the first open‐source tool to implement the complete TEN‐SPIDERS framework in linked datasets for the determination of the PDC for medication adherence. The TEN‐SPIDERS tool enables transparent, reproducible medication adherence research through automated reporting of all calculation parameters and flexible customization options ...
Adam C. Livori, Tzu‐Yung Kuo, Jenni Ilomäki, Monique F. Kilkenny, Stella Talic, Zanfina Ademi, J. Simon Bell, Jedidiah I. Morton, Lachlan L. Dalli   +8 more
wiley   +1 more source

Trial-ready external controls for gene therapy: The MATCH cohort in maple syrup urine disease. [PDF]

Cell Rep Med
Brigatti KW, Rodrigues A, Sweigert E, Williamson J, Koehler A, Meier GL, Poskitt LE, Carson VJ, Robinson D, Strauss KA.   +9 more
europepmc   +1 more source

Pharmacokinetics and safety of tezepelumab in children with mild, moderate or severe asthma and adolescents with mild‐to‐moderate asthma

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin and is approved for adolescents and adults with severe asthma. This analysis assessed pharmacokinetics (PK), pharmacodynamics and safety of tezepelumab up to 85 days postdose in adolescents and children.
Anna Lundahl, Jonathan Grigg, Lubna Abuqayyas, Piotr Kuna, Gillian Hunter, Beata Pawlikowska, Jacob Leander, Michael Levin, Atul Gupta, James Paton, Katharine C. Pike, Jane R. Parnes, Gun Almqvist, Stephanie L. Roseti, on behalf of the study investigators   +14 more
wiley   +1 more source

The effect of mild and moderate hepatic impairment on the pharmacokinetics, safety and tolerability of balcinrenone

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Balcinrenone (previously AZD9977) is a novel selective non‐steroidal mineralocorticoid receptor antagonist (MRA) with a differential mechanism of action relative to approved MRAs. The aim of this trial was to assess the pharmacokinetics, safety and tolerability of balcinrenone in participants with mild and moderate hepatic impairment ...
Anna L. Eriksson, Deeyen Karsanji, Bonifride Tuyishimire, Joanna Parkinson, Maria Heijer, Tadeusz Pawlik, Judith Hartleib‐Geschwindner, Maria Leonsson‐Zachrisson, Hans Ericsson   +8 more
wiley   +1 more source

A scientometric dataset on pharmaceuticals and illicit drugs (including cocaine) in the water resources of Latin America and the Caribbean (1990-2024). [PDF]

Data Brief
Roveri V, Correia AT, Toma W, Rodrigues AZ, Pereira CDS, Guimarães LL.   +5 more
europepmc   +1 more source