Results 181 to 190 of about 423,139 (306)

Nurses' Ethical Reasoning About Digital Ethical Risks: A Vignette-Elicited Qualitative Study. [PDF]

Int Nurs Rev
Bal B, Köroğlu Kaba N, Apaydin E.
europepmc   +1 more source

Early‐stage health technology assessment of a curative gene therapy for multiple sclerosis

British Journal of Clinical Pharmacology, EarlyView.
Aims Multiple sclerosis (MS) is associated with significant early morbidity, reduced life expectancy and substantial healthcare and societal costs. The primary objective of this study is to assess the early cost‐effectiveness potential of a novel gene therapy, IMMUTOL, for MS compared with current high‐efficacy treatment sequences.
Attila Imre, Balázs Nagy, Rok Hren
wiley   +1 more source

Editorial Note: Comparing public willingness-to-pay for different low-carbon measures: A case study of Shenzhen, China. [PDF]

PLoS One
PLOS One Editors.
europepmc   +1 more source

Clinical Images: Angiolymphoid hyperplasia with eosinophilia mimicking Temporal Arteritis

Arthritis &Rheumatology, EarlyView.
Jonas Menz, Konstanze Holl‐Ulrich, Lukas Brachaczek, Gabriela Riemekasten, Peter Lamprecht   +4 more
wiley   +1 more source

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

Confidentiality

São Paulo Medical Journal
doaj   +1 more source

Implementation and use of risk minimization control tools in the EU: A multistakeholder survey

British Journal of Clinical Pharmacology, EarlyView.
Aims This study characterized stakeholders' experiences with national implementation of risk minimization control tools (RMCTs), such as healthcare professional qualification, healthcare facility accreditation and medical intervention prior to treatment initiation, for eight medicinal products across eight European Union countries. Methods We conducted
Sharon C. M. Essink, Iris R. Joosse, Maximilian Salcher‐Konrad, Melanie Walter, Elena Deligianni, Dimitra Tsioumela, Christos Kontogiorgis, Elita Poplavska, Iluta Žīgure, Christina E. Hoeve, Teresa Leonardo Alves, Ella D. van Vliet, Renato Ferreira‐da‐Silva, Ana Kodrič, Mitja Kos, Juan Erviti, Marta Gutiérrez‐Valencia, Luis Carlos Saiz, Sofia Kälvemark Sporrong, Emelie Karlsson, Christine Leopold, Marie L. De Bruin   +21 more
wiley   +1 more source

Perceived barriers and facilitators to the feasibility and acceptability of a peer-to-peer (P2P) HIV self-testing distribution model among adolescents and young people aged 15-24 years in Uganda: a qualitative study. [PDF]

BMJ Public Health
Ndekezi D, Muhumuza R, Namara J, Nagawa R, Awino E, Rutaro F, Nassali J, Ssemata AS.   +7 more
europepmc   +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

Prevalence of pregnancy and birth outcomes following biologic exposure in immune‐mediated inflammatory diseases: A population‐based study

British Journal of Clinical Pharmacology, EarlyView.
Aims Almost 5% of pregnancies are affected by immune‐mediated inflammatory diseases (IMIDs). As treatments become available, understanding their use during pregnancy is important. We aimed to describe maternal, pregnancy and infant outcomes among IMID pregnancies exposed to biologic therapies. Methods Using the Merative™ MarketScan® Commercial Database,
Leah K. Flatman, Lisiane F. Leal, Gabra Nohmie, Anick Bérard   +3 more
wiley   +1 more source