Results 111 to 120 of about 58,279 (261)

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

TOMSK BRANCH OFFICE OF THE CHEKA-GPU (1920 – 1925)

Вестник Кемеровского государственного университета, 2016
The paper considers the establishment of the guberniya’s Cheka and its completion by communists using mobilization among the communists of the central regions of the country, as well as from the local comrades.
Vladimir N. Guzarov
doaj  

Safety concerns reported by coroners following fentanyl patch fatalities in England, Wales and Northern Ireland between 1997 and 2024

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim To identify safety concerns reported by coroners following fentanyl patch‐related deaths in England, Wales and Northern Ireland, and determine differences in coronial reporting. Methods A systematic case series linking the National Programme on Substance Use Mortality (NPSUM) and the Preventable Deaths Tracker (PDT) (https ...
Eman Mshari, Caroline S. Copeland, Georgia C. Richards   +2 more
wiley   +1 more source

Time to start a research agenda on electoral integrity within political organizations. [PDF]

Open Res Eur
Villaplana FR, Borz G, Fitzpatrick J, Lisi M, Barberà O.   +4 more
europepmc   +1 more source

Exploring new avenues: Psychedelic‐assisted therapy for young people

British Journal of Clinical Pharmacology, EarlyView.
Rates of mental illness in young people are increasing, whereas the development of novel mental health treatments has not significantly progressed. Psychedelic‐assisted therapy, using substances such as psilocybin and 3,4‐methylenedioxymethamphetamine (MDMA), has shown potential in the treatment of mental illnesses in the adult population, including ...
Ioanna Artemis Vamvakopoulou, Dasha Nicholls, David J. Nutt, Martina Di Simplicio   +3 more
wiley   +1 more source

Best Practices and Gaps in Current Regulatory and Health Technology Assessment Real-World Evidence Policies for Medicines and Medical Devices: Current State of Play and Next Steps. [PDF]

Clin Transl Sci
Cresswell K, Claire R, Issa L, Kubehl L, Bilal O, Purcell R, Clemente A, Wested J, Jensen LG, Sasane M, Peeters R, Shinkins B, Colvin H.   +12 more
europepmc   +1 more source

British National Formulary Guidance on prescribing in pregnancy: A descriptive cross‐sectional study

British Journal of Clinical Pharmacology, EarlyView.
Aim To assess how well pregnancy‐specific guidance within the British National Formulary supports healthcare professionals to facilitate safe and effective medication use. Methods We performed a manifest content analysis of the text of all pregnancy sections within British National Formulary drug monographs, with inductive and iterative coding.
Hannah Johnson, Cleodie Swire, Lakshiv Dhingra, Toqa El‐Nahhas, Michelle Essiam, Salma Muse, Maria Tonkova, Nazmin Begum, Joan Morris, Emma Baker   +9 more
wiley   +1 more source

Sovietization of sports in Czechoslovakia and the establishment of the institute of physical education and sport (1948-1953). [PDF]

Front Sports Act Living
Waic M, Pechman V.
europepmc   +1 more source

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

Scientific leadership and sustainable innovation in Chinese knowledge-intensive firms: unpacking the roles of talent ecosystem and green innovation capability. [PDF]

Front Psychol
Liang R.
europepmc   +1 more source