Results 191 to 200 of about 133,601 (307)

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

The Futures of Digital Democracy: Four Scenarios. [PDF]

Open Res Eur
Fuchs C, Museba J, Friesch K.
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

Mao's Cultural War: The Origins of the Cultural Revolution Revisited. [PDF]

Mod China
Wu Y.
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

When Science Outpaces Infrastructure: People, Process, and Technology Challenges for Precision Dosing in Children. [PDF]

Clin Transl Sci
Lewis T, Jessa K, Ivaturi V, Noack A, Aluthge DP, Müller-Widmann D, Capello K, Fong M, Miatello A, Barwick M.   +9 more
europepmc   +1 more source

Semaglutide vs. liraglutide and incidence of diabetes and cardiovascular disease: A target trial emulation using real‐world data

British Journal of Clinical Pharmacology, EarlyView.
Aims The glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) semaglutide and liraglutide are approved for chronic weight management. Both drugs also have favourable effects on the risk of developing diabetes and cardiovascular disease (CVD) compared with placebo, but their comparative effectiveness for these outcomes is unclear.
Ethan J. Cannon, Wendy Wang, Faye L. Norby, Rob F. Walker, Shalini Kulasingam, Lisa S. Chow, Joel F. Farley, Pamela L. Lutsey   +7 more
wiley   +1 more source

EUPopLink Country report - Serbia. [PDF]

Open Res Eur
Lazarevic A, Markovic A.
europepmc   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

The evolution of China's youth sport policies-a systematic analysis based on national policy texts 2013-2023. [PDF]

Front Sports Act Living
Shi P, Bairner A.
europepmc   +1 more source