Results 151 to 160 of about 56,129 (269)

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

Productive and Reproductive Record Keeping in Low-to-Middle-Income Tropical Livestock Systems: Challenges and Perspectives. [PDF]

Animals (Basel)
Romero-Zúñiga JJ, Galina CS, Geffroy M, Corro MD, Maquivar M.   +4 more
europepmc   +1 more source

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

British Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh, Boitumelo Semete‐Makokotlela, Ivana Škrnjug‐Yudov, David Mukanga, Delese Mimi Darko, Eric Karikari‐Boateng, Peter Stonier, Luther Gwaza, Precious Matsoso, Bernd Rosenkranz, Birka Lehmann, Arnold G. Vulto, John G. Woodland, Shabir Banoo, Frieda Shigwedha, Maphutheho Selikane, Unathi Mabona‐Mgoqi, Asare Yeboah, Ntombi Mthembu, Goonaseelan ( Colin) Pillai   +19 more
wiley   +1 more source

Global stratospheric methane loss from satellite observations. [PDF]

Proc Natl Acad Sci U S A
Fu Q, Dong C.
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

Tropics-wide intraseasonal oscillations. [PDF]

Proc Natl Acad Sci U S A
Bao J, Bony S, Takasuka D, Muller C.
europepmc   +1 more source

Pharmacometric evaluation of pre‐referral rectal artesunate in children with severe malaria

British Journal of Clinical Pharmacology, EarlyView.
Aims Parenteral artesunate is the preferred first‐line treatment for severe malaria. Pre‐referral rectal artesunate suppositories are recommended where parenteral treatment is inaccessible. In this study, we compared dihydroartemisinin exposure and model‐predicted early parasite clearance following rectal artesunate and intravenous artesunate in ...
Ayorinde Adehin, Marie A. Onyamboko, Caterina Fanello, Nicholas J. White, Nicholas P. J. Day, Richard M. Hoglund, Joel Tarning   +6 more
wiley   +1 more source

A plain language summary of the TROPiCS-04 study: sacituzumab govitecan use after platinum-based chemotherapy and immunotherapy in people with locally advanced or metastatic cancer of the bladder, urethra, or upper urinary tract. [PDF]

Future Oncol
Powles T, Tagawa ST, Vulsteke C, Gross-Goupil M, Park SH, Necchi A, De Santis M, Duran I, Morales-Barrera R, Guo J, Sternberg CN, Bellmunt J, Goebell PJ, Kovalenko M, Boateng F, Sierecki M, Wang L, Sima CS, Waldes J, Bangs R, Loriot Y, Grivas P.   +21 more
europepmc   +1 more source

Forest canopy insects are safer from predators in the tropics than at higher latitudes. [PDF]

Nat Commun
Sam K, Sivault E, Fernandez Garzon S, Finnie S, Kollross J, Houska Tahadlova M, Lenc J, Libra M, Ludwig A, Maraia H, Philip AJ, Re Jorge L, Xiao X, Volf M.   +13 more
europepmc   +1 more source

Young children's right to be heard on the quality of their education: Addressing potential misunderstandings in the context of early childhood education

British Educational Research Journal, EarlyView.
Abstract In early childhood education many researchers and professionals across the world have embraced the United Nations Convention on the Rights of the Child's requirement to include young children in decision‐making. In the context of ongoing discussion about young children's capacity to share their views and opinions about matters affecting them ...
Laura Lundy, Colette Murray, Kylie Smith, Carmel Ward   +3 more
wiley   +1 more source