Results 181 to 190 of about 1,254,325 (306)

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

Tropical Easterly Waves in the Tropical North Atlantic Basin. [PDF]

Ann N Y Acad Sci
Córdova-García OL, Sorí R, Trigo RM, Nieto R, Gimeno L, Stojanovic M, Pérez-Alarcón A.   +6 more
europepmc   +1 more source

Tropical Diabetes? [PDF]

Tropical Doctor, 1996
openaire   +2 more sources

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

Correction: Implementation of syndromic surveillance systems in two rural villages in Senegal. [PDF]

PLoS Negl Trop Dis
PLOS Neglected Tropical Diseases Editors.
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

Correction: Prevalence, infection intensity, and risk factors of soil-transmitted helminthiasis and intestinal schistosomiasis among schoolchildren in Southern Ethiopia. [PDF]

PLoS Negl Trop Dis
PLOS Neglected Tropical Diseases Staff.
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

Food crisis in tropical Africa : the challenge of IITA

, 1982
International Institute of Tropical Agriculture
core   +1 more source

Periorbital Cutaneous Larva Migrans. [PDF]

Am J Trop Med Hyg
Lobo C, Kaimal S.
europepmc   +1 more source