Results 201 to 210 of about 97,809 (308)

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

Rethinking cancer control in low- and middle-income countries: from workforce expansion to systems transformation. [PDF]

BMC Cancer
Stefan DC, Dee EC, Ting FIL, Buckle GC.
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

Cost and impact of decentralized tuberculosis testing: a modeling analysis of price thresholds for molecular instruments in high-burden settings. [PDF]

EClinicalMedicine
Ockhuisen T, de Nooy A, Girdwood S, Hansen MA, Kohli M, Ruhwald M, Ismail N, Nichols BE.   +7 more
europepmc   +1 more source

Safety outcomes of antidiabetic medications: A comprehensive review of the EU summaries of product characteristics and international clinical practice guidelines

British Journal of Clinical Pharmacology, EarlyView.
Aims Information on the safety profile of antidiabetic medications is essential for informed treatment decisions in type 2 diabetes mellitus. Although this information is available in regulatory documents of individual drugs, a comprehensive overview across all approved antidiabetics is lacking.
David Liang, Daniala L. Weir, Safana Thevasahayam, Vera H. M. Deneer, Arno Siebes, Helga Gardarsdottir   +5 more
wiley   +1 more source

No Place to Hide? Regional Resilience and Vulnerability to Global Catastrophic Risk. [PDF]

Glob Chall
Jehn FU, Rössler M, Kemp L, Cassidy M, Kallenborn Z, García Martínez JB, Mani L, Boyd M.   +7 more
europepmc   +1 more source

Publicly funded private schools and academic achievement: A comparative analysis of PISA data in European countries

British Educational Research Journal, EarlyView.
Abstract This paper analyses differences in academic achievement associated with attendance at publicly funded private schools and public schools across 11 European countries. Using eight waves of PISA data (2000–2022), we apply OLS, IPW and IPWRA estimators to account for observed heterogeneity and mitigate selection bias.
Priya Maurya, Léonard Moulin, Denis Fougère   +2 more
wiley   +1 more source

Decentralized clinical trials: A comprehensive analysis of trends, technologies, and global challenges. [PDF]

PLOS Digit Health
Kijewski S, McBride C, Owens E, Bernheim E, Vayena E.   +4 more
europepmc   +1 more source

‘Self’ and ‘othering’ as a byproduct of large‐scale assessment: An investigation into the Gaokao retake policy

British Educational Research Journal, EarlyView.
Abstract While Gaokao, the National College Entrance Examination (NCEE), has been extensively discussed outside the Chinese academic circle, the retake policy of the test has not received much attention. Moreover, Gaokao research in China has predominantly examined the effectiveness of the retake decision in relation to students' demographic ...
Yifeng Cheng, M. Obaidul Hamid
wiley   +1 more source

Ethical considerations in decentralizing antivenom treatment in indigenous territories of the Brazilian Amazonia. [PDF]

PLoS Negl Trop Dis
Serrão-Pinto T, Murta F, Machado V, de Farias AS, Guimarães Figueira EA, da Silva Chagas ÉC, Habibe LS, Dourado FS, Montebello L, Casewell NR, Lalloo DG, Almeida-Val F, Lacerda M, Vissoci JRN, Gerardo CJ, Wen FH, Sachett J, Monteiro W.   +17 more
europepmc   +1 more source