Results 21 to 30 of about 16,753 (176)

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

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

Take away/take the word: censorship, prohibition and secrecy in literature and publishing

Estudios de Teoría Literaria, 2022
Readers of this dossier will find here an invitation to analyze some of the effects of what John M. Coetzee called the "passion to silence" (Coetzee), an issue that, we maintain, is more relevant today than ever in the face of the worrying rise of new ...
Laura Maccioni, Amandine Guillard
doaj  

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

Form flows function: Learner‐centered game Re‐design in a STEM classroom

British Educational Research Journal, EarlyView.
Abstract Re‐designing games facilitates interest‐driven learning and immerses learners in systems thinking. However, there are limited studies exploring how the form and function of tabletop games influence learners' design decisions and learning experiences. To address this gap, we conducted a mixed‐methods study in a STEM classroom in western Canada.
Farzan Baradaran Rahimi, Beaumie Kim, Shima Dadkhahfard   +2 more
wiley   +1 more source

Historia de la industria en México, siglos XIX y XX

H-Industri@
Presentacion del dossier sobre historia de la industria en Mexico durante los siglo XIX y XX.
Juan Odisio, Iliana Marcela Quintanar Zárate   +1 more
doaj   +1 more source

Enhancing the Secretion Systems: Genetic Engineering of Super Bioagents for Effective Plant Disease Control

Biotechnology and Bioengineering, EarlyView.
Genetic engineering (GE) overcomes BCA limits, enabling robust, scalable crop protection. “Super Bioagents” (SBs) use optimized SSs to enhance bioactive molecule delivery. Optimizing SSs enhance precise, sustainable effector deployment for stable disease suppression. SBs use microbiome‐informed design for scalable, next‐gen sustainable crop protection.
Michael Dare Asemoloye
wiley   +1 more source

Comparative Analysis of Bioreactor Design and Scale‐Up for Cultivated Meat Using Monte Carlo‐Based Timescale Modeling

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Cultivated meat offers a sustainable alternative to conventional livestock production but faces significant scale‐up challenges, particularly in bioreactor design for mammalian cell suspension cultures. This study presents a comparative analysis of stirred tank reactors (STR), bubble columns (BC), and airlift reactors (ALR) to assess their ...
Pieter Jan Theodoor Brorens, Marcel Ottens, Cees Haringa   +2 more
wiley   +1 more source

The transversality of ICTs applied in the pedagogical strategy Integrative training dossier

Revista Ingenio, 2015
Higher education institutions must train students to become well-informed and deeply motivated citizens, equipped with a critical sense and capable of analyzing society's problems, seeking solutions for those that arise in society, applying these and ...
Marta Milena Peñaranda Peñaranda
doaj   +1 more source

Schülerexperimente zur Synthese naturidentischer, geruchsaktiver Ester im Mikromaßstab durch alkalisch katalysierte Umesterung von Glyceriden

CHEMKON, EarlyView.
In diesem Beitrag wird ein einfaches Schülerexperiment vorgestellt, bei dem durch Umesterung von Triacylglyceriden mit n‐Alkanolen im Mikromaßstab geruchsaktive Alkylalkanoate hergestellt werden. Die Reaktion erfolgt alkalisch katalysiert bei Raumtemperatur in kleinen Gefäßen; es entstehen flüchtige Ester mit charakteristischen Frucht‐ und ...
Horst Klemeyer
wiley   +1 more source