Results 41 to 50 of about 73,544 (245)

Optimization of pharmaceutical research and development by early‐phase assessment of investigational medicinal products

British Journal of Clinical Pharmacology, EarlyView.
Small and mid‐sized pharmaceutical innovators often have limited in‐house health economics and market access expertise, and may struggle to align development strategies of investigational medicinal products with health system needs and payer expectations.
Zoltán Kaló, Attila Imre, Gábor Varga, Sándor Kovács, György Tímár, Balázs Nagy   +5 more
wiley   +1 more source

Paper Affairs: Discipline by the Dossier in a Mao-Era Work Unit

Administory, 2019
This article examines how dossier files informed the handling of personnel misconduct in Chinese work units using an investigation of adultery as a case study.
J. M. Chris Chang
semanticscholar   +1 more source

How the HTAR will contribute to a value‐based decision‐making for medicinal products across the EU

British Journal of Clinical Pharmacology, EarlyView.
The European Union Health Technology Regulation 2021/2282 (HTAR) introduces joint assessment of health technologies (including medicinal products and medical devices) across EU Member States. It was signed into law in 2021 and came into full force in January 2025.
Roisin Adams, Michal Stanak
wiley   +1 more source

Beyond the label: Rethinking off‐label drug use in paediatrics. Towards a scientifically grounded and safer future for paediatric pharmacotherapy

British Journal of Clinical Pharmacology, EarlyView.
Abstract Despite regulatory progress being made in the past two decades, off‐label drug use in paediatrics remains pervasive, with prevalence estimated between 3% and 97% of prescriptions across different clinical settings. Off‐label use—defined as prescribing outside the conditions described in the Summary of Product Characteristics (SmPC)—is often ...
Tjitske M. van der Zanden, Miriam G. Mooij, Matthijs de Hoog, Saskia N. de Wildt   +3 more
wiley   +1 more source

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

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  

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

Mimic, target, and adapt: Cell membrane‐coated nanoplatforms for precision and immune‐guided cancer treatment

BMEMat, EarlyView.
This Perspective explores the emerging landscape of cell membrane‐coated nanoparticles (CM‐NPs) as intelligent, immune‐compatible platforms for cancer therapy. Highlighting design strategies, translational challenges, and competitive positioning, it outlines how integrating biomimetic targeting with advanced analytical and manufacturing tools could ...
A. K. M. M. Alam, Xiaojun Cai, Malik Ihsan Ullah Khan, Robert Musiol, Quazi T. H. Shubhra   +4 more
wiley   +1 more source

El vacío del corazón

AULA Revista de Humanidades y Ciencias Sociales
Para llegar al cielo, como diría Julio Cortázar, tan solo se requiere una piedrita y la punta de un zapato; y tal es quizá lo necesario para adentrarse en la espesura de la rayuela que es el pensamiento de María Zambrano. Apenas se ha pensado acerca del
Borja López Arranz
doaj   +3 more sources

Introduction au dossier thématique

Créativité organisationnelle : quels enjeux en management stratégique dans un contexte mondialisé ?, 2018
La mondialisation impose aux organisations d’innover et se renouveler à un rythme très rapide. Dans un tel contexte, les idées s’imposent comme une ressource centrale et stratégique que l’organisation doit gérer et développer.
G. Parmentier, Bérangère L. Szostak, Charles-Clemens Rüling   +2 more
semanticscholar   +1 more source