Results 21 to 30 of about 127,612 (265)

Portada del dossier. Psicología y música. Comunicación, enacción y emoción

Revista de Psicología, 2018
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UNLP RevPsi
doaj   +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

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

Dialectic and Refutation in Plato and Aristotle

Archai: Revista de Estudos sobre as Origens do Pensamento Ocidental, 2022
The papers in this dossier were written within the framework of two research projects on the refutation strategies of radical adversaries in Plato’s and Aristotle’s writings.
Pilar Spangenberg
doaj   +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

DOSSIER ANALYSIS FOR DEVELOPMENT OF THE CHILD IN PRESCHOOL INSTITUTIONS

Facta Universitatis. Series, Teaching, Learning and Teacher Education, 2023
Educators in preschool institutions monitor the development and progress of each child, which leads to keeping a dossier for the child (development portfolio).
Suzana Nikodinovska - Bancotovska
doaj   +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

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

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

La industria siderúrgica en la Argentina, segunda mitad del siglo XX

H-Industri@, 2008
En este número de H-industri@ presentamos un dossier sobre la evolución de la industria siderúrgica de la Argentina en el crucial período comprendido entre 1947 y 1990; es decir, desde la aparición del sector en la “agenda” de las preocupaciones ...
Martín Schorr
doaj   +2 more sources