Results 121 to 130 of about 14,665 (304)

Appendix D. Figures presenting autocorrelation (ACF) and partial autocorrelation (PACF) analyses of differenced ring width (RWd) chronologies. [PDF]

, 2016
Figures presenting autocorrelation (ACF) and partial autocorrelation (PACF) analyses of differenced ring width (RWd ...
Robert J. Naiman (2904611), D. C. Drake (2904716)   +1 more
core   +1 more source

Real-world data: a comprehensive literature review on the barriers, challenges, and opportunities associated with their inclusion in the health technology assessment process

Journal of Pharmacy & Pharmaceutical Sciences
Objective: This review aimed to assess the current use and acceptance of real-world data (RWD) and real-world evidence (RWE) in health technology assessment (HTA) process.
Konstantinos Zisis, Konstantinos Zisis, Elpida Pavi, Mary Geitona, Kostas Athanasakis   +4 more
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

Diseño de un kit de transformación de AWD a RWD para vehículo de competición a escala [PDF]

, 2020
[ES] El objetivo de este proyecto consistirá en el diseño de un kit de transformación de chasis AWD a RWD de automodelismo rc a escala 1:10, el kit tiene que reaprovechar el mayor número de piezas del chasis original, y tiene que poderse fabricar en ...
Ramos Escortell, Vicente
core  

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 national evaluation analysis and expert interview study of real-world data sources for research and healthcare decision-making

Scientific Reports
Real-world data (RWD) can provide intel (real-world evidence, RWE) for research and development, as well as policy and regulatory decision-making along the full spectrum of health care.
Veronika Mikl, Dejan Baltic, Thomas Czypionka, Alexander Degelsegger-Márquez, Nikolaus Forgó, Ghazaleh Gouya-Lechner, Arnold Herzog, Peter Klimek, David Benjamin Lumenta, Bernhard Mraz, Herwig Ostermann, Robert Scharinger, Tanja Stamm, Michael Strassnig, Markus Zeitlinger, Johannes Pleiner-Duxneuner   +15 more
doaj   +1 more source

Repeated intradermal lipopolysaccharide challenge responses in healthy volunteers: Implications for clinical pharmacology studies

British Journal of Clinical Pharmacology, EarlyView.
Aim Intradermal application of lipopolysaccharide (LPS), a Toll‐like receptor 4 agonist, induces a local inflammatory response and is used as a human challenge model to evaluate the pharmacodynamics of investigational medicinal products. While currently applied in a single, parallel‐group setting, alternative within‐subject designs involving repeated ...
Alexandra A. J. Sillé, Juliette A. van den Noort, Iva Lelios, Diana R. Pereira, Marzia A. Scelsi, Erica S. Klaassen, Philipp Schoenenberger, Naomi B. Klarenbeek, Pierre‐Eric Juif, Pascal Espie, Manon A. A. Jansen, Matthijs Moerland, Richard W. D. Welford   +12 more
wiley   +1 more source

Evaluating effectiveness of risk minimization through healthcare professional surveys: A review of post‐authorization studies, 2022–2024

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Risk minimization measures (RMMs) are key regulatory tools to ensure safe medicinal product use. Regulatory guidelines recommend pre‐specifying the targets, or ‘thresholds’, for assessing RMM effectiveness. We aimed to review recent industry‐sponsored post‐authorization safety studies (PASS) that evaluated the effectiveness of RMMs ...
Kexin Zhu, William A. Blumentals, Froilan G. Celzo, G. Caleb Alexander, Lingyun Zhou, Juhaeri Juhaeri, Corinne Jouquelet‐Royer, Jian‐Yu E   +7 more
wiley   +1 more source

Assessing real-world evidence utilization in oncology health technology assessments: insights from external control-arm studies

Oncology Reviews
BackgroundWhile health technology assessment (HTA) acceptance of contextual real-world data (RWD) studies describing burden of disease, disease natural history, or treatment pathways is relatively common, HTA practices for RWD studies addressing real ...
Gleicy Macedo Hair, Melinda E. Hanisch, Shahrul Mt-Isa, Hozefa A. Divan, Courtney Ramus, Matthew Barrett, Harvinder S. Cheema, YangYang Lu, Sridevi Krishnamurthy, Robert Krüger   +9 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