Results 81 to 90 of about 12,767 (235)

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

Reductions in Gastrointestinal Intolerance, Healthcare Resource Utilization and Cost Associated with a Plant-Based Peptide Enteral Formula with Fruit and Vegetable Ingredients: Retrospective Analysis of Children and Adults in Post-Acute Care

Nutrition and Dietary Supplements
Gerard Minor,1 Pamela Cekola,2 Amarsinh Desai,3 Pradeep Kumar,4 Sayan Mondal,4 Yashashree Vijay Kadam,4 Katherine Fazioli,4 Abby Klosterbuer2 1Pediatric Gastroenterology Hepatology and Nutrition, KIDZ Medical Services, Hollywood, FL, USA; 2Medical ...
Minor G, Cekola P, Desai A, Kumar P, Mondal S, Kadam YV, Fazioli K, Klosterbuer A   +7 more
doaj  

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

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

Reading and writing difficulties in adolescence and later risk of welfare dependence. A ten year follow-up, the HUNT Study, Norway

BMC Public Health, 2011
Background Welfare dependence and low work participation among young people have raised concern in many European countries. Reading and writing difficulties (RWD) might make young people vulnerable to work integration problems and welfare dependence ...
Holmen Turid L, Westin Steinar, Bjørngaard Johan H, Pape Kristine, Krokstad Steinar   +4 more
doaj   +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

Overcoming intranasal delivery barriers with ultrastable polyzwitterionic siRNA nanocages for enhanced glioblastoma therapy

BMEMat, EarlyView.
A ROS‐responsive, zwitterionic nanocage enables stable, intranasal siRNA delivery to glioblastoma, promoting deep tumor penetration via non‐degradative pathways and trigeminal nerve transport. This platform achieves durable gene silencing and tumor suppression, offering a non‐invasive, storage‐stable strategy for treating glioma and other neurological ...
Jingwen Xie, Jingxing Si, Xiaobei Deng, Jing Tan, Ruijie Zhu, Jizhou Qi, Gaoxia Ma, Bin Wang, Yi Wang, Yunzhou Guo, Yuping Chen, Shiqun Shao, Youqing Shen   +12 more
wiley   +1 more source

Periodontitis and atherosclerotic cardiovascular disease: A critical appraisal

Periodontology 2000, EarlyView., 2023
Abstract In spite of intensive research efforts driving spectacular advances in terms of prevention and treatments, cardiovascular diseases (CVDs) remain a leading health burden, accounting for 32% of all deaths (World Health Organization. “Cardiovascular Diseases (CVDs).” WHO, February 1, 2017, https://www.who.int/news‐room/fact‐sheets/detail ...
Maria Clotilde Carra, Hélène Rangé, Giuseppina Caligiuri, Philippe Bouchard   +3 more
wiley   +1 more source

Beyond wound sealing: A dual‐functional adhesive nanofiber membrane promoting coagulation and osteogenesis in extraction sites

BMEMat, EarlyView.
Inspired by the suction mechanics of octopus suckers, a dual‐layer nanofiber membrane integrates antibacterial protection, strong wet adhesion, and osteogenic support, offering a bioinspired strategy for effective hemostasis and alveolar bone preservation.
Huijing Ma, Liheng Gao, Hao Liang, Wentao Jiang, Junyi Wang, Jiajia Wang, Shuhan Duan, Lingxi Meng, Adilijiang Yimiti, Wenjie Zhang   +9 more
wiley   +1 more source

An International Standard RWD Database Designed – Taiwan Experience

The use of Real-World Data (RWD) in medical data analysis is nowadays required. RWD may come from electronic health records (EHRs), insurance claims, medical products, Internet of Things sensors, health screenings, etc. The goal of RWD is that the data used for analysis should not be affected by environmental variables, experimental control, research ...
Hsiu-An Lee, Po-Sheng Yang, Chien-Yeh Hsu   +2 more
openaire   +2 more sources