Zobrazeno 1 - 10
of 237
pro vyhledávání: '"real world data (RWD)"'
Autor:
Huiyao Huang, Shuopeng Jia, Xin Wang, Huilei Miao, Hong Fang, Hanqing He, Dawei Wu, Yu Tang, Ning Li
Publikováno v:
Thoracic Cancer, Vol 15, Iss 14, Pp 1187-1194 (2024)
Abstract Introduction Restrictive eligibility criteria in cancer drug trials result in low enrollment rates and limited population diversity. Relaxed eligibility criteria (REC) based on solid evidence is becoming necessary for stakeholders worldwide.
Externí odkaz:
https://doaj.org/article/9a7df16946554f71a18e8f79aa451014
Autor:
Marcus Carvalho Borin, Juliana Alvares-Teodoro, Francisco Assis Acurcio, Augusto Afonso Guerra
Publikováno v:
Frontiers in Pharmacology, Vol 15 (2024)
BackgroundGaucher’s disease (GD), a lysosomal storage disorder, poses significant treatment challenges. This 23-year study assesses survival rates and treatment efficacy in Brazilian GD patients, integrating data from a 16-year cohort (2000–2015)
Externí odkaz:
https://doaj.org/article/84a44a09539a450c99722898061a4dd6
Publikováno v:
Frontiers in Pharmacology, Vol 15 (2024)
Externí odkaz:
https://doaj.org/article/e83efa1c753d444d8dcdb7b49484bea3
Publikováno v:
Фармакоэкономика, Vol 16, Iss 4, Pp 671-680 (2024)
The article is devoted to the study of regulatory approaches to the sphere of real-world data (RWD) and real world evidence (RWE) in the countries of the Asia-Pacific Region (China, South Korea, Japan, Taiwan, etc.) and examples of their practical ap
Externí odkaz:
https://doaj.org/article/853acf45b342447abd3db6c338f51c2d
Autor:
Benjamin Ackerman, Ryan W. Gan, Craig S. Meyer, Jocelyn R. Wang, Youyi Zhang, Jennifer Hayden, Grace Mahoney, Jennifer L. Lund, Janick Weberpals, Sebastian Schneeweiss, James Roose, Juned Siddique, Omar Nadeem, Smith Giri, Til Stürmer, Sikander Ailawadhi, Ashita S. Batavia, Khaled Sarsour
Publikováno v:
Frontiers in Drug Safety and Regulation, Vol 4 (2024)
Introduction: While randomized controlled trials remain the reference standard for evaluating treatment efficacy, there is an increased interest in the use of external control arms (ECA), namely in oncology, using real-world data (RWD). Challenges re
Externí odkaz:
https://doaj.org/article/c00455226d6749b884e3043112d1c680
Autor:
Núria Folguera-Blasco, Florencia A. T. Boshier, Aydar Uatay, Cesar Pichardo-Almarza, Massimo Lai, Jacopo Biasetti, Richard Dearden, Megan Gibbs, Holly Kimko
Publikováno v:
Frontiers in Systems Biology, Vol 4 (2024)
Quantitative Systems Pharmacology (QSP) has become a powerful tool in the drug development landscape. To facilitate its continued implementation and to further enhance its applicability, a symbiotic approach in which QSP is combined with artificial i
Externí odkaz:
https://doaj.org/article/0cb7cec9626f46dc9ec362e97e7a4602
Autor:
Matthew Deady, Ray Duncan, Lance D. Jones, Arianna Sang, Brian Goodness, Abhishek Pandey, Sylvia Cho, Richard A. Forshee, Steven A. Anderson, Hussein Ezzeldin
Publikováno v:
Frontiers in Public Health, Vol 12 (2024)
IntroductionThis study is part of the U.S. Food and Drug Administration (FDA)’s Biologics Effectiveness and Safety (BEST) initiative, which aims to improve the FDA’s postmarket surveillance capabilities by using real-world data (RWD). In the Unit
Externí odkaz:
https://doaj.org/article/3786dea64474417dbd5591f7433df0e9
Autor:
Zhang, Chenyang a, 1, Shao, Jun b, Tang, Xiaolong c, 1, Wu, Jiayang b, Li, Peiyi d, ⁎, Li, Weimin b, ⁎, Wang, Chengdi b, ⁎
Publikováno v:
In International Immunopharmacology 15 June 2024 134
Autor:
Sung Hwan Joo, Seungwon Yang, Suhyun Lee, Seok Jun Park, Taemin Park, Sang Youl Rhee, Jae Myung Cha, Sandy Jeong Rhie, Hyeon Seok Hwang, Yang Gyun Kim, Eun Kyoung Chung
Publikováno v:
Pharmaceuticals, Vol 17, Iss 10, p 1369 (2024)
Background/Objectives: This study aimed to investigate trends in antidiabetic drug use and assess the risk of metformin-associated lactic acidosis (MALA) in patients with chronic kidney disease (CKD). Methods: A retrospective observational analysis b
Externí odkaz:
https://doaj.org/article/9036dd968d094d24a848e372b77d4396
Autor:
Peijin Wang, Shein-Chung Chow
Publikováno v:
Orphanet Journal of Rare Diseases, Vol 18, Iss 1, Pp 1-11 (2023)
Abstract For the development of a test treatment or drug product, it is necessary to conduct composite hypothesis testing to test for effectiveness and safety simultaneously, since some approved drug products have been recalled due to safety concerns
Externí odkaz:
https://doaj.org/article/dcfd746856f94923b82d06d3bb64dfcf