Results 241 to 250 of about 2,472,934 (283)

Perceptions About Asymptomatic Hyperuricemia and Views About Urate‐Lowering Therapy in People With Asymptomatic Hyperuricemia

Arthritis Care &Research, EarlyView.
Objective Asymptomatic hyperuricemia is a precursor of gout and is also associated with cardiovascular disease and chronic kidney disease. The aim of this study was to understand perceptions about asymptomatic hyperuricemia and views about urate‐lowering therapy in people with asymptomatic hyperuricemia. Methods Participants in a multinational study of
Nicola Dalbeth, Sarah Stewart, Gregory D. Gamble, Borislav Mihov, Lisa K. Stamp, Janine Haslett, William J. Taylor, Tony R. Merriman, Adwoa Dansoa Tabi‐Amponsah, Anne Horne, Tuhina Neogi, Tristan Pascart, Mariano Andrés, Maria‐Luisa Peral‐Garrido, Eleonora Norkuviene, Janitzia Vazquez‐Mellado, Till Uhlig, Mingshu Sun, Changgui Li, Keith J. Petrie   +19 more
wiley   +1 more source

Cost-effectiveness modelling for benefit-risk assessment [PDF]

, 2019
openaire   +1 more source

Prevalence, Determinants, and Outcomes of Low Disease Activity and Remission Attainment in Patients With Systemic Lupus Erythematosus That Is Clinically Active

Arthritis Care &Research, EarlyView.
Objective This study aimed to identify in patients with systemic lupus erythematosus (SLE) with clinically active disease the attainment of frequency and determinants of Lupus Low Disease Activity State (LLDAS) and Definition of Remission in SLE (DORIS) and the frequency and determinants of flare and damage accrual after target attainment.
Yanjie Hao, Dylan Hansen, Rangi Kandane‐Rathnayake, Worawit Louthrenoo, Yi‐Hsing Chen, Jiacai Cho, Aisha Lateef, Laniyati Hamijoyo, Shue Fen Luo, Yeong‐Jian Jan Wu, Sandra Navarra, Leonid Zamora, Zhanguo Li, Sargunan Sockalingam, Yasuhiro Katsumata, Masayoshi Harigai, Zhuoli Zhang, Madelynn Chan, Jun Kikuchi, Tsutomu Takeuchi, Sang‐Cheol Bae, Fiona Goldblatt, Sean O'Neill, Kristine (Pek Ling) Ng, Annie Law, B. M. D. B. Basnayake, Nicola Tugnet, Sunil Kumar, Cherica Tee, Michael Tee, Naoaki Ohkubo, Yoshiya Tanaka, Shirley Chan, C. S. Lau, Vera Golder, Alberta Hoi, Shereen Oon, Eric Morand, Mandana Nikpour, for the Asia‐Pacific Lupus Collaboration   +39 more
wiley   +1 more source

Preferences for post‐traumatic osteoarthritis prevention strategies in individuals with anterior cruciate ligament injury

Arthritis Care &Research, Accepted Article.
Objectives There is growing interest in evaluating new strategies to delay or prevent post‐traumatic osteoarthritis (PTOA) in individuals who have sustained anterior cruciate ligament (ACL) injury. This study sought to determine characteristics of potential treatments that are acceptable to patients with ACL injury.
Kevin Kennedy, Lily Waddell, Adam Easterbrook, Jeffrey N. Katz, Cale Jacobs, Morgan Jones, Faith Selzer, Elena Losina, Liana Fraenkel, Nick Bansback   +9 more
wiley   +1 more source

Benefit-risk methodology project:work package 1 report: description of the current practice of benefit-risk assessment for centralised procedure products in the EU regulatory network [PDF]

, 2011

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Estimand in benefit-risk assessment

Journal of Biopharmaceutical Statistics, 2023
ICH E9(R1) introduces the estimand framework to strengthen dialogues between sponsors and regulators during drug development. A well-structured benefit-risk assessment (BRA) framework also intends to facilitate communication among stakeholders. However, the estimand in ICH E9(R1) is written mainly from the perspective of a single measure of treatment ...
Xinru, Ren, X Gregory, Chen, William, Wang, Yodit, Seifu   +3 more
openaire   +2 more sources

Planning Benefit-Risk Assessments Using Visualizations

Therapeutic Innovation & Regulatory Science, 2023
A Benefit Risk Assessment Plan (BRAP) describes the assessments planned to determine whether the benefits of an investigational drug outweigh the risks. The plan can have two sections, one with timelines for aligning resources with decision milestones and the other for pre-specifying assessments for decision milestones. Regulatory guidance recommends a
Michael W. Colopy, Lovemore Gakava, Chen Chen   +2 more
openaire   +2 more sources

Implementing Benefit-Risk Assessment for the Periodic Benefit-Risk Evaluation Report

Therapeutic Innovation & Regulatory Science, 2016
In 2012, the International Conference on Harmonisation (ICH) E2C (R1) guideline for periodic safety update reporting (PSUR) for medicines was revised. Several new concepts that expanded the scope of the report were added, including a new section focused on benefits and an additional section focused on integrated benefit-risk (B-R) assessment.
Margaret R, Warner, Anne M, Wolka, Rebecca A, Noel   +2 more
openaire   +2 more sources

Benefit/risk assessment today

Journal of the American Oil Chemists' Society, 1978
AbstractA systematic approach to benefit/risk assessment is presented which recognizes (a) the potentially broad exposure of humans and the environment to soap and detergent materials, (b) current regulatory requirements, and (c) the desirability for making these assessments at various stages of product development to minimize both unnecessary testing ...
openaire   +2 more sources