日期:
2020 年 — 2026 年
2020
2021
2022
2023
2024
2025
2026
影响因子:

APPRAISE: A Tool for Appraising Potential for Bias in Real-World Evidence Studies on Medication Effectiveness or Safety

APPRAISE:一种用于评估药物有效性或安全性真实世界证据研究中潜在偏倚的工具

Bykov, Katsiaryna; Jaksa, Ashley; Lund, Jennifer L; Franklin, Jessica M; Girman, Cynthia J; Gazarian, Madlen; Yuan, Hongbo; Duffield, Stephen; Kent, Seamus; Patorno, Elisabetta

Real-World Evidence in FDA Approvals for Labeling Expansion of Small Molecules and Biologics

FDA批准小分子药物和生物制剂标签扩展的真实世界证据

Deng, Yung-Fang; Girman, Cynthia J; Ritchey, Mary E

A Framework for the Use and Likelihood of Regulatory Acceptance of Single-Arm Trials

单臂试验的使用及监管机构接受的可能性框架

Subramaniam, Disha; Anderson-Smits, Colin; Rubinstein, Rebecca; Thai, Sydney T; Purcell, Rose; Girman, Cynthia

Current Practices and Challenges When Submitting Patient Experience Data for Regulatory Decisions by the US Food and Drug Administration: An Industry Survey

美国食品药品监督管理局 (FDA) 监管决策中提交患者体验数据的现状与挑战:一项行业调查

Pinto, Cathy Anne; Tervonen, Tommi; Jimenez-Moreno, Cecilia; Levitan, Bennett; Soriano Gabarró, Montse; Girman, Cynthia; Norquist, Josephine M; Hauber, Brett

Assessment of Codispensing Patterns of Mirabegron and Prespecified CYP2D6 Substrates in Patients with Overactive Bladder

对膀胱过度活动症患者同时服用米拉贝隆和预先指定的CYP2D6底物药物的模式进行评估

Wang, Jingjun; Ritchey, Mary E; Reynolds, Kamika; Carbonneau, Madeleine; Carrera, Adam; Goti, Noelia; Horn, John R; Girman, Cynthia J

Strategy for Generating Blinded Evidence for Single-Arm Trials with External Controls Using Expert Review of Home Video

利用专家对家庭视频的审查,为具有外部对照的单臂试验生成盲法证据的策略

Zhang, Xinruo; Brind'Amour, Katherine; King, Kelly E; Hartmaier, Susan; Harris, Katherine; Weinstein, David A; Girman, Cynthia J

Interpretation of the Meaningfulness of Symptom Reduction with Vibegron in Patients with Overactive Bladder: Analyses from EMPOWUR

对维贝格隆治疗膀胱过度活动症患者症状缓解意义的解读:来自EMPOWUR的分析

Frankel, Jeffrey; Staskin, David; Varano, Susann; Kennelly, Michael; Newman, Diane K; Rosenberg, Matt T; Jankowich, Rachael A; Shortino, Denise; Mudd, Paul N Jr; Girman, Cynthia J

Pain and Fatigue Improvements in Patients Treated with Repository Corticotropin Injection Across Five Indications: A Narrative Review

五种适应症患者接受促皮质素注射治疗后疼痛和疲劳症状的改善:一项叙述性综述

Girman, Cynthia; Panaccio, Mary P; Hayes, Kyle; Niewoehner, John; Wan, George J

Risk of bias in non-randomized observational studies assessing the relationship between proton-pump inhibitors and adverse kidney outcomes: a systematic review

评估质子泵抑制剂与不良肾脏结局之间关系的非随机观察性研究中的偏倚风险:系统评价

Rajan, Pradeep; Iglay, Kristy; Rhodes, Thomas; Girman, Cynthia J; Bennett, Dimitri; Kalantar-Zadeh, Kamyar

Efficacy of Vibegron and Mirabegron for Overactive Bladder: A Systematic Literature Review and Indirect Treatment Comparison

维贝格隆和米拉贝格隆治疗膀胱过度活动症的疗效:系统性文献综述和间接治疗比较

Kennelly, Michael J; Rhodes, Thomas; Girman, Cynthia J; Thomas, Elizabeth; Shortino, Denise; Mudd, Paul N Jr