Priyanka A Abraham,Joseph T Kannarkat,Benjamin N Rome et al.
Priyanka A Abraham et al.
The Medicaid Drug Rebate Program (MDRP) is a federal-state partnership program that aims to control prescription drug costs through contractual agreements enabling manufacturers to secure Medicaid coverage for their drugs by paying rebates ...
Evaluating Post-Progression Survival in the Context of Progression-Free Survival Benefits: A Revisit of the CodeBreaK200 Design [0.03%]
无进展生存期获益情况下的进展后生存评估——重新审视CodeBreaK200设计
Zhoujingpeng Wei,Yuanyuan Han,Luoying Yang et al.
Zhoujingpeng Wei et al.
Background: Overall survival (OS) remains the gold-standard endpoint in oncology trials, while progression-free survival (PFS) is a widely used surrogate endpoint that captures tumor progression earlier. However, an incre...
Advancing Biomarker Qualification: FDA Perspective on Efficiency, Surrogate Endpoints, and Future Directions [0.03%]
从效率、替代终点和未来方向看FDA的生物标志物认证进展的观点
Vanitha Sekar,Jeffrey Siegel
Vanitha Sekar
Patient Preferences for Electronic Versus Paper Patient Information Leaflets: A Survey Among Patients in Sweden [0.03%]
瑞典患者对电子版和纸质版患者信息手册的偏好的调查研究
Annika Forsberg,Wenche Olsen Boström,Klaus Kaae Andersen et al.
Annika Forsberg et al.
Objectives: In compliance with legal requirements, medications are mandated to include a patient information leaflet (PIL) in a physical/paper format that serves as a vital source of information about the medication. Whil...
Quantifying Eligibility Pattern Shifts: a Data-Driven Paradigm for Early Risk Detection in Clinical Trials [0.03%]
量化资格标准变化：临床试验中早期风险检测的数据驱动范式
Atanu Bhattacharjee,Ayon Mukherjee
Atanu Bhattacharjee
Traditional Risk-Based Monitoring (RBM) strategies emphasise key risk indicators and site-level performance metrics but seldom address the heterogeneity of patient eligibility profiles. We present a data-driven framework that captures tempo...
Hierarchical Transit Compartment Model to Describe Absorption Delay in Orally Administered Drugs in Heterogeneous Populations [0.03%]
用于描述异质人群中口服药物吸收延迟的分层转运室模型
Abhisek Chakraborty,Anirban Chakraborty
Abhisek Chakraborty
Following oral administration of a drug, we observe an absorption delay before the drug enters systemic circulation. This delay is attributed to the time taken for disintegration of the drug delivery system, drug dissolution from the delive...
Indian Pharmacopoeia Reference Standards: A Key Tool to Regulate the Quality of Pharmaceuticals [0.03%]
印度药典标准品：监管药品质量的关键工具
Arvind Kumar Sharma,Shruti Rastogi,Priyanka Nagar et al.
Arvind Kumar Sharma et al.
Pharmacopoeia reference standards play a vital role in the pharmaceutical industry by setting benchmarks for the quality, purity and consistency of drugs. Established by official pharmacopeia bodies like British Pharmacopoeia Commission, Eu...
The Utilization of Externally Sourced Data and Data Collected and Analyzed from Previously Completed Studies Using Modelling and Simulation and Other Methodologies to Support Pediatric-Focused Regulatory Commitments [0.03%]
模型仿真及其它方法学途径对儿科药物研发的支持作用：外部数据和已完成研究数据的使用分析
Nancy A Sherman,Kevin D Wolter,Elena Soto
Nancy A Sherman
There can be many challenges to conducting and completing clinical research trials, which may impact the successful and timely achievement of regulatory commitments. General difficulties can include a rare disease under study which limits t...
Patient-Perceived Overall Side Effect Bother at and After Cancer Treatment Discontinuation: An Analysis Using Commercial Cancer Trial Data [0.03%]
基于商业癌症试验数据的癌症治疗期间和停药后的患者感知不良事件干扰分析
Jessica Roydhouse,Monique Breslin,Anne Zola et al.
Jessica Roydhouse et al.
Introduction: There is widespread interest among patients, clinicians, regulators and other constituents in post-treatment patient-reported cancer data. Side effect bother is a patient-reported outcome (PRO) that can capt...
Enhancing Safety Evaluations: A Comprehensive Framework for Evidence-Based Safety Assessment Using the Bradford Hill Criteria [0.03%]
提升安全评估：一种基于证据的安全评估综合框架，使用布拉德福德希尔标准
Anja Loos,Elian Khazneh,Jürgen Kübler
Anja Loos
In drug development, safety assessments must integrate data from heterogeneous sources including clinical trials, non-clinical toxicology, mechanistic evidence, and real-world evidence. At any given timepoint-such as protocol development, d...