Impact of Japanese Subpopulation Data and Overall Survival in Pivotal Trials on Oncology Drug Approvals in Japan [0.03%]
Takanobu Watanabe,Ikuo Sugiyama,Hideyuki Kondo
Takanobu Watanabe
Globalization of oncology drug development has accelerated the adoption of multiregional clinical trials (MRCTs) as pivotal evidence for regulatory approvals in major markets, including Japan. While MRCTs enhance efficiency and generalizabi...
Critical to Quality Assessment Methodology: An Adaptable Clinical Trial Risk Management and Quality Assurance Approach for Quality Functions in Pharmaceutical Companies, Developed by the Inter-Company IMPALA Consortium [0.03%]
Kiernan Trevett,Jennifer Emerson,Paula Walker et al.
Kiernan Trevett et al.
Clinical trial regulations recommend a dynamic and risk-based approach to the quality management strategy for a medicinal product development program. Sponsor companies are required to identify factors that are critical to quality, to perfo...
Eleonora Castellana,Patricia Madalina Budau,Cecilia Miglietta et al.
Eleonora Castellana et al.
Background: Dasatinib, a second-generation tyrosine kinase inhibitor widely used for chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL), has been reported in associ...
Therapeutic Horizon in Multiple Myeloma: Analysis of the Emerging Landscape of Clinical Trials [0.03%]
多发性骨髓瘤的治疗前景：临床试验新兴格局分析
Marina Alacoque Rodrigues,Cristiane Aparecida Menezes de Pádua,Paula Lana de Miranda Drummond et al.
Marina Alacoque Rodrigues et al.
Background: Emerging therapies for multiple myeloma (MM) have significantly improved patient outcomes extending survival and advancing treatment toward more targeted, effective, and less toxic approaches. However, the dis...
Advancing Wider Implementation of Multi-regional Clinical Trials in East Asia [0.03%]
推进东亚多区域临床试验的广泛实施
John H Skerritt,Irene Chan,Aloka Chakravarty
John H Skerritt
The ICH E17 guideline is intended to promote the effective and efficient use of multi-regional clinical trials in simultaneous global medicines development, contributing to faster patient access. However, its uptake has been slower than hop...
Pharmacovigilance Data From Digital Health Systems: Regulations, Implications, and Opportunities-A TransCelerate Perspective [0.03%]
数字化卫生系统中的药物警戒数据：法规、影响和机会——TransCelerate观点
James Whitehead,Rajesh Ghosh,Anna Monaco et al.
James Whitehead et al.
Digital health technologies (DHTs) represent a clear potential to advance the science of pharmacovigilance and promote patient safety. A project was created to assess the current landscape for use of DHTs and identify opportunities to use D...
Analyses of U.S. FDA GCP Assessments and Recommendations for Marketing Applications, 2015-2024 [0.03%]
2015—2024年美国FDA对IND/IDE核查及市场准入申请建议的分析
Courtney McGuire,Michelle Foringer,David Burrow et al.
Courtney McGuire et al.
Background: The U.S. Food and Drug Administration conducts Good Clinical Practice (GCP) assessments and provides recommendations through Clinical Inspection Summary (CIS) reports to inform marketing application reviews. D...
Comparative Assessment of the Pharmaceutical Quality of Amoxicillin Capsules Marketed in Authorized and an Unregulated Point of Sale in Mexican Market [0.03%]
墨西哥授权和非授权销售点市场上阿莫西林胶囊的药品质量比较评估
Gael Marmolejo-Bernal,Leny Mejía-Amaro,Teresa Benítez-Escamilla et al.
Gael Marmolejo-Bernal et al.
Development of a Novel Risk Assessment Scale to Improve the Consistency and Reliability of Risk-Based Approaches in Clinical Trials [0.03%]
开发一种新型风险评估量表以提高临床试验中基于风险方法的一致性和可靠性
Takahiro Kuwahara,Ryota Kidena,Naoki Kato et al.
Takahiro Kuwahara et al.
Background: The introduction of Quality Management Systems and Risk-Based Approaches (RBA) in clinical trials has been promoted. In RBA risk assessment, Risk Priority Numbers (RPNs), similar to Failure Mode and Effects An...
Training Needs Assessment and Capacity Building of Clinical Trial Assessors and Ethical Reviewers to Strengthen Regulatory Review in Tanzania [0.03%]
坦桑尼亚临床试验评审员和伦理审查员培训需求评估及能力培养以加强监管审查项目
Kissa W Mwamwitwa,Castory G Munishi,Paul Malaba Makoye et al.
Kissa W Mwamwitwa et al.
Background: Sub-Saharan Africa carries 25.0% of the global disease burden but hosts only 2.0% of clinical trials worldwide. A key measure to address this challenge is shortening review timelines and enhancing the capacity...