Correction: Exploring Additional Strength Biowaiver Perspectives in the ICH M13B Framework for Immediate Release Solid Oral Dosage Forms: Opportunities & Challenges [0.03%]
关于ICH M13B框架下即释固体制剂额外强度生物豁免视角探索：机遇与挑战纠正文中错误
Rajkumar Boddu,Arvind Rachapally,Mohammed Shareef Khan et al.
Rajkumar Boddu et al.
Published Erratum
Therapeutic innovation & regulatory science. 2026 Jan 7. DOI:10.1007/s43441-025-00901-z 2026
Laith Thamer Al-Ameri,Mohammed Shihab Al-Edanni,Zaki Noah Hasan
Laith Thamer Al-Ameri
Insights Informing Strategies for Optimizing the Collection of Clinical Trial Data [0.03%]
关于优化临床试验数据收集的策略见解
Kenneth Getz,Emily Botto,Ana Calduch Arques et al.
Kenneth Getz et al.
Although past research has quantified the proportion and types of procedures that support clinical trial endpoints, little is known about the volume and nature of data collected by these procedures and their impact on participant and site b...
Safety Comparison of Risk of Liver Dysfunction between Generic and Brand Statin Drugs Marketed in Japan: A Cohort Study Using MID-NET® [0.03%]
日本市场仿制他汀类药物和品牌他汀类药物引起肝功能异常风险的安全性比较：基于MID-NET®的队列研究
Hotaka Maruyama,Yuki Kinoshita,Takashi Ando et al.
Hotaka Maruyama et al.
To verify safety profiles of generic statins in a real-world setting, the risk of liver dysfunction as a common adverse event was compared between generic and brand drugs. A new user cohort design was employed in which patients prescribed o...
Digitalizing Risk Minimization Measures in EU: Explorative Co-design Workshops with Expert Stakeholders [0.03%]
欧盟数字化风险管理措施探索性协同设计专家研讨会
Mathias Møllebæk,Amalie Christine Bagger,Kirstine Lund Hansen et al.
Mathias Møllebæk et al.
Background: Post-marketing risk minimization measures for medicines, e.g. package leaflets and patient cards, aim to ensure that patients and health care professionals receive timely and relevant medicines safety informat...
Philipp Schlatter,Nina Heiss,Pedro Franco et al.
Philipp Schlatter et al.
Background: Options for patients to receive unauthorised medicines through compassionate use (CU) in Europe vary greatly. There are two CU pathways: cohort programmes, regulated uniformly by the Regulation across EU membe...
Patent Term Extension for Innovative Drugs in China: A Cohort Study from 2021 to 2024 [0.03%]
中国创新药物的专利期限延长：2021年至2024年的队列研究
Xuefang Yao,Yan Zhang,Jin Zhou
Xuefang Yao
Background: In January 2024, China officially implemented the patent term extension (PTE) system, that is, began to implement PTE for innovative drugs approved after June 1, 2021. This study analyzed the PTE system's outc...
A Call To Action: Developing an Agile Global Regulatory Affairs Workforce for the Future [0.03%]
行动起来：为未来培养敏捷型全球法规事务人才
Lina AlJuburi,Nicole Mahoney,Eddie Reilly et al.
Lina AlJuburi et al.
Sequential Monitoring of Clinical Trials with Weighted Logrank Test in the Presence of Random Delayed Treatment Effect [0.03%]
基于随机延迟的治疗效应的加权log-rank检验的序贯临床试验监测方法研究
Xiaotian Chen,Sheng Zhong,Li Wang
Xiaotian Chen
The standard logrank test may lose statistical power substantially when the underlying proportional hazards (PH) assumption is violated. Among non-PH patterns, delayed treatment effects are very commonly anticipated and actually observed no...
Exploring Additional Strength Biowaiver Perspectives in the ICH M13B Framework for Immediate Release Solid Oral Dosage Forms: Opportunities & Challenges [0.03%]
ICH M13B 框架下固体制剂即时释放口服固体速释制剂额外强度生物豁免视角的机遇与挑战探索
Rajkumar Boddu,Arvind Rachapally,Mohammed Shareef Khan et al.
Rajkumar Boddu et al.
In generic drug development, achieving bioequivalence followed by biowaivers for additional strengths are crucial for timely market entry. As per regulatory guidance, bioequivalence must be demonstrated for at least one strength-typically t...