Translating Asian-Dominant Pivotal Evidence Into EU Marketing Authorization: An EMA Regulatory Document Analysis, 2021-2025 [0.03%]
亚裔占多数的关键证据向欧盟营销授权的转化：一项对EMA监管文件（2021-2025年）的研究分析
Prerona Boruah,Alex Zwiers
Prerona Boruah
An increasing number of novel molecular entities and biosimilars reach the European Medicines Agency (EMA) supported by pivotal evidence derived predominantly from Asian patient populations. This creates regulatory challenges that the exist...
Omics Biomarkers in Precision Oncology: From the Lens of the ASCPT Biomarkers and Translational Tools and Oncology Communities [0.03%]
精准肿瘤学中的组学生物标志物：ASCPT生物标志物和转化工具及肿瘤学领域的视角
Mai Mehanna,Hardik Mody,Joy C Hsu et al.
Mai Mehanna et al.
Omics biomarkers comprise several molecular entities, including genomic, epigenomic, transcriptomic, proteomic, and metabolomic signatures. They play an essential role in oncology drug development and clinical settings by enabling personali...
Bridging the Pregnancy Knowledge Gap: A Real-World Analysis of Medication Use and Drug-Drug Interaction Risk in Crohn's Disease and Multiple Sclerosis [0.03%]
缩小孕期用药知识差距：克罗恩病和多发性硬化症患者用药及药物相互作用风险的现实世界分析
Jacqueline Williams,Rucha Sane,Amita Joshi et al.
Jacqueline Williams et al.
The exclusion of pregnant individuals from clinical trials has resulted in a significant medical knowledge gap for this population. Leveraging real-world data (RWD) provides a critical window into the prevalence and use of medications durin...
Quantitative and Clinical Pharmacology Perspectives on Next-Generation Malaria Prevention Using Vaccines and Long-Acting Monoclonal Antibodies [0.03%]
下一代疟疾预防的量化和临床药理学观点：使用疫苗和长效单克隆抗体
Sabiha R Mim,Leonardo C Xavier,Francine J Azeredo et al.
Sabiha R Mim et al.
Malaria remains a significant global health burden, particularly among pediatric populations in endemic regions. Recent advances in preventive interventions highlight the complementary roles of vaccines and long-acting monoclonal antibodies...
Quantitative and Clinical Pharmacology Perspectives on Next-Generation Malaria Prevention Using Vaccines and Long-Acting Monoclonal Antibodies [0.03%]
下一代疟疾预防的量化和临床药理学视角：疫苗与长效单克隆抗体
Sabiha R Mim,Leonardo C Xavier,Francine J Azeredo et al.
Sabiha R Mim et al.
Malaria remains a significant global health burden, particularly among pediatric populations in endemic regions. Recent advances in preventive interventions highlight the complementary roles of vaccines and long-acting monoclonal antibodies...
Prognostic Value of Systemic Inflammatory Markers in Predicting Peritoneal Metastasis in Gastric and Gastroesophageal Junction Cancer [0.03%]
系统炎性标志物在预测胃及胃食管结合部癌腹膜转移中的预后价值分析
Mahesh Wadhwa,Dipali Raju,Harish Premkumar et al.
Mahesh Wadhwa et al.
Gastric cancer and gastroesophageal junction cancer, primarily adenocarcinoma, originate in the stomach's mucosa. Peritoneal metastasis is a common pattern in gastric cancer. The neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocy...
Observational Study
Clinical and translational science. 2026 Aug;19(8):e70688. DOI:10.1111/cts.70688 2026
Pharmacokinetic Drug-Drug Interactions of Imlunestrant in Healthy Female Participants of Nonchildbearing Potential [0.03%]
绝经后妇女受试者中Imlunestrant的药物相互作用的药代动力学研究
Amita Datta-Mannan,Elaine Shanks,Eunice Yuen et al.
Amita Datta-Mannan et al.
Imlunestrant is a next-generation, oral, selective estrogen receptor degrader approved for treating adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced/metastatic breast cancer. I...
Applying a Pharmacometrics-Enabled Machine Learning Analysis to Predict 2-Month Culture Conversion Using Phase 2a Data in a Tuberculosis Clinical Trial [0.03%]
基于药理学的机器学习分析预测结核病临床试验中两个月培养转换的模型构建与验证：二期a研究数据
Huifang You,Ulrika S H Simonsson
Huifang You
Phase 2a trials in tuberculosis patients traditionally assess early bactericidal activity over two weeks, often using the time-to-positivity biomarker, followed by a phase 2b study typically lasting 8-week with time-to-event of culture conv...
Clinical Trial
Clinical and translational science. 2026 Aug;19(8):e70694. DOI:10.1111/cts.70694 2026
Association of the NOS1AP rs10494366 Genetic Variant With Drug-Induced QT Prolongation [0.03%]
NOS1AP基因多态性与药物致QT间期延长的关系
Christina A Pippis,Ana I Lopez-Medina,Choudhary Anwar A Chahal et al.
Christina A Pippis et al.
Drug-induced QTc prolongation (diQTP) is a major risk factor for torsades de pointes and sudden cardiac death. This study evaluated whether carriers of the G allele of the NOS1AP rs10494366 T > G variant have greater risk for diQTP when pre...
Drug-Drug Interaction Risk Assessment Strategies for Biologics in Inflammatory Bowel Disease: A Literature-Based Evidence Mini-Review [0.03%]
基于文献的证据 mini-回顾：炎症性肠病生物制品药物-药物相互作用的风险评估策略
Claire Steinbronn,Susan E Stanley,Tjerk Bueters et al.
Claire Steinbronn et al.
Biologic therapies are traditionally regarded as having low potential for drug-drug interactions (DDIs) due to their large molecular size and limited direct involvement with drug-metabolizing enzymes and transporters (DMETs). However, accum...