From Pharmacodynamic Biomarker to Evaluating Treatment Response: Biomarkers in Primary Mitochondrial Diseases [0.03%]
从药理动力学生物标志物到评估治疗反应：原发性线粒体疾病中的生物标志物
Sydney Stern,Karryn Crisamore,John Patton et al.
Sydney Stern et al.
Primary mitochondrial diseases (PMDs) result from genetic variants in nuclear DNA and mitochondrial DNA which commonly lead to aberrant oxidative phosphorylation. The clinical complexity, often attributed to the underlying genetics, include...
Challenges in Implementing Revocation of Oncology Drugs Under Conditional Early Approval in Japan: Regulatory Insights From Comparisons With FDA/EMA [0.03%]
日本有条件提前批准的肿瘤药物撤市实施中的挑战——与FDA/EMA比较后的监管思考
Takahiro Handa,Arata Tanaka,Mayumi Shikano et al.
Takahiro Handa et al.
Expedited pathways in the United States (U.S.), European Union (EU), and Japan (JP) enable earlier access to innovative therapies for rare and serious diseases. In 2025, Japan explicitly introduced revocation provisions to its Conditional E...
Comparative Study
Clinical and translational science. 2026 Jun;19(6):e70642. DOI:10.1111/cts.70642 2026
Thorough QT/QTc Clinical Study to Evaluate the Effect of Remdesivir on Cardiac Repolarization in Healthy Participants [0.03%]
一项在健康受试者中评价瑞德西韦对心电图QT/QTc影响的临床研究
Chi-Chi Peng,Ran Duan,Mazin Abdelghany et al.
Chi-Chi Peng et al.
QT interval prolongation associated with drug administration is an important consideration in drug development. Patients with COVID-19 are at increased risk for cardiac complications, and QT interval prolongation correlates with higher mort...
Clinical Trial
Clinical and translational science. 2026 Jun;19(6):e70645. DOI:10.1111/cts.70645 2026
Transcriptomic Profiling of Cutaneous Melanoma Metastases Treated With Microwave Ablation-Pilot Study [0.03%]
微波消融治疗黑色素瘤转移病灶的转录组谱分析-一项初步研究
Purevsuren Losol,Daniel O&#x;Driscoll,Andres Vallejo Pulido et al.
Purevsuren Losol et al.
Microwave ablation induces heating of tissue. High energy results in thermal cell death, but low energy treatment without tissue necrosis has been shown to induce cutaneous immunity in an HPV wart model. It is approved as an effective cance...
A Generative AI Framework for Pharmacokinetic Clinical Study Report Authoring [0.03%]
一种用于药代动力学临床研究报告撰写的生成式AI框架
John Samuelsson,Samuel Blakeman,Ezra Alexander et al.
John Samuelsson et al.
Clinical Study Reports (CSRs) constitute the final consolidation of findings from clinical studies and routinely include Pharmacokinetic (PK) results. To assist with PK results authoring, we developed a generative Artificial Intelligence (A...
Utilization of Healthy Volunteers in Oncology Drug Development in Japan: A 10-Year Analysis of Approved Anticancer Agents (2014-2024) [0.03%]
日本肺癌药物开发中健康受试者利用情况（2014-2024）十年分析
Kana Morihisa,Hiroyuki Yoshitsugu,Hirokazu Wakuda et al.
Kana Morihisa et al.
Anticancer agents with favorable safety profiles, such as immunomodulators and molecular-targeted agents, are increasingly used in recent cancer therapy, and clinical trials for these agents increasingly incorporate healthy volunteers as we...
Interpretation of Chemistry, Hematology and Coagulation Laboratory Results in Early-Phase Clinical Pharmacology Trials; a Retrospective Analysis Based on the Placebo Arm of Randomized-Controlled Trials [0.03%]
基于随机对照试验中的安慰剂臂的回顾性分析：早期临床药理学试验中化学、血液学和凝血实验室结果的解读
Jannik Rousel,Tessa Niemeyer-van der Kolk,Matthijs Moerland et al.
Jannik Rousel et al.
Early-phase clinical trials focus heavily on demonstrating safety and tolerability of drug candidates. Clinical laboratory test results outside of reference intervals (RIs) are often interpreted as possible indicators of harm. However, valu...
Quantitative Medicine to Support Drug Development and Regulatory Decisions: A UK Regulatory Approach Informed by ICH M15 [0.03%]
定量医学支持药物研发和监管决策：英国监管部门的ICH M15方法论视角
Essam Kerwash,Andrew S Butler,Maria Malamatari et al.
Essam Kerwash et al.
Quantitative medicine supports modern drug development and regulatory decision-making by integrating non-clinical and clinical data to inform dose selection, trial optimization, and extrapolation across populations and benefit-risk assessme...
Tacrolimus Concentration/Dose Ratio in Hematopoietic Cell Transplantation Recipients: An Exploratory Study of Metabolizer Phenotyping and Clinical Outcomes [0.03%]
他莫昔芬浓度/剂量比在造血细胞移植受者中的研究：代谢表型和临床结局的探索性研究
Luiz Carlos da Costa-Junior,Rita de Cássia Barbosa da Silva Tavares,Marina Izu et al.
Luiz Carlos da Costa-Junior et al.
Tacrolimus pharmacokinetics shows wide interindividual variability after allogeneic hematopoietic cell transplantation (HCT), potentially influencing both effectiveness and toxicity. The concentration-to-dose (C/D) ratio has been proposed a...
Severe Thiopurine-Induced Myelosuppression in a Pediatric Acute Lymphoblastic Leukemia Patient With the NUDT15 *1/*6 Genotype: A Brief Report [0.03%]
NUDT15*1/*6型儿童急性淋巴细胞白血病患者发生严重噻嘌呤骨髓抑制的简报
Jillian Fry,Erin C Boone,Wendy Y Wang et al.
Jillian Fry et al.
Variants in TPMT and NUDT15 genes that affect thiopurine metabolism can guide personalized dosing to minimize toxicity. Decreased or no appreciable NUDT15 activity demonstrates impaired breakdown of active thiopurine metabolites which can l...