Bayesian Workflow for Minimal PBPK Models: Case Study of Dapagliflozin [0.03%]
基于最小PBPK模型的贝叶斯工作流程：达格列净案例研究
Anna Mikhailova,Kirill Peskov,Gabriel Helmlinger et al.
Anna Mikhailova et al.
Numerous clinical trials (CTs) and population pharmacokinetic (PK) models have been published on dapagliflozin, an approved SGLT2 inhibitor used to treat type 2 diabetes, heart failure, and chronic kidney disease. This study proposes a Baye...
Utilizing Virtual Clinical Trials to Inform Target Coverage That Drives RSV Antiviral Efficacy [0.03%]
利用虚拟临床试验指导目标覆盖范围以提高RSV抗病毒药物疗效
J Cody Herron,Kathryn G Link,Natalie Meacham et al.
J Cody Herron et al.
Respiratory syncytial virus (RSV) infection can result in a range of disease severity from mild upper respiratory tract symptoms to lower respiratory tract illness, with clinical manifestations dependent on age, co-morbidities, and immune s...
Machine Learning Enables Rapid Prediction of Acid-Reducing Agent Drug Interactions: A Streamlined Complement to PBPK Modeling [0.03%]
机器学习能够快速预测酸性减少剂的药物相互作用：一种简化的方法补充PBPK建模
Yuanfang Qin,Lehua Yu,Tao Chen et al.
Yuanfang Qin et al.
pH-dependent drug-drug interactions (DDIs) commonly occur when acid-reducing agents (ARAs) are co-administered with weakly basic drugs. Although physiologically based pharmacokinetic (PBPK) modeling effectively evaluates such DDIs, its use ...
Structured Schemas for Provenance-Rich, LLM-Assisted QSP Model Calibration [0.03%]
基于结构化模式的丰富来源、大型语言模型辅助的QSP模型校准
Joel Eliason,Aleksander S Popel
Joel Eliason
Quantitative systems pharmacology (QSP) models require calibration data from literature, yet manual curation is inconsistently documented and large language model (LLM) extraction can hallucinate values and fabricate citations. We present M...
Refinement of Operating Characteristics for Model-Based TGI Metrics Decision Support to Ungate a Pivotal Trial in Oncology [0.03%]
基于模型的TGI指标操作特征优化以在肿瘤药物开发关键性试验中启用无门控Meta-Analysis
Mathilde Marchand,Kenta Yoshida,Antonio Gonçalves et al.
Mathilde Marchand et al.
The oncology market is evolving, with an increasing number of therapeutic options making the inference of treatment benefit from early development critical. The "Go" versus "No Go" decisions from such trials usually rely on probabilities of...
Marianela Chavarría-Rojas,Mub Murshed,Marianela Lorier et al.
Marianela Chavarría-Rojas et al.
Physiologically based pharmacokinetic (PBPK) and physiologically-based biopharmaceutics (PBBM) modeling are valuable tools in drug development, allowing mechanistic predictions of drug absorption and disposition. However, sex-related differ...
Post-Marketing Requirements for Anticancer Drugs Approved in Japan, 2001-2024: A Cross-Sectional Analysis [0.03%]
2001年至2024年日本批准的抗癌药物上市后要求的横断面分析
Aina Tsuno,Hiroe Kitagaki,Hideki Maeda
Aina Tsuno
The accelerated development of innovative anticancer therapies has led to the early approval of an increasing number of drugs. However, clinical evidence available at the time of approval is often limited, necessitating additional post-mark...
Correction to "Development of an Agent-Based Model to Investigate Durability of Factor IX Activity in Hemophilia B Patients Treated With Etranacogene Dezaparvovec" [0.03%]
“开发用于研究血友病B患者接受Etranacogene dezaparvovec治疗的IX因子活性耐久性的代理模型的研究”的勘误通知
Published Erratum
CPT: pharmacometrics & systems pharmacology. 2026 Aug;15(8):e70312. DOI:10.1002/psp4.70312 2026
DDIapp-A Web-Based Application for Static Drug-Drug Interaction Assessment [0.03%]
DDIapp-一个基于Web的药物相互作用评估软件
Hirotaka Watase,Sylvie Klieber,Yorgos M Psarellis et al.
Hirotaka Watase et al.
In this work we describe the development of a web-based application for static drug-drug interaction (DDI) risk assessment in accordance with the International Council for Harmonization (ICH) M12 guidance. The app was built using the Shiny ...
Physiologically Based Pharmacokinetic Model of Brigatinib in Healthy Volunteers and Patients With Cancer [0.03%]
健康志愿者和癌症患者体内brigatinib的生理药代动力学模型
Yichao Xu,Xinhua Hu,Pengfei Zhao et al.
Yichao Xu et al.
Brigatinib, an oral ALK inhibitor for metastatic NSCLC, lacks dosing guidance for special populations such as the Chinese. This study developed a physiologically based pharmacokinetic (PBPK) model using European data from patients with hepa...