Quantitative Systems Pharmacology Modeling of Platelet Responses to Recombinant ADAMTS13 in Patients With Congenital Thrombotic Thrombocytopenic Purpura [0.03%]
重组ADAMTS13对先天性血栓性血小板减少性紫癜患者血小板反应的定量系统药理学建模
Cameron McBride,Jiaolong Jiang,Zhiwei Zhang et al.
Cameron McBride et al.
Congenital thrombotic thrombocytopenic purpura (cTTP) is an ultra-rare, life-threatening thrombotic microangiopathy caused by a severe inherited deficiency of ADAMTS13, a von Willebrand factor (VWF) cleaving enzyme. Inadequate clinical endp...
Population Pharmacokinetic and Exposure-Response Analyses of Ibrutinib Combined With Bendamustine and Rituximab in Patients With Mantle Cell Lymphoma [0.03%]
伊布替尼联合苯达莫司汀和利妥昔单抗治疗套细胞淋巴瘤患者的人群药代动力学及暴露反应分析
Per Olsson Gisleskog,Belén Valenzuela,Nicoline Treijtel et al.
Per Olsson Gisleskog et al.
Efficacy and safety of ibrutinib 560 mg once daily or placebo combined with bendamustine and rituximab (BR) were assessed in patients with mantle cell lymphoma in a randomized phase 3 study (SHINE). The analysis described explores the ibrut...
Pirana and Integrated PMX Tools, a Workbench for NONMEM, NLME, pyDarwin, and RsNLME [0.03%]
Pirana及集成PMX工具包，一个用于NONMEM、NLME、pyDarwin和RsNLME的工作平台
Rong Chen,Mark Sale,James Craig et al.
Rong Chen et al.
Keizer initially described Pirana as a workbench designed to streamline management of NONMEM modeling, visualization, and analysis. Initial versions of Pirana integrated tools included NONMEM and PSN. As new tools have become available to p...
Prediction of a CLDN18.2 Targeted Antibody Drug Conjugate Pharmacokinetics in Cancer Patients Using PBPK Modeling and Simulation [0.03%]
基于生理的药代动力学模型和模拟预测抗体药物偶联物DS-8201a在癌症患者中的药代动力学行为
Chiara Zunino,Sichen Wang,Yanyan Zhang et al.
Chiara Zunino et al.
Antibody-drug conjugates (ADCs) represent a promising anticancer approach. Although physiologically based pharmacokinetics (PBPK) modeling became essential in Pharmacometrics to characterize exposure in different tissues, very few PBPK mode...
Shap-Cov: An Explainable Machine Learning Based Workflow for Rapid Covariate Identification in Population Modeling [0.03%]
基于可解释机器学习的快速群体模型协变量识别工作流-Shap-Cov
Logan Brooks,Rashed Harun,Jin Y Jin et al.
Logan Brooks et al.
Covariate identification in population pharmacokinetic/pharmacodynamic (popPK/PD) modeling is a key component in model development that is often prone to bias, time-consuming, and even intractable when too many covariates or complicated mod...
Moustafa M A Ibrahim,Matti Uusitupa,Jaakko Tuomilehto et al.
Moustafa M A Ibrahim et al.
Clinical studies often observe one interesting event in the presence of other competing events. When both types of events can occur at any time but are only observed at clinical visits (i.e., interval censored), standard survival models may...
A Pharmacometric Workflow for Resolving Model Instability in Model Use-Reuse Settings [0.03%]
模型用法重用设置下解决模型不稳定的药代动力学工作流程
Stephen B Duffull,Daniel F B Wright,Xiao Zhu et al.
Stephen B Duffull et al.
The development of fit-for-purpose pharmacokinetic-pharmacodynamic (PKPD) models based on clinical and pre-clinical data is a critically important process in model informed drug development. This process is often hampered by modeling stabil...
Incorporating Multiple Imputation Into Tanezumab Dose-Response Modeling of WOMAC Pain CFB Across Six Randomized Placebo-Controlled Phase 3 Trials [0.03%]
将多重插补法用于Tanezumab剂量反应建模：6项随机双盲安慰剂对照III期临床试验中WOMAC止痛分数变化的汇总分析
Martin Boucher,Scott Marshall,Puneet Gaitonde
Martin Boucher
Multiple imputation is increasingly being used to deal with missing data in clinical trials. It is a simulation approach leading to multiple analyses of a pre-defined number of datasets. For a pre-defined statistical model, this is relative...
Evaluation of the Drug-Drug Interaction Potential of the GlyT1 Inhibitor Iclepertin (BI 425809): A Physiologically Based Pharmacokinetic (PBPK) Modeling Approach [0.03%]
基于生理学的药代动力学（PBPK）模型方法评估甘氨酸转运蛋白1抑制剂Iclepertin（BI 425809）的药物相互作用潜力
Elin M Matsson,Michael Desch,Valerie Nock et al.
Elin M Matsson et al.
Despite predicting poor functional outcomes and being a significant patient burden, there are no approved pharmacotherapies to treat symptoms of cognitive impairment associated with schizophrenia (CIAS). Iclepertin (BI 425809) is a potent a...
A Combined Model-Based Meta-Analysis of Aggregated and Individual FEV1 Data From Randomized COPD Trials [0.03%]
Liang Yang,Carolina Llanos-Paez,Shuying Yang et al.
Liang Yang et al.
Model-based meta-analysis allows integration of aggregated-level data (AD) from different clinical trials in one model to assess population efficacy/safety. However, AD is limited in individual-level information, while individual-patient-le...