Evaluating Preclinical-to-Human Bioavailability Classification Using Smooth ROC Curve Estimation [0.03%]
Mahmut Sami Erdoğan
Mahmut Sami Erdoğan
Human oral bioavailability is a critical pharmacokinetic parameter that determines systemic drug exposure, informs dose selection, and guides compound prioritization during early-stage drug development. Although animal models are routinely ...
Development of a Predictive Flow Through Cell Dissolution Method for Carbamazepine Modified-Release Tablets [0.03%]
Laura Carvajal Barbosa,Sandra Milena Echeverry,Diana Marcela Aragón
Laura Carvajal Barbosa
Predictive in vitro dissolution methods are crucial for anticipating in vivo drug performance, particularly for poorly soluble drugs like carbamazepine. In vitro-in vivo correlations (IVIVC) link dissolution characteristics to pharmacokinet...
Midazolam Dosing During CRRT: A Combined Ex Vivo and Physiologically-Based Pharmacokinetic Approach [0.03%]
Autumn M McKnite,Abdullah Hamadeh,J Porter Hunt et al.
Autumn M McKnite et al.
Children supported with continuous renal replacement therapy have high mortality rates ranging from 30% to 70%. The cause of this high mortality is multifactorial and includes ineffective drug dosing and altered drug pharmacokinetics. Chang...
Intestinal Organoid-Based Mathematical Modeling Predicts Clinical Gastrointestinal Toxicity of Oral Oncology Drugs [0.03%]
Carmen Pin,Deepa Maheshvare M,Louis Gall et al.
Carmen Pin et al.
Gastrointestinal (GI) toxicity is a common and potentially severe side effect of antiproliferative cancer therapies that often requires dose reduction or treatment interruption. Despite the clinical implications, there are currently no robu...
Integration of Time-Varying Pharmacometric Modeling With Cox Regression for Time-to-Event Analysis in NONMEM [0.03%]
Chih-Wei Lin,Po-Wei Chen,Sameer Doshi et al.
Chih-Wei Lin et al.
Although time-varying Cox regression modeling approaches have been developed, exposure-response analyses for time-to-event (TTE) endpoints often rely on static exposure covariates and may overlook the real-world dosing variability and drug ...
Machine Learning Meets Pharmacokinetics: A Comparative Analysis of Predictive Models for Plasma Concentration-Time Profiles [0.03%]
Felix Jost,Clemens Giegerich,Christoph Grebner et al.
Felix Jost et al.
Predicting pharmacokinetic (PK) profiles from molecular structures represents a significant advancement in pharmaceutical research with substantial implications for expediting drug discovery processes. We evaluated five approaches to system...
Comparative Study
CPT: pharmacometrics & systems pharmacology. 2026 May;15(5):e70226. DOI:10.1002/psp4.70226 2026
Population Pharmacokinetics and Pharmacokinetics-Pharmacodynamics Analyses of Elafibranor to Support Dose Selection in Primary Biliary Cholangitis [0.03%]
依拉戈替钠在原发性胆汁性胆管炎患者中的药物代谢动力学和药物代谢动力学-药物效应动力学分析以确定给药剂量
Qing Xi Ooi,Karl Brendel,Stijn van Beek et al.
Qing Xi Ooi et al.
Elafibranor 80 mg/day is approved for second-line primary biliary cholangitis (PBC) treatment. We present pharmacokinetic (PK) analyses of elafibranor and its metabolite, GFT1007, and pharmacokinetic-pharmacodynamic (PKPD) analyses describi...
Pharmacokinetics, Pharmacodynamics, Efficacy and Drug Resistance Selection of Injectable Long-Acting Lenacapavir Pre-Exposure Prophylaxis (PrEP) Against HIV [0.03%]
长效注射型LENACAPAVIR作为HIV暴露前预防（PrEP）的药代动力学、药效学、疗效及耐药性选择压力研究
Hee-Yeong Kim,Antonia Liebenberg,Lanxin Zhang et al.
Hee-Yeong Kim et al.
Oral pre-exposure prophylaxis (PrEP) can substantially reduce HIV infection risk when taken as prescribed. However, many individuals struggle adhering to the daily regimen. Twice-yearly injections of the novel HIV capsid inhibitor lenacapav...
Hybrid Systems Modeling of Donor T-Cell Responses and Graft-Versus-Host-Disease After Posttransplantation Cyclophosphamide Administration [0.03%]
环磷酰胺治疗后的供体T细胞反应和移植物抗宿主病的混合系统模型
Hsuan-Hao Fan,Jeannine S McCune,Christopher G Kanakry et al.
Hsuan-Hao Fan et al.
The optimal post-transplant cyclophosphamide (PTCy) dose to prevent graft-versus-host disease (GVHD) after allogeneic hematopoietic cell transplant (HCT) is undefined. Data from a novel murine HLA-haploidentical HCT model suggested that PTC...
Yuchen Guo,Tingjie Guo,J G Coen van Hasselt et al.
Yuchen Guo et al.
Patient-specific covariates are commonly incorporated in pharmacometric and quantitative system pharmacology models to predict differences in pharmacokinetic or pharmacodynamic profiles between patients. When simulating new virtual populati...