Advancing drug development with "Fit-for-Purpose" modeling informed approaches [0.03%]
基于“适合目的”的模型推动药物研发进展
Jennifer Sheng,Tongli Zhang
Jennifer Sheng
Model-informed Drug Development (MIDD) is an essential framework for advancing drug development and supporting regulatory decision-making. The current review presents a strategic blueprint to closely align MIDD tools with key questions of i...
Computational approaches for toxicology and Pharmacokinetic properties prediction [0.03%]
毒性与药代动力学性质预测的计算方法
Navid Kaboudi,Tara Shekari,Ali Shayanfar et al.
Navid Kaboudi et al.
Pharmacokinetics and toxicological studies how the body reacts to a specific administered substance, such as a drug, toxin, or food. Each substance experiences these four steps: absorption, distribution, metabolism, and excretion, which are...
Concentration-dependent blood binding: assessing implications through physiologically based Pharmacokinetic modeling of tacrolimus as a case example [0.03%]
浓度依赖性的血浆结合：通过Tacrolimus的生理药代动力学模型评估其影响
Eman El-Khateeb,Deeyen Karsanji,Adam S Darwich et al.
Eman El-Khateeb et al.
Concentration-dependent binding to red blood cells is a characteristic of several drugs, complicating the understanding of how pathophysiological factors influence drug behavior. This study utilized user-friendly, physiologically-based phar...
APOE4 genotypes and the trajectory of biomarkers, neuroimaging, and cognitive measures in Alzheimer's Disease: A mixed-effects disease progression model [0.03%]
APOE4基因型和阿尔茨海默病生物标志物、神经影像学和认知测量指标的轨迹：混合效应疾病进展模型
Carson Essenburg,Murali Ramanathan
Carson Essenburg
Background: The ε4 allele of the apolipoprotein E gene (APOE4) is a major risk factor for developing sporadic Alzheimer's disease (AD). APOE4 homozygosity has been recently proposed as the defining signature of a genetic...
Sample size determination for cardiodynamic ECG assessment using the Concentration-QTc analysis method [0.03%]
基于浓度-QTc分析方法的心动力ECG评估的样本量估算方法研究
Hongqi Xue,Georg Ferber,Ellen Freebern et al.
Hongqi Xue et al.
Concentration-QTc (C-QTc) analysis was accepted to serve as an alternative to the by-time point analysis with intersection-union test (IUT) as the primary basis for decisions to classify the arrhythmogenic risk of a drug by ICH E14 Q&As (R3...
Pharmacometrics education for all by overcoming language barriers to enhance global collaboration [0.03%]
克服语言障碍进行药代动力学教育，以增强全球合作能力
Sonia Khier,Anna H-X P Chan Kwong,Maud Harnichard et al.
Sonia Khier et al.
Proficiency in English is essential in scientific disciplines; however, it is unevenly distributed globally, creating barriers for those with limited training. Research in neuroscience supports the benefits of teaching in a student's native...
Correction: Cross-species translational modelling of targeted therapeutic oligonucleotides using physiologically based pharmacokinetics [0.03%]
基于生理的药代动力学在靶向治疗寡核苷酸跨物种转化模型中的修正应用研究
Abdallah Derbalah,Felix Stader,Cong Liu et al.
Abdallah Derbalah et al.
Lessons learned from QT prolongation risk assessment for antibody-drug conjugates in oncology [0.03%]
抗体偶联药物抗肿瘤药学研究中延长QT间期的风险评估经验总结
Shruti D Shah,Roxanne C Jewell,Geraldine Ferron-Brady et al.
Shruti D Shah et al.
Antibody-drug conjugates (ADCs) are advanced cancer therapeutics that link monoclonal antibodies to cytotoxic drugs, enhancing targeted delivery to tumors. Since the FDA's first ADC approval in 2000, 14 ADCs have received approval to date (...
Joanna Parkinson,Corina Dota,Dinko Rekić
Joanna Parkinson
Concentration-QTc (C-QTc) analysis is a model-based method widely used to assess the impact of drugs on QT interval duration. C-QTc modelling was enabled to be used after the publication of the International Council for Harmonisation (ICH) ...