Targeted Gene Therapy for Mutated H-ras and C-raf.1 Genes Exhibited Variable Efficacy in Inhibiting Hepatocellular Carcinoma in Rats: A Mechanistic Approach [0.03%]
靶向基因治疗对携带突变H-ras和C-raf.1基因的肝细胞癌抑制效果不同：机制方法研究
Alankar Mukherjee,Samrat Chakraborty,Ramkrishna Sen et al.
Alankar Mukherjee et al.
Objective: Mutated H-ras or c-raf.1 gene expressions are often associated with HCC development and progression. Using intravenous administration of respective backbone modified antisense oligomer (ASO) in chemically induc...
Application of a Stochastic Simulation-estimation Approach to Optimize Pharmacokinetic Study Design in the Context of Paediatric Extrapolation: A Tool to Support Decision-making by Drug Sponsors and Regulators [0.03%]
一种随机模拟估算方法在儿科外推药代动力学研究设计中的应用：支持申办方和监管机构决策的工具
Happy Phanio Djokoto,Lara Ernst,Jean-Michel Dogné et al.
Happy Phanio Djokoto et al.
Background: Extrapolation-based approaches are widely used in paediatric drug development. These often rely on pharmacokinetic (PK) matching to support inference on the benefit-risk balance (BRB). PK-based extrapolation r...
Regional Extrathoracic Deposition of Inhaled Epinephrine in an Idealized Child Airway: Influence of Pressurized Metered Dose Inhaler Actuator Orifice Diameter [0.03%]
理想化儿童气道吸入肾上腺素的区域腔外沉积：压力定量吸入器喷嘴直径的影响
Kineshta Pillay,Scott Tavernini,Conor A Ruzycki et al.
Kineshta Pillay et al.
Objective: The actuator orifice diameter (OD) of pressurized metered dose inhalers (pMDIs) is known to influence the plume geometry and spray pattern exiting the orifice. Actuator OD has previously been found to influence...
Population Pharmacokinetic/Pharmacodynamic Modeling of Volagidemab, a Glucagon Receptor Antagonist, in Healthy Chinese and US Subjects Following Single Subcutaneous Administration [0.03%]
单次皮下给药后，在中国和美国受试者中健康地进行针对胰高血糖素受体拮抗剂（Volagidemab）的群体药代动力学/药效学建模
Zihan Hu,Mingzhe Zhu,Linxiu Tang et al.
Zihan Hu et al.
Aims: Volagidemab, a fully human IgG2 monoclonal antibody, is a competitive glucagon receptor (GCGR) inhibitor that blocks endogenous glucagon (GCG) activity. This study developed a population pharmacokinetics/pharmacodyn...
Freezing-Induced Stress in mRNA-Lipid Nanoparticles During Lyophilization: Mechanistic Insights From Process and Formulation Studies [0.03%]
冷冻过程中mRNA-脂质纳米颗粒内应力的产生：来自工艺和配方研究的机理见解
Anna Ruppl,Andrei Hutanu,Monika Köll-Weber et al.
Anna Ruppl et al.
Introduction: Lyophilization is a promising strategy to enhance the long-term stability of messenger RNA lipid nanoparticles (mRNA-LNPs). However, lyophilization-induced stresses can impact product quality and the underly...
Biopharmaceutic Assessment of Post-Approval Changes for Azithromycin Immediate Release Tablets Using Predictive In Vitro Dissolution and a Model-Informed Approach [0.03%]
基于预测的体外溶出试验和模型依赖方法评估阿奇霉素片剂上市后变更的生物药剂学影响
Mauricio A García,Pablo M González
Mauricio A García
Background: Post-approval changes (PACs) in formulations requires a risk assessment of safety and efficacy for extending the product lifecycle. While BCS class I and III are candidates for biowaivers, standard bioequivale...
Shaheen Mahira,Priyadarshini Sathe,Siddharth Krishnan et al.
Shaheen Mahira et al.
Background: Ovarian cancer remains a challenging oncology concern owing to its late diagnosis, high risk of recurrence, and predisposition for developing chemoresistance. Despite their initial effectiveness, traditional c...
Mechanistic Modelling of Transdermal Delivery Dependence on Drug Properties [0.03%]
经皮吸收模型及其对药物性质依赖性研究
Neil Benbrook,Wenbo Zhan
Neil Benbrook
Purpose and objective: Microneedles have emerged as a promising platform for transdermal drug delivery, offering high patient compliance, ease of use, and minimal invasiveness. Despite extensive research on microneedle de...
Evaluation of Low-Field NMR as a PAT Technology for Upstream Bioprocess Monitoring [0.03%]
低场核磁共振作为PAT技术监测生物制药上游工艺的评估研究
Gabriella Gerzon,Christian Fischer,Matteo Pennestri et al.
Gabriella Gerzon et al.
Purpose: This study aimed to evaluate the capacity of low-field nuclear magnetic resonance (LF NMR) as a standalone or orthogonal method for monitoring key parameters of interest for upstream cell culture fermentation in ...
The Advanced Integrated Respiratory (AIR) Model: Comparative Analysis of Salbutamol Sulphate Deposition from pMDI, DPI, and Nebuliser Versus the NGI [0.03%]
先进的综合呼吸模型(AIR):与NGI相比，从pMDI、DPI和雾化器沉积沙丁胺醇硫酸盐的比较分析
Patrick He,Hazel Lam,Damien Chong et al.
Patrick He et al.
Purpose: In vitro respiratory models such as the Next Generation Impactor (NGI), remain the gold standard for aerodynamic particle size distribution (APSD) testing, however, they lack the anatomical complexity, limiting t...