Femke A Elzinga,Samira Lier,Paul R V Malik et al.
Femke A Elzinga et al.
Objective: To evaluate physiological and anatomical changes in children with liver cirrhosis supporting the development of physiologically based pharmacokinetic (PBPK) models. ...
Effects of Normothermic Hepatic Ischemia-Reperfusion Injury on the Hepatic Disposition of Arachidonic Acid and Its Cytochrome P450-Generated Metabolites in Rats [0.03%]
normothermic缺血/再灌注对大鼠肝脏花生四烯酸及其细胞色素P450代谢产物处置的影响
Vindhya Edpuganti,Reza Mehvar
Vindhya Edpuganti
Purpose: Cytochrome P450 (P450) metabolites of arachidonic acid (AA) are potential therapeutic targets in ischemia-reperfusion (IR) injury, yet their disposition and actions in hepatic IR are unknown. Cellular AA and its ...
Biomedical Large Language Models and Prompt Engineering for Causality Assessment of Individual Case Safety Reports in Pharmacovigilance [0.03%]
生物医学大型语言模型及提示工程在药物警戒个例安全性报告因果关系评估中的应用
Nicole Sonne Heckmann,Despoina Georgia Papoutsi,Maria Antonietta Barbieri et al.
Nicole Sonne Heckmann et al.
Background: Biomedical Large Language Models (LLMs) combined with prompt engineering offer domain-specific reasoning, yet their application to individual-level causality assessment remains unexplored. This study evaluated...
Targeting VAMPs in Aging-Related Diseases: From Mechanisms to Pharmacotherapy [0.03%]
靶向老化相关疾病中的VAMPs：从机制到药物治疗
Binru Jia,Huidan Dong,Yu Liu et al.
Binru Jia et al.
Background: Vesicle-associated membrane proteins (VAMPs) are key regulators of membrane fusion, vesicular trafficking and intercellular communication. Structurally and functionally diverse, VAMPs participate in multiple p...
Multiscale Dissolution Simulation of Particles from a Tablet in Dissolution Apparatus by Coupling Discrete Element with Lattice Boltzmann Methods [0.03%]
基于离散元与格子boltzmann方法的多尺度片剂溶出模拟
Yue Li,Peng Hou,Lei Xing et al.
Yue Li et al.
Purpose: Dissolution kinetics of tablets is pivotal to therapeutic performance, quality assessment, and troubleshooting in manufacturing. We aimed to develop and validate a simulation framework to predict tablet dissoluti...
Reassessing and Updating Regulatory Standards on the Declaration of Storage Conditions in the Product Information of Medicinal Products: An Evidence-Based Proposal under EMA Guidance [0.03%]
EMA指南下的证据-based提案：重新评估和更新药品产品信息中声明的储存条件的监管标准
Helena Pericão,Henrique Cavaco,Miguel Dias et al.
Helena Pericão et al.
Purpose: The European Medicines Agency (EMA) guideline Declaration of Storage Conditions in the Product Information of Medicinal Products (CPMP/QWP/609/96/Rev.2) was last revised in 2007. Since then, advances in stability...
CFD study on deposition pattern of adult oropharyngeal drug particles with inhalation devices using realistic anatomical models under steady-state flow [0.03%]
基于稳定流条件下使用真实解剖模型的吸入装置成人口咽部药物颗粒沉积规律的数值模拟研究
Yingzhe Ding,Shiqi Wang,Shufan Liu et al.
Yingzhe Ding et al.
Purpose: With the rising burden of chronic respiratory diseases, inhalation therapy is essential for efficient drug delivery, yet oropharyngeal retention still limits effective lung deposition. Delivery efficiency depends...
NIPTE 2030: The Nation's Digital Trust Anchor for Pharma 5.0 [0.03%]
NIPTE 2030：面向Pharma 5.0的国家数字信任锚
Ajaz S Hussain,Kenneth Morris,Vadim J Gurvich
Ajaz S Hussain
As the National Institute for Pharmaceutical Technology and Education (NIPTE) marks its 20th anniversary, the pharmaceutical ecosystem faces a widening gap between regulatory "risk-to-quality" compliance and real-world "risk-to-patient" out...
Formulation and Evaluation of Indomethacin Nanosuspensions Stabilized by Poly(2-oxazine) and Poly(2-oxazoline)-Based Polymers for Solubility Enhancement [0.03%]
聚（2-恶嗪）和基于聚（2-恶唑啉）的聚合物稳定布洛芬纳米悬浮液的设计及其评价以增强溶解度
Erika Espo,Dipti Potdar,Kiana Baas et al.
Erika Espo et al.
Objective: The challenges associated with poorly water-soluble drugs have been recognized for several decades. Poor aqueous solubility directly impairs the bioavailability of a drug, but this can be significantly improved...
Residual Content Impacts Critical Quality Attributes and Performance of Risperidone Microspheres [0.03%]
残留物含量影响利培酮微球关键质量属性及性能研究
Saurabh Bhorkade,Bo Wan,Pawan Kumar Pandey et al.
Saurabh Bhorkade et al.
Purpose: Poly (lactic-co-glycolic acid) (PLGA) microspheres are widely used long-acting injectable depots. However, their performance is highly sensitive to polymer material attributes that can influence microsphere struc...