Meta-Analysis of the Placebo Response in Chronic and Episodic Migraine: Insights from Migraine Preventive Drug Trials [0.03%]
偏头痛发作的安慰剂反应的元分析：来自预防性药物试验的启示
Anantha Ram Nookala,Nimishraj Panse,Gopichand Gottipati et al.
Anantha Ram Nookala et al.
Randomized, well-controlled trials are the gold-standard for evaluating novel therapies, but they often fail to fully account for the placebo response, particularly in pain-related conditions such as migraine, where subjective improvement i...
Meta-Analysis
The AAPS journal. 2025 Dec 9;28(1):31. DOI:10.1208/s12248-025-01181-z 2025
Simultaneous Target-Mediated Drug Disposition-Pharmacodynamic (TMDD-PD) Modeling of Finasteride and Dutasteride: Impact of Target Binding and Turnover on Non-linear Pharmacokinetics [0.03%]
非那雄胺和杜螺亭的靶点介导药物处置-药效学(TMDD-PD)模型同时建模：靶标结合和周转对非线性药动学的影响
Yuki Iwaki,Wooin Lee,Yasunori Aoki et al.
Yuki Iwaki et al.
Target-mediated drug disposition (TMDD) refers to non-linear pharmacokinetic (PK) profiles arising from the saturable interaction between a drug and its pharmacological target. Recently, our group revisited the TMDD cases observed in small-...
Drug Dissolution Enhancement Using 3D-Printed Silica-Based Oral Films [0.03%]
基于二氧化硅的3D打印口腔膜增强药物溶解性能
Dagmar Blaháčková,Jan Elbl,Lukas C Lammerding et al.
Dagmar Blaháčková et al.
Orodispersible films (ODFs) are increasingly employed for individualized drug delivery due to their ease of administration and precise dosing. However, their drug loading capacity is often limited by the need to maintain thin, flexible stru...
Reference Standard Calibration Challenges in the Case of Erythropoietin: Impact on Potency and Biosimilarity Determination [0.03%]
以促红细胞生成素为例说明参考标准校正中的难题及其对活性和类似生物药确定的影响
Julie TerWee,Kaila Wilson-Landy,Yihua Wang et al.
Julie TerWee et al.
International reference standards have been established as gold standards for several biological products. Use of international units can drive consistency and standardization for biosimilar products across manufacturers. However, our resea...
Utilizing Physiologically Based Pharmacokinetic Modeling and Virtual Simulation for Simvastatin Tablets to Evaluate the Sensitivity of Using Parent vs Metabolite as Analyte on Bioequivalence Assessment [0.03%]
基于生理药动学建模和虚拟仿真相对辛伐他汀片以母体化合物与代谢产物为检测对象的生物等效性评价的敏感性影响研究
Yi-Hsien Cheng,Fang Wu,Miyoung Yoon et al.
Yi-Hsien Cheng et al.
Typically, parent drug is measured for bioequivalence (BE) assessment because it's more sensitive to detect formulation differences, compared to its metabolite(s). For simvastatin immediate release (IR) tablets, current product-specific gui...
A Design of Experiments and Risk Management-Driven Analytical Platform for Charge Variant Analysis of Therapeutic Antibodies by Imaged Capillary Isoelectric Focusing [0.03%]
一种用于治疗性抗体电荷异构体分析的成像毛细管等电聚焦风险管理和实验设计驱动型分析平台
Virginia Ghizzani,Serena Orlandini,Alessandro Ascione et al.
Virginia Ghizzani et al.
The evaluation of monoclonal antibodies (mAbs) charge variants during their entire life cycle is crucial, as their profiles represent a critical quality attribute of biotherapeutics. While the current scenario still shows marked analytical ...
Improvements in Data Quality Can Boost Efficiency and Reduce Development Costs: A Pharmacometric CRO's Perspective [0.03%]
从药代动力学合同研究组织的角度看，提高数据质量可以提升效率并降低研发成本
Amparo de la Peña,Jill Fiedler-Kelly,Rebecca L Humphrey et al.
Amparo de la Peña et al.
Drug development can take up to 15 years, costing as much as $11 billion USD, and relies heavily on high-quality data. The goal of this investigation of contract research organizations (CROs) was to assess the impact of data management acti...
Metronidazole Pharmacokinetics Across Species: Meta-Analysis Integrating Allometric Scaling and Minimal Physiologically-Based Pharmacokinetic Modeling [0.03%]
基于所有ometry缩放和最小生理药动学建模的甲硝唑药动学跨物种元分析研究
Fatma Kir,William J Jusko
Fatma Kir
Metronidazole (MTZ) is frequently used in both human and veterinary medicine to treat infections caused by certain protozoa and anaerobic bacteria. This study investigates the pharmacokinetic (PK) profiles of MTZ for available species in th...
Meta-Analysis
The AAPS journal. 2025 Dec 5;28(1):25. DOI:10.1208/s12248-025-01191-x 2025
The Impact of Cognate Antigen Binding on the FcRn-mediated Transcytosis and Recycling of Monoclonal Antibodies [0.03%]
半抗原结合对Fc受体n介导的单克隆抗体跨细胞转运和回收的影响
Sharon Vijayanand,H A Daniel Lagasse,Million A Tegenge et al.
Sharon Vijayanand et al.
Immunoglobulin G (IgG) antibodies rely on neonatal Fc receptor (FcRn)-mediated recycling and transcytosis for prolonged serum half-life and tissue distribution. However, high antigen loads during infection may alter FcRn-mediated traffickin...
Preclinical Development of GT-14, a Novel Inhibitor of Gαi2 Protein: Comprehensive Evaluation of Physicochemical, Metabolic Characteristics and Tissue Distribution [0.03%]
GTA014新型Gαi2蛋白抑制剂临床前开发研究：药代动力学、代谢及组织分布特性综合评价
Mahua Sarkar,Ting Du,Yuan Chen et al.
Mahua Sarkar et al.
GT-14, identified as [(E)-4-((1-(1-methyl-1H-indol-2-yl) ethylidene)amino)phenol], is a novel inhibitor targeting the Gαi2 protein, which is crucial in facilitating cell migration and invasion in prostate, ovarian, and breast cancer cells....