Response to the Comment on "Intranasal Mucoadhesive Chitosan Microspheres of Ranolazine: Formulation, Design, and Pharmacokinetic Evaluation" [0.03%]
对“利诺嗪鼻用粘附性壳聚糖微球的制备、设计及药动学评价”一文的答复
Gyati Shilakari Asthana Dr,V Shilpa,B Geethika Reddy et al.
Gyati Shilakari Asthana Dr et al.
Comment on "Intranasal Mucoadhesive Chitosan Microspheres of Ranolazine: Formulation, Design, and Pharmacokinetic Evaluation" [0.03%]
关于“雷诺嗪鼻用黏膜吸附性壳聚糖微球的制备、设计及药代动力学评价”的评论
Sagar Nanasaheb Kharde,Prasad Laxman Gorde,Sandip Gangadhar Laware
Sagar Nanasaheb Kharde
Enhancing patient experience through tablet design: A study on the swallowability of almond-shaped tablets [0.03%]
改良药物制剂以提升患者体验——橄榄形药片的吞咽性研究
Jeremy Chen,Heidi Yang,Mahesh Venkatachalam et al.
Jeremy Chen et al.
Tablet geometry significantly influences medication adherence and comfort, especially among individuals with swallowing difficulties. Conventional tablet shapes such as oval or cylindrical may hinder esophageal transit, causing discomfort a...
Physicochemical developability insights into human Fab fragments with extended hypervariable loops [0.03%]
人源Fab片段延长超变区的物理化学可开发性研究见解
Marcel Passon,Gianluca Bandera,Leonard Mayerhöfer et al.
Marcel Passon et al.
Human antibodies with extended complementarity-determining regions (CDRs) can offer distinctive therapeutic opportunities by enabling binding to difficult targets. However, potential developability issues could pose problems for pharmaceuti...
Single-use mixing systems for protein products: Evaluation of dissolution performance and mechanical stress [0.03%]
单次使用蛋白质产品的混合系统：溶解性能和机械应力的评估
Dilara Ali,Julian Plaga,Michael Adler et al.
Dilara Ali et al.
Sterile manufacturing (fill & finish) of biologic drug products involves critical operations like freezing/thawing, mixing, filtration, and filling. These processes must be well characterized to understand their impact on product quality. W...
Translational PBPK modeling and model-informed drug development of IDH305, a complex CYP3A4 modulator [0.03%]
IDH305的复杂CYP3A4调节剂的 translational PBPK建模及模型指导药物研发
Yan Ji,Wen Lin,Tycho Heimbach et al.
Yan Ji et al.
IDH305 was developed as an orally available, mutant-selective, allosteric inhibitor of isocitrate dehydrogenase (IDH)1 for cancer treatment. It is a substrate, time-dependent inhibitor, and inducer of cytochrome P450 (CYP)3A4. As part of mo...
Development of a robust optimization strategy for primary drying in lyophilization, considering intra- and inter-batch variability [0.03%]
考虑批次内和批间变异性在冻干 primary drying中的稳健优化策略的开发
Roland Pérez,Natália M Bexiga,Argimiro R Secchi et al.
Roland Pérez et al.
Conventional models for primary drying in freeze-drying, whether deterministic or stochastic, fail to adequately account for inherent process variability, including vial-to-vial heterogeneity and batch-to-batch variation, limiting their app...
A rapid strategy for domain-specific Fab glycosylation profiling of monoclonal antibodies via selective native deglycosylation and ultrafiltration [0.03%]
一种通过选择性天然去糖基化和超滤快速建立单克隆抗体特定领域Fab糖型谱系的策略
Yangguo Xie,Zhenzhen Shao,Zhuoyu Liu et al.
Yangguo Xie et al.
A high-throughput method for domain-specific Fab glycosylation analysis was developed for monoclonal antibodies. Fab glycosylation can affect a product's efficacy and safety. Conventional domain-specific glycan analysis-typically relying on...
Technical note on the impact of particle flocculation on the dissolution and bioavailability of triamcinolone acetonide injectable suspensions [0.03%]
有关颗粒聚结对曲安奈德注射混悬液溶解度及生物利用度影响的技术说明
Maziar Kakhi,William C Smith
Maziar Kakhi
Ensuring drug product quality depends on understanding and controlling the variability of quality attributes that can have a clinically relevant impact. Triamcinolone acetonide (TA2) suspension for injection constitutes a widely-used class ...
Reply to the Comment on "Improved Sub-Visible Particle Classification in Flow Imaging Microscopy via Generative AI-Based Image Synthesis" [0.03%]
关于“基于生成AI的图像合成改进流式成像显微镜下的亚可见粒子分类”的评论回复
Utku Ozbulak,Michaela Cohrs,Hristo L Svilenov et al.
Utku Ozbulak et al.