Closed System Transfer Devices (CSTDs): Understanding Potential Over- and Under- Dosing of Liquid Vial Drug Products and How to Generally Mitigate [0.03%]
关于封闭系统转移设备(CSTD)的认识：液体制剂药物产品潜在的过量和不足以及一般缓解措施
Christian Lehermayr,Bernhard Schmelzer,Maximilian Kropf
Christian Lehermayr
Closed system transfer devices (CSTDs) are a major challenge for drug manufacturers to assess and assure drug compatibility and acceptable dosing accuracy for a range of clinical administration strategies. In this article, we systematically...
Drug Permeability - Best Practices for Biopharmaceutics Classification System (BCS)-Based Biowaivers: A workshop Summary Report [0.03%]
基于生物药剂学分类系统（BCS）的仿制药豁免的最佳实践-研讨会总结报告
M Mehta,J E Polli,P Seo et al.
M Mehta et al.
The workshop "Drug Permeability - Best Practices for Biopharmaceutics Classification System (BCS) Based Biowaivers" was held virtually on December 6, 2021, organized by the University of Maryland Center of Excellence in Regulatory Science a...
Pharmaceutical Scientists' Perspectives on Capacity Building in Pharmaceutical Sciences [0.03%]
药学科学家谈药学科学能力建设
Z Kusynová,H A van den Ham,H G M Leufkens et al.
Z Kusynová et al.
With the anticipated health challenges brought by demographic and technological changes, ensuring capacity in underlying workforce in place is essential for addressing patients' needs. Therefore, a timely identification of important drivers...
Advances in the Specificity of Mass Spectrometry and Nuclear Magnetic Resonance Spectroscopy Based Structural Characterisation Methods for Synthetic Oligonucleotides [0.03%]
基于质谱和核磁共振光谱结构表征法的合成寡核苷酸特异性的研究进展
David M Dias,Steven R Coombes,David Benstead et al.
David M Dias et al.
Identity testing is a critical part in the development of a therapeutic synthetic oligonucleotide. Tandem Mass Spectrometry (MS/MS) is commonly used for the analysis of oligonucleotides to obtain structural and sequence information, however...
Formation of Hemihydrate Crystal form Overcomes Milling Issue Induced by Exposed Functional Groups on Cleavage Plane for a Y5 Receptor Antagonist of Neuropeptide Y [0.03%]
半水合物晶型的形成克服了神经肽Y受体五型拮抗剂解离面官能团引起的研磨问题
Daiki Nagamatsu,Shigeru Ando,Yuko Fujimura et al.
Daiki Nagamatsu et al.
This study aimed to investigate the crystal forms of an originally designed Y5 receptor antagonist of neuropeptide Y. Polymorphic screening was performed via solvent evaporation and slurry conversion using various solvents. The obtained cry...
Hadi M Fares,Miriam Carnovale,Megane O N Tabouguia et al.
Hadi M Fares et al.
Downstream processing of antibodies consists of a series of steps aimed at purifying the product and ensuring it is delivered to formulators structurally and functionally intact. The process can be complex and time-consuming, involving mult...
A Novel Molecular Reservoir Based on Reverse Self-Assembled Liquid Crystals - A New Strategy for Prolonging the Duration in Action of Analgesics [0.03%]
基于反向自组装液晶的新型分子缓释体系——一种新的长效镇痛药物策略
Wenxuan Cao,Jingbao Chen,Long Wu et al.
Wenxuan Cao et al.
Purpose: The aim of this study was to develop liquid crystal (LC) precursors to obtain novel long-acting analgesics for injection based on depot systems and compare the difference between the cubic and hexagonal precursor...
Temperature and pH-responsive PNIPAM@PAA Nanospheres with a Core-Shell Structure for Controlled Release of Doxorubicin in Breast Cancer Treatment [0.03%]
温控和pH响应性的PNIPAM@PAA核壳结构纳米球在乳腺癌治疗中控制阿霉素释放的作用
Vahab Ghalehkhondabi,Alireza Fazlali,Meysam Soleymani
Vahab Ghalehkhondabi
Stimuli-responsive polymers have been of great interest in the fabrication of advanced drug delivery systems. In this study, a facile approach was developed to synthesize a dually temperature/pH-responsive drug delivery system with a core-s...
Biodegradable Microneedles Array with Dual-Release Behavior and Parameter Optimization by Finite Element Analysis [0.03%]
具有双重释放行为的可降解微针阵列及有限元分析参数优化
Shuai Xu,Wenyuan Liu,Mingwei Peng et al.
Shuai Xu et al.
Microneedles (MNs) are particularly attractive for transdermal administration because of the improved safety, patient compliance and convenience. Dissolving MNs could provide rapid transdermal delivery, but with relatively low mechanical st...
Pharmacokinetics of Monoclonal Antibody and Antibody Fragments in The Mouse Eye Following Intravitreal Administration [0.03%]
玻璃体内给药小鼠眼中单克隆抗体及抗体片段的药代动力学研究
David Bussing,Yingyi Li,Leiming Guo et al.
David Bussing et al.
Mice are rarely used in pharmacokinetic (PK) studies of ocular therapeutics due to the small size of their eyes and challenges in drug administration, tissue collection, and analysis of drug concentrations. Therefore, ocular PK of protein t...