Clinical drug development in thromboembolic diseases: regulatory and methodological approach [0.03%]
血栓性疾病药物临床开发的监管和方法学路径研究
Gonzalo Calvo-Rojas,Antonio Gómez-Outes
Gonzalo Calvo-Rojas
Coinciding in time with the expiration of the patent of enoxaparin and clopidogrel, a number of new antithrombotics (anticoagulants and antiplatelets with new mechanisms of action) have been developed or are still under development for both...
New oral anticoagulants for venous thromboembolism: focus on factor Xa and thrombin inhibitors [0.03%]
新型口服抗凝药物在静脉血栓栓塞治疗中的应用:focus于因子Xa和凝血酶抑制剂
Cecilia Becattini,Alessandra Lignani,Giancarlo Agnelli
Cecilia Becattini
Several oral direct anti-Xa agents and one antithrombin agent are currently under clinical development for the prevention and treatment of venous thromboembolism (VTE). The anti-Xa inhibitors rivaroxaban (10 mg once daily) and apixaban (2.5...
New parenteral anticoagulants: focus on factor Xa and thrombin inhibitors [0.03%]
新型抗凝药物的临床应用——以FXa和凝血酶抑制剂为重点
Ingo Ahrens,Christoph Bode
Ingo Ahrens
For decades, unfractionated heparin (UFH) was the most widely used parenteral anticoagulant in a variety of clinical scenarios requiring rapid and reversible anticoagulation. The shortcomings of UFH include a high inter-individual variabili...
Regulatory considerations for generic or biosimilar low molecular weight heparins [0.03%]
仿制低分子肝素的监管考量因素分析
Alfredo García-Arieta,Antonio Blázquez
Alfredo García-Arieta
The aim of the present paper is to address the legal aspects, technical requirements and possible conditions of use associated to low molecular weight heparin generics and biosimilars that are arriving to the market in United States and the...
Jack Ansell,David Askin
Jack Ansell
Unfractionated heparin (UFH) and the vitamin K antagonists (VKA), have been standard anticoagulants for the last 70 years. They have a widespread effect on many coagulation factors, the serine proteases for UFH and the vitamin K dependent f...
Supporting the design of efficient dendritic DNA and siRNA nano-carriers with molecular modeling [0.03%]
基于分子模拟的高效树状DNA和siRNA纳米载体的设计与优化
Giovanni M Pavan,Andrea Danani
Giovanni M Pavan
The design of macromolecules able to generate a stable binding with nucleic acids is of great interest for their possible application in gene delivery. During the last years particular attention has been addressed to the use of dendritic sc...
Crosslinked, polymerized, and PEG-conjugated hemoglobin-based oxygen carriers: clinical safety and efficacy of recent and current products [0.03%]
交联、聚合和聚乙二醇接枝的血红蛋白氧载体：近期及当前产品的临床安全性和有效性
Jonathan S Jahr,Arezou Sadighi Akha,Randall J Holtby
Jonathan S Jahr
Blood substitutes, especially hemoglobin based oxygen carriers (HBOC) have been widely studied and reviewed over the past 30 years. The development of HBOCs was highlighted by crosslinking to minimize adverse effects. However, even early at...
Physicochemical properties of pDNA/chitosan complexes as gene delivery systems [0.03%]
基于壳聚糖的pDNA/壳聚糖复合物作为基因传递系统的理化性质研究
Kenji Hagiwara,Riany Anastasia,Mitsuhiro Nakata et al.
Kenji Hagiwara et al.
Successful gene therapy depends on the development of effective gene carriers. Naturally occurring chitosan has been employed widely as a non-viral gene carrier because of its low toxicity, low immunogenicity, biocompatibility, and biodegra...
Yan Sun
Yan Sun
Lipoplexes, the complexes of plasmid DNA with cationic lipids, are considered as an attractive alternative to viral delivery systems. However, synthesized lipoplexes showed several limitations including insufficient transfection, low reprod...
Igor Meerovich,Alexander Koshkaryev,Vladimir P Torchilin
Igor Meerovich
The effectiveness of many promising drug candidates (e.g. anticancer agents) awaits the development of drug forms capable of delivery of their drug load specifically to particular sites of an organism or a cell. To make universal and effici...