biosimilar相关论文
Equivalent efficacy assessment of QL1101 and bevacizumab in nonsquamous non-small cell lung cancer p
Objective:Anti-vascular endothelial growth factor(VEGF)monoclonal antibodies are an effective means of treating non-smal......
Phase 1 studies comparing safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01(a rit
Objective: This study aimed to compare the pharmacokinetic, pharmacodynamic and safety profiles of HLX01(a rituximab bio......
Equivalent efficacy study of QL1101 and bevacizumab on untreated advanced non-squamous non-small cel
Objective:This phase 3 study aimed to test equivalence in efficacy and safety for QL1101,a bevacizumab analogue in Chine......
生物类似药是指在质量、安全性和有效性方面与已获准注册的参照药具有相似性的治疗用生物制品。要做到生物类似药与参照药具有可互......
Phase 1 studies comparing safety,tolerability,pharmacokinetics and pharmacodynamics of HLX01(a ritux
Objective:This study aimed to compare the pharmacokinetic,pharmacodynamic and safety profiles of HLX01(a rituximab biosi......
通过检索依那西普及其生物类似物的临床药动学研究文献,对其药动学研究进展进行综述.结果显示,依那西普及其生物类似物具有相似的......
目的：比较IBI305和安维汀的临床前安全性。方法：将50只食蟹猴随机分为溶媒对照组、IBI305低剂量组、中剂量组、高剂量组和安维汀组,......
目的:对食蟹猴重复给予重组人-鼠嵌合抗CD20单克隆抗体IBI301,考察与参照药的非临床安全性相似性,并为临床设计人用剂量及临床毒副......
Loss of efficacy and safety of the switch from infliximab original to infliximab biosimilar(CT-P13)i
BACKGROUND Infliximab original has changed the natural history of inflammatory bowel diseases(IBD) over the past two dec......
Biologic compounds are obtained from living organisms or cell cultures by means of biotechnology methods.A similar biolo......
Challenges of modern day transition care in inflammatory bowel disease: From inflammatory bowel dise
In this article we discuss the challenges of delivering a high quality Transition care. A good understanding of the adol......
本文将战略性新兴生物医药产业——生物类似物作为研究对象，在Web of Science的SCI数据库中以2004-2013年全球范围内该领域的研究论......
利妥昔是当前主要的单抗靶向治疗药物,伴随着越来越多的相关生物类似药临床评价需求,对于开发快速有效的定量方法来分析生物基质中......
建立了基于1H NMR指纹技术的生物类似药高级结构相似性分析方法，利用相关系数r和决定系数R2定量评估生物类似药与其原研药的结构相......
在鼓励生物类似药的发展中,适应证外推是一个关键概念。生物类似药审批过程严格,但生物类似药的接受程度仍然很低。欧盟是生物类似......
Immunogenicity, Safety and Efficacy Comparison of Wockhardt’s Biosimilar Insulin Glargine—Glaritus&a
Objective: Present Phase IV Trial is aimed at evaluating the immunogenicity, safety, and efficacy of Wockhardt’s insuli......
Cancer is a major public health issue worldwide, especially in the developing world where 70% of the cancer-related deat......
The cost to U.S.consumers of specialty drugs is too high,and cost-sharing obligations are reducing patient access to aff......
"生物类似药"(biosimilar)这一术语指的是生物制品的后续产品,与原研药之间有极高的相似性或可比性,通常生物类似药被批准用于与原......
期刊
<正>世界卫生组织(WHO)发布的生物类似药指导原则(科学指南)解读生物技术制品(生物药)是指采用现代生物技术(重组DNA)工艺,借助微......
期刊
