Rubén Queiro,Sara Alonso,Jose A Pinto-Tasende
Rubén Queiro
The role of bDMARDs in the prevention and treatment of inflammatory-related comorbidities in Psoriatic Arthritis [0.03%]
生物制剂在银屑病关节炎相关性炎症共病预防及治疗中的作用
Francesco Caso,Mauro Fatica,Mario Ferraioli et al.
Francesco Caso et al.
Introduction: Psoriatic arthritis (PsA) is an immune-inflammatory disease that affects both joints and entheses, and with diverse extra-articular manifestations (psoriasis, inflammatory bowel disease (IBD), and uveitis). ...
Systematic review: effectiveness and safety of switching between originator infliximab and biosimilar infliximab in patients with inflammatory bowel disease [0.03%]
系统评价：在炎症性肠病患者中改变使用原研类克和生物类似药类克的有效性和安全性
Gary R Lichtenstein,Arif Soonasra,Mark Latymer et al.
Gary R Lichtenstein et al.
Introduction: Infliximab (IFX) biosimilars are available to treat inflammatory bowel disease (IBD), offering cost reductions versus originator IFX in some jurisdictions. However, concerns remain regarding the efficacy and...
Infliximab biosimilar GP1111: a review of 5 years' post-approval experience [0.03%]
GP1111英夫利西单抗生物类似药：上市后5年的回顾性研究
Thomas W J Huizinga,Valeria Dipasquale,Markus Zabransky et al.
Thomas W J Huizinga et al.
Introduction: Infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha, and GP1111 (Zessly®, Sandoz) is the most recently approved infliximab biosimilar in Europe. We reviewed the approval process...
Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan [0.03%]
日本类似药研发所需临床试验数据要求的修订
Ryosuke Kuribayashi,Kanoko Goto,Aya Hariu et al.
Ryosuke Kuribayashi et al.
Background: The 'Questions and Answers (Q&A)' document regarding Japanese biosimilar guideline elucidated that Japanese participant enrollment in at least one comparative clinical study was required for the marketing auth...
Industry perspective on regulatory authority (RA) quality reviews of biosimilar applications - an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis [0.03%]
监管机构(RA)对生物类似药申请的质量审查的行业视角——通过深入查询分析评估RA关于化学，生产与控制信息指南和期望
Heather Rae Hufnagel,Scott D Tennyson
Heather Rae Hufnagel
Purpose: Evaluate the type and quantity of quality information (i.e. Chemistry, Manufacturing, and Control) requested by the US FDA and EMA in queries pertaining to biosimilar applications. ...
Long-acting delivery and therapies for neovascular age-related macular degeneration [0.03%]
治疗年龄相关性黄斑变生成长因子的长效输送和疗法
Lucas W Rowe,Thomas A Ciulla
Lucas W Rowe
Introduction: Neovascular age-related macular degeneration (nAMD) represents a leading cause of severe visual impairment in individuals over 50 years of age in developed nations. Intravitreal anti-vascular endothelial gro...
Small molecule-regulated switches to provide functional control of CAR T cells within the patient [0.03%]
用于在患者体内提供CAR-T细胞功能控制的 small分子调节开关
Charlotte U Zajc,Elise Sylvander,Manfred Lehner et al.
Charlotte U Zajc et al.
Introduction: CAR T cells have generated great excitement due to their remarkable clinical response rates in selected hematologic malignancies. However, these engineered immune cells are living drugs which are hard to con...
Marco Battista,Valerio Carelli,Leonardo Bottazzi et al.
Marco Battista et al.
Introduction: Leber hereditary optic neuropathy (LHON) is among the most frequent inherited mitochondrial disease, causing a severe visual impairment, mostly in young-adult males. The causative mtDNA variants (the three c...
Comparison of the efficacy and safety of rapid-acting insulin analogs, lispro versus aspart, in the treatment of diabetes: a systematic review of randomized controlled trials [0.03%]
利普拉和门冬胰岛素治疗糖尿病疗效及安全性的比较：系统综述和meta分析
Rahul Kapur,Shivani Mittra,Geetanjali Tonpe et al.
Rahul Kapur et al.
Introduction: We evaluated a potential move from one rapid-acting insulin analog to another, or their biosimilars, to aid better and faster decisions for diabetes management. ...