首页> 外文OA文献 >Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE®-PK) in healthy subjects

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Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE®-PK) in healthy subjects

机译：与在健康受试者的随机检测，双盲，活性比较剂阶段I临床研究（Voltaire®-PK）中的参考生物学相比，Bi 695501的生物等级，安全性和免疫原性。

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Christopher Wynne; Mario Altendorfer; Ivo Sonderegger; Lien Gheyle; Rod Ellis-Pegler; Susanne Buschke; Benjamin Lang; Deepak Assudani; Sandeep Athalye; Niklas Czeloth;
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1. Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE (R)-PK) in healthy subjects [J] . Wynne Christopher, Altendorfer Mario, Sonderegger Ivo, Expert opinion on investigational drugs . 2016,第12期

机译：在健康受试者的一项随机，双盲，活性比较剂I期临床研究（VOLTAIRE（R）-PK）中，阿达木单抗生物仿制药BI 695501与参考生物制剂相比，其生物等效性，安全性和免疫原性
2. Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomised VOLTAIRE-RA equivalence study [J] . Cohen Stanley B., Alonso-Ruiz Alberto, Klimiuk Piotr A., Annals of the Rheumatic Diseases: A Journal of Clinical Rheumatology and Connective Tissue Research . 2018,第6期

机译：Adalimalab BioSimilar Bi 695501和Humira参考产物的类似疗效，安全性和免疫原性在患者中适度到严重活性的类风湿性关节炎：III期随机伏尔雷对等效研究的结果
3. Long-term safety, efficacy, and immunogenicity of adalimumab biosimilar Bl 695501 and adalimumab reference product in patients with moderately-to-severely active rheumatoid arthritis: results from a phase 3b extension study (VOLTAIRE-RAext) [J] . Stanley B. Cohen, Niklas Czeloth, Eric Lee, Expert opinion on biological therapy . 2019,第7a12期

机译：具有中度至严重活性的类风湿性关节炎的患者Adalimalab BioSimilar BL 695501和Adalimalab参考产物的长期安全性，疗效和免疫原性：来自第3B期扩展研究的结果（Voltaire-Reext）
4. A double-blind, randomized phase II trial of thesafety and immunogenicity of 26-valent group A streptococcus vaccine in healthy adults [C] . Shelly A. McNeil, Scott A. Halperin, Joanne M. Langley, Lancefield International Symposium on Streptococci and Streptococcal Diseases . 2006

机译：一种双盲，随机期II试验，对健康成人的26岁的26岁群体的疫苗疫苗
5. Concise report: Similar efficacy safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomised VOLTAIRE-RA equivalence study [O] . Stanley B Cohen, Alberto Alonso-Ruiz, Piotr A Klimiuk, -1

机译：简明报告：阿达木单抗BI 695501和Humira参考产品在中度至重度活动性类风湿关节炎患者中的相似功效安全性和免疫原性：来自VOLTAIRE-RA III期随机对照研究的结果
6. FRI0189 Similar efficacy and safety of biosimilar candidate BI 695501 and adalimumab originator reference product in patients with moderate to severe active rheumatoid arthritis: 24 week results from a phase III clinical study (voltaire®-ra) [O] . S Cohen, A Alonso-Ruiz, PA Klimiuk, 2017

机译：Fri0189生物仿生候选BI 695501和Adalimalab发起者参考产物中度至严重的活性类风湿性关节炎患者的类似疗效和安全性：III期临床研究的24周结果（Voltaire®-ra）
7. Randomized Double-Blind Phase III Pivotal Field Trial of the Comparative Immunogenicity Safety and Tolerability of Two Yellow Fever 17D Vaccines (ARILVAX(Trademark) and YF-VAX(Trademark)) in Healthy Infants and Children in Peru [R] . Belmusto-Worn, V. E. , Sanchez, J. L. , McCarthy, K. , 2004

机译：秘鲁健康婴儿和儿童两种黄热病17D疫苗（aRILVaX（商标）和YF-VaX（商标））的比较免疫原性安全性和耐受性的随机双盲III期关键现场试验

Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE®-PK) in healthy subjects

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