Comparative Preclinical Evaluation of Tuznue Versus Referent Herceptin: A Registered Trastuzumab Biosimilar [0.03%]
替扎木单抗与赫赛汀相似性药代动力学和药效学桥接研究的临床前评估研究报告
Herve Bischoff,Neil K O&#x;Connor,Jamie Kim et al.
Herve Bischoff et al.
Introduction: The high cost of trastuzumab (Herceptin®) limits its accessibility for patients worldwide. Biosimilars, such as Tuznue® (HD201), represent a promising alternative to improve access to this essential therap...
Analyses of Adverse Drug Reactions to Fluoroquinolones in Spontaneous Reports Before and After the Referral and in Clinical Routine Cases [0.03%]
氟喹诺酮类药物自发报告系统中的不良反应及临床常规病例中不良反应的事后分析研究
Diana Dubrall,Julia Wicherski,Maike Below et al.
Diana Dubrall et al.
Introduction: In November 2018, the European Medicines Agency (EMA) restricted the use of fluoroquinolones (used by mouth, injections or inhalation) in the context of a referral due to long-lasting and potentially irrever...
A Real-World Data Analysis of Alglucosidase Alfa in the FDA Adverse Event Reporting System (FAERS) Database [0.03%]
α葡萄糖苷酸在FDA不良事件报告系统（FAERS）数据库的现实世界数据分析
Yi Yin,Jie Jiang,Youpeng Jin
Yi Yin
Background and objective: Alglucosidase alfa for injection is used as an enzyme replacement therapy for the treatment of Pompe disease. The safety profile of alglucosidase alfa-associated adverse events requires a compreh...
Characterization for the Similarity Assessment Between the Proposed Biosimilar SB17 and Ustekinumab Reference Product Using State-of-the-Art Analytical Methods [0.03%]
基于最新分析方法的候选药SB17与乌司奴单抗原研药相似性评估研究
Sung-Yong Yang,Changsoo Lee,Keumbi Hwang et al.
Sung-Yong Yang et al.
Background: SB17 is being developed as a biosimilar to ustekinumab reference product (RP), a human monoclonal antibody (IgG1 kappa immunoglobulin) that binds to the common p40 subunit of cytokines interleukin (IL)-23 and ...
Evaluation of BCRP-Related DDIs Between Methotrexate and Cyclosporin A Using Physiologically Based Pharmacokinetic Modelling [0.03%]
基于生理的药代动力学模型评估甲氨蝶呤和环孢素A之间的BCRP相关药物相互作用
Stephan Schaller,Ingrid Michon,Vanessa Baier et al.
Stephan Schaller et al.
Background and objective: This study provides a physiologically based pharmacokinetic (PBPK) model-based analysis of the potential drug-drug interaction (DDI) between cyclosporin A (CsA), a breast cancer resistance protei...
Correction: Damoctocog Alfa Pegol, a PEGylated B-domain Deleted Recombinant Extended Half-life Factor VIII for the Treatment of Hemophilia A: A Product Review [0.03%]
关于巴氯珠杆菌吸附血栓莫唑的纠正：一种重组延长半衰期的八因子A（用于治疗甲型血友病）产品分析报告
Mark T Reding,Shadan Lalezari,Gili Kenet et al.
Mark T Reding et al.
Published Erratum
Drugs in R&D. 2024 Dec 20. DOI:10.1007/s40268-024-00494-2 2024
Population Pharmacokinetic and Pharmacokinetic/Pharmacodynamic Analyses of Pegcetacoplan in Patients with Paroxysmal Nocturnal Hemoglobinuria [0.03%]
用于阵发性睡眠性血红蛋白尿症患者的Pegcetacoplan的人群药代动力学和药代动力学/药效学分析
Ryan L Crass,Brandon Smith,Sven Adriaens et al.
Ryan L Crass et al.
Background and objective: Paroxysmal nocturnal hemoglobinuria is a rare blood disorder characterized by life-threatening hemolysis and thrombosis. Complement C5 inhibitor therapy improves symptoms and life prognosis; howe...
In-Use Physicochemical Stability of Sandoz Rituximab Biosimilar in 0.9% Sodium Chloride Solution After Prolonged Storage at Room Temperature Conditions [0.03%]
室温下生理盐水中Sandoz利妥昔单抗生物类似药延长储存后的在用理化稳定性研究
Roman Borišek,André Mischo,Tobias Foierl
Roman Borišek
Background and objective: Often, stability studies do not cover all facets of ensuring patient safety for biologics, unless the impact of the in-use and out-of-fridge conditions is also assessed. This study investigated t...
Pharmacokinetics and Pharmacodynamics of Rusfertide, a Hepcidin Mimetic, Following Subcutaneous Administration of a Lyophilized Powder Formulation in Healthy Volunteers [0.03%]
一种模仿肝肽素的药物Rusfertide的小分子药物鲁菲替丁的冻干粉制剂皮下给药在健康受试者中的药代动力学和药效学研究
Nishit B Modi,Sarita Khanna,Sneha Rudraraju et al.
Nishit B Modi et al.
Background and objective: Hepcidin, an endogenous peptide hormone, binds to ferroportin and is the master regulator of iron trafficking. Rusfertide, a synthetic peptide, is a potent hepcidin mimetic. Clinical studies sugg...
Randomized Controlled Trial
Drugs in R&D. 2024 Dec;24(4):539-552. DOI:10.1007/s40268-024-00497-z 2024
Bioequivalence Analysis of Ondansetron Hydrochloride Tablets in Healthy Chinese Subjects: A Randomized, Open-Label, Two-Period Crossover Phase I Study [0.03%]
盐酸昂丹司琼片在中国健康受试者中的生物等效性研究：一项随机、开放、两周期交叉I期试验
Caiyun Jia,Na Zhao,Haojing Song et al.
Caiyun Jia et al.
Background: Ondansetron is a highly selective 5-HT3 receptor antagonist that alleviates nausea and vomiting. Bioequivalence evaluation ensures that the efficacy of generic drugs is consistent with that of the original dru...
Clinical Trial
Drugs in R&D. 2024 Dec;24(4):531-538. DOI:10.1007/s40268-024-00493-3 2024