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
Pharmacokinetics and Bioequivalence of Two Powders of Azithromycin for Suspension: A Nonblinded, Single-Dose, Randomized, Three-Way Crossover Study in Fed and Fasting States Among Healthy Chinese Volunteers [0.03%]
两种阿奇霉素颗粒剂型在-fed和空腹健康受试者中的药代动力学及生物等效性非盲法、随机、三周期交叉试验
Junbo Shao,Xingxing Liu,Jing Lin et al.
Junbo Shao et al.
Background and objectives: Azithromycin, a macrolide antibiotic, is commonly used to treat mild-to-moderate bacterial infections. This research aimed to evaluate the pharmacokinetics (PK) properties and bioequivalence (BE...
Randomized Controlled Trial
Drugs in R&D. 2024 Dec;24(4):517-529. DOI:10.1007/s40268-024-00492-4 2024
Pharmacokinetics, Pharmacodynamics, and Safety of Intravenous Efgartigimod and Subcutaneous Efgartigimod PH20 in Healthy Chinese Participants [0.03%]
健康中国受试者中艾加替莫德注射液和艾加替莫德PH20皮下注射的药代动力学、药效学及安全性研究
Shan Jing,Yu Zhang,Yang Lin et al.
Shan Jing et al.
Background: Efgartigimod, a human immunoglobulin G (IgG)1-derived Fc fragment targeting the neonatal Fc receptor, has been developed into intravenous (IV) and subcutaneous (SC) formulations for treating generalized myasth...
Clinical Trial
Drugs in R&D. 2024 Dec;24(4):505-515. DOI:10.1007/s40268-024-00490-6 2024
Trametinib Sensitivity is Defined by a Myeloid Differentiation Profile in Acute Myeloid Leukemia [0.03%]
急性髓系白血病中 trametinib 敏感性由髓系分化谱型决定
Mathieu Quesnel-Vallières,David C Schultz,Alena Orlenko et al.
Mathieu Quesnel-Vallières et al.
Background and objective: Acute myelogenous leukemia (AML) is a common blood cancer marked by heterogeneity in disease and diverse genetic abnormalities. Additional therapies are needed as the 5-year survival remains belo...