考虑到本研究的目的是探索导致APX3330口服吸收高变异的潜在机制,因此选择使用了二房室模型来描述APX3330的分布和清除,k12和k21是在PopPK模型和GastroPlus软件的PKPlus模块计算值的基础上优化获得。比较了模拟的日本健康受试者空腹状态下口...
- Opus Genetics,Inc .(纳斯达克股票代码:IRD)今天宣布与美国美国食品药品监督管理局(FDA)就一项特殊方案评估(SPA)达成协议,该方案用于评估口服APX3330治疗中度至重度非增殖性糖尿病视网膜病变(NPDR)的3期临床试验。 SPA协议反映了拟定的3期试验设计、终点和计划分析将足以支持用于治疗NPDR的新药申请(NDA)的提交,前提...
The purpose was to determine the efficacy of oral administration of APX3330 to reduce lesion size in a laser-induced choroidal neovascularization (L-CNV) mouse model and to develop a physiological-based pharmacokinetic (PBPK) model for retinal delivery of APX3330 to confirm dosing for a Phase ...
“We are pleased to have FDA agreement on the primary endpoint for Phase 3 pivotal trials of APX3330 which we believe is the most advanced oral therapy currently in development for diabetic retinopathy,” said George Magrath, M.D, MBA., M.S., ...
Ocuphire Pharma, Inc. (Nasdaq: OCUP) today announced that a presentation titled, Safety and Efficacy of an Oral Therapeutic APX3330 from ZETA-1 Phase 2 Trial in Patients with Diabetic Retinopathy, was delivered by David Lally, M.D. F.A.S.R.S. at the Clin
TN-S接地方式水电站枢纽布置区域较大,且有可靠的大面积电站接地网,其户外照明场所各有特点。阐述了照明配电系统4种保护接地方式,分析了各种保护接地方式的可靠性及... 薛斌,杨党锋,宋山茂 - 《电网与清洁能源》 被引量: 0发表: 2009年 路灯接地系统浅析 接地系统路灯道路照明道路通行能力触电伤亡事故TN-S系统交...
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The company announced it has scheduled an End-of-Phase 2 meeting with the FDA in Q4 2023 to discuss the specifics of the APX3330 development program. (Image Credit: AdobeStock/Pcess609) Ocuphire Pharma Inc. announced that results from the ZETA-1 Phase 2 trial evaluating APX3...
口服吸收PBPK模型采用GastroPlus 9.8建立,结合APX3330醌和对苯二酚形式的极性表面积(PSA)和氢键供体数(HBD),根据公式logPeff = 4-2.546 - 0.011×PSA - 0.278×HBD,计算了人体有效渗透率(Peff),血浆游离药物分数、pKa使用了实验值,其余理化和生物药剂学参数均使用了ADMET Predictor 10.0的预测值(见表1)。
Purpose : APX3330 is a novel, small molecule inhibitor of Ref-1, a transcriptional regulator of key angiogenic (VEGF) and inflammatory signaling pathways relevant to diabetic retinopathy (DR), diabetic macular edema (DME), and neovascular age-related macular degeneration (AMD). In over 300 ...