技术特点:
【仿制药开发】基于生物药剂学理论,通过"临床PK参数-处方工艺优化"闭环研发路径,构建体外-体内相关性研究评价体系,确保制剂生物等效性与临床疗效一致性。
【改良型新药】基于改良的临床优势与特点,关联应达到的临床PK特点,整合临床药理与生物药剂学技术平台,运用PK-PD建模与仿真技术建立定量研发策略,实现处方工艺优化与临床开发方案的科学决策,充分凸显改良新药的的临床价值。
【创新药开发】聚焦药物作用机制、体内过程与临床药理研究数据,指导科学合理的临床试验设计,建立临床价值导向的开发策略体系,挖掘创新药的临床精准患者人群与优效的临床适应症,提高创新药上市的成功率。
Technical Features
【Generic Drug Development】: Leveraging biopharmaceutics principles, we implement a closed-loop R&D pathway integrating "Clinical PK Parameters - Formulation Process Optimization" to establish in vitro-in vivo correlation (IVIVC) studies. This ensures therapeutic equivalence between bioequivalence and clinical efficacy outcomes.
【Improved New Drugs】: Building on enhanced clinical advantages and target-specific PK profiles, we synergize clinical pharmacology and biopharmaceutics platforms. Through PK-PD modeling & simulation-driven quantitative strategies, we enable science-based optimization of formulations and clinical development plans, maximizing the therapeutic value of reformulated drugs.
【Innovative Drug Development】: Guided by mechanistic insights into drug action, in vivo processes, and clinical pharmacology data, we design value-oriented clinical trial frameworks. Our precision development strategies identify optimized clinical indications and target patient populations, unlocking superior therapeutic potential for novel drugs.
质量与管理 :
Quality Management
成熟的人员培训体系 (A mature personnel training system)
“PDCA”质量持续改进体系 (a PDCA-based quality continuous improvement system)
"方案设计-质量管理-风险控制"为核心的三位一体协同管理体系 (A trinity collaborative management system with the core of "scheme design - quality management - risk control")