安全药理学

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安全药理学

安全药理学

安全药理学是大多数小分子开发项目的基本要素，并与一般毒理学一同提交IND申请。在方达医药，我们为 GLP 安全药理学试验和早期Non- GLP探索药理学试验提供综合服务，从研发到 IND 申报，都遵循国际规范ICH（S7A,S7B）来进行。无论何种药物类型、适应症或采用何种治疗途径，方达医药都能满足您的安全药理学服务需求。

我们为您的非临床项目提供体外和体内心血管系统(CV) 研究以及中枢神经 (CNS) 和呼吸系统评价的一系列核心研究。

中枢神经系统安全性评价

在方达医药，我们可以单独或作为一般毒理学和安全药理学实验方面拥有丰富经验。的组合试验对中枢神经系统（CNS）进行安全性评价。

体内中枢神经系统（CNS）研究（Irwin试验，功能观察组合FOB）

自发活动
行为改变
协调功能
感觉运动反射
体温变化

心血管系统安全性评价

在方达医药，我们提供体外和体内心血管安全性评价服务。

体外心血管系统研究

标准 hERG 离子通道研究
符合 CiPA 标准的研究方法
追加的Cav1.2和Nav1.5离子通道评估也可开展

体内心血管系统研究

通过植入遥测评估心血管效应
- 血压
收缩压、舒张压、平均压
- 心率
- 兽医、兽医专家
  对心电图数据进行定性评估
- 心电图定量评估
PR 间期、QRS 波、QT 间期和心率校正 QT间期
- (QTcV) 间期
- 内部温度

呼吸系统安全性评价

我们的呼吸系统安全性研究包括全身体积描记法。

潮气量
呼吸深度
呼吸频率

方达医药提供全套药物安全性评价服务，为新药的开发到上市提供支持。

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