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分析化学
分析化学

产品开发的方法开发、验证和转移

分析化学

CMC GMP 1 300x200 - 分析化学我们专注于为制剂开发和临床试验用药(CTM)生产支持提供分析服务和方法开发、 验证和转移, 以及产品商业化和稳定性测试。

我们致力于帮助申办方在整个药物开发过程中充分鉴定原料药、进行制剂工艺开发和产品商业化。

  • 方法开发、验证和转移
  • 未知杂质鉴定
  • 萃取和渗透试验
  • GMP条件下原料药和制剂的检测放行
  • GMP商业产品稳定性测试和储存
  • GLP 给药样品分析
  • 检测管制类药物(Schedule I-V)的DEA证书

体外溶出试验(IVRT)及体外渗透试验(IVPT)

方达为外用产品提供全面的 IVRT 和 IVPT 测试服务,并可以提供临床前处方评估到早期人体试验服务。

可以帮助您进行各种体外试验:

  • 开发和选择最佳配方
  • 评估渗透增强剂/调节剂对经皮吸收的影响
  • 开发和验证新型的分析检测和样品处理方法,以优化灵敏度及选择性
  • 用于FDA SUPAC-SS申报的体外溶出试验(IVRT)分析方法的开发、验证和实施
  • 提供GLP试验和分析方法验证的合规服务
  • 针对包括膏剂、霜剂、乳液剂、凝胶剂和液体剂等外用剂型的体外溶出试验方法开发和验证:
    • 仿制药和原研药的对比研究
    • 处方变更前后对比研究
    • 质量控制/批检测放行、批间差异性研究
    • 处方优化
    • 分析方法开发和验证

cGMP条件下的生物制剂分析检测

生物制剂或生物药在本质上比小分子药物复杂,您需要适合的团队支持产品开发。针对复杂生物制剂,方达医药具备专业技术,拥有必需的先进仪器设备,以确保方法的开发、验证及转移。

  • 检测放行
  • 稳定性研究
  • 标准品标定
  • 结构鉴定
  • 可比性和相似性研究
  • 强降解研究
  • 制剂开发服务
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