分析服务

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。 

Our services are designed to help sponsors throughout the drug development process in their effort to fully characterize drug substances, developmental formulations, and commercial drug products. 

• Method development, validation, and transfer 
• 未知杂质鉴定 
• 萃取和渗透试验 
• In Vitro Release Testing (IVRT) and In Vitro Permeation Testing (IVPT) 
• Microbiological Services
• 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 

Get in touch with our analytical services experts for a quote. 

In Vitro Release Testing (IVRT) and In Vitro Permeation Testing (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 
• Our IVRT method development and validation services for topical dosage forms such as ointments, creams, lotions, gels, and liquid include: 
  • 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 

稳定性服务 

Frontage offers a variety of storage conditions for test samples to meet the demands of drug development requirements in different markets throughout the world. We have the expertise and equipment to handle large scale studies and specialized studies alike. 

• Over 10,000 cubic feet of storage
  • 4 walk-in large rooms 8’x20’x8’; 6 walk-in 8’x8’x8’ rooms; 6 reach-in chambers
• Typical ICH storage conditions & WHO (Zone IVb hot/higher humidity)
  • 25°C/60%RH, 30°C/65%RH, 40°C/75%RH, 30°C/75%RH
• Low Humidity for Semi Permeable Containers (Ophthalmic Products)
  • 5°C, 25°C/40%RH, 40°C/25%RH
• Low Temperature for Parenteral & Lyophilized Products
  • -70°C, -20°C, 5°C, 25°C/60%RH 
• ICH compliant temperature-controlled photo-stability chamber
• 24/7 e-monitoring system/Emergency back-up power generator for continuous operations