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SEND
SEND

SEND毒理学研究数据集

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SEND

什么是SEND？

SEND 是非临床数据交换标准。它是提交临床前单次和重复给药一般毒理学研究所需的标准数据格式和术语，以支持 新药（IND） 申请或向美国食品药品监督管理局 (FDA) 提交新药 (NDA)申请 药物评价 和审查 (CDER)。

  • 方达医药可以为您整理 生物分析 和来自 Provantis® 数据采集系统的 一般毒理学 的SEND 数据集，并使用 Submit™ 软件套件提供报告。每个数据集都经过全面的 QC 审查和 Pinnacle21 验证。
  • 方达医药根据需要为您提供以下文件：
    • SAS 传输文件（XPT 格式）
    • 定义文件（XPT 格式）
    • 非临床研究数据审阅者指南 (nsdrg)
  • 可根据要求提供其他格式（XML 和 XLSX）。

参考资源

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