“单克隆抗体检定”的概念、定义、翻译、参考文献-科学参考

单克隆抗体检定

Encyclopedia

医学单克隆抗体检定释
quality control of monoclonal antibody单克隆抗体检定
根据制品关键质量属性、对制品和工艺理解认识的积累和风险评估的原则，制定相应质量控制策略并对制品进行检定。制品检定采用的检测方法应经验证并符合要求。纳入质量标准的检定项目和可接受标准限度，应结合来自临床前和（或）临床研究时多批样品的数据、用于证明生产一致性批次的数据及稳定性等研究数据综合确定。

单词	单克隆抗体检定
释义	单克隆抗体检定 Encyclopedia 医学单克隆抗体检定释 quality control of monoclonal antibody单克隆抗体检定根据制品关键质量属性、对制品和工艺理解认识的积累和风险评估的原则，制定相应质量控制策略并对制品进行检定。制品检定采用的检测方法应经验证并符合要求。纳入质量标准的检定项目和可接受标准限度，应结合来自临床前和（或）临床研究时多批样品的数据、用于证明生产一致性批次的数据及稳定性等研究数据综合确定。
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