“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。
随便看	stability factor stability group stability index stability in finite interval stability in finite time stability in large stability in probability stability in the first approximation stability island stability margin stability matrix stability number stability of a computational process stability of a control system stability of a equilibrium stability of a finite difference method stability of a mechanical system in the equilibrium state stability of an algorithm stability of an elastic system stability of a numerical method stability of arch dam abutment stability of a singular point stability of a solution stability of attention stability of boundary layer