“单克隆抗体检定”的概念、定义、翻译、参考文献-科学参考

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	quality control of recombinant enzyme drug quality control of recombinant hormone drug quality control of remodeled recombinant human acid α-glucosidase quality control of remodeled recombinant human placental-derived β-glucocerebrosidase quality control of therapeutic biological product quality control of toxoid vaccine quality control (QC) quality control, QC quality control sample quality control software for electrical data acquisition quality control testing method of biotechnology drug quality control testing of gene therapy product quality control testing of gene therapy products using non-viral vector quality control testing of gene therapy product using viral vector quality course quality criterion quality data management quality defect severity quality deterioration quality earnings analysis quality education quality engineering technology quality evaluation quality evaluation of airborne radioactivity survey quality evaluation of forage products

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