“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	A Vulture Hunting the Swan avuncalate avunculate AVV Avvakum Petrov AWACS Awaiting Husband Cloud, legend from the Bai People Awaiting the Ferry at the Foot of the Mountains in Summer Awake and Sing! Awakening from Hibernation Awakening Marriage Story awakening period of general anesthesia A. Wald A. Wald (1902—1950) Awami National Party Award for National Disciples of Francisco Balagtas awards in graded examination in dance Award Winning Essays of The 1ST-3RD Music Society for Chinese Ethnic Minorities Competitions A Warming Earth Awash National Park Awash West Wildlife Reserve A Wasp A Waterside Studio at Dusk, by Tang Yin Awat Xian Away from Her