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单克隆抗体检定
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单克隆抗体检定
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医学
单克隆抗体检定
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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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Fu on Criticizing the Ills of this World
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Fu on Demonstrating My Aspiration
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Fu on Flute
Fu on Han River
Fu on Maidservant
Fu on Ostrich
Fu on Parrots
Fu on Recalling Recluses
Fu on Repentance for Non-Allegiance to the Han Court
Fu on Returning to the Fields
Fu on Sai Chess Game
Fu on the Admonishment of Hunting
Fu on the Eastern Expedition
Fu on the Excursion Hunt of the Son of Heaven
Fu on the Goddess of the Luo River
Fu on the Hall of Great Blessings
Fu on the Location of the Capital
Fu on the Northern Expedition
Fu on Western and Eastern Metropolises
Fu on Wine Vessels
Fuor
FU Orionis object
FU Orionis star
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