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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
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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nondeterministic machine
non-deterministic optimization
nondeterministic polynomial
nondeterministic polynomial time class NP
non-deterministic polynomial time complexity class
non-deterministic polynomial time complexity class, NP
non-deterministic space
non-deterministic space complexity
non-deterministic space complexity theorem
non-deterministic space, NSPACE
non-deterministic time
non-deterministic time complexity
non-deterministic time hierarchy theorem
non-deterministic time, NTIME
non deterministic Turing machine
non-deterministic Turing machine
nondeterministic Turing machine
non-developable
non-developable ruled surface
non-developable surface
non-diagonal
non-diagonal element
non-diagonal term
non-diamagnetic plasma
non-differentiability
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