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生物技术药质量标准
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生物技术药质量标准
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生物技术药检定
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quality specification of biotechnology drug
生物技术药质量标准
把反映生物技术药的安全、有效质量属性的技术参数、指标、限度、范围等明确规定下来,形成技术文件,确定生物技术药理化性质、含量、生物学活性、纯度、杂质和安全性等质量属性和检定方法,保证生物技术药质量的规定。
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