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关于国家药品评价性抽验风险指数计算的思考与建议

Thoughts and Suggestions on Calculation of Risk Index in State Sampling Analysis for Quality Evaluation
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摘要 通过对国家药品评价性抽验风险指数计算模板的应用,发现存在"含量均匀度"、"重(装)量差异"项目的计算不完全适用等问题,针对这些问题进行了思考并提出合理化建议,建议相关部门进一步完善该计算模板,使其更好地应用于国家药品评价性抽验工作。 In application of the calculation template of risk index in state sampling analysis for quality evaluation,some problems have been identified.For example,we found that it was not very suitable for the calculation of content uniformity and weight variation.By considering these problems,some reasonable suggestions were provided.Related departments were suggested to further perfect the calculation template and to make it more suitable for the state sampling analysis for quality evaluation.
出处 《中国药物警戒》 2013年第5期276-277,共2页 Chinese Journal of Pharmacovigilance
关键词 国家药品评价性抽验 风险指数 风险评估 state sampling analysis for quality evaluation risk index risk assessment
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